Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer
Phase II study of first-line sequential chemotherapy with gemcitabine-carboplatin followed by docetaxel in patients with advanced non-small cell lung cancer
复制标题
DOI：
10.1159/000086979
复制
发表时间：
2005-01-01
期刊：
影响因子：
3.5
通讯作者：
Antonia, S
中科院分区：
文献类型：
--
作者：
Chiappori, A;Simon, G;Antonia, S
理由：尽管使用了新的化疗药物，晚期非小细胞肺癌（NSCLC）患者的生存率仍然很低。目的：评估一种新的序贯且假定无交叉耐药的化疗方案的安全性和有效性。方法：入选条件包括：IV期和IIIB期（恶性胸腔积液），身体机能状态0-1，肾脏、肝脏和骨髓功能正常。既往接受过治疗并得到控制的脑转移患者；没有被排除在外。根据实体肿瘤反应评价标准确定反应。2治疗包括吉西他滨，1000 mg/m(2)，第1天和第8天，卡铂，AUC = 5，每4周第1天（2-4周期），然后是多西他赛，75 mg/m(2)，每3周第1天（4周期）。在吉西他滨-卡铂治疗四个周期后给予多西他赛，或者如果疾病发生进展，在前两个周期后给予。结果：40例患者入组。所有患者均接受了至少一个疗程的吉西他滨-卡铂治疗。由于PD， 15例患者接受了少于4个周期的治疗，只有1例患者随后接受了多西他赛。在完成4个疗程吉西他滨-卡铂治疗的25例患者中，23例接受了多西紫杉醇治疗。总共有24名患者接受了至少一个周期的多西紫杉醇治疗，12名患者完成了两个方案的四个周期。总有效率为23.6%(9/38例，95%可信区间，Cl, 11-40%)，其中吉西他滨-卡铂和多西他赛的有效率分别为15.8%（6/38例，95% Cl, 6-31%）和12.5%（3/24例，95% Cl, 3-32%）。没有接受吉西他滨-卡铂治疗的PD患者对多西紫杉醇有反应。毒性是可以忍受的，主要是血液学上的。中位生存期和无进展生存期分别为6.7个月和4.9个月，1年生存率为37.5%。结论：吉西他滨-卡铂联合多西他赛序贯治疗晚期NSCLC是安全的。我们的结果与其他类似方案的结果相当，并不代表晚期非小细胞肺癌治疗的显着改善。版权所有(C) 2005 S. Karger AG，巴塞尔。
Rationale: Despite the use of novel chemotherapeutic agents, patients with advanced non-small cell lung cancer (NSCLC) continue to show a poor survival. Objectives: To assess the safety and efficacy of a novel sequential and putatively non-cross-resistant chemotherapy regimen. Methods: Eligibility included: stages IV and IIIB (malignant pleural effusion), performance status 0-1, and adequate renal, hepatic and bone marrow function. Patients with previously treated and controlled brain metastases; were not excluded. Responses were determined according to the Response Evaluation Criteria in Solid Tumors. 2 Treatment consisted of gemcitabine, 1,000 mg/m(2), on days 1 and 8, and carboplatin, AUC = 5, on day 1 every 4 weeks (2-4 cycles) followed by docetaxel, 75 mg/m(2), on day 1 every 3 weeks (4 cycles). Docetaxel was given after four cycles of gemcitabine-carboplatin or if progression of disease occurred, after the first two cycles. Results: Forty patients were enrolled. All patients received at least one cycle of gemcitabine-carboplatin. Due to PD, 15 patients received fewer than four cycles and only 1 received docetaxel subsequently. Of the 25 patients who completed four cycles of gemcitabine-carboplatin, 23 received docetaxel. In total, 24 patients received at least one cycle of docetaxel, and 12 patients completed four cycles of both regimens. The overall response rate was 23.6% (9/38 patients, 95% confidence interval, Cl, 11-40%), with 15.8% (6/38 patients, 95% Cl, 6-31%) and 12.5% (3/24 patients, 95% Cl, 3-32%) response rates to gemcitabine-carboplatin and docetaxel, respectively. No patient with PD on gemcitabine-carboplatin responded to docetaxel. Toxicities were tolerable and mostly hematologic. Median survival time and progression-free survival were 6.7 and 4.9 months, respectively, with a 1-year survival of 37.5%. Conclusion: Sequential gemcitabine-carboplatin and docetaxel can be safely administered in advanced NSCLC. Our results are comparable to those achieved with other similar regimens and do not represent a significant improvement in the treatment of advanced NSCLC. Copyright (C) 2005 S. Karger AG, Basel.