Wasserheit C, Frazein A, Oratz R, Sorich J, Downey A, Hochster H, Chachoua A, Wernz J, Zeleniuch-Jacquotte A, Blum R, Speyer J
Kaplan Comprehensive Cancer Center, New York University Medical Center, New York, NY, USA. Carolyn
J Clin Oncol. 1996 Jul;14(7):1993-9. doi: 10.1200/JCO.1996.14.7.1993.
A phase II study of paclitaxel and cisplatin in patients with advanced breast cancer was performed to determine the objective response rate and make further observations about the toxicity of this regimen.
Patients were required to have histologically proven adenocarcinoma of the breast with no more than one chemotherapeutic treatment for advanced disease. Treatment consisted of paclitaxel 200 mg/m2 administered as a 24-hour intravenous (i.v.) infusion followed by cisplatin 75 mg/m2 i.v. Patients received granulocyte colony-stimulating factor (G-CSF) 5 micrograms/kg subcutaneously on day 3 until WBC recovery. Cycles were repeated every 21 days. Patients continued to receive therapy until disease progression or unacceptable toxicity.
Forty-four patients entered the trial. Forty-two patients were assessable for response. Nineteen patients (43%) had no prior chemotherapy and 41 had no chemotherapy for metastatic disease. The median number of cycles administered per patient was five (range, one to seven). There were five complete responses (CRs) (11.9%) and 17 partial responses (PRs) (40.5%), with an overall response rate of 52.4% (95% confidence interval [CI], 36.4% to 68.0%). Nine patients had stage III disease. The response rate for this group was 66.7% (95% CI, 33.0% to 92.5%), with three CRs and three PRs. Among 35 patients with stage IV disease, there were two CRs and 14 PRs, with an overall response rate of 48.5% (95% CI, 30.8% to 66.5%). Overall, the median response duration was 10.6 months. Thirty patients (68%) developed transient grade 4 neutropenia. Cumulative neuropathy was the major dose-limiting toxicity. After five cycles of chemotherapy, 96% of patients had at least grade 1 neurotoxicity and 52% had at least grade 2 neurotoxicity. One patient had a toxic death after cycle 1 of therapy.
The combination of paclitaxel and cisplatin as first-line chemotherapy for women with advanced breast cancer is an active regimen. However, the cumulative neurotoxicity was significant and dose-limiting in the majority of patients.
开展一项关于紫杉醇和顺铂用于晚期乳腺癌患者的II期研究，以确定客观缓解率，并对该方案的毒性进行进一步观察。
患者需经组织学证实为乳腺腺癌，且针对晚期疾病接受的化疗不超过一种。治疗方案为紫杉醇200mg/m²，静脉输注24小时，随后给予顺铂75mg/m²静脉输注。患者在第3天皮下注射粒细胞集落刺激因子（G-CSF）5μg/kg，直至白细胞恢复。每21天重复一个周期。患者持续接受治疗，直至疾病进展或出现不可接受的毒性。
44例患者进入试验。42例患者可评估缓解情况。19例患者（43%）未曾接受过化疗，41例患者未曾接受过转移性疾病的化疗。每位患者接受的周期数中位数为5个（范围为1至7个）。有5例完全缓解（CR）（11.9%）和17例部分缓解（PR）（40.5%），总缓解率为52.4%（95%置信区间[CI]，36.4%至68.0%）。9例患者为III期疾病。该组的缓解率为66.7%（95%CI，33.0%至92.5%），有3例CR和3例PR。在35例IV期疾病患者中，有2例CR和14例PR，总缓解率为48.5%（95%CI，30.8%至66.5%）。总体而言，缓解持续时间中位数为10.6个月。30例患者（68%）出现短暂的4级中性粒细胞减少。累积神经病变是主要的剂量限制性毒性。化疗5个周期后，96%的患者至少有1级神经毒性，52%的患者至少有2级神经毒性。1例患者在第1周期治疗后因毒性死亡。
紫杉醇和顺铂联合作为晚期乳腺癌女性的一线化疗方案是一种有效的方案。然而，累积神经毒性在大多数患者中显著且为剂量限制性。
