Morris M, Gershenson D M, Burke T W, Mitchell M F, Levenback C, Atkinson N, Wharton J T
Department of Gynecologic Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030.
Gynecol Oncol. 1994 May;53(2):234-8. doi: 10.1006/gyno.1994.1121.
Between March 1990 and July 1992, 42 women with squamous carcinoma of the uterine cervix were prospectively treated with carboplatin (260 mg/m2) on Day 1 and cisplatin (50 mg/m2) on Day 2 every 28 days. Patients had either stage IVb (FIGO) cancer (5 patients) or recurrent cancer (37 patients) and a Zubrod score < or = 2. Forty-one patients had received either radiation or surgery as primary therapy; 179 cycles of chemotherapy were delivered. The mean number of cycles administered to each patient was 4 (range, 2-8 cycles). Dose escalation was possible in 32 cycles (23.4%) and dose reduction was required in 10 cycles (7.3%). The dose-limiting toxic effect was myelosuppression, with grade 3-4 thrombocytopenia in 39 cycles (22%) and neutropenia in 19 cycles (11%). Neurotoxic effects were observed in 3 patients. Forty-two patients were evaluable for response: 1 had a complete response and 11 had a partial response (response rate 28.6%, 95% confidence interval, 14.9-42.3%). For all patients and for responders, median progression-free interval was 4.4 and 9.5 months, respectively, and median length of survival was 8.9 and 9.5 months, respectively. This regimen was well tolerated and had significant activity in the treatment of cervical cancer. Comparison to other platinum-based regimens in a Phase III trial should be considered.
1990年3月至1992年7月，42例子宫颈鳞状癌患者接受前瞻性治疗，每28天在第1天给予卡铂（260mg/m²），第2天给予顺铂（50mg/m²）。患者为IVb期（国际妇产科联盟）癌症（5例）或复发性癌症（37例），Zubrod评分≤2。41例患者曾接受放疗或手术作为初始治疗；共进行了179个化疗周期。每位患者接受的平均周期数为4个（范围2 - 8个周期）。32个周期（23.4%）可进行剂量递增，10个周期（7.3%）需要剂量减少。剂量限制性毒性作用为骨髓抑制，39个周期（22%）出现3 - 4级血小板减少，19个周期（11%）出现中性粒细胞减少。3例患者观察到神经毒性作用。42例患者可评估疗效：1例完全缓解，11例部分缓解（缓解率28.6%，95%置信区间14.9 - 42.3%）。所有患者及缓解患者的无进展生存期分别为4.4个月和9.5个月，中位生存期分别为8.9个月和9.5个月。该方案耐受性良好，在宫颈癌治疗中具有显著活性。应考虑在III期试验中与其他铂类方案进行比较。
