Multicenter Phase 2 Study of Peri-Irradiation Chemotherapy Plus Intensity Modulated Radiation Therapy With Concurrent Weekly Docetaxel for Inoperable or Medically Unresectable Nonmetastatic Gastric Cancer
Multicenter Phase 2 Study of Peri-Irradiation Chemotherapy Plus Intensity Modulated Radiation Therapy With Concurrent Weekly Docetaxel for Inoperable or Medically Unresectable Nonmetastatic Gastric Cancer
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围照射化疗联合调强放疗联合每周多西他赛治疗无法手术或医学上无法切除的非转移性胃癌的多中心 2 期研究
DOI：
10.1016/j.ijrobp.2017.03.032
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发表时间：
2017-08-01
影响因子：
7
通讯作者：
Chen, Tingfeng
中科院分区：
文献类型：
--
作者：
Liu, Yong;Zhao, Guoqi;Chen, Tingfeng
目的：评价同期放化疗(CCRT)加放疗前后化疗对不能手术的非转移性胃癌患者的疗效和可行性。方法：不能手术(因内科合并症或患者拒绝手术)或不能手术的胃癌患者分别接受2个21天的放疗和放疗后化疗周期(多西紫杉醇37.5 mg/m(2)，第1~3天；顺铂25 mg/m(2)，第1~3天；氟尿嘧啶750 mg/m(2)，第1~5天持续滴注)。放疗前和放疗后分别于放疗前和放疗后进行持续适形放射治疗(CCRT)，共6周。结果：36例患者可评价，21例合并不适宜手术(第1组)，8例不能切除(第2组)，7例拒绝手术(第3组)。36例可评价患者的临床完全缓解率为36%(95%可信区间为19%~53%)，总有效率为83%(95%可信区间为75%~97%)。中位生存期25.8个月(95%CI，7.1~44.5个月)，2年生存率52%(95%CI，38%~67%)。第1、2、3组的中位OS和2年OS率分别为37.0个月(95%CI，7.9~66.1个月)和52%(95%CI，31%~73%)，17.7个月(95%CI，7.8~27.6个月)和20%(95%CI，0%~49%)，38.9个月(95%CI，16.6~58.3个月)和67%(95%CI，30%~100%)。达到CCR与显著改善的总体存活率(P=.004)和无进展存活率(P=.003)相关。化疗期间最常见的3级或更大的毒性是中性粒细胞减少症。CCRT中常见的3/4级毒性反应为恶心和呕吐。结论：该方案对不能手术或内科不能切除的GC具有良好的疗效，耐受性好。(C)2017 Elsevier Inc.保留所有权利。
Purpose: To assess the efficacy and feasibility of concurrent chemoradiation therapy (CCRT) plus preradiation and postradiation chemotherapy for patients with nonmetastatic gastric carcinoma who do not undergo surgery.Methods and Materials: Patients with inoperable (due to medical comorbid conditions or patient's refusal to undergo surgery) or unresectable gastric cancer received up to 2 21-day cycles of preradiation and postradiation chemotherapy (docetaxel 37.5 mg/m(2) on days 1 and 8, cisplatin 25 mg/m(2) on days 1-3, and a continuous infusion of fluorouracil [FU] 750 mg/m(2) on days 1-5), respectively. CCRT between preradiation and postradiation chemotherapy was initiated on day 43 and consisted of intensity modulated radiation therapy (50.4 Gy) plus concurrent docetaxel 20 mg/m 2 weekly for 6 weeks.Results: 36 patients were evaluable; 21 patients with comorbid conditions were unsuitable for surgery (group 1), 8 had unresectable disease (group 2), and 7 refused surgery (group 3). The clinical complete response (cCR) rate for the 36 evaluable patients was 36% (95% confidence interval [CI], 19%-53%) and the overall response rate was 83% (95% CI, 75%-97%). The median survival time and estimated 2-year survival rate were 25.8 months (95% CI, 7.1-44.5 months) and 52% (95% CI, 38%-67%), respectively. The estimated median OS and 2-year OS rates for groups 1, 2, and 3 were 37.0 months (95% CI, 7.9-66.1 months) and 52% (95% CI, 31%-73%), 17.7 months (95% CI, 7.8-27.6 months) and 20% (95% CI, 0%-49%), and 38.9 months (95% CI, 16.6-58.3 months) and 67% (95% CI, 30%-100%), respectively. Achieving a cCR was associated with significantly better overall survival (P = .004) and progressionfree survival (P = .003). The most common grade 3 or greater toxicity during the chemotherapy phase was neutropenia. Common grade 3/4 toxicities during CCRT were nausea and vomiting.Conclusions: This regimen is tolerable and shows promising efficacy in inoperable or medically unresectable GC. (C) 2017 Elsevier Inc. All rights reserved.