Docetaxel plus S-1 versus cisplatin plus S-1 in unresectable gastric cancer without measurable lesions: a randomized phase II trial (HERBIS-3)
Autor: | Kazuhiro Nishikawa, Kazumasa Fujitani, Yutaka Kimura, Atsushi Takeno, Yoichi Makari, Jin Matsuyama, Ryohei Kawabata, Taroh Satoh, Daisuke Sakai, Hisato Kawakami, Toshio Shimokawa, Tetsuji Terazawa, Yukinori Kurokawa |
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Rok vydání: | 2020 |
Předmět: |
Adult
Male Cancer Research medicine.medical_specialty medicine.medical_treatment Docetaxel Gastroenterology 03 medical and health sciences 0302 clinical medicine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Aged Proportional Hazards Models Tegafur Cisplatin Chemotherapy business.industry Hazard ratio General Medicine Middle Aged Confidence interval Survival Rate Drug Combinations Oxonic Acid Treatment Outcome Oncology 030220 oncology & carcinogenesis Toxicity Female 030211 gastroenterology & hepatology business medicine.drug Abdominal surgery |
Zdroj: | Gastric Cancer. 24:428-434 |
ISSN: | 1436-3305 1436-3291 |
Popis: | 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. Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions. Patients were randomized to DS (docetaxel 40 mg/m2 on day 1, S-1 80–120 mg on days 1–14, every 3 weeks) or CS (cisplatin 60 mg/m2 on day 8, S-1 80–120 mg on days 1–21, every 5 weeks). The primary endpoint was overall survival (OS). 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 |
Databáze: | OpenAIRE |
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