Dittrich C, Baur M, Vavra N, Hudec M, Fazeny B, Barrada M, Salzer H, Sevelda P
Department of Internal Medicine I, University of Vienna, Austria.
Ann Oncol. 1993 Sep;4(8):697-9. doi: 10.1093/oxfordjournals.annonc.a058629.
The agents etoposide and carboplatin are active against ovarian cancer and display synergistic anti-tumor activity in animal tumor models. The objective of these two phase II trials was to determine the efficacy and toxicity of the combination of etoposide with carboplatin in previously treated and untreated patients with ovarian cancer.
Etoposide (100 mg/m2) was administered as a one-hour infusion on three consecutive days and carboplatin (400 mg/m2) as a 30-minute infusion on day 2 of each monthly scheduled cycle. In 20 patients, previously treated with cisplatin-containing regimens, a total of 102 cycles was applied as salvage therapy (ST) and in 27 patients, a total of 168 cycles as first-line therapy (FLT).
ST yielded 2 complete remissions (CR) and one partial remission (PR); in 7 patients, no evidence of disease (NED) and in 6 patients, no change (NC) were observed. The progression-free intervals (PFI) lasted a median 7.0 months (range < 2-14 months). FLT resulted in 7 CR (4 of them pathologically (p) verified), 11 NED (1 pNED), 3 PR (1 pPR) and 6 NC. The objective response rate was 63% (95% confidence interval: 36-89%). PFI lasted a median 8.0 months (range 3-25+ months); median survival had not been reached at the time of evaluation. Thrombocytopenia (WHO grade 4) was the limiting toxicity.
Although not fulfilling the expectations of synergistic activity as shown in preclinical models, the combination of etoposide with carboplatin is an active and feasible therapy regimen in the out-patient management of ovarian cancer.
依托泊苷和卡铂对卵巢癌具有活性，并在动物肿瘤模型中显示出协同抗肿瘤活性。这两项II期试验的目的是确定依托泊苷与卡铂联合用药在既往接受过治疗和未接受过治疗的卵巢癌患者中的疗效和毒性。
依托泊苷（100mg/m²）连续三天进行一小时静脉输注，卡铂（400mg/m²）在每个月计划周期的第2天进行30分钟静脉输注。在20例既往接受含顺铂方案治疗的患者中，共应用102个周期作为挽救治疗（ST），在27例患者中，共应用168个周期作为一线治疗（FLT）。
挽救治疗产生2例完全缓解（CR）和1例部分缓解（PR）；7例患者疾病无证据（NED），6例患者病情无变化（NC）。无进展生存期（PFI）的中位数为7.0个月（范围<2-14个月）。一线治疗导致7例CR（其中4例经病理（p）证实），11例NED（1例病理证实的NED），3例PR（1例病理证实的PR）和6例NC。客观缓解率为63%（95%置信区间：36-89%）。PFI的中位数为8.0个月（范围3-25+个月）；评估时中位生存期尚未达到。血小板减少（WHO 4级）是限制毒性。
虽然未达到临床前模型中显示的协同活性预期，但依托泊苷与卡铂联合用药在卵巢癌门诊治疗中是一种有效的可行治疗方案。
