Phase I Study of Etoposide and Cisplatin Chemotherapy Dose Escalation with Concurrent Twice-daily Radiotherapy for Patients with Limited-stage Small Cell Lung Cancer
10.3779/j.issn.1009-3419.2017.01.08
- VernacularTitle: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
- Author:
YOU JING
1
;
YU HUIMING
;
SONG MAXIAOWEI
;
SHI CHEN
;
WANG XIAOHANG
;
ZHENG YE
;
YU RONG
;
SHI ANHUI
;
ZHU GUANGYING
Author Information
1. 100142北京，北京大学肿瘤医院暨北京市肿瘤防治研究所，恶性肿瘤发病机制及转化研究教育部重点实验室，放疗科
- Keywords:
Limited stage small cell lung cancer;
Concurrent chemo-radiotherapy;
Accelerated hyperfractionation;
Chemotherapy dose escalation
- From:
Chinese Journal of Lung Cancer
2017;20(1):55-60
- CountryChina
- Language:Chinese
-
Abstract:
Background and objective Concurrent twice-daily radiotherapy with chemotherapy of EP regimen is one of the current standard treatments for limited-stage small cell lung cancer. However, the safely tolerated dose of standard chemotherapy for Chinese patients is not decided. hTis study was to evaluate the toxicity and the maximum tolerated dose (MTD) of etoposide and cisplatin concurrent with thoracic radiation therapy for patients with limited-stage small cell lung cancer. Methods Patients with histologically proven limited-stage small cell lung cancer (LS-SCLC) were eligible. hTe pa-tients underwent thoracic radiotherapy (45 Gy, 1.5 Gy bid, 30 fractions for 3 weeks) delivered concurrently with etoposide (100 mg/m2 iv, days 1-3) and cisplatin dose escalating from the two levels ( 70 mg/m2 and 75 mg/m2 on d1). hTe primary end-points were hematologic toxicities during treatment. hTe secondary endpoints were non-hematologic toxicities, overall survival (OS) and progression-free survival (PFS). According to Common Terminology Criteria for Adverse Events 4.0 (CTC-AE 4.0), maximum tolerant dosage (MTD) was deifned as the highest safely tolerated dose at which no more than one patient out of six experiences dose-limiting toxicity (Grades 4 hematologic), with the next higher dose having at least two out of six patients experience dose-limiting toxicity. Results From January 2013 to August 2016, 20 patients were enrolled in this study. hTe median age was 49.5 (30-68). Atfer the ifrst 6 patients were enrolled in Arm 1 (70 mg/m2 on d1), one patient had Grade 4 neu-tropenia. Another 14 patients were enrolled in Arm 2 (75 mg/m2 on d1), one patient had Grade 4 neutropenia. hTe MTD was determined to be etoposide (100 mg/m2 iv, d1-d3) and cisplatin dose (75 mg/m2 on d1). 4 patients had≥Grade 3 neutropenia and 1 patients had≥Grade 3 acute esophagitis in Arm 1. 10 patients had≥Grade 3 neutropenia and no patient had≥Grade 3 acute esophagitis in Arm 2. All patients with a median follow-up time was 9.0 months, median OS and PFS were not achieved, 1-year OS and PFS were 91%and 61%, respectively. Conclusion hTe MTD of RT with concurrent chemotherapy of EP regi-men for patients with LS-SCLC was etoposide (100 mg/m2 iv, d1-d3) and cisplatin dose (75 mg/m2 on d1).
