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Found 33 Presentations For Request "joan carles"
639P - 223Ra in asymptomatic patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who progressed to first-line abiraterone acetate or enzalutamide
- Joan Carles (Barcelona, Spain)
Abstract
Background
223Ra is indicated for mCRPC pts with symptomatic bone metastases, while limited data exist on its impact as monotherapy in asymptomatic pts. Androgen Receptor splice Variant 7 (AR-V7) is a negative prognostic/predictive marker for response to new hormonal treatments but its correlation with 223Ra is lacking. Study aim was to assess the activity and safety of 223Ra in mCRPC pts and the association of AR-V7 status with 223Ra efficacy.
Methods
This single-arm, phase 2 trial enrolled asymptomatic mCRPC pts with bone metastases and no visceral involvement. Pts who have progressed to ≥24 weeks (w) of 1st line abiraterone acetate or enzalutamide received 223Ra (55 kBq/kg) every 4w for 6 cycles. Primary endpoint was radiographic progression-free survival (rPFS) as per PCWG2 criteria. Secondary endpoints included rPFS according to circulating tumor cell AR-V7 status, overall survival (OS), time to first symptomatic skeletal event (SSE), time to prostate-specific antigen (PSA) progression, PSA response (≥30% at 12w), and safety.
Results
Between 12/2016 and 11/2018, 52 pts were enrolled from 9 sites in Spain. Median (m) age was 76 years (range 51–89) and mPSA 20.3 μg/L (0.04–703.3). Bone lesions were <6, 6–20, >20 in 28.8%, 69.2%, and 1.9% of pts, respectively. 94.2% of pts had ≥2 prior any hormone therapies and 7.7% had received docetaxel in the hormonosensitive setting. 9.6% pts were AR-V7+. Median duration of treatment and follow-up were 5.5 and 6.6 months (mo), respectively. Study met primary endpoint with mrPFS of 5.4 mo (95% CI 4–5.5). Results were inconclusive for AR-V7 analysis (p=0.118). OS data were immature (14 deaths, 26.9%). SSE events were reported in 9.6% of pts. Median time to PSA progression was 3.6 mo. PSA responders were 15.4%. 65.4% of pts received 5/6 treatment cycles. Grade (G)3/4 adverse events (AEs) were reported in 25% of pts. Most frequent G3/4 AEs were anemia (11.5%) and thrombocytopenia (5.8%). 3.8% of pts discontinued 223Ra due to AEs. No therapy-related deaths occurred.
Conclusions
223Ra is active and safe for 2nd line treatment in asymptomatic mCRPC pts with bone metastases who have progressed to 1st line new hormonal regimens.
Clinical trial identification
NCT03002220.
Legal entity responsible for the study
MedSIR.
Funding
Bayer.
Disclosure
J. Carles: Advisory/Consultancy: Bayer, Johnson & Johnson, Bristol-Myers Squibb, Astellas Pharma, Pfizer, Sanofi, MSD Oncology, Roche, AstraZeneca; Speaker Bureau/Expert testimony: Bayer, Johnson & Johnson, Asofarma, Astellas Pharma; Travel/Accommodation/Expenses: BMS, Ipsen, Roche, AstraZeneca; Research grant/Funding (institution): AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, INC, Astellas Pharma., AstraZeneca AB, Aveo Pharmaceuticals INC, Bayer AG, Blueprint Medicines Corporation, BN Immunotherapeutics INC, Boehringer Ingelheim España, S.A., Bristol-Myers Squibb Intern. M.J. Mendez Vidal: Honoraria (self): Astellas Pharma, Roche, BMS, Ipsen; Advisory/Consultancy: Janssen-Cilag, Pfizer, Astellas Pharma, Sanofi, Bayer, BMS, Novartis, Roche, Ipsen, EUSA Pharma; Travel/Accommodation/Expenses: Janssen-Cilag, Pfizer, Astellas Pharma, BMS, Roche. S. Vazquez Estevez: Advisory/Consultancy: Pfizer, Astellas, Janssen, MSD, Bayer, Roche, BMS, Boehringer, AstraZeneca, Ipsen, Novartis, Eusa Pharma, Eisa and Sanofi; Speaker Bureau/Expert testimony: Lilly, Astellas, Bayer, Roche, Boehringer, Ipsen, Novartis, AstraZeneca and Sanofi; Travel/Accommodation/Expenses: Pfizer, Roche and AstraZeneca. A. González del Alba: Honoraria (self): Sanofi/Aventis, Roche, Pfizer, Astellas Pharma, Janssen-Cilag, Novartis, Ipsen; Advisory/Consultancy: Astellas Pharma, Sanofi, Bayer, Janssen Oncology, Pfizer, Bristol-Myers Squib,b Eisai, Pierre Fabre, EUSA Pharma, Roche, Novartis, Ipsen, AstraZeneca; Speaker Bureau/Expert testimony: Ipsen, Roche, Pfizer, Pierre Fabre, Janssen-Cilag; Travel/Accommodation/Expenses: Astellas Pharma, Pfizer, Janssen Oncology, Sanofi, Bristol-Myers Squibb, MSD Oncology, Roche, Ipsen. J.M. Piulats: Advisory/Consultancy: Roche, Novartis, Jansen, Astellas, Bayer, Sanofy-Genzyme, MSD, BMS, Merk-Serono, Clovis, AstraZeneca, Beigene, VCN biotech; Research grant/Funding (self): Roche, Jansen, Astellas, MSD, BMS, Merk-Serono, AstraZeneca, Beigene, VCN biotech.; Travel/Accommodation/Expenses: Roche, Astellas, Jansen. P. Borrega García: Advisory/Consultancy: Sanofi, Roche; Advisory/Consultancy: BAYER; Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: Ipsen. E. Gallardo: Advisory/Consultancy: Sanofi, Janssen, Astellas, Pfizer, Bayer, Roche, Ipsen, Novartis, Eisai, EUSA Pharma, BMS, AstraZeneca, Merck, Rovi, Daiichi Sankyo, Techdow; Speaker Bureau/Expert testimony: Astellas, Janssen, Sanofi, Bayer, Ipsen, Pfizer, Roche, BMS, Novartis, Rovi, Daiichi Sankyo, Leo Pharma, Menarini, Eisai, MSD, Boehringer Ingelheim, Merck; Research grant/Funding (institution): Astellas, Janssen, Sanofi, Pfizer, Bayer, Ipsen, Roche, Ferrer, GSK, BMS; Travel/Accommodation/Expenses: Astellas, Janssen, Sanofi, Bayer, Ipsen, Roche, Novartis, Pierre Fabre, Pfizer, Eisai. R. Morales Barrera: Advisory/Consultancy: Sanofi Aventis, Bayer, Janssen, AstraZeneca, Merck Sharp & Dohme, Asofarma.; Travel/Accommodation/Expenses: Roche, Sanofi Aventis, Astellas, Janssen, Merck Sharp & Dohme, Bayer, Pharmacyclics, Clovis Oncology and Lilly. O. Reig: Speaker Bureau/Expert testimony: BMS, Ipsen, Pfizer; Travel/Accommodation/Expenses: Ipsen, Pfizer. C. Garcías de España: Advisory/Consultancy: Bayer, Janssen. C. Suarez: Honoraria (self): Astellas, AstraZeneca, Bayer, BMS, Eusa, Ipsen, Novartis, Pfizer, Sanofi-Aventis, Roche, Merck Sharp & Dohme Corp; Honoraria (institution): AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, INC, Astellas Pharma, AstraZeneca AB, Aveo Pharmaceuticals INC, Bayer AG, Blueprint Medicines Corporation, BN Immunotherapeutics INC, Boehringer Ingelheim España, S.A., Bristol-Myers Squibb Intern; Non-remunerated activity/ies: Steering Committee Roche, Steering Committee BMS. All other authors have declared no conflicts of interest.
695TiP - ORACULUM: A retrospective observational epidemiological study using artificial intelligence and natural language processing in electronic health records to characterize the prostate cancer pathway, management and outcomes in Europe, Middle East and Africa (EMEA region)
- Joan Carles (Barcelona, Spain)
Abstract
Background
In Prostate Cancer, there is a need for real-world clinical practice data given the high prevalence and incidence of the disease and the rapid changes in treatment options and diagnosis over recent years. Prostate cancer is a scenario in which ‘Big Data’ is particularly applicable because patients have a long disease course, generating an immense amount of data. The outcomes would improve our understanding of the potential implication of different diagnostic /treatment approaches in the different profile of patients suffering from this serious disease in clinical practice. The result of this analysis could also inform the scientific community on new hypothesis for future clinical studies.
Trial design
ORACULUM is a multi-country, multi-centre, Artificial Intelligence driven, retrospective, observational study analysing deidentified and aggregated information from original EHRs, in four languages (Spanish, English, French and German). ORACULUM uses SAVANA’s EHRead technology, an innovative data-driven system that applies Artificial Intelligence and Natural Language Program techniques. SAVANA software is able to meaningfully interpret physician notes and numerical values included in clinical records from thousands of patients and translate these into hundreds of variables. ORACULUM uses EHR population-based data since January 2014, to more accurately describe the epidemiology, diagnosis, management, outcomes, prognostic and predictive factors of response of Prostate Cancer (PCa) patients, across all disease stages. ORACULUM may also provide potential correlations that could have remained hidden so far in the existing literature. Here we describe the methodology for data collection and privacy.
Legal entity responsible for the study
Janssen.
Funding
Janssen.
Disclosure
J. Carles: Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas ; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Ipsen. A. Alcaraz: Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer. N.W. Clarke: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ferring; Honoraria (self), Travel/Accommodation/Expenses: Ipsen. A. Conde: Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy: Astellas; Advisory/Consultancy: Bayer; Advisory/Consultancy: Ipsen; Travel/Accommodation/Expenses: Gp Pharm. A. Heidenreich: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Astellas; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Bayer; Advisory/Consultancy: Clovis; Honoraria (self), Speaker Bureau/Expert testimony: Amgen; Honoraria (self), Speaker Bureau/Expert testimony: Ipsen; Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (self): Sanofi; Honoraria (self), Speaker Bureau/Expert testimony: Takeda; Speaker Bureau/Expert testimony: Pfizer; Honoraria (self): Ferring. A. Juarez: Advisory/Consultancy: Janssen; Advisory/Consultancy: Astellas; Advisory/Consultancy: Bayer. J.P. Maroto Rey: Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer. J. Puente: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers & Squibb; Advisory/Consultancy: Clovis Oncology; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self): AstraZeneca; Honoraria (self): MSD Oncology; Honoraria (self): EUSA Pharma; Honoraria (self): Pierre Fabre. I. Haddad: Full/Part-time employment: Janssen. J. Munoz del Toro: Full/Part-time employment: Janssen. A. Servan: Full/Part-time employment: Janssen. G. Pissart: Full/Part-time employment: Janssen. J. Casariego: Full/Part-time employment: Janssen. K. Fizazi: Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer. All other authors have declared no conflicts of interest.
1729P - Influence of recent administration and type of oncological treatment (T) in survival of oncological patients (p) with COVID-19: Experience of Vall d’Hebron University Hospital
- David García-Illescas (Barcelona, Spain)
Abstract
Background
SARS-CoV-2 outbreak has impacted on the management of oncological p, leading to treatment delays in a considerable number of cases. The aim of this study was to evaluate if oncological T affected negatively COVID-19 outcome.
Methods
We retrospectively analyzed clinical data from p with solid tumors under active systemic T (received in the last 6 months) that were diagnosed with SARS-CoV-2 infection (defined as positive PCR) between March and 11th May 2020 in our center. Study endpoint was death due to COVID-19. We divided the patients in two groups; those who had received treatment in the last 4 weeks and those who had not. Descriptive and univariate analysis were performed to detect the effect of T type and other variables on COVID-19 related mortality.
Results
A total of 70 p were included with a median follow-up of 28 days (10-47) and active oncological T had been administered in the past 4 weeks to 44 p. Median age was 66 (IQR 56-74), 23 p (52.27%) were female and 41 (93.2%) had a baseline ECOG≤1. The most frequent primary site was lung tumor (12 p [27.3%]), followed by breast (11 p [25%]) and gastrointestinal (5 p [11.4%]). Thirty-one p (70.5%) had metastatic disease and 13 (29.5%) were included in clinical trials. Twenty-four p (54.5%) received chemotherapy (CT), 14 (31.8%) targeted therapies, 9 (20.4%) immunotherapy (IT), 5 (11.4%) radiotherapy and 6 (13.6%) hormonotherapy. A total of 13 p (29.5%) received different combinations of oncological T. Death due to COVID-19 occurred in 5/22 (22.7%) p receiving CT and 6/21 (28.5%) p in the non-CT (p>0.05). Only 1/9 (11.1%) p treated with IT died compared to 11/35 (31.4%) p in the rest of the cohort (p>0.05). Age>71, comorbidities such as chronic obstructive pulmonary disease and ECOG status
Conclusions
Our results suggest that CT and other anticancer T might not worsen COVID-19 related mortality; nevertheless, the number of patients was small. and decision making has to be individualized. Our findings may warrant further investigation in larger studies.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
E. Felip: Advisory/Consultancy, Speaker Bureau/Expert testimony: AbbVie; AstraZeneca; Blueprint medicines; Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Eli Lilly; Guardant Health; Janssen; Medscape; Merck KGaA; Novartis; Pfizer; Roche; Takeda; Touchtime; Research grant/Funding (self), Research grant/Funding (institution): Fundación Merck Salud; Oncology Innovation EMD Serono. J. Carles: Advisory/Consultancy, Speaker Bureau/Expert testimony: Johnson & Johnson; Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Astellas Pharma; Advisory/Consultancy: Pfizer; Sanofi; MSD Oncology; Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZéneca; Speaker Bureau/Expert testimony: Asofarma; Research grant/Funding (self), Travel/Accommodation/Expenses: BMS; ravel/Accommodation/Expenses: Ipsen; Roche; Research grant/Funding (self): AB Science; Aragon Pharmaceuticals; Pharmaceuticals; INC; Blueprint Medicines Corporation; N Immunotherapeutics INC; Boehringer Ingelheim España, S.A.; Clovis Oncology; Cougar Biotechnology INC; Deciphera Pharmaceuticals LLC; Exelixis INC; F. Hoffmann-La Roche LTD; Genentech INC; Glaxosmithkline; Incyte Corporation; Janssen-Cilag International NV; Karyopharm Therapeutics INC; Laboratoires Leurquin Mediolanum SAS. J. Tabernero: Honoraria (self): Array Biopharma; AstraZeneca; Bayer; BeiGene; Boehringer Ingelheim; Chugai; Genentech; Genmab A/S; Halozyme; Imugene Limited; Inflection Biosciences Limited; Ipsen; Kura Oncology; Lilly; MSD; Merck Serono; Menarini; Merrimack; Merus; Molecular Partners; Novartis; Peptomyc; Pfizer; Pharmacyclics; ProteoDesign SL; Rafael Pharmaceuticals; F. Hoffmann-La Roche Ltd;): Sanofi; SeaGen; Seattle Genetics, Servier, Symphogen, Taiho, VCN Biosciences, Biocartis, Foundation Medicine, HalioDX SAS and Roche Diagnostics. All other authors have declared no conflicts of interest.
1858P - Role of depression and quality of life (QOL) status as predictors of hospital length of stay (HLOS) and overall survival (OS) in hospitalized oncologic patients (pts)
- Oriol Mirallas (Barcelona, Spain)
Abstract
Background
Prognostic factors for oncologic pts after surgery or curative systemic treatment have been described, including malnutrition, ECOG status or tumour staging. However, there is no solid evidence on which parameters predict outcomes after hospitalization of unselected cancer pts.
Methods
A review of the prospective database PLANTOLOGY of all hospitalized oncology pts between January and April 2020 at Vall d’Hebron Hospital was conducted. Clinical factors such as ECOG, comorbidities and analytical parameters were collected at admission. Mental status (depression and anxiety) and QOL were assessed through the HADS and EORTC-QLQ30 questionnaires, respectively. The identification of the optimal cut-off points was set by the maximization of the log-rank test. HLOS and overall survival (OS) since the first day of admission were calculated with the Kaplan-Meier method and univariate and multivariate Cox models were fitted to estimate hazard ratios (HR) with CI95%.
Results
Overall, 206 pts were included, median age was 65 years, 44% were active smokers, 57% had an ECOG ≤1, most frequent tumour types were lung (24%) and colorectal (15%) cancer, median Charlson comorbidity index was 9 (4 - 13) and 33% were treated under clinical trial prior to admission. Median number of treatment lines was 2 (1 - 8) with median follow-up of 2.2 months (m). The median HOLS was 8 days (CI95% 8 – 10) and median OS was 2.8 m (CI95% 2.1 – NA). Longer HOLS was observed in pts with ECOG≥2 (HR: 1.33, p=0.04) and albumin <3.3 mg/dL (HR: 1.61, p<0.001). In OS analysis, EORTC-QL30≥65, HADS≥11, LDH≥365, ECOG≥2, Stage=4 and albumin<3.3 were associated with worse OS (all p-values <0.05). In the multivariable analysis, the most parsimonious model included: HADS, stage and ECOG. HADS depression scale ≥11 was an independent factor for worse OS after adjusting for ECOG and stage (HR: 2.17; (1.08 – 4.36), p= 0.001).
Conclusions
In our cohort, QOL and depression scores measured with standardized tests were associated with OS after oncology ward admission, independently of stage and ECOG status. Factors linked to nutritional status and disease aggressiveness remain strong predictors of HOLS and OS.
Legal entity responsible for the study
Vall d'Hebron Institute of Oncology.
Funding
Has not received any funding.
Disclosure
O. Mirallas: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Kyowa Kirin; Travel/Accommodation/Expenses: Leo Pharma. D.E. López Valbuena: Travel/Accommodation/Expenses: Kyowa Kirin; Pierre Fabre. M.A. Rezqallah Aron: Travel/Accommodation/Expenses: Kyowa Kirin. G. Villacampa Javierre: Honoraria (institution), Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy: Astrazeneca. R. Dienstmann: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Ipsen; Amgen; Servier; Sanofi; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Merck Sharp & Dohme; Research grant/Funding (institution): Pierre fabre. J. Carles: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Research grant/Funding (institution): Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Johnson&Johnson; Travel/Accommodation/Expenses: Ipsen; Research grant/Funding (institution): AB Science; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma; Pfizer; Sanofi; MSD Oncology;Speaker Bureau/Expert testimony: Asofarma; Research grant/Funding (institution): Aragon Pharmaceuticals; AVEO Pharmaceuticals; Blueprint Medicine Corporation; Boehringer Ingelheim España; Clovis Oncology; Research grant/Funding (self): Arog Pharmaceuticals; BN Inmunotherapeutics; Puma Biotechnology; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Astra Zeneca. All other authors have declared no conflicts of interest.
629P - Neutrophil-lymphocyte ratio (NLR) as a prognostic and predictive biomarker in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel (CBZ) vs abiraterone or enzalutamide in the CARD study
- Ronald De Wit (Rotterdam, Netherlands)
Abstract
Background
High NLR as a biomarker of inflammation is associated with poor overall survival (OS) in different malignancies, including mCRPC (
Methods
Multivariable Cox regression analysis with stepwise selection of covariates (stratification factors and pre-planned prognostic factors), including adjustment for treatment, was used to investigate the prognostic association between baseline NLR (as a continuous variable) and OS. The associations between baseline NLR (< vs ≥ median), and OS, rPFS, time to prostate-specific antigen (PSA) progression, and PSA response (confirmed PSA decline ≥ 50% from baseline) were also evaluated.
Results
Baseline median NLR in both arms overall was 3.38; higher baseline NLR independently associated with poor OS (HR [95% CI]: 1.05 [1.02–1.08]; p = 0.0003). Additional factors associated with poor OS were lower hemoglobin and high PSA at baseline. Greater clinical activity in terms of rPFS, time to PSA progression and PSA response was seen with CBZ irrespective of baseline NLR, with the benefits of CBZ vs ARTA particularly marked in patients with NLR ≥ median (Table). CBZ also significantly prolonged OS vs ARTA in patients with baseline NLR ≥ median (HR [95% CI]: 0.49 [0.30–0.81]; log-rank p = 0.004). * Post-hoc analyses.
NLR ≥ median NLR < median CBZ (n = 63) ARTA (n = 60) CBZ (n = 62) ARTA (n = 61) Median rPFS, months (95% CI) 8.5 (4.9–11.4) 2.8 (2.7–4.5) 7.5 (5.4–8.5) 5.1 (3.1–7.0) Median OS, months (95% CI)* 15.3 (11.8–20.3) 9.5 (9.0–11.8) 12.9 (10.5–19.1) 13.3 (9.3–17.3) Time to PSA progression, months (95% CI)* 6.9 (3.5–10.3) 2.1 (1.7–2.8) 5.8 (3.5–8.8) 2.1 (1.4–2.8) PSA response, %* 37.5 17.3 35.7 12.0
Conclusions
This present analysis of CARD confirms that NLR is prognostic for poor outcomes in mCRPC. The superiority of CBZ vs a second ARTA was particularly marked in patients with high baseline NLR.
Clinical trial identification
EudraCT: 2014-004676-29. Release date: 1 March 2019.
Editorial acknowledgement
Editorial assistance was provided by Annie Berkley and Amber Wood of MediTech Media, funded by Sanofi.
Legal entity responsible for the study
Sanofi Genzyme.
Funding
Sanofi Genzyme.
Disclosure
R. de Wit: Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Sanofi; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp & Dohme; Advisory/Consultancy: Roche/Genetech; Advisory/Consultancy: Janssen; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: Clovis Oncology; Travel/Accommodation/Expenses: Lily. D. Castellano Gauna: Advisory/Consultancy, Research grant/Funding (self): Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Bayer; Advisory/Consultancy: Lilly; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Boehringer Ingelheim. G. Kramer: Honoraria (self): Sanofi; Honoraria (self): Bayer; Honoraria (self): Takeda; Honoraria (self): Astellas Pharma; Honoraria (self): Janssen; Honoraria (self): Ipsen; Honoraria (self): AstraZeneca ; Honoraria (self): Novartis. J-C. Eymard: Honoraria (self), Leadership role: Sanofi. C.N. Sternberg: Advisory/Consultancy: Bayer; Advisory/Consultancy: MSD; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Incyte; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Merck; Advisory/Consultancy: Medscape; Advisory/Consultancy: UroToday; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Bayer; Advisory/Consultancy: MSD; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy: Incyte; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Merck; Advisory/Consultancy: Medscape; Advisory/Consultancy: UroToday; Advisory/Consultancy: Astellas Pharma. K. Fizazi: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Astellas Pharma; Honoraria (self), Advisory/Consultancy: Sanofi; Advisory/Consultancy: Orion Pharma GmbH; Advisory/Consultancy: Curevac; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: ESSA; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen. B. Tombal: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas Pharma; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy: Ferring; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy: Takeda; Advisory/Consultancy: Steba Biotech; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Travel/Accommodation/Expenses: Ferring; Honoraria (self): Pfizer; Honoraria (self): Myovant Sciences. A. Bamias: Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Ferring; Honoraria (self): Astellas Pharma; Honoraria (self): Sanofi; Honoraria (self): Debiopharm Roche. J. Carles: Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy: J&J; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Research grant/Funding (self): Astellas Pharma; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (self): Sanofi; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Roche; Advisory/Consultancy: Asofarma ; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Roche ; Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (self): AB Science; Research grant/Funding (self): Aragon Pharmaceuticals; Research grant/Funding (self): Arog; Research grant/Funding (self): AVEO; Research grant/Funding (self): Blueprint Medicines; Research grant/Funding (self): BN ImmunoTherapeutics; Research grant/Funding (self): Boehringer Ingelheim; Research grant/Funding (self): BMS; Research grant/Funding (self): Clovis Oncology; Research grant/Funding (self): Cougar Biotechnology; Research grant/Funding (self): Deciphera; Research grant/Funding (self): Exelixis; Research grant/Funding (self): Roche/Genentech; Research grant/Funding (self): GSK; Honoraria (self): Incyte; Research grant/Funding (self): Janssen-Cilag; Research grant/Funding (self): Karyopharm Therapeutics; Research grant/Funding (self): Medimmune; Research grant/Funding (self): Millennium; Research grant/Funding (self): Nanobiotix; Research grant/Funding (self): Novartis; Research grant/Funding (self): Pfizer; Research grant/Funding (self): Puma Biotechnology; Research grant/Funding (self): SFJ Pharmaceuticals Group; Research grant/Funding (self): Teva; Research grant/Funding (self): Mediolanum Laboratories Leurquin; Research grant/Funding (self): Lilly. R. Iacovelli: Honoraria (self): Sanofi; Honoraria (self): Janssen; Honoraria (self): Pfizer; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): BMS; Honoraria (self): MSD. B. Melichar: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): MSD; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Merck Serono; Honoraria (self), Advisory/Consultancy: Sanofi; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Astellas Pharma; Honoraria (self), Advisory/Consultancy: SERVIER; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Pfizer; Research grant/Funding (self): Novcartis; Research grant/Funding (self): Merck Serono. E. M. Poole: Full/Part-time employment: Sanofi. A. Ozatilgan: Shareholder/Stockholder/Stock options, Full/Part-time employment: Sanofi. C. Geffriaud-Ricouard: Full/Part-time employment: Sanofi. J. de Bono: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Astellas Pharma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck Serono; Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Sierra Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Menarini Silicon Biostystems; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Celgene; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Taiho Pharmaceuticals; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Daiichi Sankyo; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Genmab; Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Orion Pharma GmbH; Advisory/Consultancy: Eisai and BioXCel therapeutics ; Travel/Accommodation/Expenses: Qiagen; Travel/Accommodation/Expenses: Vertex; Honoraria (self), Research grant/Funding (self): Astex Pharmaceuticals; Honoraria (self), Research grant/Funding (self): CellCentric; Honoraria (self), Research grant/Funding (self): MedImmune; Honoraria (self), Research grant/Funding (self): Medivation; Honoraria (self), Research grant/Funding (self): BioExcel. All other authors have declared no conflicts of interest.
1971P - Neuroendocrine (NE) expression profiling in non-castrate tumours is associated with poor therapy benefit and adverse clinical outcome in metastatic castration-resistant prostate cancer (mCRPC) patients
- Natalia Jimenez (Barcelona, Spain)
Abstract
Background
NE dedifferentiation is associated to clinical aggressiveness and resistance to androgen receptor (AR) inhibition in prostate cancer. We analyzed the correlation of a NE expression signature in non-castrate tumors with the clinical outcome of mCRPC patients treated with taxanes or AR signaling inhibitors (ARSI; abiraterone or enzalutamide).
Methods
Patients with mCRPC were retrospectively tested for a customized signature of 45 NE-related genes in total RNA from formalin-fixed paraffin-embedded non-castrate tumor samples by the nCounter platform (Nanostring Technologies). Patients were grouped as high and low NE profile according to the unsupervised clustering of gene expression data and correlated with treatment response and clinical outcome.
Results
Ninety-six patients were included, with a median follow-up of 20 (1.17-81.3) months. Median age was 69.2 (55.8-87.1) years. All patients received taxanes (68 docetaxel, 10 cabazitaxel and 18 both), 29 received ARSI as first line in CRPC and 53 received ARSI after taxanes. Patients classified as high NE expression profile (59 vs. 37 patients) were associated with a shorter time of CRPC development (median 12.6 vs. 30.8 mo, HR 3.3, 95%CI 2-5.5,
Conclusions
NE-related gene expression in non-castrate tumor samples is associated with adverse clinical outcome and both poor taxanes and ARSI benefit in mCRPC patients. Thus, molecular characterization of primary tumors may be useful to guide treatment strategies in mCRPC.
Legal entity responsible for the study
Hospital Clínic de Barcelona.
Funding
Instituto de Salud Carlos III-Subdirección General de Evaluación y Fomento de la Investigación; European Regional Development Fund; CERCA Programme/Generalitat de Catalunya.
Disclosure
N. Jimenez: Travel/Accommodation/Expenses: Sanofi. O. Reig: Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer. L. Ferrer-Mileo: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Kyowa kirin. A. Font: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Janssen; Research grant/Funding (institution), Travel/Accommodation/Expenses: Astra-Zeneca; Research grant/Funding (institution), Travel/Accommodation/Expenses: Astellas Pharma; Research grant/Funding (institution): Pierre-Fabre. M. Domènech: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Janssen. A. Rodríguez-Vida: Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas Pharma; Speaker Bureau/Expert testimony: Astra-Zeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Sanofi-Aventis; Advisory/Consultancy: Clovis. J. Carles: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Johnson&Johnson; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas Pharma; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy: MSD; Advisory/Consultancy: Roche; Advisory/Consultancy: Astra-Zeneca; Speaker Bureau/Expert testimony: Asofarma. C. Suárez: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: EUSA Pharma; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Novartis; Speaker Bureau/Expert testimony: Roche/Genentech; Speaker Bureau/Expert testimony: Astra-Zeneca; Travel/Accommodation/Expenses: Roche. N. Sala-González: Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen. A. Prat: Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Amgen; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Daiichi Sankyo; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Nanostring technologies; Advisory/Consultancy: Puma; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: MSD; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Officer/Board of Directors: Breast International Group; Officer/Board of Directors: Solti's Foundation; Officer/Board of Directors: Actitud frente al cáncer Foundation; Research grant/Funding (institution): Boehringer; Research grant/Funding (institution): Sysmex Europe GmbH; Research grant/Funding (institution): Medica Scientia Innovation Research; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Astellas Pharma. M. Marín-Aguilera: Travel/Accommodation/Expenses: Bristol-Myers Squibb. B. Mellado: Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Ipsen; Research grant/Funding (institution): Bayer. All other authors have declared no conflicts of interest.
1068P - Rescue chemotherapy (CT) after immune-oncology (IO) drugs in patients (pts) with refractory solid tumours: A propensity score (PS) matched cohort study
- Vladimir Galvão (Barcelona, Spain)
Abstract
Background
Case reports and uncontrolled studies have shown great responses to CT in pts with solid tumors and hematological malignancies after IO drugs, suggesting a chemosensitization of the checkpoint inhibitors. We explored this effect in a prospective database of pts included in IO, tyrosine kinase inhibitor (TKI) or epigenetic agent (EPI) phase I trials.
Methods
All pts with solid tumors on phase I trials at VHIO are followed post-progression and CT response was assessed based on standard clinical practice. A propensity score-matched population (CT post-IO vs. CT-post TKI) adjusted for clinico-pathological factors that could influence response to CT and prognosis was identified. Endpoints were RECIST objective response rate (ORR) and progression-free survival (PFS).
Results
From 986 pts enrolled between 2010 and 2019, 132 received CT post-progression (post-IO in 55 [42%], post-TKI in 70 [53%] and post-EPI in 7 [5%]). Median age was 61y, 66% females, most common tumors were breast (22%), head & neck (12%), colorectal (10%) and melanoma (10%). Median prior lines in CT post-IO or CT post-EPI groups was 2 and in the CT post-TKI pts was 3 (P = 0.02). Partial response (PR) of 5% and stable disease of 38% were achieved with phase I trial drug. At post progression CT, ORR was 16.4% post-IO, 8.6% post-TKI and 14.3% post-EPI (P = 0.43). An unadjusted Cox model showed no differences in CT PFS across groups (2.4 months post-IO, 2.8 months post-TKI, and 10.3 months post-EPI; P > 0.14 all comparisons). Due to small numbers, post-EPI pts were excluded for PS analysis. Remaining post-IO (n = 55) and post-TKI (n = 55) PS-matched cohort showed no differences in CT ORR (odds ratio 1.96 in favor of post-IO, CI95% 0.6-6.3, P = 0.27) or CT PFS (hazard ratio 0.85 in favor of post-IO, CI95% 0.6-1.3; P = 0.44). In a multivariable model, predictors of PR with CT post-progression on phase I trials were breast cancer (OR = 16.3; p = 0.002) and clinical benefit while on the trials (OR = 5.18; p = 0.04).
Conclusions
This unbiased controlled cohort study, despite numerically higher ORR with CT post-IO vs. post-TKI, showed no significant PFS differences with rescue CT between the groups, questioning the chemosensitization effect of IO drugs across solid tumors.
Legal entity responsible for the study
Vall d´Hebron Institute of Oncology.
Funding
Has not received any funding.
Disclosure
V. Galvão: Travel/Accommodation/Expenses: F. Hoffmann-La Roche Ltd. F.J. Ros Montañá: Advisory/Consultancy: Sanofi. G. Villacampa Javierre: Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy: AstraZeneca. I. Braña: Advisory/Consultancy: Orion Pharma; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Serono; Advisory/Consultancy: Rakutan Pharma; Speaker Bureau/Expert testimony: Roche. A.B. Azaro Pedrazzoli: Advisory/Consultancy: Orion Corporation. Amcure GmbH; Research grant/Funding (institution): Amcure GmbH. M. Vieito Villar: Advisory/Consultancy: Debio, Roche, TFS; Travel/Accommodation/Expenses: Roche, Merck-Serono. O. Saavedra Santa Gadea: Travel/Accommodation/Expenses: Kyowakirin; Travel/Accommodation/Expenses: Roche. A. Hernando-Calvo: Travel/Accommodation/Expenses: Kyowa Kirin. J. Carles: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Johnson & Johnson; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Astellas Pharma; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Speaker Bureau/Expert testimony: Asofarma; Travel/Accommodation/Expenses: Ipsen; Research grant/Funding (institution): AB Science; Research grant/Funding (institution): Aragon Pharmaceuticals; Research grant/Funding (institution): Arog Pharmaceuticals; Research grant/Funding (institution): INC; Research grant/Funding (institution): Aveo Pharmaceuticals; Research grant/Funding (institution): Blueprint; Research grant/Funding (institution): BN Immunotherapeutics INC; Research grant/Funding (institution): Boehringer Ingelheim España; Research grant/Funding (institution): Clovis Oncology; Research grant/Funding (institution): Cougar Biotechnology; Research grant/Funding (institution): Deciphera Pharmaceuticals; Research grant/Funding (institution): Exelixis; Research grant/Funding (institution): F. Hoffmann-La Roche; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Janssen-Cilag; Research grant/Funding (institution): Karyopharm; Research grant/Funding (institution): Laboratories Leurquin Mediolanum. T. Macarulla Mercade: Honoraria (self), Advisory/Consultancy: Advance Medical HCMS; Honoraria (self), Advisory/Consultancy: Baxter; Honoraria (self), Advisory/Consultancy: Biolinerx; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self), Advisory/Consultancy: Eisai; Honoraria (self), Advisory/Consultancy: Genzyme; Honoraria (self), Advisory/Consultancy: Incyte; Honoraria (self), Advisory/Consultancy: Ipsen; Honoraria (self), Advisory/Consultancy: Lab Servier; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Qed Therapeutics; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Prime; Honoraria (self), Advisory/Consultancy: QED; Honoraria (self), Advisory/Consultancy: Sanofi - Aventis; Research grant/Funding (institution): Agios; Research grant/Funding (institution): Aslan; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Hallozyme; Research grant/Funding (institution): Immunomedics; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Merimarck; Research grant/Funding (institution): Millenim; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Pharmacyclics; Research grant/Funding (institution): Roche. E. Munoz Couselo: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pierre Fabre; Honoraria (self), Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi. E. Elez: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: F. Hoffmann-La Roche Ltd; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Servier; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Serono; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Array; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Honoraria (institution): MSD; Honoraria (institution): AbbVie; Honoraria (institution): GSK; Honoraria (institution): AstraZeneca; Honoraria (institution): Novartis; Honoraria (institution): Boehringer Ingelheim. E. Felip: Advisory/Consultancy: AbbVie; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Blueprint Medicines; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Advisory/Consultancy: Guardant Health; Advisory/Consultancy: Janssen; Speaker Bureau/Expert testimony: Medscape; Advisory/Consultancy: Merck Kgaa; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sharp & Dohme; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Prime Oncology; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Samsung; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Speaker Bureau/Expert testimony: Touchime; Advisory/Consultancy: GSK; Advisory/Consultancy: Bayer; Research grant/Funding (institution): GOI; Research grant/Funding (institution): Fundación Merck Salud. J. Tabernero: Advisory/Consultancy: Array Biopharma; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: Beigene; Advisory/Consultancy: Boehringer; Advisory/Consultancy: Chugai; Advisory/Consultancy: Genentech; Advisory/Consultancy: Genmab; Advisory/Consultancy: Halozyme; Advisory/Consultancy: Imugene; Advisory/Consultancy: Inflection Biosciences; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Kura; Advisory/Consultancy: Lilly; Advisory/Consultancy: MSD; Advisory/Consultancy: Menarini; Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Merrimack; Advisory/Consultancy: Merus; Advisory/Consultancy: Molecular Partners; Advisory/Consultancy: Novartis; Advisory/Consultancy: Peptomyc; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Pharmacyclics; Advisory/Consultancy: Proteodesign; Advisory/Consultancy: Rafael Pharmaceuticals; Advisory/Consultancy: F Hoffmann-La Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Seagen; Advisory/Consultancy: Seattle Genetics. R. Dienstmann: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony: Servier; Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony, Research grant/Funding (self): Merck Sharp & Dohme; Research grant/Funding (self): Pierre Fabre. M. Oliveira: Honoraria (institution), Advisory/Consultancy: Roche; Honoraria (institution), Speaker Bureau/Expert testimony: Novartis; Honoraria (institution), Advisory/Consultancy: GSK; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Seattle Genetics; Honoraria (institution), Advisory/Consultancy: Puma; Honoraria (institution), Advisory/Consultancy: AstraZeneca; Honoraria (institution): Philips; Honoraria (institution): Genentech; Honoraria (institution): Zenith Epigenetics; Honoraria (institution): Immunomedics; Honoraria (institution): Boehringer Ingelheim. E. Garralda: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche/Genentech; Advisory/Consultancy: F. Hoffmann-La Roche; Advisory/Consultancy: Ellipses Pharma; Advisory/Consultancy: Neomed; Advisory/Consultancy: Boehringer; Advisory/Consultancy: Janssen; Advisory/Consultancy: Seagen; Advisory/Consultancy: TFS; Advisory/Consultancy: Alkermes; Advisory/Consultancy, Speaker Bureau/Expert testimony: Thermo Fisher; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Travel/Accommodation/Expenses: Menarini; Travel/Accommodation/Expenses: Glycotope. All other authors have declared no Conflicts of interest.
374P - Temozolamide (TMZ) rechallenge at standard or metronomic dose versus other treatments in patients (pts) with high grade glioma with TMZ free-interval (TFI) longer than 3 months (mo)
- Alejandro Garcia-Alvarez (Barcelona, Spain)
Abstract
Background
No standard of care after Stupp protocol for high grade glioma exists. Prospective (RESCUE trial) and retrospective studies have shown that TMZ rechallenge, either standard (S-TMZ) or dose-dense (D-TMZ) regimens, could be an option for patients with treatment free-interval (TFI) > 2mo after Stupp. IDH1 mutant (mut) and patients with grade 3 tumors could specially benefit from TMZ rechallenge.
Methods
VHIO institutional database was queried for treatment history and outcomes in pts with WHO grade III-IV glioma with TFI > 3 mo between January 2010 and April 2020. Second line progression free survival (PFS) was estimated using Kaplan-Meier methods.
Results
N=39 pts were identified. Majority of pts had grade 4 WHO gliomas (n=31; 79.5%). IDH1 status was available for 30 pts; with 4 pts (13.3%) having IDH1 mut. Most underwent complete (n=10; 25.6%) or partial (n=23; 59%) resection. All pts completed Stupp protocol and had a median TFI of 11.3mo (CI95% 8.3-15.0). N=33 pts (84.6%) were retreated with TMZ (82% with S-TMZ and 18% with D-TMZ) while. N=6 pts (15.6%) received other treatments (OTHER), including Bevacizumab in 10% and clinical trials in 2.5%. Having TFI > 11 mo (p=0.05) and being younger than ≤65 years (p=0.03) were associated with increased PFS, but neither IDH1 mut status nor grade were prognostic. Median PFS was longer in pts receiving TMZ (S-TMZ and D-TMZ) than OTHER options (5.4 vs 2.9 mo; HR 0.4, p=0.08). Because there was a bias towards TMZ use in patients with longer TFI (TMZ use 49% in TFI <11mo vs 95% in over TFI>11mo) we compared outcomes only in patients with TFI between 3 and 11 months. The D-TMZ group had longer median PFS compared to OTHER (11.58 vs 2.94 mo; HR=4.1, p=0.03). In its with TFI>11 mo, median PFS with S-TMZ rechallenge was 7.62 mo. Pts with response to 2L had longer previous TFI (18 vs 9 mo; p=0,05) and PFS to Stupp protocol (27,6 vs 18,6 mo; p=0,1 - not significant).
Conclusions
TMZ rechallenge is a feasible option for pts with high grade glioma with TFI > 3 mo, with D-TMZ having improved outcomes in selected pmts with short TFI. Although prospective studies and larger number of pts are needed; younger pts, and those with long TFI > 11 mo seem to have better outcomes with TMZ.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Gonzalez: Advisory/Consultancy: Roche; Travel/Accommodation/Expenses: Astellas, Bayer and Pand Lilly. R. Dienstmann: Advisory/Consultancy: Roche, Boehringer Ingelheim; Speaker Bureau/Expert testimony: Roche, Ipsen, Amgen, Servier, Sanofi, Merck Sharp and Dohme; Research grant/Funding (self), Research grant/Funding (institution): Merck, Pierre Fabre. J. Carles: Advisory/Consultancy: Bayer Johnson & Johnson Bristol-Myers Squibb Astellas Pharma Pfizer Sanofi MSD Oncology Roche AstraZeneca; Speaker Bureau/Expert testimony: Bayer Johnson & Johnson Asofarma Astellas Pharma; Travel/Accommodation/Expenses: BMS, Ipsen, Roche, AstraZeneca; Research grant/Funding (institution): AB Science, Aragon Pharmaceuticals, Arog Pharmaceuticals, INC, Astellas Pharma., Astrazeneca AB, Aveo Pharmaceuticals INC, Bayer AG, Blueprint Medicines Corporation, BN Immunotherapeutics INC, Boehringer Ingelheim España, S.A., Bristol-Myers Squibb Intern. M. Vieito Villar: Advisory/Consultancy: Debio, Roche, TFS; Travel/Accommodation/Expenses: Roche, Merck-Serono. All other authors have declared no conflicts of interest.
380P - Ten-year experience of the Vall d’Hebron Institute of Oncology early drug development unit (VHIO-UITM) treating patients (pts) with primary CNS tumours (pCNS)
- Nadia Saoudi Gonzalez (Barcelona, Spain)
Abstract
Background
PCNS pts are under-represented in early clinical trials. We aimed to describe the characteristics and outcomes of the VHIO-UITM cohort and develop tools to optimize pt selection.
Methods
Of all referrals between 2010 to 2019, subset of 141 pts considered eligible was retrospectively studied. Patient data, pathological characteristics, OS and PFS data were collected and analyzed.
Results
Median age 46 y (range 21-75), 59.6% male, ECOG 0/1 28.3%/71.6% , 57.4% glioblastoma, 25.5% low-grade glioma, 12.8% grade 3 gliomas, median of 2 prior therapies (range 0-8), including chemoradiation (70%), bevazicumab (50%) and secondary resection (41%); 45% were using steroids. Median time from diagnosis to first VHIO-UITM visit was 3.2 years (CI95% 2.28-4.31). 49.6% were treated in dose escalations, 23.4% in dose expansion/baskets, 26.9% were not enrolled, (due to lack of promising molecular target (36%), lab abnormality (28%, mostly thrombocytopenia) or clinical deterioration (14%)). Pts received targeted agents (74%), immunotherapies (9%), epigenetic modulators (4%). Median PFS was 2.3 months (2.0- 3.1), PFS>1 year was seen in 13.3% of cases, but most (75%) had clinical or radiological progression as best response. Median OS was 5.0 months (4.2-6.2), with 28% dying within 12 weeks. NGS based enrichment was used in 32%: MET (8.5%), NOTCH (8.5%), IDH (7.1%), SMO (2.8%), FGFR (2.8%), BRAF (2.8%) NTRK(2.8%). Pts with matched targeted treatment had a median PFS of 2.2 months vs. 2.3 unmatched population (HR 1.2, 95% CI (0.72-1.72), p=0.60). Using the LASSO selection method we generated a prognostic model for PFS with a 67% c-index including ECOG, grade, extent of resection, antecedent of chemoradiation, number of previous progressions and systemic therapies, antiepileptic use and neutrophil count.
Conclusions
pCNS pts referred to VHIO-UITM tend to be young, have a good PS despite being pretreated. Screening failure rates are comparable to pts with other primary tumors, but a higher early mortality rate is seen. Clinical benefit is over 10%, without impact of molecular enrichment on PFS. Clinicopathological and laboratory factors are could be relevant predictors of outcome in this population.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
M. Vieito Villar: Advisory/Consultancy: Debio; Advisory/Consultancy: Roche; Advisory/Consultancy: TFS; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Merck-Serono. A.B. Azaro Pedrazzoli: Advisory/Consultancy: Orion Pharma; Advisory/Consultancy: Amcure GmbH. I. Braña: Advisory/Consultancy: Orion Pharma; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Serono; Advisory/Consultancy: Rakutan Pharma; Speaker Bureau/Expert testimony: Roche. M. Gonzalez: Advisory/Consultancy: Roche; Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: Bayer; Travel/Accommodation/Expenses: Pand Lilly. O. Saavedra Santa Gadea: Travel/Accommodation/Expenses: KYOWAKIRIN; Travel/Accommodation/Expenses: MSD. V. Galvao de Aguiar: Travel/Accommodation/Expenses: F Hoffman la Roche. A. Hernando-Calvo: Travel/Accommodation/Expenses: Kyowa Kirin. J. Carles: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Johnson & Johnson; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas Pharma; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sanofi; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: AstraZéneca; Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: AstraZéneca. R. Dienstmann: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Boehringer Ingelheim; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony: Servier; Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony: Sharp & Dohme; Research grant/Funding (self): Merck; Research grant/Funding (institution): Pierre Fabre. E. Garralda: Research grant/Funding (institution): Novartis; Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche ; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Thermo Fisher; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: F.Hoffmann/La Roche; Advisory/Consultancy: Ellipses Pharma; Advisory/Consultancy: Neomed Therapeutics; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Janssen Global Services; Advisory/Consultancy: SeaGen; Advisory/Consultancy: TFS; Advisory/Consultancy: Alkermes; Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Mayers Squibb; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck Sharp & Dohme; Travel/Accommodation/Expenses: Menarini; Travel/Accommodation/Expenses: Glycotope. All other authors have declared no conflicts of interest.
1925P - DNA methylation signature for prediction of metastasis and response to multikinase inhibitors of differentiated thyroid carcinoma (DTC)
- Jorge Hernando (Barcelona, Spain)
Abstract
Background
Despite good prognosis, about 5% of patients (pts) with DTC will develop metastasis (mDTC) which eventually fails to respond to radioactive iodine (RAI). Currently, no effective biomarkers are available to identify prognostic groups in DTC. DNA methylation, one of the most studied epigenetic mechanisms, is altered in thyroid cancer. DNA hypomethylation is associated with the progression of thyroid cancer, and our group identified a prognostic signature of 156-CpGs associated with mDTC, independently of histology and BRAF/RAS mutations, that differs between metastatic (both synchronous and metachronous) and low-risk non-metastatic primary tumors. The aim of this study is to evaluate the prognostic and predictive value of the 156-CpG signature and global DNA hypomethylation in RAI-refractory (RAI-R) mDTC pts.
Methods
RAI-R mDTC pts treated with at least one multikinase inhibitor (MKI) were included. DNA methylation was profiled using Illumina Infinium Human MethylationEPIC. The stepwise AIC method was used for variable selection and leave-one-out cross-validation method to evaluate predictive performance of the model. Selected candidate biomarkers were validated by bisulfite pyrosequencing. DNA global hypomethylation was assessed using Quantification of Unmethylated Alu (QUAlu) technique.
Results
15 RAI-R mDTC pts were included. The 156-CpG methylation signature identified in DTC was validated in RAI-R mDTC. Using 4 CpGs from the 156-signature we developed a high classification power model that predicted metastasis and RAI-R status in thyroidectomy samples. In addition, we established new quantitative DNA methylation assays based on pyrosequencing to measure the DNA methylation of these 4 CpGs. Predictive analysis revealed that most pts with complete or partial response to MKI did not show global DNA hypomethylation while those presenting stable or progressive disease were increasingly affected by global DNA hypomethylation.
Conclusions
We developed a methylation algorithm to predict distant metastases and RAI-R status in pts with DTC, easily implementable in clinical practice. Increased global DNA hypomethylation seems to be associated with a worse response to MKI in RAI-R mDTC pts.
Legal entity responsible for the study
Vall d'Hebron Institute of Oncology (VHIO).
Funding
Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE).
Disclosure
J. Hernando: Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: AAA; Speaker Bureau/Expert testimony: Angelini. J. Capdevila: Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Ipsen; Honoraria (self): Exelixis; Honoraria (self): Bayer; Honoraria (self): Eisai; Honoraria (self): AAA; Honoraria (self): Amgen; Honoraria (self): Sanofi; Honoraria (self): Merck Serono. All other authors have declared no conflicts of interest.
427P - Value of magnetic resonance diffusion weighted imaging in the identification of complete responder patients with rectal cancer treated with neoadjuvant therapy
- Juan-ramon Ayuso (Barcelona, Spain)
Abstract
Background
The identification of pathologic complete responder (pCR) patients with locally advanced rectal cancer (LARC) after neoadjuvant treatment (NAT) is of interest in terms of patient prognosis and subsequent therapy options. A four-pattern based evaluation combining diffusion weighted imaging (DWI) and tumor morphology on T2-weighted magnetic resonance has shown promising results in identification pCR. Our aim was to evaluate the performance and reproducibility of this approach in a retrospective series in our center.
Methods
Pre and post NAT MRI scans obtained in 120 patients with LARC between 2009 and 2014 were retrospectively evaluated by 2 radiologists with 20 and 3 years of experience respectively. Due to artifacts in DWI, tumoral mucine or absence of pathologic specimen, 79 patients were finally evaluated. Reviewers (R), blinded to pathologic final result, assigned 1 of 4 morphologic and DWI tumoral response patterns to every case, including assessment of the absence or presence of residual tumor.
Results
R1 and R2 identified 6 and 5 of 15 patients with pCR respectively. Assignments of patients to each group and data on sensitivity and specificity both global and per group are listed in the table. Correlation for pattern assignment between both reviewers showed a k=0.68.
Global A B C D 79 32 23 18 17 26 37 3 2 97 87 96 80 100 100 94 85 100 100 40 33 100 100 0 0 12 20 - -
Conclusions
The identification of residual tumor with DWI in LARC after NAT can be achieved with high sensitivity and modest specificity. Distinguishing morphologic and DWI patterns allow us to select a group with very good results (pattern A) and identify a group in which pCR rarely occur (pattern B). Group classification of patients into each group could be done with good correlation between reviewers. The majority of the discrepancies concentrate in patterns A and C assignments.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
471P - Identification and validation of a new prognostic score in metastatic colorectal cancer (mCRC): GEMCAD score
- Elia Seguí (Barcelona, Spain)
Abstract
Background
Survival of patients with metastatic colorectal cancer (mCRC) has improved in the last decade but remains heterogeneous. The two main prognostic scores for mCRC (Köhne and GERCOR) were developed before targeted therapy approval and do not account for resectability of liver-only metastases. We propose a new prognostic score - GEMCAD score.
Methods
Patients with mCRC treated with first-line doublet/triplet chemotherapy (CT) with or without monoclonal antibodies (mABs) were analyzed. The score was first tested in a training set of 634 patients from three phase II trials and one prospective cohort and later validated in a larger cohort of 1088 patients (validation set) from a prospective observational study (GEMCAD 14-01). Patients were classified as: (low-risk) if liver metastases were considered resectable (<10 nodules), PS 0-1 and LDH ≤1.5 ULN; (intermediate-risk) if liver metastases were not resectable (>10 nodules) or with extrahepatic spread, PS 0-1 and LDH ≤1.5 ULN; (high-risk) if PS 2 or LDH >1.5 ULN. GEMCAD score discrimination capacity was evaluated and compared to Köhne and GERCOR scores using Harrel’s C index (HCI).
Results
In the training and validation sets, distribution of patients according to GEMCAD score was: 21.1% and 16.6% in low-risk, 53.6% and 50.1% in intermediate-risk, and 25.1% and 33.3% in high-risk. Median overall survival (OS) was 30.5, 19.2 and 15 months (p<0.0001, HCI 0.607) and 25.3, 19.3 and 14.2 months (p<0.0001, HCI 0.621) in low, intermediate and high-risk, respectively. Similar results were obtained when applying Köhne and GERCOR scores in the training (p<0.0001, HCI 0.604; p<0.0001, HCI 0.604) and validation sets (p<0.0001, HCI 0.620; p<0.0001, HCI 0.623). When comparing patients treated with CT + mABs (n=1025)
Conclusions
GEMCAD score defines clearly three prognostic groups for death and allows treatment guidance. Its performance is comparable to Köhne and GERCOR scores. All three scores perform better in patients treated with chemotherapy alone.
Legal entity responsible for the study
Joan Maurel.
Funding
Has not received any funding.
Disclosure
C. Fernández-Martos: Honoraria (self): Merck; Honoraria (self), Research grant/Funding (self): Sanofi; Honoraria (self): Servier; Honoraria (self): Amgen; Leadership role: GEMCAD. A. Ruiz-Casado: Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Sanofi; Speaker Bureau/Expert testimony: Merck; Speaker Bureau/Expert testimony: Bayer; Speaker Bureau/Expert testimony: BTG; Speaker Bureau/Expert testimony: Servier; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: Lilly. J. Gallego: Speaker Bureau/Expert testimony, Research grant/Funding (self): Lilly; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Research grant/Funding (self): BMS; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Roche; Advisory/Consultancy: Servier; Advisory/Consultancy: Merck; Travel/Accommodation/Expenses: Novartis; Leadership role: Agamenon Spanish Registry Gastric Cancer. J. Aparicio: Advisory/Consultancy: Roche; Advisory/Consultancy: Amgen; Advisory/Consultancy: Merck; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Bayer; Advisory/Consultancy: Servier; Advisory/Consultancy: Celgene. E. Gálvez: Speaker Bureau/Expert testimony: Hoffmann-La Roche; Speaker Bureau/Expert testimony: Bristol Myers Squibb; Speaker Bureau/Expert testimony: Merck; Speaker Bureau/Expert testimony: Boehringer Ingelheim. J. Maurel: Honoraria (self): Sirtex; Honoraria (self): Servier; Honoraria (self): Pierre-Fabre; Honoraria (self): Advance Medical; Honoraria (self): Shire; Honoraria (self): Astra-Zeneca; Honoraria (self): Bayer; Honoraria (self): Sanofi; Honoraria (self): Roche; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Biocartis; Research grant/Funding (institution): Nanostring; Research grant/Funding (institution): Incyte. All other authors have declared no conflicts of interest.