Phase II study of concurrent chemoradiotherapy with high-dose-rate intracavitary brachytherapy in patients with locally advanced uterine cervical cancer: Efficacy and toxicity of a low cumulative radiation dose schedule
Phase II study of concurrent chemoradiotherapy with high-dose-rate intracavitary brachytherapy in patients with locally advanced uterine cervical cancer: Efficacy and toxicity of a low cumulative radiation dose schedule
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DOI：
10.1016/j.ygyno.2012.04.036
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发表时间：
2012-08-01
影响因子：
4.7
通讯作者：
Takizawa, Ken
中科院分区：
文献类型：
--
作者：
Toita, Takafumi;Kitagawa, Ryo;Takizawa, Ken
客观的。进行了一项多中心 II 期试验，以评估采用低累积处方剂量方案的同步放化疗 (CCRT) 与高剂量腔内近距离放射治疗 (HDR-ICBT) 对局部晚期宫颈癌患者的疗效和毒性。方法。日本妇科肿瘤学组 (JGOG) 研究 JGOG1066 纳入了FIGO III-IVA期宫颈癌患者，经CT评估，这些患者没有主动脉旁淋巴结肿大（>10毫米）。患者接受了确定性放疗 (RT)，包括外照射全盆腔放疗和 HDR-ICBT。在 A 点规定的累积线性二次当量剂量 (EQD2) 为 62-65 Gy。顺铂 40 mg/m(2) 每周与 RT 同时给药，持续 5 个疗程。结果。在登记的 72 名患者中，有 71 名符合资格。中位随访时间为 28 个月，2 年无进展生存率和盆腔疾病无进展率分别为 66%（95% Cl，54% 至 76%）和 73%（95% Cl，61% 至 82%）。随着中心肿瘤大小的增加，无进展生存期显着降低（P=0.036）。所有级别的 2 年累积晚期并发症发生率为 24%，1 级为 9%，2 级为 12%，3 级为 3%，4/5 级为 0。结论。 JGOG1066 证明，在日本人群中，使用 HDR-ICBT 和低累积 RT 剂量方案的 CCRT 与采用全局剂量方案 (EQD2 = 85 Gy) 取得的结果相当，且晚期毒性发生率较低。 (C) 2012 Elsevier Inc. 保留所有权利。
Objective. A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with high-dose-rate intracavitary brachytherapy (HDR-ICBT) using a low cumulative prescribed dose schedule in patients with locally advanced uterine cervical cancer.Methods. The Japanese Gynecologic Oncology Group (JGOG) study JGOG1066 enrolled patients with FIGO stages III-IVA uterine cervical cancer who had no para-aortic lymphadenopathy (>10 mm) assessed by CT. Patients received definitive radiotherapy (RT) consisting of external beam whole pelvic RT and HDR-ICBT. The cumulative linear quadratic equivalent dose (EQD2) was 62-65 Gy prescribed at point A. Cisplatin 40 mg/m(2) weekly was administered concurrently with RT for 5 courses.Results. Of the 72 patients registered, 71 were eligible. With a median follow-up of 28 months, the 2-year progression-free survival rate and pelvic disease progression-free rate were 66% (95% Cl, 54% to 76%) and 73% (95% Cl, 61% to 82%), respectively. Progression-free survival decreased significantly with increased central tumor size (P=0.036). The 2-year cumulative late complication rates were 24% for all grades, 9% for grade 1, 12% for grade 2, 3% for grade 3, and 0 for grades 4/5.Conclusions. The JGOG1066 demonstrated that CCRT using HDR-ICBT with a low cumulative RT dose schedule achieved comparable outcome as those achieved with global dose schedules (EQD2 = 85 Gy) with a lower incidence of late toxicity for locally advanced uterine cervical cancer in a Japanese population. (C) 2012 Elsevier Inc. All rights reserved.