Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer
Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer
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DOI：
10.1200/jco.2007.13.6606
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发表时间：
2008-02-20
影响因子：
45.3
通讯作者：
Scambia, Giovanni
中科院分区：
文献类型：
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作者：
Ferrandina, Gabriella;Ludovisi, Manuela;Scambia, Giovanni
目的研究吉西他滨（GEM）与聚乙二醇脂质体阿霉素（PLD）挽救治疗复发性卵巢癌的疗效、耐受性和生活质量。（1,000 mg/m2，第1、8、每28天15次）（40 mg/m2，每28天一次）在仅接受一种铂类药物治疗失败的卵巢癌患者中，结果150例患者接受紫杉醇方案治疗，在完成初步治疗后12个月内复发或进展。3名患者被随机分配到PLD组（n=76）或GEM组（n=77）。治疗组的临床病理学特征平衡良好。GEM治疗患者中3级或4级中性粒细胞减少症的发生率高于PLD治疗患者（P=.007）。PLD患者（6%）与GEM患者（0%; P= 0.061）相比，记录了更高比例的3级或4级掌跖红肿。PLD组的总体缓解率为16%，GEM组为29%（P= 0.056）。根据治疗分配，至疾病进展时间（TTP）曲线无统计学显著差异（P=.411）。然而，与GEM组相比，PLD组记录了更有利的总生存率趋势，尽管P值具有边缘统计学显著性（P= 0.048）。PLD治疗的患者在第一次和第二次基线后QOL assessment.Conclusion全球QOL评分显着较高，GEM并没有提供一个优势，PLD在TTP方面的卵巢癌患者经历复发后12个月内的主要治疗，但应考虑在药物谱可能用于挽救设置。
Purpose We aimed at investigating the efficacy, tolerability, and quality of life (QOL) of gemcitabine (GEM) compared with pegylated liposomal doxorubicin (PLD) in the salvage treatment of recurrent ovarian cancer.Patients and Methods A phase III randomized multicenter trial was planned to compare GEM (1,000 mg/m(2) on days 1, 8, and 15 every 28 days) with PLD (40 mg/m2 every 28 days) in ovarian cancer patients who experienced treatment failure with only one platinum/paclitaxel regimen and who experienced recurrence or progression within 12 months after completion of primary treatment.Results One hundred fifty-three patients were randomly assigned to PLD (n=76) or GEM (n=77). Treatment arms were well balanced for clinicopathologic characteristics. Grade 3 or 4 neutropenia was more frequent in GEM-treated patients versus PLD-treated patients (P=.007). Grade 3 or 4 palmar-plantar erythrodysesthesia was documented in a higher proportion of PLD patients (6%) versus GEM patients (0%; P=.061). The overall response rate was 16% in the PLD arm compared with 29% in the GEM arm (P=.056). No statistically significant difference in time to progression (TTP) curves according to treatment allocation was documented (P=.411). However, a trend for more favorable overall survival was documented in the PLD arm compared with the GEM arm, although the P value was of borderline statistical significance (P=.048). Statistically significantly higher global QOL scores were found in PLD-treated patients at the first and second postbaseline QOL assessments.Conclusion GEM does not provide an advantage compared with PLD in terms of TTP in ovarian cancer patients who experience recurrence within 12 months after primary treatment but should be considered in the spectrum of drugs to be possibly used in the salvage setting.