Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma.
Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma.
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完全 (R0) 切除胃癌患者同步多西紫杉醇调强放疗前后使用多西紫杉醇/顺铂/5-氟尿嘧啶辅助放化疗的 II 期研究
DOI：
10.1097/coc.0000000000000373
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发表时间：
2018-07
期刊：
影响因子：
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通讯作者：
Chen T
中科院分区：
文献类型：
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作者：
Liu Y;Zhao G;Xu Y;Zhang T;Chen Z;Yan G;Tu W;Hu Y;Chen Y;He X;Li X;Chen H;Yao S;Hu Z;Chen X;Chen T
目的：Intergroup 0116研究已经证明了接受氟尿嘧啶/亚叶酸钙放化疗方案治疗的完全切除（R 0）胃癌患者的显著生存获益。然而，该方案也是有毒的，并且在远距离疾病控制方面效果较差。因此，迫切需要更有效和更安全的方案。研究方法：R 0切除的胃癌患者接受了最多2个21天周期的术后辅助放疗前和放疗后DCF化疗（多西他赛37.5 mg/m2，第1天和第8天，顺铂25 mg/m2，第1天至第3天，氟尿嘧啶750 mg/m2，第1天至第5天持续输注）。在第43天开始放疗前和放疗后化疗之间的放化疗，包括调强放疗（45戈伊）加同步多西他赛20 mg/m2每周一次，持续5周。结果：共对55例患者进行了评价，76%（42例）的患者完成了规定的治疗。中位随访时间为61个月，3年和5年无进展生存率为67%（95%置信区间[CI]，54%-80%）和59%（95%CI，46%-72%）; 3年和5年总生存率分别为72%（95%CI，60%-84%）和61%（95%CI，48%-74%）。化疗期间最常见的3级或以上毒性为中性粒细胞减少症（24%）。同步放化疗期间常见的3/4级毒性反应为恶心（32%）、呕吐（26%）、疲乏（15%）和厌食（19%）。结论：这些结果表明，这种辅助治疗方案是有效的，具有可接受的毒性。一项比较Intergroup 0116放化疗方案与该方案的随机III期试验正在进行中。
Objectives: The Intergroup 0116 study has demonstrated a significant survival benefit for completely resected (R0) gastric cancer patients treated with a fluorouracil/leucovorin chemoradiotherapy regimen. However, this regimen is also toxic and less effective in terms of distant disease control. Therefore, a more efficacious and safer regimen is urgently needed. Methods: Patients with R0 resected gastric carcinoma received up to two 21-day cycles of postoperative adjuvant preradiation and postradiation DCF chemotherapy (docetaxel 37.5 mg/m2 on days 1 and 8, cisplatin 25 mg/m2 on days 1 to 3, and a continuous infusion of fluorouracil 750 mg/m2 on days 1 to 5), respectively. Chemoradiotherapy between preradiation and postradiation chemotherapy was initiated on day 43 and consisted of intensity-modulated radiotherapy (45 Gy) plus concurrent docetaxel 20 mg/m2 weekly for 5 weeks. Results: A total of 55 patients were evaluated and 76% (42) of patients completed the prescribed therapy. With a median follow-up of 61 months, the 3- and 5-year progression-free survival rates were 67% (95% confidence interval [CI], 54%-80%) and 59% (95% CI, 46%-72%), respectively; and the 3- and 5-year overall survival rates were 72% (95% CI, 60%-84%) and 61% (95% CI, 48%-74%), respectively. The most common grade 3 or greater toxicity, during the chemotherapy phase, was neutropenia (24%). Common grade 3/4 toxicities during concurrent chemoradiotherapy were nausea (32%), vomiting (26%), fatigue (15%), and anorexia (19%). Conclusions: These results demonstrate that this adjuvant regimen is active with an acceptable toxicity profile. A randomized phase 3 trial comparing the Intergroup 0116 chemoradiotherapy regimen with this regimen is underway.