676 Background: TASCO1 is a phase II study which evaluated the safety and efficacy of trifluridine/tipiracil + bevacizumab (TT-B) and capecitabine + bevacizumab (C-B) in first-line unresectable mCRC patients non-eligible for intensive therapy. Promising activity was shown on progression-free survival with TT-B (9.2 months) and C-B (7.8 months). Here we present the Quality of Life (QoL) analysis of the two treatment arms. Methods: In TASCO1, patients were randomized 1:1 to receive TT-B (n = 76) on a four-week cycle or C-B (n = 77) on a three-week cycle. QoL was assessed in TASCO1 at baseline and at each 12 weeks thereafter, until discontinuation of study treatment, using the QLQ-C30 and QLQ-CR29 questionnaires. Responses were described separately in each arm using descriptive statistics. Results: For QLQ-C30, 121 patients completed baseline questionnaire. No clinically relevant difference was observed on treatment in mean change of score from baseline for the global health status, functioning scales, and for most of the symptom scales, except for nausea/vomiting and diarrhoea (worsening in the TT-B group and stable in the C-B group for both symptoms), fatigue (stable in the TT-B group and worsening in the C-B), loss appetite (worsening in the two groups) and insomnia (improvement in the two groups). For QLQ-CR29, 117 patients completed baseline questionnaire. No clinically relevant difference on treatment was observed in mean change of score from baseline for most of items except for the following: hair loss, trouble with taste (worsening for both symptoms in the TT-B group while stable for hair loss and improvement for trouble with taste in the C-B group), sore skin, dry mouth (stable in the TT-B group and worsening in the C-B group for both symptoms), and anxiety (stable in the TT-B group and improvement in the C-B group). Conclusions: The Global Health Scale was maintained in Trifluridine/tipiracil+bevacizumab arm as well as in the capecitabine+bevacizumab arm. No clinically relevant difference from baseline was observed over time in both groups except for few sub-scales. Clinical trial information: NCT02743221.
A phase II study of docetaxel weekly in combination with carboplatin every three weeks as first line chemotherapy in stage IIB-IV epithelial ovarian cancer: Neurological toxicity and quality-of-life evaluation