Abstract 1726
Background
Ramucirumab (RAM) with weekly paclitaxel (wPTX) is the recommended standard second-line therapy for advanced and recurrent gastric cancer (GC). In a recent phase II study, wNab-PTX + RAM combination for GC showed promising safety and efficacy, but it remains unclear whether wPTX + RAM or wNab-PTX + RAM should be used as second-line therapy. The previous ABSOLUTE Trial compared triweekly Nab-PTX, wNab-PTX, and wPTX in patients with advanced/recurrent GC as second-line therapy. Subgroup analysis of subjects with peritoneal dissemination (52.8%) showed that the hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS) in the wNab-PTX arm compared with the wPTX arm were 0.78 and 0.64, respectively. Therefore, we are investigating whether wNab-PTX + RAM is more effective than wPTX + RAM for patients with peritoneal dissemination.
Trial design
WJOG10617G/P-SELECT is an open-label, randomized, phase II study evaluating wPTX + RAM (arm A) versus wNab-PTX + RAM (arm B). Key eligibility criteria: 1) Histological diagnosis of primary GC, 2) unresectable or recurrent GC, 3) patients with peritoneal dissemination, 4) intolerant or refractory to first-line therapy including a fluoropyrimidine, and 5) ECOG Performance Status (PS) 0-2. Stratification factors are: institution, PS, and severity of ascites. Arm A comprises PTX 80 mg/m2(day 1,8,15) and RAM 8 mg/kg (day 1,15) every 4 weeks. Arm B comprises Nab-PTX 100 mg/m2(day 1,8,15) instead of PTX. The primary endpoint is OS, and the main secondary endpoints are PFS, objective response rate (ORR), safety, and neuropathy-specific quality of life (QOL). SPARC and Caveolin-1 (Cav-1) expression in tumor tissues will be evaluated as predictive biomarkers for efficacy. Pharmacokinetics of RAM will also be assessed. The required sample size for the full analysis was 50 patients per group to maintain a probability of 70% or higher that the HR for OS in arm B would be lower than 0.90. Enrollment was therefore set at 105 subjects. This study has enrolled 26 patients as of March 31, 2019.
Clinical trial identification
jRCTs031180022, 27 September 2018.
Editorial acknowledgement
Legal entity responsible for the study
WJOG (West Japan Oncology Group).
Funding
Taiho Pharmaceutical Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5203 - Novel fusion genes identified from matched primary and recurred breast cancers by RNA-sequencing
Presenter: Soojeong Choi
Session: Poster Display session 2
Resources:
Abstract
5873 - Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer
Presenter: Donna Fitzgerald
Session: Poster Display session 2
Resources:
Abstract
3588 - The role of AXL as mechanism of resistance to trastuzumab and a prognostic factor in breast cancer HER2 positive: a translational approach.
Presenter: Anna Adam-Artigues
Session: Poster Display session 2
Resources:
Abstract
5640 - Untargeted assessment of tumor fractions in plasma for monitoring and prognostication from metastatic breast cancer patients undergoing systemic treatment
Presenter: Marija Balic
Session: Poster Display session 2
Resources:
Abstract
2616 - Clinical application of mutational analysis in breast cancer patients: the relevance of PIK3CA analysis for precision medicine.
Presenter: Juan Miguel Cejalvo
Session: Poster Display session 2
Resources:
Abstract
3870 - A retrospective gene expression analysis of surgically-removed Breast Cancer Brain Metastasis (BCBM)
Presenter: Meritxell Mallafré-Larrosa
Session: Poster Display session 2
Resources:
Abstract
1240 - Endocrine therapy alone versus targeted combination strategy as first line treatment in elderly patients with hormone receptor-positive advanced breast cancer: meta-analysis of Phase II and III randomized clinical trials
Presenter: Claudia Omarini
Session: Poster Display session 2
Resources:
Abstract
5535 - Alpelisib (ALP) + fulvestrant (FUL) for patients with hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC): management and time course of key adverse events of special interest (AESIs) in SOLAR-1
Presenter: Hope Rugo
Session: Poster Display session 2
Resources:
Abstract
3093 - Changes in Hormone-Receptor status in Luminal breast cancers between primary tumor and metastases: results of the observational cohort GIM-13 AMBRA Study
Presenter: Marina Cazzaniga
Session: Poster Display session 2
Resources:
Abstract
1378 - MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)
Presenter: Miguel Martín
Session: Poster Display session 2
Resources:
Abstract