Docetaxel plus S-1 versus cisplatin plus S-1 in unresectable gastric cancer without measurable lesions: a randomized phase II trial (HERBIS-3)

• Published in: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association 2021-03, Vol.24 (2), p.428-434
• Main Authors: Kurokawa, Yukinori, Matsuyama, Jin, Nishikawa, Kazuhiro, Takeno, Atsushi, Kimura, Yutaka, Fujitani, Kazumasa, Kawabata, Ryohei, Makari, Yoichi, Terazawa, Tetsuji, Kawakami, Hisato, Sakai, Daisuke, Shimokawa, Toshio, Satoh, Taroh
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adult; Aged; Anorexia; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Cancer Research; Chemotherapy; Cisplatin; Cisplatin - administration & dosage; Clinical trials; Diarrhea; Docetaxel - administration & dosage; Drug Combinations; ErbB-2 protein; Female; Gastric cancer; Gastroenterology; Humans; Lesions; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Oxonic Acid - administration & dosage; Proportional Hazards Models; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Surgical Oncology; Survival Rate; Tegafur - administration & dosage; Toxicity; Treatment Outcome
• ISSN: 1436-3291; 1436-3305
• DOI: 10.1007/s10120-020-01112-1

Background Cisplatin plus S-1 (CS) is the standard first-line chemotherapy for advanced gastric cancer (AGC) in Japan. A previous phase III trial showed that docetaxel plus S-1 (DS) was effective for AGC without measurable lesions, but no studies have compared these two regimens. Methods Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions. Patients were randomized to DS (docetaxel 40 mg/m 2 on day 1, S-1 80–120 mg on days 1–14, every 3 weeks) or CS (cisplatin 60 mg/m 2 on day 8, S-1 80–120 mg on days 1–21, every 5 weeks). The primary endpoint was overall survival (OS). Results All patients had unresectable primary disease. Sixty-one patients were randomly assigned to DS ( n  = 30) or CS ( n  = 31). One CS patient was ineligible due to HER2 positivity. The median number of cycles was 9.5 (range 2–49) with DS and 5.5 (range 1–10) with CS. There were no treatment-related deaths. The most common grade 3–4 non-hematological toxicity was fatigue (7% with DS, 13% with CS), followed by anorexia (3% with DS, 10% with CS) and diarrhea (3% with DS, 10% with CS). The 2-year OS rates were 43.3% with DS and 30.0% with CS (log-rank P  = 0.113), with a hazard ratio of 0.617 (95% confidence interval 0.337–1.128), indicating non-inferiority of DS to CS with respect to OS ( P