PDF(Sci-hub)
Abstract：
BACKGROUND: Large cell neuroendocrine carcinoma (LCNEC) and small cell lung cancer (SCLC) are recognized as high-grade neuroendocrine carcinomas (HGNEC) of the lung. In patients with completely resected HGNEC, platinum-based adjuvant chemotherapy may be considered. However, the optimum chemotherapy regimen has not been determined. We conducted a multicenter single-arm phase II trial to evaluate irinotecan and cisplatin in postoperative adjuvant chemotherapy for HGNEC patients.
METHODS: Patients with completely resected stage I-IIIA HGNEC received four cycles of irinotecan (60 mg/m(2), day 1, 8, 15) plus cisplatin (60 mg/m(2), day 1). This regimen was repeated every 4 weeks. The primary endpoint was the rate of completion of chemotherapy (defined as having undergone three or four cycles), and secondary endpoints were the rate of 3-year relapse-free survival (RFS), rate of 3-year survival and toxicities.
RESULTS: Forty patients were enrolled between September 2007 and April 2010. Patients\' characteristics were: median age (range) 65 [45-73] years; male 85%; ECOG-PS 1 60%; LCNEC 57% and SCLC 43%; stage IA/IB/IIB/IIIA 32/35/8/5%; 95% received lobectomy. The rate of completion of chemotherapy was 83% (90%C.I.; 71-90%). The rate of overall survival at 3 years was estimated at 81%, and that of RFS at 3 years was 74%. The rates of overall survival and RFS at 3 years were 86 and 74% among 23 LCNEC patients, and 74 and 76% among 17 SCLC patients, respectively. Nineteen patients (48%) experienced grade 3 or 4 neutropenia, but only five patients (13%) developed febrile neutropenia. Two patients (5%) developed grade 3 diarrhea, and four patients (10%) had grade 3 nausea. No treatment-related deaths were observed in this study. All 40 specimens were also diagnosed as HGNEC by central pathological review.
CONCLUSIONS: The combination of irinotecan and cisplatin as postoperative adjuvant chemotherapy was feasible and possibly efficacious for resected HGNEC.
METHODS: Patients with completely resected stage I-IIIA HGNEC received four cycles of irinotecan (60 mg/m(2), day 1, 8, 15) plus cisplatin (60 mg/m(2), day 1). This regimen was repeated every 4 weeks. The primary endpoint was the rate of completion of chemotherapy (defined as having undergone three or four cycles), and secondary endpoints were the rate of 3-year relapse-free survival (RFS), rate of 3-year survival and toxicities.
RESULTS: Forty patients were enrolled between September 2007 and April 2010. Patients\' characteristics were: median age (range) 65 [45-73] years; male 85%; ECOG-PS 1 60%; LCNEC 57% and SCLC 43%; stage IA/IB/IIB/IIIA 32/35/8/5%; 95% received lobectomy. The rate of completion of chemotherapy was 83% (90%C.I.; 71-90%). The rate of overall survival at 3 years was estimated at 81%, and that of RFS at 3 years was 74%. The rates of overall survival and RFS at 3 years were 86 and 74% among 23 LCNEC patients, and 74 and 76% among 17 SCLC patients, respectively. Nineteen patients (48%) experienced grade 3 or 4 neutropenia, but only five patients (13%) developed febrile neutropenia. Two patients (5%) developed grade 3 diarrhea, and four patients (10%) had grade 3 nausea. No treatment-related deaths were observed in this study. All 40 specimens were also diagnosed as HGNEC by central pathological review.
CONCLUSIONS: The combination of irinotecan and cisplatin as postoperative adjuvant chemotherapy was feasible and possibly efficacious for resected HGNEC.
摘要：
背景：大细胞神经内分泌癌（LCNEC）和小细胞肺癌（SCLC）被认为是肺部高级别神经内分泌癌（HGNEC）。在完全切除HGNEC的患者中，铂类辅助化疗可以考虑.然而,最佳化疗方案尚未确定.我们进行了一项多中心单臂II期试验，以评估伊立替康和顺铂在HGNEC患者术后辅助化疗中的应用。
方法：完全切除I-IIIA期HGNEC的患者接受了四个周期的伊立替康（60mg/m（2），第1天，第8天，第15天）加顺铂（60mg/m（2），day1).该方案每4周重复一次。主要终点是化疗完成率（定义为经历了三个或四个周期），次要终点是3年无复发生存率（RFS），3年生存率和毒性。
结果：在2007年9月至2010年4月期间纳入了40例患者。患者特征为：中位年龄（范围）65[45-73]岁；男性85％；ECOG-PS160％；LCNEC57％和SCLC43％；IA/IB/IIB/IIIA期32/35/8/5％；95％接受了肺叶切除术。化疗完成率为83%(90%C.I.;71-90%)。3年总生存率估计为81%，RFS在3年的比率为74%。在23例LCNEC患者中，3年的总生存率和RFS分别为86％和74％，在17例SCLC患者中，有74％和76％，分别。19例患者（48%）经历3级或4级中性粒细胞减少症，但只有5例患者（13%）出现发热性中性粒细胞减少症。2例患者（5%）出现3级腹泻，4名患者（10％）有3级恶心。在这项研究中没有观察到治疗相关的死亡。全部40例标本经中央病理检讨也诊断为HGNEC。
结论：伊立替康联合顺铂作为术后辅助化疗是可行的，可能是有效的。
方法：完全切除I-IIIA期HGNEC的患者接受了四个周期的伊立替康（60mg/m（2），第1天，第8天，第15天）加顺铂（60mg/m（2），day1).该方案每4周重复一次。主要终点是化疗完成率（定义为经历了三个或四个周期），次要终点是3年无复发生存率（RFS），3年生存率和毒性。
结果：在2007年9月至2010年4月期间纳入了40例患者。患者特征为：中位年龄（范围）65[45-73]岁；男性85％；ECOG-PS160％；LCNEC57％和SCLC43％；IA/IB/IIB/IIIA期32/35/8/5％；95％接受了肺叶切除术。化疗完成率为83%(90%C.I.;71-90%)。3年总生存率估计为81%，RFS在3年的比率为74%。在23例LCNEC患者中，3年的总生存率和RFS分别为86％和74％，在17例SCLC患者中，有74％和76％，分别。19例患者（48%）经历3级或4级中性粒细胞减少症，但只有5例患者（13%）出现发热性中性粒细胞减少症。2例患者（5%）出现3级腹泻，4名患者（10％）有3级恶心。在这项研究中没有观察到治疗相关的死亡。全部40例标本经中央病理检讨也诊断为HGNEC。
结论：伊立替康联合顺铂作为术后辅助化疗是可行的，可能是有效的。
