1091 - Phase III Trial to Compare Weekly and Triweekly Usage of Docetaxel and Cisplatin in Concurrent Chemoradiotherapy for Patients with Unresectable Locally Advanced Non-Small Cell Lung Cancer
Presenter(s)
D. Yang1, F. Zhang2, L. Jiang1, H. Ge3, J. Li4, X. LI5, S. Yan6, J. Yu1, X. Chang1, H. Yu1, R. Yu1, J. Wang7, G. Zhu8, and A. Shi1; 1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China, 2Department of Radiation Oncology, Shanxi Medical University/Shanxi Province Cancer Hospital/Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China, 3Department of Radiation Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, China, 4Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, China, 5Liaoning Cancer Hospital, Shenyang, China, 6Department of Radiation Oncology, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China, 7Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Beijing, China, 8Department of Radiation Oncology, Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China
Purpose/Objective(s): Concurrent chemoradiotherapy (CCRT) was the standard treatment for unresectable locally advanced non-small cell lung cancer (LA-NSCLC). This phase III multicentre randomized trial compared weekly and triweekly usage of docetaxel and cisplatin in CCRT.
Materials/Methods: Patients with unresectable stage III LA-NSCLC and Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 were enrolled and randomized to either arm A (docetaxel and cisplatin both at 20 mg/m2 weekly for 6 weeks) or arm B (docetaxel and cisplatin both at 60 mg/m2 triweekly for 6 weeks). Concurrent chest radiotherapy was administered at 60-70 Gy in 30-35 fractions with standard fractionation. The tumour overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicities were analysed.
Results: From March 2009 to May 2016, eighty patients completed CCRT (43 in arm A and 37 in arm B). Median follow-up was 52 months (95%CI:11.3-167.4months). The objective response rate (ORR) in arms A and B was 60.5% and 73.0%, respectively (P = 0.261). The median progression-free survival (PFS) was 20.3 months and 22.9 months in arms A and B, respectively (P = 0.809). The median overall survival (OS) was 37.5 months and 32.3 months, respectively (P = 0.851). The 3-year, 5-year, and 10-year OS rates were 53.5% versus 45.9%, 39.5% versus 29.7%, and 19.9% versus 21.6%, respectively. No statistically significant differences were observed in PFS or OS between the two treatment arms. Patients in arm B had a significantly higher incidence of leukopenia and granulocytopenia (P < 0.001) but a lower rate of grade 3 acute esophagitis (P = 0.141) compared with those in arm A.
Conclusion: We failed to demonstrate that weekly docetaxel plus cisplatin was superior to the triweekly regimen. Therefore, both concurrent chemotherapy regimens are viable options. The two schedules exhibit different toxicity profiles. The weekly regimen requires attention to esophagitis, while the triweekly regimen is associated with a higher risk of myelosuppression.