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
3911 - Defining a SUV decrease cut-off in PET/CT response monitoring after one cycle of preoperative breast cancer chemotherapy
Presenter: Marcin Kubeczko
Session: Poster Display session 2
Resources:
Abstract
1849 - Effect of thioredoxin 1 quantity detection to complement the mammography in breast cancer diagnosis
Presenter: Younju Lee
Session: Poster Display session 2
Resources:
Abstract
2221 - Identification of ultralow risk breast cancer patients (probable overdiagnosis)
Presenter: Salvador Gamez Casado
Session: Poster Display session 2
Resources:
Abstract
5291 - Prevalence of Vitamin D3 deficiency among women with early breast cancer receiving chemotherapy in an oncology dayward.
Presenter: Warner Finstad
Session: Poster Display session 2
Resources:
Abstract
4247 - Changes in ER pathway activity score during neoadjuvant letrozole to assess therapy response and predict disease free survival (DFS) in ER positive breast cancer patients
Presenter: Arran Turnbull
Session: Poster Display session 2
Resources:
Abstract
568 - Second primary malignancies in patients with breast cancer.
Presenter: Carlos Erasun Lecuona
Session: Poster Display session 2
Resources:
Abstract
1428 - Phase II randomized trial of neoadjuvant trastuzumab and pertuzumab (TP) with either palbociclib + letrozole (Pal+L) or paclitaxel (Pac) for elderly patients with estrogen receptor & HER2 positive (ER+/HER2+) Breast Cancer (BC) (International Breast Cancer Study Group IBCSG 55-17, TOUCH)
Presenter: Laura Biganzoli
Session: Poster Display session 2
Resources:
Abstract
1479 - Neoadjuvant HER2-targeted therapy with or without immunotherapy with pembrolizumab (neoHIP): an open label randomized phase 2 trial
Presenter: Heather McArthur
Session: Poster Display session 2
Resources:
Abstract
1481 - A randomized phase 2 study of peri-operative ipilimumab, nivolumab and cryoablation versus standard care in women with residual, early stage/resectable, triple negative breast cancer after standard-of-care neoadjuvant chemotherapy
Presenter: Heather McArthur
Session: Poster Display session 2
Resources:
Abstract
4334 - ALEXANDRA/IMpassion030: A phase 3 study of standard adjuvant chemotherapy with or without atezolizumab in early stage triple negative breast cancer.
Presenter: Michail Ignatiadis
Session: Poster Display session 2
Resources:
Abstract