局限期小细胞肺癌加速超分割放疗同步EP方案化疗的剂量递增Ⅰ期研究

发布时间：2018-06-16 20:44

  本文选题：局限期小细胞肺癌 + 同步放化疗　； 参考：《中国肺癌杂志》2017年01期

【摘要】：背景与目的加速超分割放疗(每日两次方案)联合EP方案同步化疗是美国国立综合癌症网络(National Comprehensive Cancer Network,NCCN)指南推荐的局限期小细胞肺癌的标准治疗方式,但国人对EP方案标准化疗剂量耐受性尚不明确。本研究旨在探讨局限期小细胞肺癌同步放化疗EP方案的最大耐受剂量。方法研究纳入病理证实的局限期小细胞肺癌患者,进行加速超分割放疗同步EP方案(依托泊苷+顺铂)化疗,放疗处方剂量为45Gy/30 f,1.5 Gy/f,每日两次,同一日两次放疗间隔时间≥6 h,5天/周,共3周完成。化疗方案采用依托泊苷联合顺铂,每21天为1周期,具体依托泊苷100 mg/m~2,d1-d3,顺铂采用剂量递增的方式(第1组为70 mg/m~2 d1,第2组为75 mg/m~2 d1)。主要观察指标为治疗期间的血液学毒性。次要观察指标为非血液学毒性和1年总生存期(overall survival,OS)、无进展生存期(progression free survival,PFS)。根据不良事件常用术语评定标准(Common Terminology Criteria for Adverse Events,NCI-CTCAE)4.0,最大耐受剂量设定为6例患者中不超过1例患者出现剂量限制毒性(4级血液学毒性)的剂量,同时下一剂量组6例患者至少2例出现剂量限制性毒性。结果研究共纳入20例局限期小细胞肺癌患者,平均年龄49.50(30-68)岁。第1组入组6例患者,1例患者出现4度中性粒细胞减少;后第2组入组14例患者,1例患者出现4度中性粒细胞减少。其中,第1组有4例患者出现≥3度血液学毒性,1例患者出现3度以上放射性食管炎;第2组有10例患者出现≥3度血液学毒性,无患者出现3度以上放射性食管炎。中位随访9.0个月(3.2个月-36.2个月),1年OS、PFS分别为91%、62%。结论局限期小细胞肺癌患者采用加速超分割放疗联合EP方案化疗将顺铂剂量递增至75 mg/m~2是安全的,其有效性还需要进一步扩大样本量和随访更长的时间来证实。
[Abstract]:Background & objective accelerated hyperfractionation radiotherapy (twice a day) combined with concurrent chemotherapy with EP regimen is the standard therapy for localized small cell lung cancer recommended by the National Comprehensive Cancer Network (NCCNN) guidelines. However, the tolerance of Chinese to standard dose of EP regimen is not clear. The aim of this study was to investigate the maximum tolerated dose of EP regimen in simultaneous radiotherapy and chemotherapy for local small cell lung cancer. Methods patients with localized small cell lung cancer (SCLC) who were confirmed by pathology were treated with accelerated hyperfractionation radiotherapy combined with EP regimen (etoposide cisplatin). The prescribed dose of radiotherapy was 45 Gy / 30 fU 1.5 Gy / f, twice a day. The interval between two times of radiotherapy on the same day was more than 6 h / week for 3 weeks. The chemotherapy regimen was etoposide combined with cisplatin for one cycle every 21 days. Etoposide 100 mg / m ~ (2) ~ (-1) d ~ (-1) and cisplatin were used as dose-increasing method (group 1 was 70 mg/m~2 / d ~ (-1), group 2 was 75 mg/m~2 / d ~ (-1). The main outcome measure was hematological toxicity during treatment. The secondary indexes were non-hematological toxicity, total survival time of one year and progression free survival. According to the standard of Common Terminology criteria for Adverse events (NCI-CTCAE4), the maximum tolerated dose was set as the dose of no more than one patient out of 6 patients with hematological toxicity of grade 4. At the same time, at least 2 patients in the next dose group had dose-limited toxicity. Results A total of 20 patients with small cell lung cancer (SCLC) with an average age of 49.50- 68 years were enrolled in the study. In the first group, 6 patients with neutropenia and 1 patient with 4 degree neutropenia were found in the first group, and 14 patients in the latter group and 1 patient with neutropenia in the latter group. In the first group, there were 4 patients with hematological toxicity 鈮，

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