Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan.
Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan; Department of General Internal Medicine 4, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan.
Lung Cancer. 2015 Feb;87(2):141-7. doi: 10.1016/j.lungcan.2014.11.001. Epub 2014 Nov 8.
Although cisplatin-based chemotherapy combined with thoracic irradiation (TRT) is a standard treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC), this treatment outcome has remained unsatisfactory. We had previously conducted a phase I trial of cisplatin plus S-1, an oral 5-fluorouracil derivative, and TRT, which were safe and effective.
In this phase II trial, 48 patients with stage III NSCLC received cisplatin (40mg/m(2) on days 1, 8, 29 and 36) and S-1 (80mg/m(2) on days 1-14 and 29-42) and TRT (60Gy). The primary endpoint was the response rate.
A partial response was observed in 37 patients (77%; 95% confidence interval: 63-88%). At a median follow up of 54 months, the median progression-free survival and median survival time were 9.3 and 31.3 months, respectively. No difference in efficacy was observed when the patients were stratified by histology. Toxicities were generally mild except for grade 3 or worse febrile neutropenia and pneumonitis of 8% and 4%, respectively. No patient developed severe esophagitis. At the time of this analysis, 35 (73%) of the 48 patients recurred; 15 (31%) showed distant metastasis, 17 (35%) had loco-regional disease, and 2 (4%) showed both loco-regional disease and distant metastasis.
This chemoradiotherapy regimen yielded a relatively favorable efficacy with mild toxicities in patients with locally advanced NSCLC.
尽管顺铂为基础的化疗联合胸部放疗（TRT）是不可切除的局部晚期非小细胞肺癌（NSCLC）的标准治疗方法，但这种治疗效果仍然不尽如人意。我们之前进行了一项顺铂加 S-1（一种口服 5-氟尿嘧啶衍生物）联合 TRT 的 I 期试验，结果显示该方案安全且有效。
在这项 II 期试验中，48 例 III 期 NSCLC 患者接受顺铂（第 1、8、29 和 36 天 40mg/m²）和 S-1（第 1-14 天和 29-42 天 80mg/m²）联合 TRT（60Gy）治疗。主要终点是反应率。
37 例患者（77%；95%置信区间：63-88%）观察到部分缓解。中位随访 54 个月时，中位无进展生存期和中位总生存期分别为 9.3 个月和 31.3 个月。按组织学分层，患者的疗效无差异。毒性一般较轻，除分别为 8%和 4%的 3 级或更高级别的发热性中性粒细胞减少症和肺炎外。无患者发生严重食管炎。在本次分析时，48 例患者中有 35 例（73%）复发；15 例（31%）出现远处转移，17 例（35%）出现局部区域疾病，2 例（4%）出现局部区域疾病和远处转移。
该放化疗方案在局部晚期 NSCLC 患者中具有相对较好的疗效和较轻的毒性。
