一项关于伊立替康和顺铂辅助化疗完全切除的高级别肺神经内分泌癌（大细胞神经内分泌癌和小细胞肺癌）的初步研究。
A pilot study of adjuvant chemotherapy with irinotecan and cisplatin for completely resected high-grade pulmonary neuroendocrine carcinoma (large cell neuroendocrine carcinoma and small cell lung cancer).
机构信息
Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Division of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.
出版信息
Lung Cancer. 2014 Jun;84(3):254-8. doi: 10.1016/j.lungcan.2014.03.007. Epub 2014 Mar 13.
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.
PATIENTS AND 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.
背景
大细胞神经内分泌癌（LCNEC）和小细胞肺癌（SCLC）被认为是肺部的高级别神经内分泌癌（HGNEC）。对于完全切除的 HGNEC 患者，可能考虑使用铂类为基础的辅助化疗。然而，最佳的化疗方案尚未确定。我们进行了一项多中心单臂 II 期试验，以评估伊立替康联合顺铂在 HGNEC 患者术后辅助化疗中的疗效。
患者和方法
完全切除的 I 期-IIIA 期 HGNEC 患者接受四个周期的伊立替康（60mg/m²，第 1、8、15 天）加顺铂（60mg/m²，第 1 天）治疗。每 4 周重复一次。主要终点是化疗完成率（定义为完成三个或四个周期），次要终点是 3 年无复发生存率（RFS）、3 年生存率和毒性。
结果
2007 年 9 月至 2010 年 4 月期间共纳入 40 例患者。患者特征为：中位年龄（范围）65[45-73]岁；男性占 85%；ECOG-PS 1 占 60%；LCNEC 占 57%，SCLC 占 43%；IA/IB/IIB/IIIA 期分别占 32%/35%/8%/5%；95%的患者接受了肺叶切除术。化疗完成率为 83%（90%CI；71-90%）。3 年总生存率估计为 81%，3 年 RFS 率为 74%。23 例 LCNEC 患者的 3 年总生存率和 RFS 率分别为 86%和 74%，17 例 SCLC 患者分别为 74%和 76%。19 例（48%）患者发生 3 级或 4 级中性粒细胞减少症，但仅 5 例（13%）发生发热性中性粒细胞减少症。2 例（5%）患者发生 3 级腹泻，4 例（10%）患者发生 3 级恶心。本研究中未观察到与治疗相关的死亡。所有 40 例标本经中心病理复查均诊断为 HGNEC。
结论
伊立替康联合顺铂作为术后辅助化疗，对切除的 HGNEC 是可行的，且可能有效。
Zotero 插件