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腹腔内紫杉醇作为卵巢癌患者巩固治疗的病例对照研究。

Intraperitoneal paclitaxel as consolidation treatment in ovarian cancer patients: a case control study.

机构信息

Department of Obstetrics and Gynecology, La Sapienza University of Rome, Viale del Policlinico 155, IT-00155 Rome, Italy.

出版信息

Oncology. 2010;78(1):20-5. doi: 10.1159/000287968. Epub 2010 Feb 24.

Abstract

OBJECTIVE

It was the aim of this study to assess the role, feasibility and safety of consolidation intraperitoneal (IP) paclitaxel in patients affected by advanced ovarian cancer.

METHODS

Patients affected by advanced ovarian cancer with complete pathological response after standard treatment were enrolled in this study. The consolidation chemotherapy schedule consisted of 12-16 cycles of IP paclitaxel, 60 mg/mq weekly (group A). Chemotherapy was delivered with a direct puncture under ultrasonographic guidance at each cycle. Survival data of this group of patients were compared with those from a control group with analogous characteristics submitted to observation only (group B).

RESULTS

Seventy patients were included in the study, 28 in group A and 42 in group B. Treatment-related toxicity was mild. In 3/28 patients (11%), technical difficulties in accessing the peritoneum were observed. Median time to recurrence was 25 months (range 4-64) in group A and 17.5 months (range 2-60) in group B. Estimated 3-year disease-free survival was 56 and 33% (p < 0.05) in group A and B, respectively; no significant difference in 3-year overall survival was observed (87 vs. 83%; p value not significant).

CONCLUSION

Weekly IP consolidation chemotherapy with paclitaxel 60 mg/mq is well tolerated and, in this experience, a prolongation of progression-free survival was observed.

摘要

目的

本研究旨在评估腹腔内(IP)紫杉醇巩固治疗在晚期卵巢癌患者中的作用、可行性和安全性。

方法

本研究纳入了完全病理缓解后的标准治疗后晚期卵巢癌患者。巩固化疗方案包括 12-16 个周期的 IP 紫杉醇,每周 60mg/m²(A 组)。每个周期均在超声引导下进行直接穿刺给药。将该组患者的生存数据与仅接受观察的相似特征的对照组(B 组)进行比较。

结果

本研究共纳入 70 例患者,A 组 28 例,B 组 42 例。治疗相关毒性较轻。在 3/28 例患者(11%)中,观察到进入腹膜腔的技术困难。A 组中位复发时间为 25 个月(范围 4-64),B 组为 17.5 个月(范围 2-60)。A 组和 B 组估计的 3 年无病生存率分别为 56%和 33%(p<0.05);3 年总生存率无显著差异(87% vs. 83%;p 值无统计学意义)。

结论

每周腹腔内 60mg/m² 紫杉醇巩固化疗耐受性良好,在本研究中观察到无进展生存期延长。

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