Hagiwara, Yasuhiro, Ohashi, Yasuo, Uesaka, Katsuhiko, Boku, Narikazu, Fukutomi, Akira, Okamura, Yukiyasu, Konishi, Masaru, Matsumoto, Ippei, Kaneoka, Yuji, Shimizu, Yasuhiro, Nakamori, Shoji, Sakamoto, Hirohiko, Morinaga, Soichiro, Kainuma, Osamu, Imai, Koji, Sata, Naohiro, Hishinuma, Shoichi, Ojima, Hitoshi, Yamaguchi, Ryuzo, and Hirano, Satoshi
Background Adjuvant chemotherapy with S-1 for resected pancreatic cancer demonstrated survival benefits compared with gemcitabine in the JASPAC 01 trial. We investigated the effect of these agents on health-related quality of life (HRQOL) of patients in the JASPAC 01 trial. Methods Patients with resected pancreatic cancer were randomly assigned to receive gemcitabine (1000 mg/m 2 weekly for three of four weeks for up to six cycles) or S-1 (40, 50, or 60 mg twice daily for four of six weeks for up to four cycles). HRQOL was assessed using the EuroQol-5D-3L (EQ-5D) questionnaire at baseline, months three and six, and every 6 months thereafter. HRQOL end-points included change in EQ-5D index from baseline, responses to five items in the EQ-5D, and quality-adjusted life months up to 24 months. Results Of randomised 385 patients, 354 patients were included in HRQOL analysis. Mean change in the EQ-5D index was similar in the S-1 and gemcitabine groups within 6 months from treatment initiation (difference, 0.024; P = 0.112), whereas corresponding mean from 12 to 24 months was better in the S-1 group than in the gemcitabine group (difference, 0.071; P < 0.001). Problems in mobility and pain/discomfort were also less frequent in the S-1 group than in the gemcitabine group in that period. Quality-adjusted life months were longer in the S-1 group than in the gemcitabine group ( P < 0.001). Conclusion Adjuvant chemotherapy with S-1 does not improve HRQOL within 6 months from treatment initiation but does improve HRQOL thereafter and quality-adjusted life months. Clinical trial registration number UMIN000000655 at UMIN CTR. [ABSTRACT FROM AUTHOR]