放疗联合培美曲塞、卡铂同期及巩固化疗治疗中晚期食管癌的疗效评价

Radiotherapy combined with pemetrexed,carboplatin concurrent and consolidation chemotherapy in patients with unresectable esophageal cancer:a prospective phase Ⅱ study

目的评价放疗联合培美曲塞、卡铂同期及巩固化疗治疗中晚期食管癌的有效性及安全性。方法 16例中晚期食管癌患者接受胸部X线调强放疗50~60Gy/5~6周,同期予培美曲塞(500mg/m2)、卡铂(AUC=5)化疗,21d为1个周期;放化疗结束后继续原方案巩固化疗2个周期。治疗结束后随访16(13,40)个月,采用实体瘤的疗效评价标准(RECIST1.1)评价疗效,采用常见不良事件评价标准3.0(CTCAE3.0)评价不良反应。结果 16例患者均完成治疗。完全缓解(CR)1例,部分缓解(PR)15例;无进展生存(PFS)4例,病死12例(远处转移8例、局部进展3例、心力衰竭1例)。全组患者1、2年PFS率分别为44.0%、31.0%,PFS时间为9(6,40)个月;1、2年总生存(OS)率分别为69.0%、38.0%,OS时间为16(10,40)个月。不良反应以3、4级中性粒细胞减少为主,在粒细胞-集落刺激因子的支持下均可完成治疗;其次为2、3级食管炎。结论放疗联合培美曲塞、卡铂同期及巩固化疗治疗中晚期食管癌疗效可靠,患者耐受性良好。

Objective To evaluate the efficacy and safety of radiotherapy combined with pemetrexed, carboplatin concurrent and consolidation chemotherapy in patients with unresectable esophageal cancer. Methods Sixteen patients with local advanced esophagus carcinoma received 6MV X ray intensity-modulated radiation therapy with a total dose of 60Gy(30 fractions for 6 weeks) from 2009 to 2011. Chemotherapy consisted of pemetrexed 500mg/m2 and carboplatin (AUC=5) administered concurrently with radiotherapy and after radiotherapy. Tumor response was evaluated with thoracic CT scans performed 4 weeks after completion of treatment in accordance with RECIST 1.1 criteria. Adverse reaction were evaluated in accordance with CTCAE 3.0. Results All 16 patients completed treatment, with 1 case of complete remission (CR) and 15 cases of partial remission(PR). One- and 2-year survival rate was 69% and 38%, and 1- and 2-year progression-free survival(PFS) rate was 44% and 31%, respectively. Twelve patients died, 11 died of cancer, 1 died of other disease, and none died of treatment related toxicities. Seven patients developed grade 3/4 neutrocytopenia, and 7 developed grade 3/4 thrombocytopenia. Grade 3 acute esophagitis and pneumonitis were observed in 4 patients. Conclusion For unresectable esophageal cancer, radiotherapy combined with pemetrexed, carboplatin concurrent and consolidation chemotherapy is safe and the short-term outcomes are promising. Further investigations are warranted.