Randomised phase III study of S-1 alone versus S-1 plus lentinan for unresectable or recurrent gastric cancer (JFMC36-0701) |
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| Institution: | 1. Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine, Ube, Japan;2. Department of Surgery, Osaka National Hospital, Osaka, Japan;3. Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan;4. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan;5. Department of Digestive Surgery, Shimonoseki Medical Center, Shimonoseki, Japan;6. Department of Surgery, Toho University Omori Medical Center, Tokyo, Japan;7. Department of Gastroenterological and General Surgery, School of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan;8. Department of Palliative Care and Surgery, Koseiren Takaoka Hospital, Takaoka, Japan;9. Department of Surgery, National Hospital Organization Kobe Medical Center, Kobe, Japan;10. Department of Surgery, Tokuyama Central Hospital, Shunan, Japan;11. Department of Surgery, Ogori Daiichi General Hospital, Yamaguchi, Japan;12. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan;13. Department of Surgery, Sapporo Geka Kinen Hospital, Sapporo, Japan;14. Department of Surgery, Kinki University Faculty of Medicine, Osakasayama, Japan;15. Department of Surgery, Japan Community Health Care Organization Gunma Chuo Hospital, Maebashi, Japan;p. Department of Surgery, Mine City Hospital, Mine, Japan;q. Nippon Medical School, Tokyo, Japan;r. Digestive Tract Surgery, Okayama University Hospital, Okayama, Japan;s. Department of Surgery, Shunan City Shinnanyo Hospital, Shunan, Japan;t. Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan;u. Yamaguchi University, Yamaguchi, Japan |
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| Abstract: | BackgroundLentinan (LNT) is a purified β-1, 3-glucan that augments immune responses. The present study was conducted to assess the efficacy of LNT in combination with S-1 as a first-line treatment for unresectable or recurrent gastric cancer.Patients and methodsEligible patients were randomly assigned to receive S-1 alone or S-1 plus LNT. The primary end-point was overall survival (OS). Secondary end-points were time-to-treatment failure (TTF), overall response rate (ORR), safety, quality of life (QOL), and biomarker. The percentages of LNT-binding monocytes in peripheral blood prior to treatment were analysed for the biomarker assessment.ResultsOne hundred and fifty-four and 155 patients were randomly assigned to receive S-1 alone or S-1 plus LNT, respectively. The median OS was 13.8 and 9.9 months (P = 0.208), the median TTF was 4.3 and 2.6 months (P < 0.001), the ORR was 22.3% and 18.7% for the S-1 and S-1 plus LNT groups, respectively. The incidences of haematologic and non-haematologic adverse events were similar, and no significant changes in QOL scores were observed during the treatment in both groups. In a subpopulation of patients with LNT-binding monocytes ≥2%, patients who received more than two cycles of chemotherapy showed a longer survival time in the S-1 plus LNT group.ConclusionsOS did not improve and TTF was significantly worse in the S-1 plus LNT group as compared with the S-1-only group. This study showed no efficacy of LNT when combined with S-1 treatment in patients with unresectable or recurrent gastric cancer.Clinical trial registration ID numberUMIN 000000574. |
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| Keywords: | Lentinan S-1 Gastric cancer Quality of life Biomarker Phase III study |
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