多柔比星脂质体与托泊替康联合治疗复发性卵巢癌可延迟三线化疗并延长铂类药物无进展间期。

BACKGROUND: OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy. PATIENTS AND METHODS: a detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted. RESULTS: similar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). CONCLUSION: the superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.

背景：OVA-301 是一项大型随机试验，结果显示，在 672 名复发性卵巢癌患者中，与单药 PLD（CentoCor Ortho Biotech Products L.P.，新泽西州 Raritan，美国）相比，曲贝替定联合聚乙二醇脂质体多柔比星（PLD；CentoCor Ortho Biotech Products L.P.，新泽西州 Raritan，美国）具有优越性，尤其在部分铂敏感亚组（无铂间期[PFI]为 6-12 个月）中。这种优越性可能归因于后续（铂类）治疗的差异影响。

患者和方法：因此，对总体人群和根据铂敏感性的亚组进行了后续治疗和生存结果的详细分析。

结果：在每个治疗组中，接受后续治疗的患者比例相似（76%比 77%），包括进一步的铂类治疗方案（49%比 55%）。曲贝替定/PLD 组的患者接受后续化疗的时间较晚（中位延迟 2.5 个月）。在部分铂敏感疾病亚组中，随后使用铂类的总生存时间显著延长（风险比=0.63；P=0.0357）。

结论：在 OVA-301 中，曲贝替定/PLD 与单药 PLD 相比的优越性不能用给予这些患者的后续治疗的程度或性质的差异来解释。另一方面，这些探索性分析支持这样一种假设，即在部分铂敏感亚组中，生存获益的增强可能是由于无铂间期延长，从而导致随后使用铂类的生存时间延长。