Randomised phase III study of S-1 alone versus S-1 plus lentinan for unresectable or recurrent gastric cancer (JFMC36-0701).

Shigefumi Yoshino, Kazuhiro Nishikawa, Satoshi Morita, Tsuyoshi Takahashi, Koichiro Sakata, Jiro Nagao, Hiroshi Nemoto, Nozomu Murakami, Takeru Matsuda, Hiroyasu Hasegawa, Ryoichi Shimizu, Takaki Yoshikawa, Hiroyuki Osanai, Motohiro Imano, Hiroshi Naitoh, Akiyoshi Tanaka, Takashi Tajiri, Akira Gochi, Michinari Suzuki, Junichi Sakamoto, Shigetoyo Saji, Masaaki Oka

Journal: European journal of cancer (Oxford, England : 1990) 2017;65():164-71

PMID: 27501505

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Abstract

BACKGROUND

Lentinan (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 METHODS

Eligible 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.

RESULTS

One 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.

CONCLUSIONS

OS 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 NUMBER

UMIN 000000574.

Address: Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine, Ube, Japan. Electronic address: [email protected].; Department of Surgery, Osaka National Hospital, Osaka, Japan.; Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.; Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.; Department of Digestive Surgery, Shimonoseki Medical Center, Shimonoseki, Japan.; Department of Surgery, Toho University Omori Medical Center, Tokyo, Japan.; Department of Gastroenterological and General Surgery, School of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.; Department of Palliative Care and Surgery, Koseiren Takaoka Hospital, Takaoka, Japan.; Department of Surgery, National Hospital Organization Kobe Medical Center, Kobe, Japan.; Department of Surgery, Tokuyama Central Hospital, Shunan, Japan.; Department of Surgery, Ogori Daiichi General Hospital, Yamaguchi, Japan.; Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.; Department of Surgery, Sapporo Geka Kinen Hospital, Sapporo, Japan.; Department of Surgery, Kinki University Faculty of Medicine, Osakasayama, Japan.; Department of Surgery, Japan Community Health Care Organization Gunma Chuo Hospital, Maebashi, Japan.; Department of Surgery, Mine City Hospital, Mine, Japan.; Nippon Medical School, Tokyo, Japan.; Digestive Tract Surgery, Okayama University Hospital, Okayama, Japan.; Department of Surgery, Shunan City Shinnanyo Hospital, Shunan, Japan.; Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.; Yamaguchi University, Yamaguchi, Japan.

DOI: 10.1016/j.ejca.2016.06.012

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MeSH Terms: Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Drug Combinations, Female, Humans, Lentinan, Male, Middle Aged, Monocytes, Oxonic Acid, Quality of Life, Stomach Neoplasms, Tegafur