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).

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.

• Authors: Yasuhiro Hagiwara, Yasuo Ohashi, Katsuhiko Uesaka, Narikazu Boku, Akira Fukutomi, Yukiyasu Okamura, Masaru Konishi, Ippei Matsumoto, Yuji Kaneoka, Yasuhiro Shimizu, Shoji Nakamori, Hirohiko Sakamoto, Soichiro Morinaga, Osamu Kainuma, Koji Imai, Naohiro Sata, Shoichi Hishinuma, Hitoshi Ojima, Ryuzo Yamaguchi, Satoshi Hirano, Takeshi Sudo, JASPAC 01 Study Group
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 93 Pg. 79-88 (04 2018) ISSN: 1879-0852 [Electronic] England
• PMID: 29477795 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Elsevier Ltd. All rights reserved.

Chemical References

• Drug Combinations
• Deoxycytidine
• S 1 (combination)
• Tegafur
• Oxonic Acid
• Gemcitabine

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Chemotherapy, Adjuvant
• Combined Modality Therapy
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Drug Combinations
• Female
• Follow-Up Studies
• Humans
• Male
• Oxonic Acid (administration & dosage)
• Pancreatectomy
• Pancreatic Neoplasms (drug therapy, pathology, surgery)
• Prognosis
• Quality of Life
• Survival Rate
• Tegafur (administration & dosage)
• Gemcitabine