Health-related quality of life of adjuvant chemotherapy with S-1 versus gemcitabine for resected pancreatic cancer: Results from a randomised phase III trial (JASPAC 01)

被引：17

作者：

Hagiwara, Yasuhiro ^{[1
]}

Ohashi, Yasuo ^{[2
]}

Uesaka, Katsuhiko ^{[3
]}

Boku, Narikazu ^{[4
]}

Fukutomi, Akira ^{[5
]}

Okamura, Yukiyasu ^{[3
]}

Konishi, Masaru ^{[6
]}

Matsumoto, Ippei ^{[7
]}

Kaneoka, Yuji ^{[8
]}

Shimizu, Yasuhiro ^{[9
]}

Nakamori, Shoji ^{[10
]}

Sakamoto, Hirohiko ^{[11
]}

Morinaga, Soichiro ^{[12
]}

Kainuma, Osamu ^{[13
]}

Imai, Koji ^{[14
]}

Sata, Naohiro ^{[15
]}

Hishinuma, Shoichi ^{[16
]}

Ojima, Hitoshi ^{[17
]}

Yamaguchi, Ryuzo ^{[18
]}

Hirano, Satoshi ^{[19
]}

Sudo, Takeshi ^{[20
]}

机构：

[1] Univ Tokyo, Dept Biostat, Grad Sch Med, Bunkyo Ku, 7-3-1 Hongo, Tokyo 1130033, Japan

[2] Chuo Univ, Dept Integrated Sci & Engn Sustainable Soc, Bunkyo Ku, 1-13-27 Kasuga, Tokyo 1128551, Japan

[3] Shizuoka Canc Ctr Hosp, Div Hepatobiliary Pancreat Surg, 1007 Shimo Nagakubo, Shizuoka 4118777, Japan

[4] Natl Canc Ctr, Gastrointestinal Med Oncol Div, Chuo Ku, 5-1-1 Tsukiji, Tokyo 1040045, Japan

[5] Shizuoka Canc Ctr Hosp, Div Gastrointestinal Oncol, 1007 Shimo Nagakubo, Shizuoka 4118777, Japan

[6] Natl Canc Ctr Hosp East, Dept Hepatobiliary Pancreat Surg, 6-5-1 Kashiwanoha, Kashiwa, Chiba 2778577, Japan

[7] Kindai Univ, Fac Med, Div Hepatobiliary Pancreat Surg, 377-2 Onohigashi, Osaka 5898511, Japan

[8] Ogaki Municipal Hosp, Dept Surg, 4-86 Minaminokawacho, Ogaki, Gifu 5038502, Japan

[9] Aichi Canc Ctr Hosp, Dept Surg Gastroenterol, Chikusa Ku, 1-1 Kanokoden, Nagoya, Aichi 4648681, Japan

[10] Osaka Natl Hosp, Dept Surg, Chuo Ku, 2-1-14 Hoenzaka, Osaka, Osaka 5400006, Japan

[11] Saitama Canc Ctr, Div Gastroenterol Surg, 780 Komuro, Kita Adachi, Saitama 3620806, Japan

[12] Kanagawa Canc Ctr, Dept Gastrointestinal Surg, Asahi Ku, 2-3-2 Nakao, Yokohama, Kanagawa 2418515, Japan

[13] Chiba Canc Ctr, Dept Surg Gastroenterol, Chuo Ku, 666-2 Nitonacho, Chiba, Chiba 2608717, Japan

[14] Asahikawa Med Univ, Dept Surg, Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido 0788510, Japan

[15] Jichi Med Univ, Dept Surg, 3311-1 Yakushiji, Shimotsuke, Tochigi 3290498, Japan

[16] Tochigi Canc Ctr, Dept Hepatobiliary Pancreat Surg, 4-9-13 Yonan, Utsunomiya, Tochigi 3200834, Japan

[17] Gunma Prefectural Canc Ctr, Dept Surg Gastroenterol, 617-1 Takahayashi Nishi Cho, Ota, Gunma 3738550, Japan

[18] Kasugai Municipal Hosp, Dept Surg, 1-1-1 Takaki Cho, Kasugai, Aichi 4868510, Japan

[19] Hokkaido Univ, Dept Gastroenterol Surg 2, Grad Sch Med, Kita 15,Nishi 7, Sapporo, Hokkaido 0608638, Japan

[20] Natl Hosp Org Kure Med Ctr, Dept Surg, 3-1 Aoyama Cho, Kure, Hiroshima 7370023, Japan

来源：

EUROPEAN JOURNAL OF CANCER | 2018年 / 93卷

关键词：

Adjuvant chemotherapy; Clinical trial; Phase III; Gemcitabine; Pancreatic cancer; Health-related quality of life; S-1 (combination); INTRAARTERIAL CHEMOTHERAPY; PERIAMPULLARY CANCER; OPEN-LABEL; QLQ-C30; EQ-5D; RESPONSIVENESS; QUESTIONNAIRE; RADIOTHERAPY; SURGERY; IMPACT;

D O I：

10.1016/j.ejca.2018.01.081

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2018 Elsevier Ltd. All rights reserved.

引用

页码：79 / 88

页数：10

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