Department of Oncology, Vejle Hospital, Vejle, Denmark.
Int J Gynecol Cancer. 2013 Jan;23(1):73-80. doi: 10.1097/IGC.0b013e3182775fae.
The increasing number of negative trials for ovarian cancer treatment has prompted an evaluation of new biologic agents, which in combination with chemotherapy may improve survival. The aim of this study was to investigate the response rate in platinum-resistant, KRAS wild-type ovarian cancer patients treated with pegylated liposomal doxorubicin (PLD) supplemented with panitumumab.
Major eligibility criteria were relapsed ovarian/fallopian/peritoneal cancer patients with platinum-resistant disease, measurable disease by GCIG CA125 criteria and KRAS wild-type. Patients were treated with panitumumab 6 mg/kg day 1 and day 15 and with PLD 40 mg/m2 day 1, every 4 weeks.
Forty-six patients were enrolled by 6 study sites in this multi-institutional phase II trial. The response rate in the intention-to-treat population (n = 43) was 18.6%. Progression-free and overall survival in the intention-to-treat population was 2.7 months (2.5-3.2 months, 95% confidence interval) and 8.1 months (5.6-11.7 months, 95% confidence interval), respectively. The most common treatment-related grade 3 toxicities included skin toxicity (42%), fatigue (19%), and vomiting (12%).
The combination of PLD and panitumumab demonstrates efficacy in platinum refractory/resistant patients but the skin toxicity was considerable.
越来越多的卵巢癌治疗阴性试验促使人们评估新的生物制剂，这些制剂与化疗联合使用可能会提高生存率。本研究的目的是研究在铂类耐药、KRAS 野生型卵巢癌患者中，用聚乙二醇化脂质体阿霉素（PLD）联合帕尼单抗治疗的缓解率。
主要入选标准为复发性卵巢/输卵管/腹膜癌患者，铂类耐药疾病，GCIG CA125 标准可测量疾病和 KRAS 野生型。患者接受帕尼单抗 6 mg/kg 第 1 天和第 15 天，PLD 40 mg/m2 第 1 天，每 4 周一次。
该多中心 II 期试验在 6 个研究点共纳入 46 例患者。意向治疗人群（n=43）的缓解率为 18.6%。意向治疗人群的无进展生存期和总生存期分别为 2.7 个月（2.5-3.2 个月，95%置信区间）和 8.1 个月（5.6-11.7 个月，95%置信区间）。最常见的治疗相关 3 级毒性包括皮肤毒性（42%）、疲劳（19%）和呕吐（12%）。
PLD 和帕尼单抗的联合治疗在铂类耐药/难治性患者中显示出疗效，但皮肤毒性相当大。
