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
3034 - Efficacy and safety of neoadjuvant chemotherapy plus trastuzumab and pertuzumab in non-metastatic HER2-positive breast cancer in real life: NEOPEARL STUDY
Presenter: Maria Agnese Fabbri
Session: Poster Display session 2
Resources:
Abstract
4772 - Real world comparison of the impact of adjuvant capecitabine in women with high-risk triple-negative breast cancer after neoadjuvant chemotherapy
Presenter: Maysa Vilbert
Session: Poster Display session 2
Resources:
Abstract
5627 - Influence of age on the indication of adjuvant chemotherapy in early breast cancer using Oncotype DX. An analysis of 240 patients treated in the Institut Catala d’Oncologia (ICO) hospitals
Presenter: Sabela Recalde
Session: Poster Display session 2
Resources:
Abstract
3917 - Impact of delayed neoadjuvant systemic chemotherapy on survival among breast cancer patients
Presenter: Mariana Chavez Mac Gregor
Session: Poster Display session 2
Resources:
Abstract
2246 - Clinical Confirmation of Higher Exposure to Niraparib in Tumor vs Plasma in Patients With Breast Cancer
Presenter: Laura Spring
Session: Poster Display session 2
Resources:
Abstract
581 - The rationale for the effectiveness of systemic treatment of breast cancer depending on the body weight index
Presenter: Mohammad Hojouj
Session: Poster Display session 2
Resources:
Abstract
5327 - Response to neoadjuvant chemotherapy in HER2 non-overexpressing breast cancer subtypes
Presenter: Silvia Mihaela Ilie
Session: Poster Display session 2
Resources:
Abstract
3613 - Pre-specified interim analysis of the SAFE trial (NCT2236806): a 4-arm randomized, double-blind, controlled study evaluating the efficacy and safety of cardiotoxicity prevention in non-metastatic breast cancer patients treated with anthracyclines with or without trastuzumab.
Presenter: Lorenzo Livi
Session: Poster Display session 2
Resources:
Abstract
3736 - Safety of hypofractionated whole breast irradiation after conservative surgery for patients aged less than 60 years: a multi-center comparative study.
Presenter: Icro Meattini
Session: Poster Display session 2
Resources:
Abstract
5085 - Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab
Presenter: Isabel Blancas López-Barajas
Session: Poster Display session 2
Resources:
Abstract