Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• European journal of cancer (1990), 2016-09, Vol.65, p.164-171

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2016

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.