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对于一线使用卡铂联合紫杉醇化疗失败的IIIB/IV期非小细胞肺癌患者,二线使用低剂量紫杉醇每周给药方案。

Second-line, low-dose, weekly paclitaxel in patients with stage IIIB/IV nonsmall cell lung carcinoma who fail first-line chemotherapy with carboplatin plus paclitaxel.

作者信息

Socinski Mark A, Schell Michael J, Bakri Kamal, Peterman Amy, Lee Ji-Hyun, Unger Paul, Yates Steven, Hudgens Stacie, Kies Merrill S

机构信息

Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, 27599, USA.

出版信息

Cancer. 2002 Sep 15;95(6):1265-73. doi: 10.1002/cncr.10835.

Abstract

BACKGROUND

Second-line chemotherapy with docetaxel improves survival and quality of life (QoL) in patients with nonsmall cell lung carcinoma (NSCLC) who fail first-line platinum-based regimens. The authors sought to determine the activity of second-line, low-dose, weekly paclitaxel in patients with NSCLC who failed first-line chemotherapy with carboplatin plus paclitaxel.

METHODS

Patients with Stage IIIB/IV NSCLC who had received first-line carboplatin/paclitaxel were treated with low-dose (80 mg/m(2)), weekly paclitaxel at the time of disease progression. Response rates, QoL, and survival were outcome end points.

RESULTS

Sixty-two patients were included in this analysis. The median age was 62 years (range, 32-76 years), 55% of patients were male, 89% of patients had Stage IV NSCLC, and the Karnofsky performance status was 90-100% in 31% of patients, 70-80% in 55% of patients, and 60% in 14% of patients. Twenty-six percent of patients experienced disease progression as their best response to first-line carboplatin plus paclitaxel, whereas 52% of patients had stable disease, and 23% of patients had achieved a response. The median time from first-line carboplatin plus paclitaxel to second-line, low-dose, weekly paclitaxel was 9.5 weeks (range, 1-78 weeks). The toxicity profile was extremely favorable, with no Grade 4 toxicity and < 10% Grade 3 hematologic or nonhematologic toxicity in all patients with the exception of neuropathy. Ten percent of patients experienced both Grade 2 and Grade 3 neuropathy. The overall objective response rate was 8%. The median survival was 5.2 months (95% confidence interval [95%CI], 3.6-6.2 months), and the 1-year and 2-year survival rates were 20% (95%CI, 10-30%) and 9% (95%CI, 1-16%), respectively.

CONCLUSIONS

Second-line, low-dose, weekly paclitaxel had activity in selected patients with Stage IIIB/IV NSCLC who failed first-line chemotherapy with carboplatin plus paclitaxel. The toxicity profile of this approach is extremely favorable, and outcome expectations are similar to the outcome expectations with other single agents in this setting.

摘要

背景

对于一线铂类方案治疗失败的非小细胞肺癌(NSCLC)患者,多西他赛二线化疗可改善生存及生活质量(QoL)。作者试图确定二线低剂量每周一次紫杉醇对一线接受卡铂加紫杉醇化疗失败的NSCLC患者的活性。

方法

接受过一线卡铂/紫杉醇治疗的IIIB/IV期NSCLC患者在疾病进展时接受低剂量(80mg/m²)每周一次的紫杉醇治疗。反应率、生活质量和生存情况为观察终点。

结果

本分析纳入62例患者。中位年龄为62岁(范围32 - 76岁),55%为男性,89%为IV期NSCLC患者,31%的患者卡氏评分90 - 100%,55%的患者为70 - 80%,14%的患者为60%。26%的患者对一线卡铂加紫杉醇的最佳反应为疾病进展,52%的患者疾病稳定,23%的患者有反应。从一线卡铂加紫杉醇到二线低剂量每周一次紫杉醇的中位时间为9.5周(范围1 - 78周)。毒性特征非常良好,除神经病变外,所有患者均无4级毒性,3级血液学或非血液学毒性<10%。10%的患者出现2级和3级神经病变。总体客观反应率为8%。中位生存期为5.2个月(95%置信区间[95%CI],3.6 - 6.2个月),1年和2年生存率分别为20%(95%CI,10 - 30%)和9%(95%CI,1 - 16%)。

结论

二线低剂量每周一次紫杉醇对一线接受卡铂加紫杉醇化疗失败的部分IIIB/IV期NSCLC患者有活性。该治疗方法的毒性特征非常良好,预期疗效与该情况下其他单药治疗的预期疗效相似。

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