Browsing Over 1780 Presentations
1839P - Infectious complications post-cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: A meta-analysis
- Akhil Jain (New Delhi, Rohini, India)
Abstract
Background
The intraoperative administration of Hyperthermic Intraperitoneal Chemotherapy is a novel treatment strategy that tries to provide similar therapeutic effects while avoiding some of the limitations of traditional treatment. The purpose of this analysis is to systemically review the available clinical studies to determine the infection rates postoperatively as complication of HIPEC with CRS procedure. As there are currently evolving guidelines for clinical application of this intervention this study helps in evaluating the safety of combined CRS and HIPEC for rates of infection.
Methods
A detailed comprehensive search for all relevant studies was conducted through PubMed, MEDLINE and Google scholar using search words as (((“Cytoreduction Surgical Procedures/adverse effects”[Mesh]) AND “Hyperthermic Intraperitoneal Chemotherapy/adverse effects”[Mesh]) AND “Infections”[Mesh]) AND “Neoplasms”[Mesh]. Extracted data was analysed using Rev Man software and random effect model using self-designed tables.
Results
Out of 41 studies included, 24 were retrospective, while 17 were prospective studies. These studies matriculated a total of 10303 procedures of CRS with HIPEC; out of which, 2704 (26.24%) episodes of infections were observed while no infection was noted in 7675 (74.49%) procedures. Random effect model was used for outcome analysis which showed significant heterogeneity (I2 = 97%) but overall effect size was significant (p<0.00001). The funnel plot of infection vs no infection was asymmetrical on visual inspection. Risk ratio was 0.37 (0.30, 0.49) for development of infectious complications. The most common infections were SSI (1075, 39.8%) followed by sepsis (519, 19.2%). Mortality rate was recorded in 35 (out of 41)studies and found highest (42.1%) in study by Elgendy et al. Increased stay in hospital was reported, (minimum 1 – maximum 177 days) in patients developing infections.
Conclusions
CRS with HIPEC is a safe and effective treatment procedure under trained supervision, with no increased risk of infection. Infectious complications can be effectively managed with a multi-disciplinary approach involving oncosurgeons and infectious disease specialists for optimal patient outcomes. As a result of the possible survival advantages CRS and HIPEC provide, it would be prudent to study the complications associated with this novel surgical technique in an appropriately designed prospective study.
Editorial acknowledgement
Scientific editing was provided by Dr. Rima Shah (MD Pharmacology), Assistant professor in Department of Pharmacology, GMERS Medical College, Gandhinagar, India.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
357P - A phase II study of anlotinib in the treatment of recurrent high-grade glioma
- Hui Dai (Hangzhou, China)
Abstract
Background
Recurrent high-grade glioma is associated with limited survival and there is no standard treatment option currently. We assessed if anlotinib, a multitarget tyrosine kinase inhibitor, is safe and effective for the treatment of these patients.
Methods
This is an open-label, single-arm, single-center, phase II clinical trial (NCT04822805). Eligible patients were aged more than 18 years old, histologically confirmed high grade glioma with progression after surgery followed by radiotherapy and temozolomide chemotherapy. Additional inclusion criteria included KPS≥60, disease progression on MRI as defined by Response Assessment in Neuro-Oncology (RANO) criteria at least 12 weeks after completion of postoperative adjuvant radiotherapy. Patients were received 12mg anlotinib once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Safety assessment was done in patients who received at least one dose of anlotinib. Here we report the results of a planned interim analysis.
Results
From April 2020 to February 2021, 12 of 27 patients (9 males and 3 females) were enrolled, and the median age is 57 (range 23-69). Pathological types included glioblastoma (n=9), anaplastic astrocytoma (n=2), anaplastic oligodendroglioma (n=1). At the data cutoff date on April 22, 2021, the median duration of treatment was 8.1 months, and the median PFS was not reached. 11 patients were eligible for the evaluation of tumor response. 2 achieved complete response (CR), 3 achieved partial response (PR) and the objective response rate (ORR) was 45.4% (5/11). 6 had stale disease (SD) and the disease control rate (DCR) was 100% (11/11). The clinical benefit rate (CBR), defined as the proportion of patients who achieved durable disease control (CR/PR/SD) more than 6 months, was 72.7% (8/11). Most adverse events were grade 1 or 2. Grade 3 adverse events occurred in 3 (25%) of 12 patients, included seizures, neutropenia, leukopenia, respectively. And there was a death due to intracranial hemorrhage during the treatment.
Conclusions
This interim analysis showed anlotinib is effective and well toleranced for recurrent high-grade glioma patients.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
936P - Effects of tislelizumab (TIS) monotherapy on health-related quality of life in patients with previously treated unresectable hepatocellular carcinoma (HCC)
- Zhenggang Ren (Shanghai, China)
Abstract
Background
In a multi-national phase II study (NCT03419897), single-agent TIS, an anti-PD-1 antibody, was well tolerated and demonstrated durable antitumor activity in patients with previously systemically treated unresectable HCC. This study also assessed the effects of TIS on health-related quality of life (HRQoL) using the EORTC QLQ-C30 and QLQ-HCC18 instruments. Here we present the results from the QLQ-C30 global health status (GHS)/QoL scale and the QLQ-HCC18 index and the scales for the key symptom of fatigue.
Methods
Tislelizumab (200 mg) was administered IV every 3 weeks until no further clinical benefit was observed. HRQoL was assessed at baseline and every 6 weeks thereafter up to cycle 12. Least-squares mean score change from baseline to cycles 6 and 12 was assessed using a mixed model for repeated measurement; change from baseline ≥10 points was considered clinically meaningful. Analysis was conducted for the overall population and by subgroups with 1 prior or ≥2 prior lines of therapy.
Results
Of the 249 enrolled patients (1 prior line, n=138; ≥2 prior lines, n=111), most were male (87%), median age was 62 years (28-90 years), and the majority (94%) had previously received sorafenib. Across the population, median treatment duration was 4.1 months and the median number of cycles completed was 6. At cycles 6 and 12 GHS/QoL, index and fatigue scores remained stable ( Abbreviations CI, confidence interval; GHS/QoL, global health status/quality of life scale; LS mean, least-squares mean.
All (N=249) LS mean change (95% CI) 1 Prior Line (n=138) LS mean change (95% CI) ≥2 Prior Lines (n=111) LS mean change (95% CI) Cycle 6 Cycle 12 Cycle 6 Cycle 12 Cycle 6 Cycle 12 n = 127 n = 59 n = 75 n = 34 N = 52 n = 25 -2.0 (-4.7, 0.6) 0.4 (-3.3, 4.1) -2.4 (-5.8, 1.0) -0.9 (-5.8, 4.0) -1.7 (-5.6, 2.3) 1.7 (-3.9, 7.4) n = 128 n = 60 n = 75 n = 35 n = 53 n = 25 2.6 (0.8, 4.4) 2.2 (0.4, 4.1) 0.9 (-1.5, 3.3) 4.1 (1.7, 6.5) 4.3 (1.6, 7.0) 0.3 (-2.5, 3.1) 3.7 (0.4, 6.9) 1.3 (-1.9, 4.5) 0.6 (-3.6, 4.9) 3.5 (-0.7, 7.7) 6.7 (1.7, 11.6) -0.9 (-5.8, 4.0)
Conclusions
These results showed no deterioration of HRQoL in patients treated with TIS with unresectable HCC, a patient population where HRQoL often deteriorates overtime. These results, along with promising efficacy and manageable tolerability findings from this trial, are promising results highlighting a good benefit risk profile of TIS in HCC patients particularly in pretreated patients.
Editorial acknowledgement
Medical writing support was provided by Jason Allaire, PhD (Generativity).
Legal entity responsible for the study
BeiGene, Ltd.
Funding
BeiGene, Ltd.
Disclosure
Z. Ren: Financial Interests, Personal, Other, Consulting: AstraZeneca; Financial Interests, Personal, Other, Consulting: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Other, Consulting: Merck; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. E. Assenat: Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. L. Rimassa: Financial Interests, Institutional, Research Grant: Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Zymeworks; Financial Interests, Personal, Other, Consulting fees: Amgen, ArQule, AstraZeneca, Basilea, Bayer, BMS, Celgene, Eisai, Exelixis, Genenta, Hengrui, Incyte, Ipsen, IQVIA, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi, Zymeworks; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene; Financial Interests, Personal, Speaker’s Bureau: AbbVie, Amgen, Bayer, Eisai, Gilead, Incyte, Ipsen, Lilly, Merck Serono, Roche, Sanofi; Financial Interests, Personal, Advisory Board, Travel expenses: Ipsen. W. Fang: Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. B. Tang: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. S. Chica Duque: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. V. Li: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. J. Wu: Financial Interests, Personal, Full or part-time Employment: BeiGene; Non-Financial Interests, Personal, Other, Medical writing: BeiGene. Y. Wang: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support: BeiGene. G. Barnes: Financial Interests, Personal, Full or part-time Employment: BeiGene; Financial Interests, Personal, Stocks/Shares: BeiGene; Non-Financial Interests, Personal, Other, Medical writing support; conference registration and travel: BeiGene.
1808P - MET fusions as therapeutic targets in solid tumors
- Sabrina Borchert (Essen, Germany)
Abstract
Background
MET is a receptor tyrosine kinase being involved in a plethora of physiologic and developmental processes. MET-inhibitors, e.g. crizotinib, capmatinib or lenvatinib, are effective in cancers with MET exon 14 skipping mutations or with top-level MET amplifications. Emerging evidence indicates that also MET fusions represent a predictive biomarker for potentially effective MET inhibition. However, data on frequencies and subtypes of MET fusions among solid tumors are limited so far.
Methods
545 solid cancers has been investigated with a targeted RNA sequencing approach (Archer® FusionPlex® CTL Panel) using anchored multiplex PCR and, thus, enabling the detection of novel MET translocation partners. MET amplification status was obtained from FISH and/or DNA-based NGS analyses in a subset of samples. Biologic and clinical relevance of MET fusions was determined by analysis of intragenic breakpoints, transcript and protein expression, gene amplification status and database research.
Results
Eight cases with MET -fusions were detected, representing 1.5% of the entire cohort. We found novel subtypes which have not been described so far: ETV6-MET, CAPZA2-MET, and EPS8-MET. Previously reported fusions include TRIM26-MET, PTPRZ1-MET. Affected entities were anaplastic- and papillary thyroid carcinomas, NSCLC and cholangiocarcinomas. Several cases showed concomitant MET amplification. Based on our ancillary evaluations, we regard the majority of fusions pathogenic, but found also rearrangements with low propensity to represent an oncogenic driver and a therapeutic target, i.e. CAPZA2-MET. Some of those passenger aberrations were associated with MET amplification. Pathogenic MET fusions were mutually exclusive with any common driver mutation in the respective tumor entities.
Conclusions
MET fusions represent an ultra-rare finding among solid cancers and were found in 1.5% of our series of 545 cancers mainly originating from lung, thyroid, pancreas and biliary tract. Careful bioinformatic evaluation is mandatory to select patients who may benefit from MET inhibitor treatment. Based on our findings we conclude that detection of MET fusions can be a useful enrichment of biomarker testing in solid tumors and MET inhibitors might be considered if standards of evaluation are considered.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
322P - Intrathecal catheter for chemotherapy in leptomeningeal metastatic breast cancer
- Lila Autier (Angers, France)
Abstract
Background
Therapeutic advances have improved systemic control and overall survival (OS) in advanced breast cancer (aBC) especially in RH + / HER2- and HER2 +). Patients with leptomeningeal metastasis (LM), with an increasing frequency (5 to 20% of aBC), have limited therapeutic options in a drug sanctuary, and present short outcomes: 4–6 weeks when untreated.One of the therapeutic option consist on intrathecal (IT) CSF chemotherapy (mainly methotrexate, thiotepa, cytarabine +/- hydrocortisone). Intrathecal catheter connected to a subcutaneous port is a recent option that arose during the last decade for intrathecal chemotherapy and represent a less invasive option, easier to manage than an intraventricular device. The current study was conducted to evaluate the efficacy and safety of intra-cerebro spinal fluid (CSF) chemotherapy in aBC.
Methods
We retrieved retrospectively data from patients treated for an aBC with LM, using intrathecal device for intrathecal chemotherapy between January 2013 and May 2020 at ICO. Primary endpoint was overall survival.
Results
Thirty patients were implanted and received intrathecal Chemotherapy. All Patients harbored HER2 negative aBC included 7 patients with triple-negative BC. The median follow-up was 76.5 months (95% confidence interval (CI): 11.6-NA). All patients received Intra CSF methotrexate (15 mg) and/or received thiotepa (60%), associated with hydrocortisone. The median number of courses per patient was 8 (range: 2 to 27). The median overall survival was 158 days (95%CI: 87-235). Only three complications were worth to be reported (One dislodgment, one infection and one hematoma). Repetitive chemotherapy infusions were accurate and easy to give but also painless and well tolerated by the patient.
Conclusions
Intrathecal chemotherapy through a catheter implanted is an efficient option to manage IT chemotherapy for aBC and is suitable for long-term use with a good tolerance profile of repeated injections. The OS data are consistent with recent studies. Patient reported outcomes (PRO) in evaluation of IT chemotherapy toxicity are being developed.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
P. Augereau: Financial Interests, Other, Consulting public presentation: AstraZeneca; Financial Interests, Other, Consulting public presentation: Novartis; Financial Interests, Other, Consulting public presentation: Pfizer; Financial Interests, Other, Consulting public presentation: Lilly. D. Dupoiron: Financial Interests, Other, consultant: Medtronic. All other authors have declared no conflicts of interest.
1106P - Phase I study of hepatic intralesional rose bengal disodium (PV10), an autolytic immunotherapy, in metastatic neuroendocrine neoplasms
- Timothy J. Price (Woodville, SA, Australia)
Abstract
Background
Metastatic neuroendocrine neoplasms (mNEN) require new treatment options. We investigated intralesional (IL) PV-10, an autolytic immunotherapy that may elicit a disease-specific functional adaptive immune response.
Methods
Phase 1 study evaluating safety, tolerability and impact on symptoms and biochemical markers resulting from IL PV-10 administered percutaneously to hepatic lesions in patients (pts) with progressive mNEN following standard therapy. Injected lesion(s) had to be 1.0 to 3.9 cm in longest diameter. Cohort 1 (n = 6): PV-10 IL single lesion per treatment cycle, Cohort 2 (n = 6): injections to multiple lesions per treatment cycle if suitable. Pts could receive further PV-10 ≥6 weeks after prior injection. The primary endpoint was safety. Secondary endpoints ORR assessed by contrast enhanced CT (RECIST 1.1) and [68Ga] Ga -DOTATATE PET, biochemical response (CgA) and patient-reported outcome (EORTC QLQ-C30 and GI.NET21).
Results
Twelve pts were enrolled, 50% male, median age 66 yrs (range 47-79). Primary sites: 7 small bowel, 2 pancreas, 1 caecal, 2 unknown; grade: Gd1 = 5, Gd2 = 7. All pts had received prior SSA and PRRT with progressive disease prior to enrolment. Median CgA was 1585 (range 35-10370). One lesion was injected per procedure for all 12 pts; none were suitable for multiple injections. Median dose per cycle (ml) was 1.9 (range 0.5-8.7). PV-10 treatment cycles; 4 n=1, 2 n=3, 1 n=8. Toxicity; Grade (gd) 1/2 transient post-procedure pain reported 9 pts, Photosensitivity rash gd 3 one patient; gd 1 elevation transaminases 2 pts, gd 3 in one, resolving by day 7. Gd 1/2 Carcinoid flare or increased flushing occurred in 6 pt. Gd 1/2 chromaturia was noted in 4 pts. ORR in injected lesions was 42%; overall disease control was 84%. CgA remained stable in 10 pts. Med PFS 9.2 months; OS 22.5 months. Estimated 3 yr PFS and OS is 27% & 49% respectively. HRQOL scores were stable or improved in 8 of 11 patients at mth1, and maintained at mth3 in 6 of 10 patients.
Conclusions
PV-10 elicited no safety concerns and multiple cycles were delivered safely in suitable patients. Encouraging evidence of local and systemic disease control with improvement in HRQoL was noted in a heavily pre-treated, progressing mNEN population.
Legal entity responsible for the study
Provectus.
Funding
Provectus.
Disclosure
E. Wachter: Financial Interests, Personal, Full or part-time Employment: Provectus. D. Rodrigues: Financial Interests, Personal, Full or part-time Employment: Provectus. G. Maddern: Financial Interests, Institutional, Research Grant: Provectus. All other authors have declared no conflicts of interest.
210P - TACH101, a first-in-class KDM4 inhibitor for treatment of triple-negative breast cancer
- Frank G. Perabo (Houston, TX, United States of America)
Abstract
Background
Triple-negative breast cancer (TNBC) represents nearly 20% of all breast cancers and is considered to be more aggressive and to have poorer prognosis due to lack of effective treatments. KDM4 is a family of histone demethylases shown to drive cancer by regulating transcription, cell cycle, and DNA replication/repair. Overexpression of KDM4 leading to mistakes in post-translational histone modification is associated with many. cancers, including TNBC.
Methods
TACH101 was evaluated in in vitro and in vivo studies including RNA knock-down experiments, cell-proliferation assays, apoptotic and cell cycle analyses, and efficacy studies in TNBC xenograft tumor models.
Results
TACH101 is a reversible, α-ketoglutarate competitive, selective and potent inhibitor of KDM4, with IC50 values < 0.1 μM for KDM4 isoforms A-D. Lentiviral shRNA experiments showed knockdown of KDM4 resulted in direct inhibitory effect on colony formation of breast 3D organoid culture models. TACH101 inhibited colony formation in replating experiments, suggesting a role for KDM4 in maintenance and propagation of tumor initiating cells (TIC). Further support for this mechanism was the finding that TACH101 reduced TIC frequency by 4.4-fold. TACH101 was broadly effective in killing 67% (200 out of 300) of cancer cell lines screened, including the MDA-MB-231 TNBC cell line (IC50 of 0.0035 μM). TACH101 treatment of MDA-MB-231 cells increased the cell population in S-phase indicating cell-cycle arrest. TACH101 induced apoptosis in MDA-MB-231 cells with EC50 of 0.132 μM. In vivo, TACH101 triggered effective tumor control in COH70 TNBC xenograft model with tumor growth inhibition > 85%. TACH101 effects on gene expression were evaluated. Protein Phosphatase 1 Regulatory subunit 10 (PPP1R10), a direct target of KDM4, was significant downregulated after 24 hours of treatment with TACH101.
Conclusions
Extensive preclinical work on TACH101 KDM4 inhibitor indicates compelling data and applicability as a potential therapy for TNBC. The preparations to advance the drug into clinical trials are underway.
Legal entity responsible for the study
Tachyon Therapeutics.
Funding
Tachyon Therapeutics.
Disclosure
F.G. Perabo, S. Yoo, C. Chandhasin: Financial Interests, Personal, Full or part-time Employment: Tachyon Therapeutics. J.R. Del Rosario, Y.K. Chen, E. Filvaroff: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. J. Stafford: Financial Interests, Personal, Full or part-time Employment: 858 Therapeutics. S. Quake, M. Clarke: Financial Interests, Personal, Member of the Board of Directors: Tachyon Therapeutics.
584P - Health-related quality of life (HRQoL) in ACIS: A phase III trial of apalutamide with abiraterone acetate and prednisone (APA + AAP) vs AAP in metastatic castration-resistant prostate cancer (mCRPC)
- Stephane M. Oudard (Paris, France)
Abstract
Background
In the updated analysis of radiographic progression-free survival (rPFS) in ACIS, median rPFS (primary end point) was extended by 7.4 mo with APA + AAP vs AAP with ongoing androgen deprivation therapy (p < 0.0001) in chemo-naive mCRPC patients (pts), with no significant new safety signals identified (Rathkopf ASCO GU 2021). Here we evaluate pt HRQoL.
Methods
982 mCRPC pts were randomized 1:1 to APA (240 mg QD) + AA (1000 mg QD) + P (5 mg BID) or placebo + AAP. HRQoL: assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) at cycle (C)1 (baseline [BL]) to C6, then every 3C to 12 mo after end of treatment (EOT); and Brief Pain Inventory-Short Form (BPI-SF) for 7 consecutive days each C to EOT. Descriptive statistics and mean changes from BL using mixed model for repeated measures (LSM-MMRM) are reported.
Results
Completion rates: FACT-P, 67-75% (BL-C39); BPI-SF, 60-98% (BL-C43). There were no clinically meaningful differences between groups in LSM-MMRM for FACT-P total. BPI worst pain intensity and pain interference increased over time in both groups, with no clinically meaningful differences (threshold: ± 2 points). Median time to deterioration did not differ between groups for FACT-P total (HR 1.16, 95% CI 0.94-1.42), worst pain intensity (HR 1.11, 95% CI 0.92-1.34), and pain interference (HR 1.19, 95% CI 0.95-1.47). Most pts (90-96%) were “not at all” or “a little bit” bothered by side effects; most (70-79%) responded to “I have lack of energy” with “not at all” or “a little bit” (BL-C39). Side effect bother and fatigue were stable over time and comparable between groups. PRO scores were similar in both groups prior to radiographic progression of disease (rPD) and at last observation (Table). aPRO score prior to rPD b257 (APA + AAP) and 330 (AAP) pts had rPD cLast PRO score dHigher PRO score: more favorable HRQoL eHigher BPI score: worse pain-related outcome SE, standard error
PRO group mean scores (SE) APA + AAP AAP BL Before rPDa,b Last observationc BL Before rPDa,b Last observationc Pts, n 114 114 114 141 141 141 FACT-Pd 122.6 (1.4) 117.7 (1.8) 113.4 (1.7) 119.8 (1.6) 119.3 (1.6) 115.3 (1.8) Prostate Cancer Subscaled 35.6 (0.5) 34.3 (0.6) 33.1 (0.6) 34.9 (0.6) 34.9 (0.5) 34.0 (0.5) Pts, n 202 202 202 265 265 265 BPI-SF Average Paine 0.6 (0.1) 0.8 (0.1) 1.0 (0.1) 0.7 (0.1) 0.8 (0.1) 1.0 (0.1) BPI-SF Pain Interferencee 0.5 (0.1) 0.8 (0.1) 0.9 (0.1) 0.6 (0.1) 0.7 (0.1) 0.9 (0.1)
Conclusions
Relative to AAP, treatment intensification with APA + AAP maintained HRQoL prior to rPD. The addition of APA to AAP significantly improved rPFS without compromising HRQoL in pts with mCRPC.
Clinical trial identification
NCT02257736.
Editorial acknowledgement
Ann Tighe, PhD, of Parexel International provided editorial assistance for this abstract.
Legal entity responsible for the study
Janssen.
Funding
Janssen.
Disclosure
S.M. Oudard: Financial Interests, Personal, Advisory Role: Pfizer, Bayer, Bristol-Meyers Squibb, Novartis, Eisai, Sanofi, Janssen, Astellas Pharma, MSD Oncology, Roche, Boehringer Ingelheim, Ipsen; Financial Interests, Personal, Other, Honoraria: Pfizer, Bayer, Merck, Bristol-Meyers Squibb, Novartis, Eisai, Sanofi, Astellas Pharma, Janssen, MSD, Ipsen, Roche/Genentech; Financial Interests, Personal, Funding, Research: Ipsen, Sanofi; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer, Bayer, Merck, Bristol-Myers Squibb, Novartis, Eisai, MSD oncology, Roche, Boehinger Ingelheim. K.B. Bevans: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. G. Attard: Financial Interests, Personal, Advisory Role: Janssen-Cilag, Veridex, Ventana Medical Systems, Astellas Pharma, Medivation, Novartis, Millennium, Abbott Laboratories, Essa, Bayer, Pfizer, AstraZeneca, Ferring; Financial Interests, Personal, Speaker’s Bureau: Janssen, Astellas Pharma, Takeda, Sanofi, Ventana Medical Systems, Ipsen, AstraZeneca, Ferring; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Janssen, Astellas Pharma, Medivation, Ventana Medical Systems, Abbott Laboratories, Bayer, ESSA, Pfizer Ferring; Financial Interests, Personal, Royalties: I am on The ICR rewards to inventors list of abiraterone acetate, Institute of Cancer Research; Financial Interests, Personal, Other, Honoraria: Janssen, Astellas Pharm; Financial Interests, Personal, Research Grant: Janssen, Arno Therapeutics, Innocrin Pharma. E. Efstathiou: Financial Interests, Personal, Other, Honoraria: Janssen-Cilag; Financial Interests, Personal, Advisory Board: Janssen-Cilag, AstraZeneca, Sanofi, Merck; Financial Interests, Personal, Speaker’s Bureau: Janssen Biotech, Sanofi Pasteur, AstraZeneca. T.W. Flaig: Financial Interests, Personal, Advisory Role: Seattle Genetics, Janssen Oncology; Financial Interests, Personal, Leadership Role: Aurora Oncology; Financial Interests, Personal, Royalties: The University of Colorado has filed 2 patents related in which I am an inventor. These are related to early-stage bladder cancer treatment and detection. Neither is commercialized or licensed at this time; Financial Interests, Personal, Stocks/Shares: Norvartis, Bavarian Nordic, Dendreon, GTx, Janssen Oncology, Medivation, Sanofi, Pfizer, Bristol-Myers Squibb, Roche/Genentech, Exelixis, Aragon Pharmaceuticals, Sotio, Tokai Pharmaceuticals, AstraZeneca/Medimmune, Lilly, Astellas Pharma, Agensys, Seattle. O.B. Goodman Jr: Financial Interests, Personal, Advisory Role: Janssen Oncology, Bayer; Financial Interests, Personal, Stocks/Shares: Bristol-Myers Squibb, Abbvie. U. De Giorgi: Financial Interests, Personal, Advisory Board: Astellas, Bayer, BMS, Ipsen, Janssen, Merck, Pfizer, Sanofi; Financial Interests, Personal, Other, Travel: BMS, Ipsen, Janssen, Pfizer; Financial Interests, Personal, Funding, Research: AstraZeneca, Roche, Sanofi. C.M. Pieczonka: Financial Interests, Personal, Advisory Role: Pfizer/Astellas, Bayer, Janssen Oncology, Tolmar, Sun Pharma, Dendreon, AstraZeneca, Merck, Bristol-Myers Squibb; Financial Interests, Personal, Leadership Role: Associated Medical Professionals of New York; Financial Interests, Personal, Speaker’s Bureau: Bayer, Dendreon, Pfizer, Astellas Pharma, Merck, Sun Pharma, Myovant Sciences, Tolmar, Janssen Oncology; Financial Interests, Personal, Stocks/Shares: US Urology Partners; Financial Interests, Personal, Other, Honoraria: Janssen, Dendreon, Pfizer/Astellas, Bayer, Sun Pharma, Tolmar, Myovant Sciences, Merck, AstraZeneca, Bristol-Myers Squibb; Financial Interests, Personal, Funding, Research: Bayer, Innocrin Pharma, Pfizer, Astellas Pharma, Merck, AstraZeneca, Advantagene, Dendreon, Janssen Oncology; Financial Interests, Personal, Full or part-time Employment: Associated Medical Professionals of New York. K. Yeruva: Financial Interests, Personal, Full or part-time Employment: Janssen Research & Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. P. De Porre: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S.D. Brookman-May: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S. Dibaj: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. D. Wu: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S.D. Mundle: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S. McCarthy: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. T. Steuber: Financial Interests, Personal, Other, Honoraria: Janssen, LLC; Financial Interests, Personal, Advisory Board: Janssen, LLC; Financial Interests, Personal, Speaker’s Bureau: Janssen, LLC; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Janssen, LLC. H. Suzuki: Financial Interests, Personal, Other, Honoraria: Takeda, Astellas Pharma, Janssen, Bayer, Sanofi, AstraZeneca, Nippon Shinyaku, Pfizer; Financial Interests, Personal, Advisory Board: Takeda, Ono Pharmaceutical, AstraZeneca, Lilly, Janssen, MSD, Roche, Bayer, Sanofi, Astellas Pharma, Sumitomo Group; Financial Interests, Personal, Other, Research Funding: Takeda, Astellas Pharma, Nippon Shinyaku, Kissei Pharmaceutical, Taiho Oncology, Sanofi, Bayer, Daiichi Sankyo. D.E. Rathkopf: Financial Interests, Personal, Advisory Board: Janssen, Genentech, AstraZeneca, Bayer, Myovant Sciences; Financial Interests, Personal, Funding: Janssen Oncology, Medivation, Celgene, Takeda, millennium, Ferring, Novartis, taiho Pharmaceutical, AstraZeneca, Genentech/Roche, TRACON Pharma, Bayer, Phosplatin Therapeutics. F. Saad: Financial Interests, Personal, Other, Honoraria: AbbVie, Amgen, Astellas, AstraZeneca/MedImmune, Bayer, Janssen, Sanofi; Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca/MedImmune, Bayer, Janssen, Sanofi; Financial Interests, Personal, Research Grant: Astellas, AstraZeneca/MedImmune, Bayer, Bristol-Myers Squibb, Janssen, Pfizer, Sanofi. All other authors have declared no conflicts of interest.
224P - Value of bone scintigraphy in breast cancer patients staged with computed tomography
- Vladislav N. Evseev (Saint-Petersburg, Russian Federation)
Abstract
Background
Staging of early breast cancer is a controversial issue. Current guidelines recommend consideration of a computed tomography (CT) scan of the chest, abdominal imaging and a bone scintigraphy (BS) for patients with clinically involved lymph nodes, big primary tumors and aggressive biologic subtypes. In clinical practice patients with early breast cancer are commonly staged with BS and CT scan of chest and abdomen. Nevertheless, additional value of bone scintigraphy in patients staged with CT scan remains not well studied.
Methods
All early breast cancer patients who were initially treated in the Oncology Department of Saint-Petersburg State University Hospital during period from January 2019 to March 2021 were included in this study. We retrospectively reviewed electronic medical records to identify all bone scintigraphies and CT scans performed on these patients during initial evaluation. Results of staging CT and BS were compared to evaluate the incidence of bone metastais not detected on CT scan, incidence of additional bone metasasis in the field of CT scan and of additional bone metastasis outside of CT scan field. Additionally, we reviewed how often bone scintigraphy changed therapeutic decisions.
Results
We identified 147 breast cancer patients staged with CT scan of chest and abdomen, of whom 73 (49,6%) had also undergone a bone scintigraphy. After complete staging 23 out of 147 patients (15,6%) were diagnosed with metastatic (stage IV) breast cancer. Out of 73 patients staged both with CT scan and BS 0 (0%) were upstaged because of BS results. Additional bone metastasis in CT scan field were detected in 1 out of 20 patients (5%). Additional bone metastasis outside of CT scan field were detected in 1 (5%) out of 20 patients. This metastasis was located in temporal bone. Bone scintigraphy changed therapeutic decisions in 0 patients.
Conclusions
Bone scintigraphy is often performed in breast cancer patients but plays very limited role in patients that were already staged with computed tomography scan of chest and abdomen. Undergoing this additional test doesn't change stage of the disease and doesn't detect additional bone metastasis in the majority of patients.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
1453P - Early interdisciplinary supportive care in patients with non-small cell lung cancer: A randomised controlled trial
- Mengting Chen (Chongqing, China)
Abstract
Background
Effective interventions to improve prognosis in non-small cell lung cancer (NSCLC) are urgently needed. We assessed the effect of the early integration of interdisciplinary supportive care for patients with NSCLC on the quality of life, psychological state, cancer pain and nutritional status.
Methods
We randomly assigned (1:1) patients with newly diagnosed NSCLC receive either early interdisciplinary supportive care (ESC) integrated with standard oncologic care or standard oncological care (SC) alone. Quality of life and psychological state were assessed at baseline and at 6 months with the use of the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire-9 (PHQ-9), respectively. Cancer pain and nutritional status were assessed with the use of the Numerical Rating Scale (NRS) and Patient-Generated Subjective Global Assessment (PG-SGA), respectively.
Results
From Oct 15, 2019, to Jun 12, 2020, 60 patients were enrolled: 30 in ESC group and 30 in the SC group. Compliance at 6 months was 77% (23 patients) in the ESC group versus 73% (22) in the SC group. Patients assigned to ESC group had a better quality of life than did patients assigned to SC group (mean score on the FACT-L scale, 122.3.0 vs. 113.0; P = 0.0007). In addition, fewer patients in the ESC group than in the SC group had anxiety (mean score on the HADS Anxiety subscale, 1.13 vs 2.86, P = 0.0005) and depressive (mean score on the HADS Depression subscale, 0.65 vs 3.56, P ＜0.0001) symptoms. The PHQ-9 results showed that 100% patients were free of depression in the ESC group versus 45.5% patients were free of depression, 55.5% had mild level (score 5-9) in SC group (P ＜0.0001). Furthermore, patients in the ESC group (moderate malnutrition was 60.9% and mild malnutrition was 39.1% according to PG-SGA) than in the SC group (severe malnutrition was 40.9%, moderate malnutrition was 50.0% and mild malnutrition was 9.1% according to PG-SGA) had a better nutritional status (P=0.001).
Conclusions
Among patients with non-small cell lung cancer, early integration of interdisciplinary supportive care led to significant improvements in quality of life, psychological state and nutritional status.
Legal entity responsible for the study
H. Yu.
Funding
Research Support from: Chongqing Talents Innovation Leading Talents Program (No.CQYC201903078); Key Project of the Climbing Funding of the National Cancer Center (No.NCC201822B74).
Disclosure
All authors have declared no conflicts of interest.
358P - Anlotinib plus temozolomide for recurrent glioma: A single-center, retrospective study of 30 cases
- Yuandong Cao (Nanjing, China)
Abstract
Background
The prognosis of patients with recurrent malignant glioma (rMG) is quite poor. According to the NCCN guidelines, bevacizumab is recommended drug for rMG. Anlotinib is a multitarget tyrosine kinase inhibitor that can inhibit tumor angiogenesis and tumor cell growth. We report results from this retrospective study to determine the efficacy and tolerability of Anlotinib plus temozolomide (TMZ) as a first-line treatment for rMG.
Methods
A total of 30 eligible patients who relapsed from the standard chemoradiotherapy regimen (TMZ and radiotherapy) or had macroscopic residual tumor after surgery because of tumor located in the eloquent brain areas were enrolled in this study between March 2018 and January 2021. Patients were subjected to a concurrent treatment of Anlotinib (12mg qd) and TMZ (200mg/m2, 5 days on with 23 days off) until disease progression or intolerable toxicity. Efficacy was evaluated using Response Assessment in Neuro-Oncology criteria for high-grade glioma. Safety was assessed using NCI-CTCAE 4.0. Survival was estimated with the Kaplan-Meier curve and log-rank test.
Results
All patients were eligible for efficacy analysis. The objective response rate (ORR) was 76.7%. The disease control rate (DCR) was 90%. The median progress-free survival time was 8.3 months. The median overall survival was 10.8 months. The most common treatment-related adverse events were hand-foot syndrome (43.3%), leukopenia (40%), transaminase elevation (40%), hypertension (30%), thrombocytopenia (30%), albuminuria (26.7%), hyperbilirubin (36.7%), anemia (23.3%), neutropenia (16.7%) and gastrointestinal reaction (13.3%). The rate of grade 3/4 AE was relatively low, including hand-foot syndrome 6.7% (2/30), thrombocytopenia 6.7% (2/30), and hyperbilirubin 3.3% (1/30).
Conclusions
Anlotinib combined with TMZ was effective in terms of PFS, ORR, and DCR, and was well tolerated. Further randomized controlled clinical studies are needed to confirm the efficacy of Anlotinib combined with TMZ for the treatment of rMG.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
1361TiP - Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-mutated (HER2m) metastatic non-small cell lung cancer (NSCLC): A phase (ph) II study (DESTINY-Lung02)
- Egbert F. F. Smit (Amsterdam, Netherlands)
Abstract
Background
Trial design
DESTINY-Lung02 (NCT04644237) is a multicenter, randomized, ph 2 study of T-DXd in pts with
Clinical trial identification
NCT04644237.
Editorial acknowledgement
Under the guidance of authors, assistance in medical writing and editorial support was provided by Cindy M. Rigby, PhD, of ApotheCom and funded by Daiichi Sankyo, Inc.
Legal entity responsible for the study
Daiichi Sankyo, Inc.
Funding
Daiichi Sankyo, Inc., and AstraZeneca.
Disclosure
E.F.F. Smit: Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, Bayer, Celgene, DSI, Eli Lilly, MSD, Merck, Novartis, Pfizer, Takeda, Regeneron, Roche Genentech, Roche Diagnostics. All institutional; Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Merck, MSD, Roche, Genentech. B.T. Li: Non-Financial Interests, Personal, Advisory Role: Daiichi Sankyo, AstraZeneca, Amgen, Genentech, Boehringer Ingelheim, Lilly; Financial Interests, Institutional, Research Grant: Amgen, Genentech, AstraZeneca, Daiichi Sankyo, Lilly, Illumina, GRAIL, Guardant Health, Hengrui Therapeutics, MORE Health and Bolt Biotherapeutics; Financial Interests, Personal, Other, Travel/Accommodations/Expenses: Resolution Bioscience, MORE Health, and Jiangsu Hengrui Medicine; Financial Interests, Personal, Licensing Fees: at Karger Publishers, Shanghai Jiao Tong University Press. J. Mazieres: Financial Interests, Personal, Other, Honoraria: Roche, BMS, MSD, AstraZeneca, Takeda, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Roche, Pierre Fabre, AstraZeneca. D. Planchard: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung; Financial Interests, Institutional, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, MedImmune, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo; Financial Interests, Personal, Advisory Role: AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche, Samsung; Financial Interests, Personal, Other, Travel expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer. K. Nakagawa: Financial Interests, Personal, Other, Honoraria: Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., Nanzando Co., Ltd, AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Roche Diagnostics K.K., MSD K.K., Eli Lilly Japan K.K., Nippon Kayaku Co., Ltd., Ono Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Bayer; Financial Interests, Personal, Advisory Role: Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Pfizer Japan Inc., KYORIN Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Research Grant: MSD K.K., AstraZeneca K.K., Pfizer Japan Inc., ICON Japan K.K., Astellas Pharma Inc., Bayer Yakuhin, Ltd., Takeda Pharmaceutical Co., Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., EPS International Co., Ltd., Bayer Yakuhin, Ltd., Bri. K. Goto: Financial Interests, Personal, Other, Honoraria: Daiichi Sankyo Co., Ltd.; Financial Interests, Personal, Research Grant: Daiichi Sankyo Co., Ltd. L. Paz-Ares: Financial Interests, Personal, Speaker’s Bureau: Roche, MSD, Merck Serono, BMS, AstraZeneca, Eli Lilly, Pfizer, PharmaMar, Bayer, AbbVie, Amgen, Janssen, GSK, Novartis, Ipsen, Boehringer Ingelheim, Takeda, Sanofi, Blueprint, Mirati; Financial Interests, Institutional, Research Grant: BMS, AstraZeneca, PharmaMar. S. Novello: Financial Interests, Personal, Advisory Role: AstraZeneca, BI, Beigene, MSD, Eli Lilly, Takeda, Pfizer, Roche, Amgen, Sanofi, BMS; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, BI, Beigene, MSD, Eli Lilly, Takeda, Pfizer, Roche, Amgen, Sanofi, BMS. J.C-H Yang: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Roche, MSD, Pfizer, Novartis, BMS, AstraZeneca, Takeda Oncology; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Eli Lilly, Bayer, Roche, MSD, Pfizer, Novartis, BMS, Ono Pharmaceutical, AstraZeneca, Merck Serono, Yuhan Pharmaceutical, Daiichi Sankyo, Takeda Oncology, Amgen, Janssen, Eisai. M-J. Ahn: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Takeda, MSD, Ono, BMS, Lilly, Amgen, Merck, Roche; Financial Interests, Institutional, Advisory Role: AstraZeneca, Takeda, MSD, Ono, BMS, Lilly, Amgen, Merck, Roche, Alpha Pharmaceuticals; Financial Interests, Personal, Research Grant: AstraZeneca, Roche. G. Liu: Financial Interests, Personal, Advisory Role: Pfizer, Novartis, AstraZeneca, Takeda, BMS, Roche, Bayer; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Takeda, Pfizer; Financial Interests, Institutional, Research Grant: Takeda, AstraZeneca, Boehringer Ingelheim. K. O'Byrne: Financial Interests, Personal, Other, Honoraria: Pfizer, Roche, AZ, Boehringer Ingelheim, BMS, MSD, Novartis, Teva, Janssen, Natera, Yuhan; Financial Interests, Personal, Advisory Role: Pfizer, Roche, AZ, Boehringer Ingelheim, BMS, MSD, Novartis, Teva, Janssen, Natera, Yuhan, TriStar; Financial Interests, Personal, Speaker’s Bureau: Roche, AstraZeneca, BMS, Boehringer Ingelheim, MSD, Pfizer, Foundation Medicine; Financial Interests, Personal, Stocks/Shares: Carpe Vitae Pharmaceuticals, RepLuca Pharmaceuticals and DGC Diagnostics; Financial Interests, Institutional, Research Grant: Carpe Vitae Pharmaceuticals, RepLuca Pharmaceuticals; Financial Interests, Personal, Other, Travel/Accommodations/Expenses: Roche, BMS, MSD, Boehringer Ingelheim (conference attendance/presentations); Financial Interests, Personal, Licensing Fees: Carpe Vitae Pharmaceuticals, RepLuca Pharmaceuticals (Intellectual property/patents); Financial Interests, Personal, Member of the Board of Directors: Carpe Vitae Pharmaceuticals Board Member; Financial Interests, Personal, Other, Non-remunerated activity/ies: Convenor and co-convenor of academic meetings supported by pharm and biotech companies. M. Aregay: Financial Interests, Personal, Other, Full/Part-time employment: Daiichi Sankyo Co., Ltd.; Financial Interests, Personal, Stocks/Shares: Daiichi Sankyo Co., Ltd. R. Shiga: Financial Interests, Personal, Other, Full/Part-time employment: Daiichi Sankyo, Inc. K. Saxena: Financial Interests, Personal, Other, Full/Part-time employment: Daiichi Sankyo, Inc. G. Meinhardt: Financial Interests, Personal, Other, Full/Part-time employment: Daiichi Sankyo, Inc.; Financial Interests, Personal, Stocks/Shares: Bayer, Daiichi Sankyo. P.A. Jänne: Financial Interests, Personal, Advisory Role: Pfizer, Boehringer Ingelheim, AstraZeneca, Merrimack, Chugai Pharma, Roche/Genentech, Loxo, Mirati Therapeutics, Araxes Pharma, Ignyta, Lilly, Takeda, Novartis, Biocartis, Voronoi Health Analytics, SFJ Pharmaceuticals Group, Sanofi, Biocartis, Daiichi Sankyo; Financial Interests, Personal, Stocks/Shares: Gatekeeper Pharmaceuticals, Loxo; Financial Interests, Personal, Research Grant: AstraZeneca, Astellas Pharma, Daiichi Sankyo, Lilly, Boehringer Ingelheim, Puma Biotechnology, Takeda, Revolution Medicines; Financial Interests, Personal, Licensing Fees: I am a co-inventor of DFCI owned patent on EGFR mutations licensed to Lab Corp. I receive post-marketing royalties from this invention.