775 - Relations of QOL to Tumor Response and Adverse Events in Unresectable advanced Pancreatic Cancer Patients in the Gest Study

Abstract

ABSTRACT Background The GEST study demonstrated the non-inferiority of S-1, but not the superiority of gemcitabine plus S-1 (GS) to gemcitabine alone (G) with respect to overall survival in unresectable advanced pancreatic cancer patients (Ioka et al. ASCO 2011, Abstract 4007). The results of QOL evaluation based on EQ-5D demonstrated that S-1 and G were equivalent and GS was superior to G (Ohashi et al. ASCO 2011, Abstract 9070). We report the relations of QOL to adverse events and tumor response. Methods Chemotherapy was administered until PD, consent withdrawal, or unacceptable adverse events. EQ-5D questionnaires were filled in at baseline and 6, 12, 24, 48, and 72 weeks and converted to 0-1 utility scores by the Japanese value set. We estimated the effects of adverse events (nausea, vomiting, diarrhea, fatigue, and anorexia leveled from 0 to 4 by CTC-AE) and of tumor response on EQ-5D utility scores, using a mixed-effects model for repeated measurements. Response was classified into 4 levels (CR/PR/SD or NE/PD). Results A total of 736 patients were analyzed. Fatigue and anorexia were significantly associated with EQ-5D utility score; they decreased the estimated score by 0.034/level (p Conclusions QOL in the studied patient population was negatively affected by fatigue and anorexia, and was improved by good response probably through decreased pain. Disclosure Y. Ohashi: I have an advisory relationship and research funding to disclose. Name of Entity: Taiho Pharmaceutical Co. Ltd. T. Ioka: I have an advisory relationship and research funding to disclose. Name of Entity: Taiho Pharmaceutical Co. Ltd. T. Okusaka: I have an advisory relationship and research funding to disclose. Name of Entity: Taiho Pharmaceutical Co. Ltd