一项比较每月氟尿嘧啶和顺铂与单独每周顺铂联合同期放疗治疗局部晚期宫颈癌的随机试验的初步结果。

A preliminary results of a randomized trial comparing monthly 5-flourouracil and cisplatin to weekly cisplatin alone combined with concurrent radiotherapy for locally advanced cervical cancer.

机构信息

Department of Radiation Oncology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.

出版信息

Cancer Res Treat. 2005 Feb;37(1):37-43. doi: 10.4143/crt.2005.37.1.37. Epub 2005 Feb 28.

DOI:10.4143/crt.2005.37.1.37

PMID:19956508

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2785420/

Abstract

PURPOSE

To determine the superior chemotherapeutic regimen between monthly 5-FU plus cisplatin (FP) and weekly cisplatin alone in concurrent chemoradiotherapy for locally advanced cervical cancer, the compliance of treatment, response, survival and toxicities were analyzed between the two arms.

MATERIALS AND METHODS

Between March 1998 and December 2001, 61 patients with locally advanced cervical cancer (stage IIB through IVA) and negative para-aortic lymph nodes were randomly assigned to either 'monthly FP' (arm I, n=34) or 'weekly cisplatin' (arm II, n=27) with concurrent radiotherapy. The patients of arm I received FP (5-FU 1,000 mg/m(2)/day + cisplatin 20 mg/m(2)/day, for 5 days, for 3 cycles at 4 week intervals) and those of arm II received cisplatin (30 mg/m(2)/day, for 6 cycles at 1 week intervals) with concurrent radiotherapy. The radiotherapy consisted of 41.4 approximately 50.4 Gy external beam irradiation in 23 approximately 28 fractions to the whole pelvis, with high dose rate brachytherapy delivering a dose of 30 approximately 35 Gy in 6 approximately 7 fractions to point A. During the brachytherapy, a parametrial boost was delivered. The median follow-up period for survivors was 44 months.

RESULTS

The compliance of treatment in monthly FP weekly cisplatin arms were 62 and 81%, respectively. The complete response rates at 3 months were 96 and 88% in arms I and II, respectively. The 4-year overall survival and disease free survival rates were 64 and 54% in the arm I and 77 and 66% in the arm II, respectively. The incidence of hematologic toxicity more than grade 2 was 29% in the arm I and 15% in the arm II. Only one patient in arm I experienced grade 3 gastrointestinal toxicity. No severe genitourinary toxicity was observed.

CONCLUSION

No significant difference was observed in the compliance, responses, survival rates and acute toxicities between the two treatment arms. More patients and further follow up will be required.

摘要

目的

为了确定在局部晚期宫颈癌的同期放化疗中，每月氟尿嘧啶加顺铂（FP）与单独每周顺铂化疗的优势化疗方案，比较了两种方案的治疗依从性、反应、生存和毒性。

材料和方法

1998 年 3 月至 2001 年 12 月，61 例局部晚期宫颈癌（IIB 期至 IVA 期）且腹主动脉旁淋巴结阴性的患者被随机分为“每月 FP 组（I 组，n=34）”或“每周顺铂组（II 组，n=27）”，并进行同期放化疗。I 组患者接受 FP（5-FU 1000mg/m2/天+顺铂 20mg/m2/天，连用 5 天，每 4 周重复 3 个周期），II 组患者接受顺铂（30mg/m2/天，每 1 周重复 6 个周期），同时进行同期放化疗。放疗采用外照射 23-28 次，每次 41.4-50.4Gy，同时高剂量率近距离放疗 6-7 次，每次 30-35Gy，给予点 A 剂量。在近距离放疗期间，给予宫旁组织局部加量。生存患者的中位随访时间为 44 个月。

结果

每月 FP 组和每周顺铂组的治疗依从性分别为 62%和 81%。治疗后 3 个月的完全缓解率分别为 I 组 96%和 II 组 88%。I 组 4 年总生存率和无病生存率分别为 64%和 54%，II 组分别为 77%和 66%。I 组 2 级以上血液学毒性发生率为 29%，II 组为 15%。I 组仅有 1 例患者发生 3 级胃肠道毒性。未观察到严重的泌尿生殖系统毒性。