A Randomized Controlled Trial Comparing Two Different Schedules for Cisplatin Treatment in Patients with Locoregionally Advanced Nasopharyngeal Cancer

• Published in: Clinical cancer research 2021-08, Vol.27 (15), p.4186-4194
• Main Authors: Xia, Wei-Xiong, Lv, Xing, Liang, Hu, Liu, Guo-Ying, Sun, Rui, Zeng, Qi, Li, Si-Wei, Mo, Hao-Yuan, Han, Fei, Luo, Dong-Hua, Liu, Qing, Shi, Meng-Yun, Ye, Yan-Fang, Yang, Jing, Ke, Liang-Ru, Qiang, Meng-Yun, Qiu, Wen-Ze, Yu, Ya-Hui, Liu, Kui-Yuan, Huang, Xin-Jun, Li, Wang-Zhong, Lv, Shu-Hui, Cai, Zhuo-Chen, Miao, Jing-Jing, Guo, Ling, Chen, Ming-Yuan, Cao, Ka-Jia, Wang, Lin, Zhao, Chong, Huang, Pei-Yu, Chen, Qiu-Yan, Hua, Yi-Jun, Tang, Lin-Quan, Qian, Chao-Nan, Mai, Hai-Qiang, Guo, Xiang, Xiang, Yan-Qun
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Agents - administration & dosage; Cisplatin - administration & dosage; Clinical Trials: Targeted Therapy; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Nasopharyngeal Carcinoma - drug therapy; Nasopharyngeal Carcinoma - pathology; Nasopharyngeal Neoplasms - drug therapy; Nasopharyngeal Neoplasms - pathology; Neoplasm Staging; Young Adult
• ISSN: 1078-0432; 1557-3265
• DOI: 10.1158/1078-0432.CCR-20-4532

Previous studies suggest that a cumulative cisplatin dose of 200 mg/m might be adequate in the intensity-modulated radiation therapy (IMRT) era for locoregionally advanced nasopharyngeal carcinoma (LANPC). However, two cycles of once-every-3-weeks cisplatin at 100 mg/m has never been prospectively compared with standard once-a-week cisplatin regimen. This trial was conducted at three hospitals from 2011 to 2016. Patients who met the eligibility criteria were recruited (ChiCTR-TRC-12001979) and randomly assigned (1:1) via a computer-generated sequence to receive once-every-3-weeks cisplatin at 100 mg/m for two cycles or once-a-week cisplatin at 40 mg/m for six cycles concurrently with IMRT. Primary endpoint was failure-free survival and between-group absolute difference of 10% as the noninferiority margin. A total of 510 patients were enrolled. Median follow-up time was 58.3 months with 85.4% of 3-year failure-free survival in the once-every-3-weeks group and 85.6% in the once-a-week group. An absolute difference of -0.2% (95% confidence interval, -6.3 to 5.9; = 0.0016). Acute toxicities of grade 3 or higher occurred in 55.8% in the once-every-3-weeks group and 66.3% in the once-a-week group ( = 0.015). The most common acute toxicities were hematologic abnormalities, including leukopenia (16% vs. 27%; = 0.0022) and thrombocytopenia (1% vs. 5%; = 0.015). The late grade 3-4 auditory loss rate was significantly lower in the once-every-3-weeks group than the once-a-week group (6% vs. 13%; = 0.0039). Once-every-3-weeks cisplatin as concurrent chemoradiotherapy is noninferior to once-a-week cisplatin in the treatment efficacy in the LANPC. Although both regimens are well tolerated, severe acute toxicities and late-onset auditory loss are higher in the once-a-week group.