Department of Gynecology, Martin Luther University Halle-Wittenberg, Halle, Germany.
Int J Gynecol Cancer. 2009 Nov;19(8):1446-53. doi: 10.1111/IGC.0b013e3181b62f38.
This phase 2 trial was designed to evaluate the efficacy and toxicity of a combination of docetaxel, gemcitabine, and oxaliplatin for platinum- and paclitaxel-pretreated epithelial ovarian cancer.
Heavily pretreated patients (N = 30; median age, 61 years) received docetaxel, 55 mg/m2; gemcitabine, 500 mg/m2 (day 1); and oxaliplatin, 70 mg/m2 (day 2) biweekly. Twelve patients had platinum-sensitive disease, and 18 patients had platinum-resistant disease.
Median follow-up was 18.6 months. No differences in patient characteristics were observed between patients with carboplatinum-sensitive and carboplatinum-resistant disease. In patients with carboplatin-sensitive disease, an overall response (OR) of 83.3%, a progression-free survival of 10.6 months, and an overall survival of 18.9 months were observed. In patients with carboplatinum-resistant disease, an OR was seen in 38.9% with a progression-free survival of 5.3 months and an overall survival of 16.3 months. Patients with platinum-refractory disease (progression under previous carboplatinum therapy, n = 13) had an OR of 23%, whereas patients with objective response but relapse less than 6 months after carboplatinum therapy had an OR of 80.0%. Grade 3 and 4 toxicities were only observed for anemia (6.7%), neutropenia (20.0%), thrombopenia, peripheral neuropathy, and diarrhea (16.7%). No neutropenic fever or treatment-related death occurred.
In comparison with current standard protocols, a combination of docetaxel, gemcitabine, and oxaliplatin showed considerably higher efficacy without remarkable increased toxicity; particularly for patients with early relapse after a platinum-containing therapy.
本Ⅱ期临床试验旨在评估多西紫杉醇、吉西他滨和奥沙利铂联合方案治疗铂类和紫杉醇预处理的上皮性卵巢癌的疗效和毒性。
30 例预处理后病情严重的患者（中位年龄 61 岁）接受多西紫杉醇，55mg/m2；吉西他滨，500mg/m2（第 1 天）；奥沙利铂，70mg/m2（第 2 天），每 2 周 1 次。12 例患者为铂类敏感疾病，18 例患者为铂类耐药疾病。
中位随访时间为 18.6 个月。在铂类敏感和耐药疾病患者之间，患者特征无差异。在铂类敏感疾病患者中，总缓解率（OR）为 83.3%，无进展生存期为 10.6 个月，总生存期为 18.9 个月。在铂类耐药疾病患者中，OR 为 38.9%，无进展生存期为 5.3 个月，总生存期为 16.3 个月。铂类难治性疾病患者（既往卡铂治疗中进展，n=13）OR 为 23%，而在卡铂治疗后 6 个月内复发的患者 OR 为 80.0%。仅观察到贫血（6.7%）、中性粒细胞减少症（20.0%）、血小板减少症、周围神经病和腹泻（16.7%）为 3 级和 4 级毒性。未发生中性粒细胞减少性发热或治疗相关死亡。
与当前标准方案相比，多西紫杉醇、吉西他滨和奥沙利铂联合方案的疗效显著提高，而毒性无明显增加；特别是对于铂类治疗后早期复发的患者。
