Lau D H, Ryu J K, Gandara D R, Rosenthal S A
University of California, Davis Cancer Center and Veteran's Administration Clinics, Sacramento, CA 95817, USA.
Int J Radiat Oncol Biol Phys. 1997 Apr 1;38(1):157-61. doi: 10.1016/s0360-3016(97)00249-6.
A pilot study was conducted to assess the tolerance and efficacy of concurrent carboplatin, etoposide, and thoracic radiation in poor-risk patients with Stage III non-small-cell lung carcinoma (NSCLC).
Patients had Stages IIIA/IIIB NSCLC and were ineligible for available clinical trials employing cisplatin-based chemoradiation due to one or more protocol-defined poor-risk factors or concomitant medical conditions. Treatment consisted of thoracic radiation, 1.8 to 2 Gy daily, to the primary tumor and regional lymph nodes to a total dose of 61 Gy. Concurrently, patients received carboplatin 200 mg/m2/day intravenously on days 1, 3, 29, and 31, and etoposide 50 mg/m2/day intravenously on days 1-4 and 29-32. Response was assessed by chest computed tomography (CT) 4 weeks after treatment was completed.
A total of 26 patients were enrolled and 23 of these patients, including 11 with Stage IIIA and 12 Stage IIIB NSCLC, were eligible and assessable. Ninety-six percent (96%) of the patients completed the two planned courses of chemotherapy, and 87% completed the planned chest radiation. Grade III/IV toxicities included neutropenia in nine patients (39%), thrombocytopenia in five (22%), esophagitis in seven (30%), and nausea in two (9%). One patient died of a pulmonary embolism during treatment, and another died of complications due to a tracheoesophageal fistula. Four patients (17%) achieved a complete response and 16 (70%) a partial response, yielding an overall response rate of 87%. The median survival was 12 months, and the 2-year actuarial survival was 40%.
This treatment regimen was well tolerated, with promising response and survival in poor-risk patients with Stage III NSCLC. These results are being validated in a Phase II trial conducted by the Southwest Oncology Group.
开展一项初步研究，以评估卡铂、依托泊苷同步治疗联合胸部放疗用于Ⅲ期非小细胞肺癌（NSCLC）高危患者的耐受性和疗效。
患者为ⅢA/ⅢB期NSCLC，因一项或多项方案定义的高危因素或合并症而不符合采用顺铂为基础的放化疗的现有临床试验条件。治疗包括对原发肿瘤和区域淋巴结进行胸部放疗，每日1.8至2Gy，总剂量61Gy。同时，患者在第1、3、29和31天静脉注射卡铂200mg/m²/天，在第1 - 4天和第29 - 32天静脉注射依托泊苷50mg/m²/天。治疗完成4周后通过胸部计算机断层扫描（CT）评估反应。
共纳入26例患者，其中23例符合条件且可评估，包括11例ⅢA期和12例ⅢB期NSCLC患者。96%的患者完成了两个计划疗程的化疗，87%完成了计划的胸部放疗。Ⅲ/Ⅳ级毒性包括9例（39%）中性粒细胞减少、5例（22%）血小板减少、7例（30%）食管炎和2例（9%）恶心。1例患者在治疗期间死于肺栓塞，另1例死于气管食管瘘并发症。4例患者（17%）达到完全缓解，16例（70%）达到部分缓解，总缓解率为87%。中位生存期为12个月，2年精算生存率为40%。
该治疗方案耐受性良好，在Ⅲ期NSCLC高危患者中反应和生存情况良好。这些结果正在西南肿瘤学组进行的Ⅱ期试验中得到验证。
