Rocconi Rodney P, Straughn J Michael, Leath Charles A, Kilgore Larry C, Huh Warner K, Barnes Mack N, Partridge Edward E, Alvarez Ronald D
University of Alabama at Birmingham, 35233, USA.
Oncologist. 2006 Apr;11(4):336-41. doi: 10.1634/theoncologist.11-4-336.
To assess the feasibility of using pegylated liposomal doxorubicin (PLD) as a consolidation therapy in patients with advanced ovarian cancer who have attained a clinically defined complete response to initial platinum/paclitaxel-based chemotherapy.
Patients diagnosed with suboptimally debulked stage IIIC/IV epithelial ovarian cancer who attained a clinically defined complete response at the completion of platinum/paclitaxel-based chemotherapy were eligible for this protocol. Patients were treated with PLD at a dose of 40 mg/m(2) every 28 days for four cycles. A survival analysis was calculated using the Kaplan-Meier method.
Of the 30 patients enrolled, 29 were evaluable. Twenty-three patients (79%) completed all four cycles of consolidation therapy. Palmar-plantar erythrodysesthesia was the most common toxicity. Six patients remained clinically without evidence of disease with a median follow-up of 35 months from the completion of primary chemotherapy. The median progression-free interval was 15 months, and median overall survival time was 31 months, with 47% of patients achieving a 4-year survival.
Consolidation therapy with PLD chemotherapy administered to women with advanced epithelial ovarian cancer after initial chemotherapy appears feasible based on its toxicity profile. Considering the tolerability of this agent, further investigation is needed to depict the optimal dose and schedule needed for consolidation therapy.
评估聚乙二醇化脂质体阿霉素(PLD)作为巩固治疗药物,用于对基于铂类/紫杉醇的初始化疗达到临床定义的完全缓解的晚期卵巢癌患者的可行性。
诊断为减瘤不充分的IIIC/IV期上皮性卵巢癌且在基于铂类/紫杉醇的化疗结束时达到临床定义的完全缓解的患者符合本方案要求。患者接受PLD治疗,剂量为40mg/m²,每28天一次,共四个周期。采用Kaplan-Meier方法进行生存分析。
入组的30例患者中,29例可评估。23例患者(79%)完成了全部四个周期的巩固治疗。手足红斑性感觉异常是最常见的毒性反应。6例患者临床上无疾病证据,自初次化疗结束起的中位随访时间为35个月。中位无进展生存期为15个月,中位总生存时间为31个月,47%的患者实现了4年生存。
基于其毒性特征,对晚期上皮性卵巢癌女性患者在初始化疗后给予PLD化疗巩固治疗似乎可行。考虑到该药物的耐受性,需要进一步研究以确定巩固治疗所需的最佳剂量和疗程。