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
Department of Gynecological-Obstetrical and Urological Sciences, Sapienza University of Rome, Rome, Italy.
Oncology. 2017;93(6):359-366. doi: 10.1159/000475668. Epub 2017 Sep 26.
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.
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.
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.
Single-agent trabectedin every 10 days is an active treatment with a manageable toxicity profile in heavily pretreated advanced relapsed ovarian cancer patients.
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。
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。
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。
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。