Lund B, Hansen M, Hansen O P, Hansen H H
Department of Oncology ONB, Finsen Institute, Copenhagen, Denmark.
J Clin Oncol. 1989 Oct;7(10):1469-73. doi: 10.1200/JCO.1989.7.10.1469.
A phase II trial of carboplatin, 300 mg/m2 day 1, and cisplatin, 50 mg/m2 days 2 and 3 every 4 weeks for six cycles, was performed in 42 previously untreated patients with residual disease after primary laparotomy. Overall, 79% of patients had primary residual tumor larger than 2 cm. The overall pathologic response rate (pathologic complete response [PCR] plus partial response [PPR]) in 37 evaluable patients was 62%, and in PCRs was 22%. Of the responding patients, 78% had primary residual tumor larger than 2 cm. The toxicity was cumulative but manageable, with thrombocytopenia being the main reason for dose reduction. Dose-limiting nephrotoxicity and neurotoxicity occurred in 22% and 7% of the patients, respectively. Combined high-dose platinum as a "single agent" appears to be as active as combination chemotherapy containing cisplatin, and the treatment is feasible. Further clinical trials of this combination alone or combined with other drugs are warranted.
对42例初次剖腹手术后有残留病灶的未经治疗的患者进行了一项II期试验,卡铂剂量为300mg/m²,第1天给药,顺铂剂量为50mg/m²,第2天和第3天给药,每4周进行6个周期。总体而言,79%的患者原发性残留肿瘤大于2cm。37例可评估患者的总体病理缓解率(病理完全缓解[PCR]加部分缓解[PPR])为62%,病理完全缓解率为22%。在有反应的患者中,78%的患者原发性残留肿瘤大于2cm。毒性是累积性的但可控制,血小板减少是剂量减少的主要原因。剂量限制性肾毒性和神经毒性分别发生在22%和7%的患者中。联合高剂量铂作为“单一药物”似乎与含顺铂的联合化疗一样有效,且该治疗是可行的。有必要对这种联合方案单独或与其他药物联合进行进一步的临床试验。