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

Abstract

PURPOSE:

Previous studies suggest that a cumulative cisplatin dose of 200 mg/m2 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/m2 has never been prospectively compared with standard once-a-week cisplatin regimen.

PATIENTS AND METHODS:

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/m2 for two cycles or once-a-week cisplatin at 40 mg/m2 for six cycles concurrently with IMRT. Primary endpoint was failure-free survival and between-group absolute difference of 10% as the noninferiority margin.

RESULTS:

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; P noninferiority = 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 (P = 0.015). The most common acute toxicities were hematologic abnormalities, including leukopenia (16% vs. 27%; P = 0.0022) and thrombocytopenia (1% vs. 5%; P = 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%; P = 0.0039).

CONCLUSIONS:

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.

• Authors: Wei-Xiong Xia, Xing Lv, Hu Liang, Guo-Ying Liu, Rui Sun, Qi Zeng, Si-Wei Li, Hao-Yuan Mo, Fei Han, Dong-Hua Luo, Qing Liu, Meng-Yun Shi, Yan-Fang Ye, Jing Yang, Liang-Ru Ke, Meng-Yun Qiang, Wen-Ze Qiu, Ya-Hui Yu, Kui-Yuan Liu, Xin-Jun Huang, Wang-Zhong Li, Shu-Hui Lv, Zhuo-Chen Cai, Jing-Jing Miao, Ling Guo, Ming-Yuan Chen, Ka-Jia Cao, Lin Wang, Chong Zhao, Pei-Yu Huang, Qiu-Yan Chen, Yi-Jun Hua, Lin-Quan Tang, Chao-Nan Qian, Hai-Qiang Mai, Xiang Guo, Yan-Qun Xiang
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 27 Issue 15 Pg. 4186-4194 (08 01 2021) ISSN: 1557-3265 [Electronic] United States
• PMID: 34083231 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: ©2021 The Authors; Published by the American Association for Cancer Research.

Chemical References

• Antineoplastic Agents
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage)
• Cisplatin (administration & dosage)
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Nasopharyngeal Carcinoma (drug therapy, pathology)
• Nasopharyngeal Neoplasms (drug therapy, pathology)
• Neoplasm Staging
• Young Adult