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异环磷酰胺、紫杉醇和卡铂治疗晚期、复发性或持续性宫颈癌的新三联方案:一项 II 期试验。

Ifosfamide, paclitaxel, and carboplatin, a novel triplet regimen for advanced, recurrent, or persistent carcinoma of the cervix: a phase II trial.

机构信息

Department of Obstetrics, Gynecology and Women's Health, Division of Gynecologic Oncology, University of Minnesota, Minneapolis, MN 55455, USA.

出版信息

Gynecol Oncol. 2011 Feb;120(2):265-9. doi: 10.1016/j.ygyno.2010.10.020. Epub 2010 Dec 8.

DOI:10.1016/j.ygyno.2010.10.020
PMID:21145100
Abstract

OBJECTIVES

(1) To determine the response rate of advanced, recurrent, or persistent carcinoma of the cervix to ifosfamide, paclitaxel, and carboplatin chemotherapy; (2) to determine the progression free interval and survival rate in patients treated with this regimen; (3) to describe the toxicities associated with this regimen; and (4) to evaluate the quality of life of patients while on treatment.

METHODS

Eligible patients had histologically proven stage IVB, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. Chemotherapy was given on day 1 of a 28-day cycle: mesna (600 mg/m(2)) prior to ifosfamide (2 g/m(2)), paclitaxel (175 mg/m(2)), carboplatin (AUC 5). Response rates were determined according to RECIST criteria. Toxicity was graded according the National Cancer Institute's common toxicity criteria. Quality of life measurements were obtained using the FACT-Cx.

RESULTS

Twenty-eight patients participated in this study, with 21 evaluable for response rate. Overall, 7 patients (33%) had a demonstrated objective response (4 complete responses, 3 partial responses). Stable disease was documented in 3 patients. The overall median survival for all patients was 10 months. Median progression free survival for evaluable patients was 5.0 months. Bone marrow suppression was the most common toxicity. There were no negative effects of this treatment regimen on quality of life assessments.

CONCLUSION

Ifosfamide, paclitaxel, and carboplatin is an effective regimen in treating advanced or recurrent carcinoma of the cervix and has an acceptable toxicity profile.

摘要

目的

(1)确定晚期、复发性或持续性宫颈癌对异环磷酰胺、紫杉醇和卡铂化疗的反应率;(2)确定该方案治疗患者的无进展间隔和生存率;(3)描述与该方案相关的毒性;(4)评估患者在治疗期间的生活质量。

方法

符合条件的患者为组织学证实的 IVB 期、复发性或持续性宫颈癌,不能通过手术和/或放射治疗进行治愈性治疗。化疗在 28 天周期的第 1 天进行:异环磷酰胺(2g/m2)前给予美司钠(600mg/m2)、紫杉醇(175mg/m2)、卡铂(AUC5)。根据 RECIST 标准确定反应率。毒性根据国家癌症研究所的常见毒性标准进行分级。使用 FACT-Cx 获得生活质量测量值。

结果

28 名患者参与了这项研究,其中 21 名患者可评估反应率。总体而言,7 名患者(33%)有明显的客观反应(4 例完全缓解,3 例部分缓解)。3 名患者的疾病稳定。所有患者的总体中位生存时间为 10 个月。可评估患者的中位无进展生存期为 5.0 个月。骨髓抑制是最常见的毒性。该治疗方案对生活质量评估没有负面影响。

结论

异环磷酰胺、紫杉醇和卡铂是治疗晚期或复发性宫颈癌的有效方案,具有可接受的毒性特征。

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