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一项比较放化疗联合顺铂周疗或紫杉醇周疗治疗局部晚期宫颈癌的Ⅱ期随机临床试验。

A phase II randomized trial comparing radiotherapy with concurrent weekly cisplatin or weekly paclitaxel in patients with advanced cervical cancer.

机构信息

Department of Radiation Oncology, The American University of Beirut Medical Center, Bliss Street, Beirut, Lebanon.

出版信息

Radiat Oncol. 2010 Sep 23;5:84. doi: 10.1186/1748-717X-5-84.

DOI:10.1186/1748-717X-5-84
PMID:20863389
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2955593/
Abstract

PURPOSE/OBJECTIVE: This is a prospective comparison of weekly cisplatin to weekly paclitaxel as concurrent chemotherapy with standard radiotherapy for locally advanced cervical carcinoma.

MATERIALS/METHODS: Between May 2000 and May 2004, 31 women with FIGO stage IB2-IVA cervical cancer or with postsurgical pelvic recurrence were enrolled into this phase II study and randomized to receive on a weekly basis either 40 mg/m² Cisplatin (group I; 16 patients) or 50 mg/m² paclitaxel (group II; 15 patients) concurrently with radiotherapy. Median total dose to point A was 74 Gy (range: 66-92 Gy) for group I and 66 Gy (range: 40-98 Gy) for group II. Median follow-up time was 46 months.

RESULTS

Patient and tumor characteristics were similar in both groups. The mean number of chemotherapy cycles was also comparable with 87% and 80% of patients receiving at least 4 doses in groups I and II, respectively. Seven patients (44%) of group I and 8 patients (53%) of group II developed tumor recurrence. The Median Survival time was not reached for Group I and 53 months for group II. The proportion of patients surviving at 2 and 5 years was 78% and 54% for group I and 73% and 43% for group II respectively.

CONCLUSIONS

This small prospective study shows that weekly paclitaxel does not provide any clinical advantage over weekly cisplatin for concurrent chemoradiation for advanced carcinoma of the cervix.

摘要

目的

本研究为前瞻性对比研究,旨在比较每周顺铂与每周紫杉醇联合标准放疗治疗局部晚期宫颈癌的疗效。

材料和方法

2000 年 5 月至 2004 年 5 月,31 例国际妇产科联盟(FIGO)分期为 IB2-IVA 期的宫颈癌或术后盆腔复发患者入组本Ⅱ期研究,并随机分为每周接受 40mg/m²顺铂(I 组,16 例)或 50mg/m²紫杉醇(II 组,15 例)联合放疗组。I 组和 II 组患者的 A 点总剂量中位数分别为 74Gy(范围:66-92Gy)和 66Gy(范围:40-98Gy)。中位随访时间为 46 个月。

结果

两组患者和肿瘤特征相似。两组患者接受至少 4 个周期化疗的比例也相似,分别为 87%和 80%。I 组 7 例(44%)和 II 组 8 例(53%)患者出现肿瘤复发。I 组中位生存时间未达到,II 组为 53 个月。I 组和 II 组的 2 年和 5 年生存率分别为 78%和 54%、73%和 43%。

结论

本小样本前瞻性研究表明,每周紫杉醇联合放化疗治疗局部晚期宫颈癌并不能比每周顺铂提供更多的临床获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9543/2955593/4b29c7b23b3b/1748-717X-5-84-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9543/2955593/905cefacb119/1748-717X-5-84-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9543/2955593/4b29c7b23b3b/1748-717X-5-84-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9543/2955593/905cefacb119/1748-717X-5-84-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9543/2955593/4b29c7b23b3b/1748-717X-5-84-2.jpg

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前瞻性随机研究比较局部晚期宫颈癌同期放化疗中每周顺铂联合紫杉醇与每周顺铂的疗效。
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