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
3392 - Post-hoc analysis of the nintedanib exposure-response relationships in the CHIVA trial in advanced ovarian cancer: (a GINECO study)
Presenter: Skerdi HAVIARI
Session: Poster Display session 2
Resources:
Abstract
714 - The feasibility and efficacy of gonadotropin-releasing hormone agonists for prevention of chemotherapy-induced ovarian insufficiency in patient with malignant ovarian germ cell tumors
Presenter: Min Kyu Kim
Session: Poster Display session 2
Resources:
Abstract
1753 - Ex vivo cytotoxicity and in vivo antitumor activity of a novel highly selective STAT3 inhibitor YHO-1701 for ovarian and endometrial cancer
Presenter: Kosei Hasegawa
Session: Poster Display session 2
Resources:
Abstract
3739 - Mutational landscapes and tumor mutational burden expression in endometrial cancer
Presenter: Yingli Zhang
Session: Poster Display session 2
Resources:
Abstract
2109 - Clinical features and frequency of mismatch repair protein deficiency in ovarian clear cell and endometrioid carcinoma patients.
Presenter: Kazuhiro Takehara
Session: Poster Display session 2
Resources:
Abstract
4554 - Prospective study evaluating white adipose tissue inflammation and clinicopathologic features in endometrial cancer
Presenter: Lea Moukarzel
Session: Poster Display session 2
Resources:
Abstract
3645 - Cancer-specific survival with or without adjuvant chemotherapy in high-risk stage I endometrial cancer
Presenter: Jenny Ko
Session: Poster Display session 2
Resources:
Abstract
3394 - Pembrolizumab in Patients with MSI-H Advanced Endometrial Cancer from the KEYNOTE-158 Study
Presenter: David Omalley
Session: Poster Display session 2
Resources:
Abstract
3388 - Who drops out of cervical cancer screening? Results from the EDIFICE 6 survey
Presenter: Thibault de La Motte Rouge
Session: Poster Display session 2
Resources:
Abstract
2485 - Identification of a RNA-Seq Based Signature to Improve Prognostic for Uterine Sarcoma
Presenter: Jian-Guo Zhou
Session: Poster Display session 2
Resources:
Abstract