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Found 5 Presentations For Request "card"
627P - Real-world evidence (RWE) for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel (CBZ): Comparison with the randomized clinical study CARD
- Ronald De Wit (Rotterdam, Netherlands)
Abstract
Background
CARD demonstrated superiority of CBZ over abiraterone (ABI) or enzalutamide (ENZ) in pts with mCRPC who had previously received docetaxel (DOC) and progressed ≤ 12 months on the alternative androgen receptor-targeted agent (ARTA;
Methods
Medimix LiveTrackerTM, a retrospective, global oncology database of healthcare professional-reported electronic pt medical forms, was used to identify pts with mCRPC who received CBZ and prior DOC and ABI or ENZ (in any order), between 2001 and 2019. Only pts with available CBZ treatment duration were included.
Results
In total, 452 pts were included in the RWE cohort. Median age was similar to CARD (73 vs 70 years); Eastern Cooperative Oncology Group performance status score ≥ 2 was greater in the RWE cohort (45% vs 4.7%). More pts in the RWE cohort vs CARD received prior ARTA before DOC (48% vs 39%; ABI 57% vs 43%; ENZ 43% vs 56%) and had prior ARTA treatment duration > 12 months (30% vs 17%; Table). Pts in the RWE cohort had more aggressive disease features vs CARD: M1 at diagnosis (46% vs 38%) and Gleason 8–10 (65% vs 57%), although the proportion of pts with visceral metastases (12% vs 16%) was comparable with CARD. Despite more pts in the RWE cohort vs CARD receiving the lower CBZ dose (20 mg/m2 dose; 55% vs 21%), CBZ treatment duration in the RWE cohort was comparable with CARD (21.9 vs 22.0 weeks).
Conclusions
The RWE cohort demonstrates that for most pts receiving ARTA and DOC followed by CBZ, the ARTA was received for ≤ 12 months. Despite having a poorer performance status and more aggressive disease features, duration of CBZ was similar to the CARD study. These results may imply that the CARD study is reflective of the real-world setting.
Editorial acknowledgement
Editorial assistance was provided by Danielle Walsh of MediTech Media, funded by Sanofi.
Legal entity responsible for the study
Sanofi Genzyme.
Funding
Sanofi.
Disclosure
R. de Wit: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Sanofi; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck Sharp & Dohme; Advisory/Consultancy: Roche/Genetech; Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy: Clovis Oncology; Travel/Accommodation/Expenses: Lilly. S. Freedland: Research grant/Funding (self), Personal fee: Pfizer; Advisory/Consultancy, Personal fee: Astellas; Advisory/Consultancy, Personal fee: Janssen; Advisory/Consultancy, Personal fee: Bayer; Advisory/Consultancy, Personal fee: Myovant; Advisory/Consultancy, Personal fee: AstraZeneca; Advisory/Consultancy, Personal fee: Merck; Advisory/Consultancy, Personal fee: Dendreon; Advisory/Consultancy, Personal fee: Sanofi. S. Oudard: Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Travel/Accommodation/Expenses: Merck; Honoraria (self), Travel/Accommodation/Expenses: Janssen; Honoraria (self), Travel/Accommodation/Expenses: Astellas; Travel/Accommodation/Expenses: Sanofi. G. Marinov: Advisory/Consultancy, Personal fee (contracted by Sanofi): Sanofi. P. Capart: Full/Part-time employment: Medimix; Advisory/Consultancy, Personal fees (contracted by Sanofi): Sanofi. A. Combest: Full/Part-time employment: Medimix; Advisory/Consultancy, Personal fees (contracted by Sanofi): Sanofi. R. Peterson: Full/Part-time employment: Sanofi. A. Ozatilgan: Shareholder/Stockholder/Stock options, Full/Part-time employment: Sanofi. A. Morgans: Advisory/Consultancy, Personal fees: Janssen; Advisory/Consultancy, Personal fees: Astellas; Advisory/Consultancy, Personal fees: Seattle Genetics; Advisory/Consultancy, Personal fees: Genentech; Advisory/Consultancy, Research grant/Funding (self), Personal fees: Bayer.
628P - Treatment in CARD eligible metastatic castration resistant prostate cancer (mCRPC) patients according to the status of germline HRR mutations: Cabazitaxel (CBZ) vs enzalutamide/abiraterone
- Casilda Llacer Perez (Malaga, Spain)
Abstract
Background
The CARD trial proved that in mCRPC patients (pts), previously treated with docetaxel and an androgen-receptor signaling inhibitor (ARSi), cabazitaxel (CBZ) significantly improves progression-free (PFS) and Overall Survival (OS) compared with the alternative ARSi. Concurrently, the PROFOUND trial showed that in men with mCRPC who had progressed while receiving ARSi harboring also alterations in Homologus Recombination DNA repair related genes (HRR), olaparib improves PFS and response comparing with a subsequent ARSi.
Methods
PROREPAIR-B is a prospective study which evaluated the prognostic role of germline deleterious mutations in (g)HRR genes and the impact on mCRPC outcomes. In this study, we evaluated radiographic (r)-PFS, clinical (c)-PFS, and OS in PROREPAIR-B pts who meet CARD study eligibility criteria and who received CBZ and/or ARSi. Survival analysis were performed using Kaplan Meier method and Cox regression models.
Results
Of the 419 mCRPC pts included in PROREPAIR-B, 95 met CARD eligibility criteria and received CBZ (n=60) or ARSi (n=35) after 1/2L, including 14 gHRR carriers, 8/6 treated with CBZ/ARSi respectively. In contrast with CARD trial, ECOG 2, M1 at diagnosis, abiraterone as 1st ARSi and prior radiographic progression were more frequent in our series of pts (all p<0.05). Overall, CBZ demonstrated a greater benefit over ARSi in terms of rPFS (median 6.0 vs 3.7 months (m), p=0.03), cPFS (median 4.4 vs 3.4 m, p=0.01) and PSA50 response (39% vs 17%, p=0.027). No differences in terms of OS were observed between the two groups. Overall, gHRR carriers had a significant worse prognosis (OS HR 1.9; rPFS HR 2.4; cPFS HR 2.6) comparing with non-carriers. In gHRR carriers, CBZ treatment was not superior to ARSi in terms of rPFS (2.5 vs 3.0 m, p=0.8), cPFS (2.5 vs 2.4 m, p=0.8) and OS (4.5 vs 3.7, p=0.8).
Conclusions
The results of our study confirm the superiority of CBZ treatment over alternative ARSi in unselected mCRPC population. Selecting by the presence or not of alterations in gHRR, the results are generally poor regardless of treatment with CBZ or ARSi supporting the need of novel therapies in this setting.
Legal entity responsible for the study
IBIMA-CNIO.
Funding
Has not received any funding.
Disclosure
C. Llacer Perez: Speaker Bureau/Expert testimony: ROCHE; Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Angelini Pharma. N. Romero Laorden: Advisory/Consultancy: IPSEN; Advisory/Consultancy: Astellas; Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: Bayer; Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Research grant/Funding (institution): Pfizer; Advisory/Consultancy: Tesaro; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Sanofi. R. Lozano Mejorada: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: ROCHE; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen; Speaker Bureau/Expert testimony: Sanofi. J.M. Piulats: Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Janssen Oncology; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: VCN Biosciences; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Genentech; Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): Merck Sharp & Dohme; Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): MedImmune; Research grant/Funding (self): Pfizer; Research grant/Funding (self): EMD Serono; Research grant/Funding (self): Incyte. J. Puente: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): Astellas Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen-Cilag; Advisory/Consultancy: Merck Sharp & Dohme; Advisory/Consultancy: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Eisai; Advisory/Consultancy: EUSA Pharma; Advisory/Consultancy: Sanofi; Speaker Bureau/Expert testimony: Pierre Fabre; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: Kiowa; Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Lilly; Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Roche. D. Lorente Estelles: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Janssen Oncology; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer Health; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas Pharma; Travel/Accommodation/Expenses: Celgene. A. Medina: Honoraria (self), Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self): Merck; Travel/Accommodation/Expenses: Sanofi; Travel/Accommodation/Expenses: Roche; Non-remunerated activity/ies: Novartis. E. Almagro: Speaker Bureau/Expert testimony: MSD; Travel/Accommodation/Expenses: BMS. P. Borrega García: Advisory/Consultancy: Bayer; Advisory/Consultancy: Janssen-Cilag; Advisory/Consultancy: Astellas Pharma. R. Villatoro: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Ipsen; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas Pharma; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis. A. Rodriguez-Vida: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas Pharma; Honoraria (self): AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer Health; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self): Sanofi; Research grant/Funding (institution): Takeda; Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: Colvis Oncology; Travel/Accommodation/Expenses: Novartis. E. Gallardo: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Astellas Pharma; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self): Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer Schering Pharma; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen Oncology; Advisory/Consultancy: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Advisory/Consultancy, Speaker Bureau/Expert testimony: Rovi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Daiichi Sankyo; Advisory/Consultancy: EUSA Pharma; Speaker Bureau/Expert testimony: LEO Pharma; Speaker Bureau/Expert testimony: Menarini; Travel/Accommodation/Expenses: Pierre Fabre. E. Castro Marcos: Honoraria (institution), Travel/Accommodation/Expenses: Astellas Pharma; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen-Cilag; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Astellas Pharma. D. Olmos Hidalgo: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Honoraria (self): Sanofi; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Clovis Oncology; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Roche; Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution): Astellas Medivation; Research grant/Funding (institution): Tokai Pharmaceuticals; Travel/Accommodation/Expenses: Ipsen. 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.
626P - Cabazitaxel treatment in patients with metastatic castration-resistant prostate cancer (mCRPC) in daily practice: Interim analysis of the non-interventional SCOPE study
- Carsten Bokemeyer (Hamburg, Germany)
Abstract
Background
Docetaxel (D), cabazitaxel (C) and new hormonal therapies (H) prolong overall survival (OS) in mCRPC. CARD trial recently showed that a sequence including D, C and one H (abiraterone or enzalutamide) provides an optimal outcome in this setting (De Wit, NEJM 2019). SCOPE prospectively evaluates the activity and safety of C according to different sequences in mCRPC patients (pts) in daily practice.
Methods
SCOPE is an ongoing multinational, non-interventional study conducted in Germany, Austria and Switzerland in mCRPC pts previously treated with D in first line and starting C in daily practice. Medical history, previous therapies and outcome during C therapy are collected. Pts are followed for 24 months after start of C therapy. Primary endpoint is progression-free survival (PFS) with C according to different sequences. Here we provide interim study results at the cut-off date of Feb 20, 2020.
Results
From Oct 2015 to cut-off date, 356 pts (median age 73 yrs; bone mets 81.2%, visceral mets 25.0%, symptomatic 43.5%, ECOG 0-1 74.2%) were treated with C and completed the 24 months (mo) follow-up period. Of them, 180 (50.6%) received DCH and 176 (49.4%) received DHC. C was given at the dose of 25 mg/m2 in 93.5 % pts every 3 weeks for a median number of 5 cycles with prophylactic G-CSF in 43% of pts. Median PFS with C was 4.74 mo (95% CI 4.1-5.2) with DCH and 4.64 mo (95% CI 3.9-5.0) with DHC (p=0.52). A PSA decrease of ≥ 30% from baseline was reported by 38.3% and 33.0% of pts with DCH and DHC, respectively. Median time to PSA progression with C was 6.18 and 6.88 mo, median rPFS was 6.84 and 5.69 mo and median clinical PFS was 8.59 and 8.52 mo with DCH and DHC respectively. Percentage of pts still alive at 2 yrs from first C cycle were 15.0% and 11.4% with DCH and DHC, respectively. Most common all grade treatment emergent adverse events with C were fatigue (11.8%), anemia (8.2%), nausea (8.2%) and diarrhea (7.6%).
Conclusions
Preliminary results of SCOPE prospective study suggest that cabazitaxel administered in daily practice retains its activity after novel hormonal therapies and shows manageable safety profile. Source of funding: Sanofi.
Clinical trial identification
CABAZL07266.
Legal entity responsible for the study
Sanofi.
Funding
Sanofi.
Disclosure
C. Bokemeyer: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Sanofi; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck KGaA; Advisory/Consultancy: Merck Sharp Dohme; Honoraria (self): Roche; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb; Honoraria (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self): AstraZeneca; Advisory/Consultancy: Lilly; Advisory/Consultancy: Mundipharma; Advisory/Consultancy: Hexal; Advisory/Consultancy: GSO; Advisory/Consultancy: AOK Health Insurance. M-L. Amram: Advisory/Consultancy: Sanofi. F. Stoiber: Honoraria (self), Advisory/Consultancy: Sanofi. J. Gschwend: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Sanofi.
658P - Impact of a mutation in HSD3B1 gene on the effectiveness of androgenic deprivation treatment in prostate cancer
- Carla M. MartÃn Abreu (Santa Cruz de Tenerife, Spain)
Abstract
Background
Patients with advanced prostate cancer who receive androgen deprivation therapy (ADT) develop castration-resistant disease during the treatment.
Methods
Prospective and multicenter study was carried out during 29 months (October 2017- February 2020). Adults patients with castration-resistant prostate cancer (CRPC) on ADT treatment were included: ECOG < 3, adequate hepatic and hematopoietic function. The effectiveness was evaluated depending on progression free survival (PFS) considering biochemical, symptomatic and/or radiological progression. Germline DNA (gDNA) was isolated from a drop of dried blood deposited on a WhatmanTM 903 card paper according to the protocol of Ramos et al. (2015). Characterization of the
Results
During the study 68 patients with castration-resistant prostate cancer were included with an average age of 63 years old (48-89).
Conclusions
In our study population, rs1047303 polymorphism in
Legal entity responsible for the study
Martín-Abreu CM.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.