Markman M, Hakes T, Barakat R, Curtin J, Almadrones L, Hoskins W
Department of Medicine, and the Gynecology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
J Clin Oncol. 1996 Mar;14(3):796-9. doi: 10.1200/JCO.1996.14.3.796.
To examine the short-term and long-term results of paclitaxel therapy in patients with advanced heavily pretreated, cisplatin-refractory ovarian cancer.
The results of treatment for patients entered onto National Cancer Institute (NCI) Treatment Referral Center protocol 9103 at the Memorial Sloan-Kettering Cancer Center (MSKCC) were reviewed to evaluate toxicity, efficacy, and survival.
Of 46 individuals with measurable disease treated on the protocol at MSKCC, the objective response rate was only 4%. However, the 2- and 3-year survival rates for all 103 patients (including both measurable and nonmeasurable populations) entered onto this study at MSKCC were 18% and 11%, respectively. Twenty-one percent of patients received > or = six courses of paclitaxel, which suggests treatment-related stabilization of disease may have had a greater impact on the natural history of the malignancy than indicated by the objective response rate.
This experience supports the hypothesis that a more prolonged delivery of paclitaxel (ie, > six courses), a cell-cycle-specific cytotoxic agent with limited or no cumulative toxicity, may result in an improved therapeutic outcome in ovarian cancer. This concept will need to be tested in a randomized phase 3 clinical trial.
研究紫杉醇治疗晚期、经大量前期治疗且对顺铂耐药的卵巢癌患者的短期和长期疗效。
回顾纪念斯隆凯特琳癌症中心（MSKCC）纳入美国国立癌症研究所（NCI）治疗转诊中心9103方案的患者治疗结果，以评估毒性、疗效和生存率。
在MSKCC按照该方案治疗的46例可测量病灶患者中，客观缓解率仅为4%。然而，MSKCC纳入本研究的所有103例患者（包括可测量和不可测量病灶人群）的2年和3年生存率分别为18%和11%。21%的患者接受了≥6个疗程的紫杉醇治疗，这表明与治疗相关的疾病稳定对恶性肿瘤自然病程的影响可能比客观缓解率所显示的更大。
该经验支持以下假设：更长疗程的紫杉醇（即≥6个疗程）治疗，这种具有有限或无累积毒性的细胞周期特异性细胞毒药物，可能会改善卵巢癌的治疗效果。这一概念需要在随机3期临床试验中进行验证。
