伊立替康联合奈达铂二线治疗晚期食管鳞癌24例

Combined chemotherapy with irinotecan and nedaplatin as a second-line regimen for patients with advanced esophageal squamous cell carcinoma:a report of 24 cases

目的:观察伊立替康(CPT-11)联合奈达铂(NDP)二线治疗晚期食管鳞癌的疗效及不良反应.方法:依照开放原则,24例经组织学证实的食管鳞状细胞癌患者一线化疗疾病进展(PD)者,按CPT-1165mg/m2在第1-8天1h内静脉输注,然后NDP80mg/m2第12h内静脉输注,21d为1周期.每化疗2周期后按RECIST标准评价疗效,每1周期后根据CTCAE3.0进行不良反应分级.所有患者随访24mo,结果采用Kaplan-Meier进行生存分析.结果:24例均可评价疗效,完全缓解(CR)1例(4%),部分缓解(PR)5例(21%),稳定(SD)7例(29%),PD11例(46%),有效率25%(CR+PR),疾病控制率54%(CR+PR+SD);中位生存时间(OS)248.5d(95%CI:159-563d),中位至疾病进展时间(TTP)131d(95%CI:45-382d).3级血液学毒性:贫血1例(4%),中性粒细胞减少4例(17%),白细胞减少5例(21%),血小板减少1例(4%).仅有1例4级中性粒细胞减少,研究中未观察到3-4级非血液学毒性,无治疗相关性死亡.结论:伊立替康联合奈达铂二线治疗晚期食管鳞癌的近期疗效显著,不良反应轻,耐受性好.

AIM：To evaluate the efficacy and safety of combined chemotherapy with irinotecan and nedaplatin as a second-line regimen for advanced esophageal cancer.METHODS：An open trial was performed.Twenty-four patients with histopathologically confirmed esophageal squamous cell carcinoma who received combination chemotherapy with irinotecan and nedaplatin as a second-line regi-men were evaluated.The combination therapy consisted of intravenous administration of irinotecan 65 mg/m 2 over 1 hour on days 1 and 8 of a 21-day cycle, and nedaplatin 80 mg/m 2 over 2 hours on day 1.Efficacy was evaluated every 6 weeks（two cycles） according to RECIST criteria.Toxic side effects were graded based on CTCAE 3.0 criteria after each cycle.The follow-up period was 24 months.Survival analysis was performed using the Kaplan-Meier method.RESULTS：All the 24 patients were assessable for response.In the study, one patient（4%） experienced complete remission（CR）, 5（21%） partial remission（PR）, 7（29%） stable disease（SD）, and 11（46%） progressive disease（PD）.The overall response rate（CR ＋ PR） was 25%, and the disease control rate（CR ＋ PR ＋ SD） was 54%.The median overall survival（OS） time was 248.5 d（95% confidence interval CI：159-563 d）, and median time to disease progression（TTP） was 131 d（95%CI：45-382 d）.Severe hematological adverse events（grade 3） included：anemia（n=1;4%）, neutropenia（n=4;25%）, leucopenia（n=5;21%）, and thrombocytopenia（n =1;4%）.Grade 4 neutropenia was observed in only one patient（4%）.No grade 3-4 nonhematological adverse events occurred.No treatment-related deaths were observed.CONCLUSION：Combined therapy with irinotecan and nedaplatin as a second-line regimen is effective, safe and well-tolerated in patients with advanced esophageal squamous cell carcinoma.