Yasuhiro Hagiwara1, Yasuo Ohashi2, Katsuhiko Uesaka3, Narikazu Boku4, Akira Fukutomi5, Yukiyasu Okamura3, Masaru Konishi6, Ippei Matsumoto7, Yuji Kaneoka8, Yasuhiro Shimizu9, Shoji Nakamori10, Hirohiko Sakamoto11, Soichiro Morinaga12, Osamu Kainuma13, Koji Imai14, Naohiro Sata15, Shoichi Hishinuma16, Hitoshi Ojima17, Ryuzo Yamaguchi18, Satoshi Hirano19, Takeshi Sudo20. 1. Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo, Tokyo 113-0033, Japan. 2. Department of Integrated Science and Engineering for Sustainable Society, Chuo University, 1-13-27 Kasuga, Bunkyo, Tokyo 112-8551, Japan. Electronic address: ohashiy.00e@g.chuo-u.ac.jp. 3. Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center Hospital, 1007 Shimo-Nagakubo, Nagaizumi, Sunto, Shizuoka 411-8777, Japan. 4. Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo, Tokyo 104-0045, Japan. 5. Division of Gastrointestinal Oncology, Shizuoka Cancer Center Hospital, 1007 Shimo-Nagakubo, Nagaizumi, Sunto, Shizuoka 411-8777, Japan. 6. Department of Hepatobiliary-Pancreatic Surgery, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. 7. Division of Hepato-Biliary-Pancreatic Surgery, Kindai University Faculty of Medicine, 377-2, Onohigashi, Osakasayama, Osaka 589-8511, Japan. 8. Department of Surgery, Ogaki Municipal Hospital, 4-86, Minaminokawacho, Ogaki, Gifu 503-8502, Japan. 9. Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa, Nagoya, Aichi 464-8681, Japan. 10. Department of Surgery, Osaka National Hospital, 2-1-14, Hoenzaka, Chuo, Osaka, Osaka 540-0006, Japan. 11. Division of Gastroenterological Surgery, Saitama Cancer Center, 780, Komuro, Ina, Kita-adachi, Saitama 362-0806, Japan. 12. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi, Yokohama, Kanagawa 241-8515, Japan. 13. Department of Gastroenterological Surgery, Chiba Cancer Center, 666-2, Nitonacho, Chuo, Chiba, Chiba 260-8717, Japan. 14. Department of Surgery, Asahikawa Medical University, Midorigaoka-Higashi, 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan. 15. Department of Surgery, Jichi Medical University, 3311-1, Yakushiji, Shimotsuke, Tochigi 329-0498, Japan. 16. Department of Hepato-Biliary-Pancreatic Surgery, Tochigi Cancer Center, 4-9-13, Yonan, Utsunomiya, Tochigi 320-0834, Japan. 17. Department of Gastroenterological Surgery, Gunma Prefectural Cancer Center, 617-1, Takahayashi-nishi-cho, Ota, Gumma 373-8550, Japan. 18. Department of Surgery, Kasugai Municipal Hospital, 1-1-1, Takaki-cho, Kasugai, Aichi 486-8510, Japan. 19. Department of Gastroenterological Surgery II, Hokkaido University Graduate School of Medicine, Kita 15, Nishi 7, Sapporo 060-8638, Japan. 20. Department of Surgery, National Hospital Organization Kure Medical Center, 3-1, Aoyama-cho, Kure, Hiroshima 737-0023, Japan.
Abstract
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/m2 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.
RCT Entities:
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/m2 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.
Authors: Teresa Macarulla; Andrew E Hendifar; Chung-Pin Li; Michele Reni; Hanno Riess; Margaret A Tempero; Amylou C Dueck; Marc F Botteman; Chinmay G Deshpande; Eleanor J Lucas; Do-Youn Oh Journal: Pancreas Date: 2020-03 Impact factor: 3.243