775 - Relations of QOL to tumor response and adverse events in unresectable advanced pancreatic cancer patients in the gest study

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Supportive Care
Pancreatic Cancer
Presenter Yasuo Ohashi
Authors Y. Ohashi1, T. Ioka2, T. Okusaka3
  • 1Department Of Biostatistics, School Of Public Health, The University of Tokyo, 113-0033 - Tokyo/JP
  • 2Division Of Hepatobiliary And Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 537-8511 - Osaka/JP
  • 3Division Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital, Tokyo/JP

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 < 0.001) and 0.032/level (p < 0.001), respectively. EQ-5D utility scores were not related to nausea, vomiting, or diarrhea after adjustment of fatigue and anorexia. Tumor response (leveled from 0(PD) to 3(CR)) significantly improved the estimated score by 0.054/level (p < 0.001); interactions between response and treatments were not significant. The improvement in EQ-5D utility score associated with a better response was most strongly attributed to decreased pain among 5 questions.

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