Ⅳ期寡转移NSCLC同期放化疗后巩固化疗前瞻性Ⅱ期临床研究

目的 研究寡转移NSCLC行胸内病灶根治性同期放化疗后巩固化疗的疗效和不良反应。方法 2008—2013年间转移灶≤5个的NSCLC患者66例入组。放疗采用IGRT, 常规分割或大分割。同期及巩固化疗均以铂类为基础两药联合方案。治疗结束后评价患者近期疗效、不良反应和生存率。结果 64例完成治疗。胸内病灶PTV中位BED为72 Gy, 中位化疗周期数4个。胸内病灶客观缓解率为70%。随访率为97%。1、2、3年OS分别为72%、53%、31%, 中位OS时间25个月;1、2、3年PFS分别为56%、26%、7%, 中位PFS时间14个月。2+3级急性放射性肺炎、放射性食管炎发生率分别为11%和17%, 3+4级白细胞、血红蛋白、血小板计数减少率分别为39%、11%、16%。结论 寡转移NSCLC胸内病灶根治性放疗联合同期化疗及巩固化疗, 可获得较好近期疗效和长期生存, 不良反应可耐受。

A prospective phase II study of consolidation chemotherapy after concurrent chemoradiotherapy for oligometastatic stage IV non-small cell lung cancer

Objective To evaluate the efficacy and safety of consolidation chemotherapy after thoracic radical concurrent chemoradiotherapy for patients with oligometastatic non-small cell lung cancer (NSCLC). Methods Sixty-six NSCLC patients with more than five metastases from 2008 to 2013 were enrolled, and image-guided radiotherapy with conventionally fractionated or hypofractionated doses were performed for these patients. Platinum-based doublets chemotherapy was applied for both concurrent chemoradiotherapy and consolidation chemotherapy. Short-term outcome, adverse reactions, and survival rate were assessed for the patients after treatment. Results Sixty-four patients completed the treatment. The median biologically equivalent dose for planning target volume of thoracic primary tumor lesions was 72 Gy, with a median number of chemotherapy cycles of 4. The Objective response rate for thoracic lesions was 70%. The follow-up rate was 97%. The 1-, 2-, and 3-year overall survival (OS) rates were 72%, 53%, and 31%, respectively, with a median OS time of 25 months;the 1-, 2-, and 3-year progression-free survival (PFS) rates were 56%, 26%, and 7%, respectively, with a median PFS time of 14 months. The incidence of grade 2-3 acute radiation pneumonitis and radiation esophagitis was 1% and 17%, respectively, and the incidence of grade 3-4 decreases in leukocytes, hemoglobin, and platelet count was 39%, 11%, and 16%, respectively. Conclusions Radical radiotherapy combined with concurrent and consolidation chemotherapy for oligometastatic NSCLC can achieve good short-term outcome and long-term survival, with tolerable adverse effects.