title: Randomised phase III study of S-1 alone versus S-1 plus lentinan for unresectable or recurrent gastric cancer (JFMC36-0701).
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  UMIN 000000574.
authors: Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine, Ube, Japan. Electronic address: sigefumi@yamaguchi-u.ac.jp.
authors: Shigefumi
authors: S
authors: Yoshino
authors: Department of Surgery, Osaka National Hospital, Osaka, Japan.
authors: Kazuhiro
authors: K
authors: Nishikawa
authors: Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors: Satoshi
authors: S
authors: Morita
authors: Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors: Tsuyoshi
authors: T
authors: Takahashi
authors: Department of Digestive Surgery, Shimonoseki Medical Center, Shimonoseki, Japan.
authors: Koichiro
authors: K
authors: Sakata
authors: Department of Surgery, Toho University Omori Medical Center, Tokyo, Japan.
authors: Jiro
authors: J
authors: Nagao
authors: Department of Gastroenterological and General Surgery, School of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
authors: Hiroshi
authors: H
authors: Nemoto
authors: Department of Palliative Care and Surgery, Koseiren Takaoka Hospital, Takaoka, Japan.
authors: Nozomu
authors: N
authors: Murakami
authors: Department of Surgery, National Hospital Organization Kobe Medical Center, Kobe, Japan.
authors: Takeru
authors: T
authors: Matsuda
authors: Department of Surgery, Tokuyama Central Hospital, Shunan, Japan.
authors: Hiroyasu
authors: H
authors: Hasegawa
authors: Department of Surgery, Ogori Daiichi General Hospital, Yamaguchi, Japan.
authors: Ryoichi
authors: R
authors: Shimizu
authors: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors: Takaki
authors: T
authors: Yoshikawa
authors: Department of Surgery, Sapporo Geka Kinen Hospital, Sapporo, Japan.
authors: Hiroyuki
authors: H
authors: Osanai
authors: Department of Surgery, Kinki University Faculty of Medicine, Osakasayama, Japan.
authors: Motohiro
authors: M
authors: Imano
authors: Department of Surgery, Japan Community Health Care Organization Gunma Chuo Hospital, Maebashi, Japan.
authors: Hiroshi
authors: H
authors: Naitoh
authors: Department of Surgery, Mine City Hospital, Mine, Japan.
authors: Akiyoshi
authors: A
authors: Tanaka
authors: Nippon Medical School, Tokyo, Japan.
authors: Takashi
authors: T
authors: Tajiri
authors: Digestive Tract Surgery, Okayama University Hospital, Okayama, Japan.
authors: Akira
authors: A
authors: Gochi
authors: Department of Surgery, Shunan City Shinnanyo Hospital, Shunan, Japan.
authors: Michinari
authors: M
authors: Suzuki
authors: Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
authors: Junichi
authors: J
authors: Sakamoto
authors: Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
authors: Shigetoyo
authors: S
authors: Saji
authors: Yamaguchi University, Yamaguchi, Japan.
authors: Masaaki
authors: M
authors: Oka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000032:analysis; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007912:Lentinan / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009000:Monocytes / Q000378:metabolism; D010094:Oxonic Acid / Q000627:therapeutic use*; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D007912:Lentinan; D010094:Oxonic Acid
keywords: Biomarker; Gastric cancer; Lentinan; Phase III study; Quality of life; S-1