Ferrandina Gabriella, Paris Ida, Ludovisi Manuela, D'Agostino Giuseppe, Testa Antonia, Lorusso Domenica, Zanghi Mariangela, Pisconti Salvatore, Pezzella Giuseppa, Adamo Vincenzo, Breda Enrico, Scambia Giovanni
Gynecologic Oncology Unit, Catholic University of Rome, L.go A. Gemelli, 8 00168 Rome, Italy.
Gynecol Oncol. 2005 Aug;98(2):267-73. doi: 10.1016/j.ygyno.2005.04.018.
The combination of GEM/PLD has been tested for its efficacy on survival of recurrent ovarian cancer patients.
This is a multicenter phase II study of GEM/PLD regimen in recurrent ovarian cancer patients previously treated with at least one platinum/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.
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.
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.
已对吉西他滨（GEM）/聚乙二醇脂质体多柔比星（PLD）联合用药对复发性卵巢癌患者生存的疗效进行了测试。
这是一项针对复发性卵巢癌患者的多中心II期研究，这些患者先前至少接受过一种铂类/紫杉醇方案治疗，且有可测量疾病的证据。第1天给予PLD，剂量为30mg/m²，随后在第1天和第8天给予GEM，剂量为1000mg/m²，每21天重复一次。
106例患者可进行疗效评估。已记录到9例完全缓解（8.5%）和27例部分缓解（25.5%）。36例患者（34.0%）病情稳定，而34例（32.1%）患者在治疗期间病情进展。铂耐药患者的总生存期（OS）显著短于铂敏感患者（中位OS = 50周对中位OS = 92周）（P值 = 0.0016）。在铂敏感患者组中，对GEM/PLD联合用药有反应的患者与对GEM/PLD无反应的患者相比，OS更好（中位OS = 120周对中位OS = 60周，P值 = 0.019）。在铂耐药患者中也观察到了相同趋势。4级血液学毒性影响20例患者（18%）。16例患者（14.4%）出现3级手足红斑感觉异常（PPE）。3级和4级黏膜炎分别记录在16例（14.4%）和2例（1.8%）患者中。
GEM/PLD联合用药是复发性卵巢癌患者的一种有效治疗方法。血液学毒性易于处理，且PPE的发生率和严重程度较低。
