Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial
| Autor: | Seiji Ito, Sang-Woong Lee, Akinori Takagane, Takaki Yoshikawa, Jun Hihara, Yoshiaki Iwasaki, Hiroshi Katayama, Hitoshi Katai, Masahide Kaji, Masanori Terashima, Makoto Yamada, Junki Mizusawa, Motohiro Hirao, Hiroshi Yabusaki, Masakazu Takagi, Yutaka Kimura, Mitsuru Sasako, Akira Kurita, Narikazu Boku, Kenichi Nakamura, Takeshi Sano |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty medicine.medical_treatment Phases of clinical research Gastroenterology law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial law Gastrectomy Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Aged Neoplasm Staging Chemotherapy business.industry Standard treatment Hazard ratio Cancer General Medicine Middle Aged medicine.disease Neoadjuvant Therapy Survival Rate Drug Combinations Treatment Outcome Oncology Chemotherapy Adjuvant 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Female Laparoscopy Cisplatin business |
| Zdroj: | Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 24(2) |
| ISSN: | 1436-3305 |
| Popis: | Specific treatment strategies are sorely needed for scirrhous-type gastric cancer still, which has poor prognosis. Based on the promising results of our previous phase II study (JCOG0210), we initiated a phase III study to confirm the efficacy of neoadjuvant chemotherapy (NAC) in type 4 or large type 3 gastric cancer. Patients aged 20–75 years without a macroscopic unresectable factor as confirmed via staging laparoscopy were randomly assigned to surgery followed by adjuvant chemotherapy with S-1 (Arm A) or NAC (S-1plus cisplatin) followed by D2 gastrectomy plus adjuvant chemotherapy with S-1 (Arm B). The primary endpoint was overall survival (OS). Between October 2005 and July 2013, 316 patients were enrolled, allocating 158 patients to each arm. In Arm B, in which NAC was completed in 88% of patients. Significant downstaging based on tumor depth, lymph node metastasis, and peritoneal cytology was observed using NAC. Excluding the initial 16 patients randomized before the first revision of the protocol, 149 and 151 patients in arms A and B, respectively, were included in the primary analysis. The 3-year OS rates were 62.4% [95% confidence interval (CI) 54.1–69.6] in Arm A and 60.9% (95% CI 52.7–68.2) in Arm B. The hazard ratio of Arm B against Arm A was 0.916 (95% CI 0.679–1.236). For type 4 or large type 3 gastric cancer, NAC with S-1 plus cisplatin failed to demonstrate a survival benefit. D2 surgery followed by adjuvant chemotherapy remains the standard treatment. |
| Databáze: | OpenAIRE |
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