Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Cancer Sci. 2013 Jan;104(1):93-7. doi: 10.1111/cas.12028. Epub 2012 Nov 8.
Concurrent chemoradiotherapy is the standard treatment for unresectable stage III non-small cell lung cancer (NSCLC). The long-term feasibility and efficacy of vinorelbine and cisplatin with concurrent thoracic radiotherapy were investigated. Eighteen patients received cisplatin (80 mg/m(2)) on day 1 and vinorelbine (20 mg/m(2) in level 1, and 25 mg/m(2) in level 2) on days 1 and 8 every 4 weeks for four cycles in a phase I trial. Ninety-three patients received the same chemotherapy regimen except for the fixed vinorelbine (20 mg/m(2)) dosage and consolidation therapy with docetaxel (60 mg/m(2), every 3 weeks). The thoracic radiotherapy consisted of a single dose of 2 Gy once daily to a total dose of 60 Gy. A total of 111 patients were analyzed in the present study: male/female, 91/20; median age, 60 years; stage IIIA/IIIB, 50/61; and squamous/non-squamous histology, 26/85. The 3-, 5-, and 7-year overall survival rates (95% CI) were 43.2% (33.9-52.2), 25.2% (17.6-33.5), and 23.2% (15.8-31.4), respectively. The median progression-free survival and median survival time (95% CI) were 13.5 (10.1-16.7) months and 30.0 (24.3-38.8) months, respectively. Four patients (4%) experienced Grade 5 pulmonary toxicities from 4.4 to 9.4 months after the start of treatment. In conclusion, approximately 15% of patients with unresectable stage III NSCLC could be cured with chemoradiotherapy without severe late toxicities after 10 months of follow-up. Although based on the data from highly selected population participated in phase I and phase II trial, this analysis would strengthen and confirm the previous reports concerning concurrent chemoradiotherapy with third generation cytotoxic agents.
同期放化疗是不可切除的 III 期非小细胞肺癌(NSCLC)的标准治疗方法。本研究旨在探讨长春瑞滨和顺铂联合胸部放疗的长期可行性和疗效。
在 I 期试验中,18 例患者接受顺铂(80 mg/m2)第 1 天,长春瑞滨(第 1 天 20 mg/m2,第 2 天 25 mg/m2)第 1 天和第 8 天,每 4 周 1 个周期,共 4 个周期。93 例患者接受相同的化疗方案,但长春瑞滨(20 mg/m2)固定剂量和多西紫杉醇巩固治疗(60 mg/m2,每 3 周 1 次)除外。胸部放疗为单次 2 Gy,总剂量为 60 Gy。本研究共分析了 111 例患者:男/女,91/20;中位年龄 60 岁;III 期 A/III 期 B,50/61;鳞癌/非鳞癌组织学,26/85。3、5、7 年总生存率(95%CI)分别为 43.2%(33.9-52.2)、25.2%(17.6-33.5)和 23.2%(15.8-31.4)。中位无进展生存期和中位总生存期(95%CI)分别为 13.5(10.1-16.7)个月和 30.0(24.3-38.8)个月。4 例患者(4%)在治疗开始后 4.4-9.4 个月出现 5 级肺部毒性。
总之,在 10 个月的随访中,约 15%的不可切除的 III 期 NSCLC 患者可通过放化疗治愈,且无严重晚期毒性。虽然本研究基于 I 期和 II 期试验中高度选择的人群数据,但该分析将加强和证实之前关于第三代细胞毒性药物联合放化疗的报告。