Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: Updated results and long-term survival
Gemcitabine and liposomal doxorubicin in the salvage treatment of ovarian cancer: Updated results and long-term survival
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DOI：
10.1016/j.ygyno.2005.04.018
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发表时间：
2005-08-01
影响因子：
4.7
通讯作者：
Scambia, G
中科院分区：
文献类型：
--
作者：
Ferrandina, G;Paris, I;Scambia, G
Objective. GEM/PLD的组合已被测试其对复发性卵巢癌患者的存活率的功效。这是一项在既往接受过至少一种铂类/紫杉醇方案治疗且有可测量疾病证据的复发性卵巢癌患者中开展的GEM/PLD方案的多中心11期研究。PLD 30 mg m（-2）第1天，GEM 1000 mg m（-2）第1天和第8天，每21天1次。106例患者可用于缓解评价。9份完全答复（8.5%）和27份部分答复（25.5%）。36例（34.0%）患者病情稳定，34例（32.1%）病例在治疗期间进展。铂类耐药患者的OS（中位OS = 50周）显著短于铂类敏感患者（中位OS = 92周）（P值= 0.0016）。在铂类药物敏感患者组中，GEM/PLD联合治疗有反应的患者的OS优于GEM/PLD无反应的患者（中位OS = 120周vs中位OS = 60周，P值= 0.019）。在铂类耐药患者中观察到相同的趋势。4级血液学毒性影响20例患者（18%）。16例患者（14.4%）登记了3级掌跖红斑感觉迟钝（PPE）。3级和4级粘膜炎分别有16例（14.4%）和2例（1.8%）。GEM/PLD联合是治疗复发性卵巢癌的有效方法。血液学毒性易于管理，PPE的发生率和严重程度较低。(c)2005年爱思唯尔公司All rights reserved.
Objective. The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancer patients.Methods. This is a multicenter phase 11 study of GEM/PLD regimen in recurrent ovarian cancer patients previously treated with at least one platinurn/paclitaxel regimen, and with evidence of measurable disease. PLD, 30 mg m(-2), was administered on day 1 followed by GEM, 1000 mg m(-2), on days 1 and 8, every 21 days.Results. 106 patients were available for response evaluation. 9 complete responses (8.5%) and 27 partial responses (25.5%) have been registered. 36 patients (34.0%) experienced stabilization of disease, while 34 (32.1%) cases progressed during treatment. OS was significantly shorter in platinum-resistant (median OS = 50 weeks) than in platinum-sensitive patients (median OS = 92 weeks) (P value = 0.0016). In the group of platinum-sensitive patients, cases responsive to GEM/PLD combination showed a better OS with respect to patients unresponsive to GEM/PLD (median OS = 120 weeks versus median OS = 60 weeks, P value = 0.019). The same trend was observed in platinum-resistant patients. Grade 4 hematological toxicity affected 20 patients (18%). Grade 3 palmar-plantar erythrodysesthesia (PPE) was registered in 16 patients (14.4%). Grades 3 and 4 mucositis was documented in 16 (14.4%) and 2 (1.8%) patients, respectively.Conclusions. GEM/PLD combination represents a valid approach in recurrent ovarian cancer patients. The hematological toxicity was easily managed, and the incidence and severity of PPE was low. (c) 2005 Elsevier Inc. All rights reserved.