Quality of life at baseline in the international open-label early-access program of trifluridine/tipiracil in previously treated metastatic colorectal cancer (phase IIIb).

Abstract

803 Background: Pivotal phase 3 RECOURSE trial evaluated efficacy and safety of trifluridine/tipiracil (FTD/TPI, also known TAS-102) in metastatic colorectal cancer (mCRC) without collecting quality of life (QoL) data (Mayer et al. N Engl J Med 2015;372:1909-19). We set up a phase IIIb open-label, early access program to confirm safety and to assess QoL in mCRC in real-world practice (EudraCT Number: 2016‐002311‐18). First patient (pt) was enrolled in Oct 2016; enrolment is ongoing. Methods: Eligible pts had histologically confirmed mCRC previously treated with, or not considered candidates for, available therapies. Other inclusion criteria include Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. Pts planned to receive FTD/TPI (35 mg/m2 bid) orally on days 1–5 and days 8–12 of each 28-day cycle. Pts health-related QoL were measured with the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the EuroQol 5-dimension, 3-level (EQ-5D) questionnaires and visual analogue scale (VAS). For the EORTC QLQ-C30 global health status, EQ-5D utility values and VAS, scores could range to a maximum of 100 representing a better health-related QoL. EORTC QLQ-C30 and EQ-5D were considered non evaluable when responses were missing for one third or at least one of the dimensions, respectively. QoL was measured at baseline, every 4 weeks on treatment, and at treatment discontinuation. Results: A total of 298 pts from 7 countries had received at least 1 dose of treatment as of 7 March 2017. Among 271 patients, 39.5% and 60.1% had respectively ECOG PS 0 and 1 at baseline except 1 pt was enrolled with ECOG PS 2. Out of these 298 pts, 263, 261 and 258 were evaluable at baseline for EORTC QLQ-C30 global health status, EQ-5D utility values and VAS, respectively. These means were 62.4 (standard deviation [SD] 21.3), 73.6 (SD 20.3) and 66.1 (SD 19.1), respectively. Conclusions: Analysis of pt QoL in the real-world practice shows it may be substantially deteriorated in heavily pretreated pts with advanced mCRC in spite of having an ECOG PS of 0/1. Preliminary safety /efficacy and QoL results are expected in summer 2018. Clinical trial information: 2016-002311-18.