Petru E, Angleitner-Boubenizek L, Reinthaller A, Deibl M, Zeimet A G, Volgger B, Stempfl A, Marth C
Department of Obstetrics and Gynecology, Medical University of Graz, Auenbruggerplatz 14, A-8036 Graz, Austria.
Gynecol Oncol. 2006 Aug;102(2):226-9. doi: 10.1016/j.ygyno.2005.12.017. Epub 2006 Jan 27.
Platinum resistance is a significant problem in patients with ovarian cancer. The aim of this phase II study was to define the response rates, the progression-free survival and the toxicity profile of the combination of PEG liposomal doxorubicin (L-DXR) and gemcitabine (GEM).
Thirty one patients with histologically confirmed platinum-refractory or -resistant epithelial ovarian cancer were scheduled to receive 6 cycles of L-DXR 30 mg/m(2) on day 1 as well as GEM 650 mg/m(2) on days 1 and 8 every 28 days.
The median number of chemotherapy cycles given was 4. The mean dose intensity for L-DXR and GEM on day 1 was 96% and 97%, respectively. The mean dose intensity for GEM on day 8 was 93%. The overall response rate was 33% (10 of 30 evaluable patients; 20% complete responses). The median progression-free survival was 3.8 months, and the median overall survival was 15.8 months, respectively. Toxicity was acceptable. One quarter of patients developed grade 3 or 4 neutropenia, but none developed febrile neutropenia. Palmoplantar erythrodysesthesia (PPE) grades 2 and 3 occurred in 13% and 3% only, respectively, and no grade 4 PPE was observed. Grades 1 to 3 stomatitis was found in 58% of patients (10% grade 3).
The combination of L-DXR and GEM is an active and acceptably tolerated option in the treatment of patients with platinum-resistant and -refractory ovarian cancer. Dose reductions seem advisable in the case of > or =grade 2 stomatitis and/or PPE > or =grade 2.
铂耐药是卵巢癌患者面临的一个重大问题。本II期研究的目的是确定聚乙二醇脂质体阿霉素（L-DXR）与吉西他滨（GEM）联合用药的缓解率、无进展生存期和毒性特征。
31例经组织学确诊为铂难治性或耐药性上皮性卵巢癌的患者计划接受6个周期的治疗，每28天在第1天给予L-DXR 30 mg/m²，在第1天和第8天给予GEM 650 mg/m²。
化疗周期的中位数为4个。第1天L-DXR和GEM的平均剂量强度分别为96%和97%。第8天GEM的平均剂量强度为93%。总缓解率为33%（30例可评估患者中的10例；20%为完全缓解）。无进展生存期的中位数分别为3.8个月，总生存期的中位数为15.8个月。毒性是可接受的。四分之一的患者出现3级或4级中性粒细胞减少，但无一例出现发热性中性粒细胞减少。仅分别有13%和3%的患者出现2级和3级掌跖红细胞感觉异常（PPE），未观察到4级PPE。58%的患者出现1至3级口腔炎（10%为3级）。
L-DXR与GEM联合用药是治疗铂耐药和难治性卵巢癌患者的一种有效且耐受性可接受的选择。对于≥2级口腔炎和/或≥2级PPE，似乎建议减少剂量。
