Objective: While PLD-Trabectedin is an approved treatment for relapsed platinum-sensitive ovarian cancer, its efficacy and tolerability has so far not been tested extensively in patients who progress after poly ADP-ribose polymerase inhibitor (PARPi) treatment. Methodology: This multicenter, retrospective analysis had the objective of comparing patients receiving PLD-Trabectedin after being treated with PARP-I (cases) with PARPi-naïve patients. Descriptive and survival analyses were performed for each group. Results: Data from 166 patients were collected, composed of 109 cases and 57 controls. In total, 135 patients were included in our analyses, composing 46 controls and 89 cases. The median PFS was 11 months (95% IC 10–12) in the control group vs. 8 months (95% IC 6–9) in the case group (pvalue 0.0017). The clinical benefit rate was evaluated, with an HR for progression of 2.55 (1.28–5.06) for the case group (pvalue 0.008), persisting when adjusted for BRCA and line with treatment. We compared hematological toxicity, gastro-intestinal toxicity, hand–foot syndrome (HFS), fatigue, and liver toxicity, and no statistically significant disparity was noted, except for HFS with apvalue of 0.006. The distribution of G3 and G4 toxicities was also equally represented. Conclusion: The MITO39 study showed a statistically significant difference in terms of PFS, suggesting that previous exposure to PARPi might inhibit the efficacy of PLD-Trabectedin. Regarding tolerability, no remarkable disparity was noted; PLD-Trabectedin was confirmed to be a well-tolerated scheme in both groups. To our knowledge, these are the first data regarding this topic, which we deem to be of great relevance in the current landscape.
目的：虽然PLD-曲贝替定是获批用于复发性铂敏感卵巢癌的治疗方案，但其在聚腺苷二磷酸核糖聚合酶抑制剂（PARPi）治疗后进展患者中的疗效和耐受性迄今尚未得到广泛验证。方法：本项多中心回顾性分析旨在比较接受PARPi治疗后使用PLD-曲贝替定的患者（病例组）与未接受过PARPi治疗的患者（对照组）。对两组分别进行描述性分析和生存分析。结果：共收集166例患者数据，其中病例组109例，对照组57例。最终纳入分析135例患者，包括对照组46例和病例组89例。对照组中位无进展生存期为11个月（95%置信区间10-12），病例组为8个月（95%置信区间6-9）（p值0.0017）。临床获益率评估显示病例组进展风险比为2.55（1.28-5.06）（p值0.008），经BRCA状态和治疗线数校正后该差异持续存在。血液学毒性、胃肠道毒性、手足综合征、疲劳及肝毒性比较中，除手足综合征（p值0.006）外均无统计学显著差异。3级和4级毒性分布情况两组基本相当。结论：MITO39研究显示无进展生存期存在统计学显著差异，提示既往PARPi暴露可能影响PLD-曲贝替定疗效。在耐受性方面未观察到显著差异，PLD-曲贝替定在两组中均被证实为耐受性良好的方案。据我们所知，这是该领域的首次数据报道，我们认为这对当前临床实践具有重要参考价值。
肿瘤(癌症)患者之家