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Short-term results of a phase II study of preoperative docetaxel/cisplatin/S-1 therapy for locally advanced gastric cancer.

术前多西他赛/顺铂/S-1治疗局部进展期胃癌的II期研究的短期结果。

  • 影响因子:2.04
  • DOI:10.1093/jjco/hyaa221
  • 作者列表:"Tsuchida K","Sato T","Aoyama T","Atsumi Y","Kano K","Maezawa Y","Kazama K","Numata M","Yamada T","Tamagawa H","Murakami H","Oshima T","Saeki H","Cho H","Yukawa N","Yamamoto Y","Masuda M","Rino Y
  • 发表时间:2021-03-03
Abstract

BACKGROUND:A multi-institutional phase II study was conducted to evaluate the efficacy and safety of preoperative docetaxel, cisplatin and S-1 therapy in marginally resectable advanced gastric cancer. METHODS:Patients with macroscopic type 4, large macroscopic type 3 and bulky lymph node metastasis received two cycles of preoperative docetaxel, cisplatin and S-1 therapy (docetaxel 40 mg/m2 and cisplatin 60 mg/m2 on day 1, and S-1 80 mg/m2 for 14 days, every 4 weeks). The primary endpoint was the pathological response rate, with an expected value of 65%. RESULTS:Thirty-one patients were enrolled in this study. The pathological response rate was 54.8%, and it was higher than the threshold value but lower than the expected rate. The R0 resection rate was 93.5%. The frequencies of grade 3-4 toxicities during docetaxel, cisplatin and S-1 therapy were 41.9% for neutropenia, 6.5% for febrile neutropenia and 32.3% for nausea/vomiting. Grade 2 and 3 surgical morbidities occurred in 23.3 and 6.7% of the patients, respectively. CONCLUSIONS:Preoperative docetaxel, cisplatin and S-1 therapy was feasible in terms of chemotherapy-related toxicities and surgical morbidity, but the effect did not achieve the expected value. The association between the pathological response rate and survival will be evaluated in the final analysis of this clinical trial.

摘要

背景: 一项多机构II期研究旨在评估术前多西他赛、顺铂和S-1治疗对局部可切除进展期胃癌的疗效和安全性。 方法: 肉眼可见的4型、肉眼可见的3型、巨大淋巴结转移的患者接受术前多西他赛、顺铂和S-1治疗2个周期 (多西他赛40 mg/m2和顺铂60 mg/m2,S-1 80 mg/m2,14天,每4周)。主要终点为病理缓解率,预期值为65%。 结果: 31例患者入选本研究。病理反应率为54.8%,高于阈值但低于预期率。基本传染数切除率为93.5%。多西他赛、顺铂和S-1治疗期间3-4级毒性的频率为中性粒细胞减少41.9%,发热性中性粒细胞减少6.5% 和恶心/呕吐32.3%。2级和3级手术发病率分别为23.3和6.7%。 结论: 术前多西他赛、顺铂、S-1方案治疗在化疗相关毒性反应和手术并发症方面是可行的,但效果未达到预期价值。病理反应率和存活率之间的关联将在本临床试验的最终分析中进行评估。

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