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短程输注曲贝替定治疗多次预处理的卵巢癌患者:单机构经验

Short-Infusion Trabectedin in Heavily Pretreated Ovarian Cancer Patients: A Single-Institution Experience.

作者信息

Marchetti Claudia, Musella Angela, Romito Alessia, Vertechy Laura, Palaia Innocenza, Di Donato Violante, Boccia Serena, De Felice Francesca, Monti Marco, Muzii Ludovico, Benedetti Panici Pierluigi

机构信息

Department of Gynecological-Obstetrical and Urological Sciences, Sapienza University of Rome, Rome, Italy.

出版信息

Oncology. 2017;93(6):359-366. doi: 10.1159/000475668. Epub 2017 Sep 26.

Abstract

OBJECTIVE

The aim of this study was to assess the efficacy and tolerability of trabectedin given every 10 days as a single agent in recurrent ovarian cancer after 3 prior regimens.

METHOD

Trabectedin 0.6 mg/m2 was administered as a 3-h infusion every 10 days on a 21-day cycle. The study population was compared to patients treated with weekly paclitaxel 80 mg/m2 intravenously on days 1, 8, 15, and 22 every 4 weeks.

RESULTS

We identified 34 patients previously submitted to at least 3 lines of chemotherapy who received single-agent trabectedin between 2010 and 2015. They were matched with a historical series of 34 patients who received weekly paclitaxel. No significant differences in response rate were found. Median progression-free survival was 4 months; 5 months in the trabectedin group and 4 months in the paclitaxel group. Overall survival (OS) was 13 months for the trabectedin group and 7 months for the paclitaxel group (p = 0.015). Patients who received platinum after trabectedin had a significant OS increase compared to those who received platinum after paclitaxel (18 vs. 9 months, respectively; p = 0.009). The most frequent drug-related grade 3/4 toxicities were reversible hepatic toxicity, neutropenia, anemia, thrombocytopenia, and gastrointestinal toxicity.

CONCLUSION

Single-agent trabectedin every 10 days is an active treatment with a manageable toxicity profile in heavily pretreated advanced relapsed ovarian cancer patients.

摘要

目的

本研究旨在评估曲贝替定作为单一药物每10天给药一次,用于三线治疗后复发性卵巢癌的疗效和耐受性。

方法

曲贝替定0.6mg/m²,每10天静脉输注3小时,每21天为一个周期。将研究人群与每4周的第1、8、15和22天静脉注射80mg/m²紫杉醇的患者进行比较。

结果

我们确定了34例先前至少接受过3线化疗的患者,他们在2010年至2015年期间接受了曲贝替定单药治疗。将他们与34例接受每周紫杉醇治疗的历史队列患者进行匹配。未发现缓解率有显著差异。中位无进展生存期为4个月;曲贝替定组为5个月,紫杉醇组为4个月。曲贝替定组的总生存期(OS)为13个月,紫杉醇组为7个月(p=0.015)。与紫杉醇治疗后接受铂类药物的患者相比,曲贝替定治疗后接受铂类药物的患者的总生存期显著延长(分别为18个月和9个月;p=0.009)。最常见的3/4级药物相关毒性为可逆性肝毒性、中性粒细胞减少、贫血、血小板减少和胃肠道毒性。

结论

对于经过大量预处理的晚期复发性卵巢癌患者,每10天使用一次曲贝替定单药治疗是一种有效的治疗方法,且毒性可控。

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