Gelmon K A
Department of Medical Oncology, British Columbia Cancer Centre, Vancouver, Canada.
Semin Oncol. 1994 Oct;21(5 Suppl 8):24-8.
Two trials are being conducted to evaluate paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) combined with cisplatin in previously treated and untreated breast and ovarian cancer. Preliminary results are presented. The objectives of these nonrandomized trials are (1) to determine the toxicity of paclitaxel/cisplatin in a biweekly schedule, (2) to establish the maximum tolerated dose of paclitaxel in combination with a fixed dose of cisplatin (60 mg/m2), (3) to determine the feasibility of repeated biweekly administrations, and (4) to evaluate the efficacy of the combination in these diseases. In the breast cancer study, 22 patients have been enrolled to date and eight patients have completed treatment. Dose-limiting neutropenia, which occurred with the starting dose of paclitaxel (90 mg/m2) followed by 60 mg/m2 cisplatin, has precluded any attempts to escalate the paclitaxel dose. Overall, the regimen has been well tolerated at the doses just described. There has been little grade III and no grade IV nonhematologic toxicity. Among 16 patients currently evaluable for response, four had a complete response and II had a partial response, for an overall response rate of 94%. In the ovarian cancer study, 14 patients have been enrolled thus far. Paclitaxel/cisplatin appears to be well tolerated, although it is still too early to assess response rates or to define the MTD. Patients continue to be accrued in both trials.
正在进行两项试验，以评估紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）联合顺铂用于既往接受过治疗和未接受过治疗的乳腺癌及卵巢癌患者的疗效。现将初步结果公布如下。这些非随机试验的目的包括：（1）确定每两周一次给药方案下紫杉醇/顺铂的毒性；（2）确定紫杉醇与固定剂量顺铂（60mg/m²）联合使用时的最大耐受剂量；（3）确定每两周重复给药的可行性；（4）评估该联合用药方案对这些疾病的疗效。在乳腺癌研究中，迄今已招募了22名患者，其中8名患者已完成治疗。起始剂量为紫杉醇（90mg/m²）继以顺铂60mg/m²时出现了剂量限制性中性粒细胞减少，因此无法尝试提高紫杉醇剂量。总体而言，上述剂量的治疗方案耐受性良好。III级非血液学毒性少见，无IV级非血液学毒性。在目前可评估疗效的16名患者中，4名完全缓解，11名部分缓解，总缓解率为94%。在卵巢癌研究中，迄今已招募了14名患者。紫杉醇/顺铂似乎耐受性良好，不过评估缓解率或确定最大耐受剂量仍为时过早。两项试验仍在继续招募患者。
