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
5124 - STAR_PAC: Phase I clinical trial repurposing all trans retinoic acid (ATRA) as stromal targeting agent in a novel drug combination for pancreatic cancer.
Presenter: Hemant Kocher
Session: Poster Display session 2
Resources:
Abstract
5257 - Outcomes of First Line FOLFIRINOX (FFX) Versus Gemcitabine and Nab-Paclitaxel (GN) in Patients with Advanced Pancreatic Cancer: Multi-Institutional Canadian Sites Experience
Presenter: Neha Papneja
Session: Poster Display session 2
Resources:
Abstract
1166 - Effect of prior cancer on survival outcomes for patients with pancreatic adenocarcinoma
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1169 - Association of combination of irreversible electroporation ablation and chemotherapy with outcomes of locally advanced pancreatic cancer: a large cohort study
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1222 - Results from phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) in combination with gemcitabine plus nab-paclitaxel as first-line treatment of unresectable pancreatic cancer
Presenter: Yusuke Hashimoto
Session: Poster Display session 2
Resources:
Abstract
1698 - Multicenter retrospective study of gemcitabine plus nab-paclitaxel for elderly patients with advanced pancreatic cancer
Presenter: Masato Ozaka
Session: Poster Display session 2
Resources:
Abstract
2424 - Irinotecan Combined with Oxaliplatin and S1 in Patients with Metastatic Pancreatic Adenocarcinoma
Presenter: Keke Nie
Session: Poster Display session 2
Resources:
Abstract
2885 - Cancer-associated thrombosis in patients with pancreatic cancer and its correlation with plasma tissue factor level: A Japanese prospective cohort study
Presenter: Satoshi Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3702 - A Phase I/Ib, multi-center trial of ARQ-761 (Beta-Lapachone) with gemcitabine/nab-Paclitaxel in patients with advanced pancreatic cancer
Presenter: Muhammad Beg
Session: Poster Display session 2
Resources:
Abstract
5185 - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: first-in-human clinical trial
Presenter: Rocio Garcia-Carbonero
Session: Poster Display session 2
Resources:
Abstract