A pilot phase II trial of valspodar modulation of multidrug resistance to paclitaxel in the treatment of metastatic carcinoma of the breast (E1195): A trial of the eastern cooperative oncology group
A pilot phase II trial of valspodar modulation of multidrug resistance to paclitaxel in the treatment of metastatic carcinoma of the breast (E1195): A trial of the eastern cooperative oncology group
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DOI：
10.1080/07357900600981349
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发表时间：
2006-11-01
影响因子：
2.4
通讯作者：
Wood, William C.
中科院分区：
文献类型：
--
作者：
Carlson, Robert W.;O'Neill, Anne M.;Wood, William C.
背景：评价Valspodar(PSC-833)联合紫杉醇治疗转移性蒽环类难治性乳腺癌的疗效和毒性。患者和方法：有限的、多机构的II期试验，Valspodar 5 mg/kg/剂量，每6小时口服一次，共12剂，联合紫杉醇70 mg/m(2)静脉滴注3小时，从第5剂Valspodar后4小时开始，每3周一次。符合条件的患者有二维可测量的转移性乳腺癌，既往曾接受蒽环类药物治疗或有药物禁忌症，复发或转移性乳腺癌既往化疗不超过一次，以及器官功能良好。继续治疗，直到病情恶化或出现不可接受的毒性。结果：34例患者可评价疗效，37例可评价毒性。2例(6%)患者完全缓解，5例(15%)部分缓解，客观缓解率为21%(95%的可信区间为9%至38%)。中位有效时间9.7个月(95%可信区间8.0~17.2个月)，中位进展时间3.3个月(95%可信区间2.0~4.2个月)，中位生存期12个月(95%可信区间8.1~17.3个月)。这种毒性是可以接受的。结论：Valspodar联合紫杉醇是一种有效的治疗方案，毒性可接受。联合用药并不明显比单药紫杉醇更有效。
Background: To assess the activity and toxicity of valspodar (PSC-833) in combination with paclitaxel in women with anthracycline refractory, metastatic breast cancer. Patients and Methods: Limited, multi-institutional, Phase II trial of valspodar at 5 mg/kg/dose orally every 6 hours for 12 doses in combination with paclitaxel 70 mg/m(2) administered intravenously as a 3-hour infusion beginning 4 hours after the fifth dose of valspodar, every 3 weeks. Eligible patients had bi-dimensionally measurable metastatic carcinoma of the breast, prior anthracycline therapy or a medical contraindication to anthracycline therapy, no more than one prior chemotherapy for recurrent or metastatic breast cancer, and adequate organ function. Treatment was continued until disease progression or unacceptable toxicity. Results: Thirty-four patients are evaluable for response and 37 for toxicity. Two (6 percent) patients achieved a complete response and 5 (15 percent) a partial response for an objective response rate of 21 percent (95 percent confidence interval of 9 to 38 percent). Median duration of response was 9.7 months (95 percent confidence interval 8.0-17.2 months), median time to progression was 3.3 months (95 percent confidence interval 2.0-4.2 months), and median survival was 12 months (95 percent confidence interval 8.1-17.3 months). The toxicity experienced was acceptable. Conclusions: Combination valspodar plus paclitaxel is an active regimen and has acceptable toxicity. The combination is not clearly more active than single agent paclitaxel.