Meden H, Wittkop Y, Kuhn W
Department of Obstetrics and Gynecology, University of Göttingen, Germany.
Anticancer Res. 1997 May-Jun;17(3C):2221-3.
To evaluate the feasibility and toxicity of maintenance oral treosulfan chemotherapy for ovarian cancer patients after surgical treatment and response to first-line chemotherapy.
Thirty-nine patients were entered onto this trial. This was a pretreated patient population. The pretreatment consisted of radical surgery and chemotherapy. The treatment that immediately preceded oral treosulfan was standard-dose platin-based chemotherapy. Daily oral treosulfan was administered at a dose of 1250 mg for 5 consecutive days every five weeks for at least three cycles. All patients started daily oral treosulfan while in complete remission.
A total of 322 cycles of oral treosulfan was administered, with a median of 6 cycles (range 3-24). Treosulfan in this schedule was generally well tolerated. The major toxic effects were leukopenia and thrombocytopenia, which, however, were manageable and rapidly reversible. There were no episodes of bleeding or leukopenic fever. No anti-emetic drugs were required. Alopecia was not observed, 20 patients had progressive disease (after 3-6 months: n = 8, after > 6 months: n = 12). The median survival for all patients was 24 (range 9.44+) months, and median time to progression 8 (range 3-24) months.
Maintenance oral treosulfan was well tolerated in this pretreated patient population. In an attempt to further improve overall survival in ovarian cancer patients, prospective random assignment trials will be necessary to determine the benefit of this approach.
评估口服苏消安维持化疗对卵巢癌患者手术治疗及一线化疗后的可行性、毒性反应及疗效。
39例患者进入本试验。这是一组经过预处理的患者群体。预处理包括根治性手术和化疗。在口服苏消安之前进行的治疗是标准剂量的铂类化疗。每五周连续5天每日口服苏消安，剂量为1250毫克，至少进行三个周期。所有患者在完全缓解时开始每日口服苏消安。
共给予322个周期的口服苏消安，中位周期数为6个周期（范围3 - 24个周期）。按照该方案使用苏消安一般耐受性良好。主要毒性反应为白细胞减少和血小板减少，但这些反应可控且可迅速逆转。未发生出血或白细胞减少性发热事件。无需使用止吐药物。未观察到脱发。20例患者出现疾病进展（3 - 6个月后：8例，> 6个月后：12例）。所有患者的中位生存期为24个月（范围9.44 +），中位疾病进展时间为8个月（范围3 - 24个月）。
在这组经过预处理的患者群体中，口服苏消安维持化疗耐受性良好。为进一步提高卵巢癌患者的总生存期，有必要进行前瞻性随机分组试验以确定这种治疗方法的益处。
