Abstract 2198
Background
A phase 2 study in first-line mCRC patients non-eligible for intensive therapy (TASCO1, NCT02743221) treated with trifluridine/tipiracil-bev (TT-B, n = 77) or capecitabine-bev (C-B, n = 76), reported a longer median PFS with TT-B (9.2 months) than with C-B (7.8 months). The hazard ratio (HR) for progression between TT-B and C-B was 0.71 (95% CI, 0.48 to 1.06). Preliminary median OS was 18 months with TT-B and 16.2 months with C-B (HR, 0.56; 95% CI 0.32 to 0.98). The safety of TT-B was found to be acceptable with, for all-grade toxicities, more gastrointestinal and hematologic toxicities but a much lower rate of hand-foot syndrome than C-B (serious febrile neutropenia 3.9% with TT-B or C-B and diarrhoea grade 3-4: 1.3% with TT-B vs. 7.9% with C-B). Following this phase 2 trial, a global confirmatory phase 3 trial (SOLSTICE) has been initiated.
Trial design
This phase 3, international, open-label, randomized study will include 854 first-line mCRC-patients, not candidate for intensive oxaliplatin- or irinotecan-based chemotherapy and non-eligible for curative resection, according to investigator’s judgment and in relation with age, performance status (PS), low tumour burden, comorbidities or non-clinical reasons. The stratification factors are ECOG PS (0 vs 1 vs 2), tumour localization (right vs left) and reason for non-eligibility to intensive therapy. Patients will be randomly allocated to trifluridine/tipiracil (35 mg/m2 given orally bid on days 1–5 and 8–12 in a 28-day cycle) plus bev (5 mg/kg on days 1 and 15 of a 28-day treatment cycle) or capecitabine (1250 or 1000 mg/m²/dose bid on days 1-14 in a 21-day) plus bev (7.5 mg/kg on day 1 in a 21-day treatment cycle). The primary endpoint is PFS and the key secondary endpoint is OS. Other secondary endpoints include safety and quality of life assessed by EORTC QLQ-C30 and EQ-5D questionnaires. Patients will also undergo comprehensive geriatric assessment using G8 questionnaire and Charlson Comorbidity Index at baseline. Inclusion of the first patient was done in March 2019. It is planned to open approximately 200 centers in 25 countries.
Clinical trial identification
NCT03869892; March 11, 2019.
Editorial acknowledgement
Legal entity responsible for the study
Institut de Recherches Internationales Servier.
Funding
Institut de Recherches Internationales Servier.
Disclosure
T. Andre: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche/Genentech, Amgen, Bristol-Myers Squibb, MSD Oncology and Servier, and honoraria from Roche/Genentech, Sanofi, Baxter, Bayer, Bristol-Myers Squibb, Amgen, MSD Oncology, Servier, XBiotech, and Novartis. M.P. Saunders: Advisory / Consultancy: Roche, Merck, Servier, Amgen, Sanofi, and Eisai. A. Kanehisa: Full / Part-time employment: IRIS. E. Gandossi: Full / Part-time employment: IRIS. R. Fougeray: Full / Part-time employment: IRIS. N. Causse-Amellal: Full / Part-time employment: IRIS. A. Falcone: Advisory / Consultancy, Research grant / Funding (institution): Amgen, Bayer, Merck, MSD, Roche, Lilly, Servier, Bristol.
Resources from the same session
4317 - Prognostic factors analysis of 343 patients with adenocarcinoma of esophagogastric junction
Presenter: Yixun Lu
Session: Poster Display session 2
Resources:
Abstract
4099 - Effects of preoperative preparation time on efficacy of neoadjuvant chemotherapy (SOX) in patients with advanced gastric cancer
Presenter: Xinxin Wang
Session: Poster Display session 2
Resources:
Abstract
3769 - The prognostic value of higher absolute lymphocyte counts for patients with surgically resected non-advanced gastric cancer
Presenter: Se Jun Park
Session: Poster Display session 2
Resources:
Abstract
1718 - Trastuzumab and pertuzumab added to neoadjuvant chemoradiotherapy in resectable HER2+ esophageal adenocarcinoma patients: an update on survival and predictive biomarkers in the TRAP study
Presenter: Charlotte Stroes
Session: Poster Display session 2
Resources:
Abstract
5403 - Interim analysis of a phase II trial of perioperative chemotherapy plus avelumab in esophagogastric and gastric adenocarcinoma
Presenter: Thierry Alcindor
Session: Poster Display session 2
Resources:
Abstract
591 - Evaluation of the introduction of primary G-CSF prophylaxis to the FLOT chemotherapy regimen.
Presenter: Kelly-Marie Crampton
Session: Poster Display session 2
Resources:
Abstract
1402 - Subgroup analyses of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with 2 and 4 courses of cisplatin/S-1 (CS) and docetaxel/cisplatin/S-1 (DCS) as neoadjuvant chemotherapy for locally advanced gastric cancer
Presenter: Tsutomu Hayashi
Session: Poster Display session 2
Resources:
Abstract
3743 - HER2 Copy Number as Predictor of Disease-Free Survival in HER2-Positive Resectable Gastric Cancer
Presenter: Zimin Liu
Session: Poster Display session 2
Resources:
Abstract
2032 - Effect of neoadjuvant chemotherapy on the Programmed Death-1 pathway in esophageal and gastric cancer
Presenter: Maria Svensson
Session: Poster Display session 2
Resources:
Abstract
4304 - A user-friendly nomogram to predict relapse-free survival (RFS) in western patients with resected gastric cancer (GC)
Presenter: Massimiliano Salati
Session: Poster Display session 2
Resources:
Abstract