Phase II study of Neoadjuvant chemotherapy with gemcitabine and vinorelbine in resectable non-small cell lung cancer
Phase II study of Neoadjuvant chemotherapy with gemcitabine and vinorelbine in resectable non-small cell lung cancer
复制标题
DOI：
10.1378/chest.128.5.3467
复制
发表时间：
2005-11-01
期刊：
影响因子：
9.6
通讯作者：
Bepler, G
中科院分区：
文献类型：
--
作者：
Ramnath, N;Sommers, E;Bepler, G
化疗，吉西他滨和长春瑞滨作为IB-IIIA期和选定IIIB期非小细胞肺癌（NSCLC）患者手术切除前的诱导治疗。主要临床终点是放射学疾病反应率，和次要终点是病理反应率，治疗相关的毒性，手术切除和结果，和整体和无病survival.Methods：患者进行了分期与CT的胸部和上腹部，全身F-18氟脱氧葡萄糖正电子发射断层扫描，支气管镜，纵隔镜检查。患者必须有医学和手术可切除的疾病。化疗包括第1、8、22和29天的2、2、艾德。给予吉西他滨1，000 mg/m2和长春瑞滨25 mg/m2，在第43 - 50天之间重复成像研究。根据实体瘤的缓解评价标准评估疾病缓解，可切除疾病患者在第50 - 70天接受手术。结果：2000年1月至2004年3月，27例IB期NSCLC患者，15例11期NSCLC患者，20例III期NSCLC患者进入。诱导化疗后，34%（95%置信区间[CI]，23 - 48%）的患者有客观放射学缓解，2%有完全病理学缓解，90%接受了开胸手术，77%接受了完全切除术。术后6周内有4例死亡，没有与化疗相关的死亡。手术或化疗未导致意外发病。1年和2年的总生存率分别为80%（95%CI，68至88%）和65%（95%CI，50至76%），中位总生存期为38.2个月。结论：诱导化疗与吉西他滨和长春瑞滨的结果在1年和2年的生存率和中位生存时间与含铂的双。然而，它似乎是有效的放射学和病理学反应率相比，含铂化疗双。
chemotherapy, of gemcitabine and vinorelbine as induction therapy prior to surgical resection in patients with stage IB-IIIA and selected stage IIIB non-small cell lung cancer (NSCLC). The primary clinical end point was radiographic disease response rate, and the secondary end points were pathologic response rate, treatment-related toxicity, surgical resectability and outcome, and overall and disease-free survival.Methods: Patients underwent staging with CT of the chest and upper-abdomen, whole-body F-18 fluorodeoxyglucose positron emission tomography, bronchoscopy, and mediastinoscopy. The patients had to have medically and surgically resectable disease. Chemotherapy consisted of 2, 2, ed on days 1, 8, 22, and 29. gemcitabine, 1,000 mg/m and vinorelbine, 25 mg/m administered Imaging studies were repeated between days 43 and 50. Disease response was assessed by response evaluation criteria in solid tumors, and patients with resectable disease were offered surgery between days 50 and 70. Patients were followed tip every 3 months for 2 years with chest CT.Results: Between January 2000 and March 2004, 27 patients with stage IB NSCLC, 15 patients with stage 11 NSCLC, and 20 patients with stage III NSCLC were entered. After induction chemotherapy 34% (95% confidence interval [CI], 23 to 48%) had an objective radiographic response, 2% had a complete pathologic response, 90% underwent thoracotomy, and 77% underwent a complete resection. There were four deaths in the 6-week period following surgery, and there were no deaths related to chemotherapy. There were no unexpected morbidities from surgery or chemotherapy. The 1-year and 2-year overall survival rates were 80% (95% CI, 68 to 88%) and 65% (95% CI, 50 to 76%), and the median overall survival was 38.2 months.Conclusions: Induction chemotherapy with genicitabine and vinorelbine results in 1-year and 2-year survival rates and a median survival time comparable to those obtained with platinum-containing doublets. However, it appears to be less efficacious in terms of radiographic and pathologic response rates compared with platinum-containing chemotherapy doublets.