First-line treatment with chemotherapy plus cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety results of the randomised, phase III CHANGE-2 trial.

Abstract

BACKGROUND:

The EXTREME regimen (chemotherapy [CT; cisplatin/carboplatin and 5-fluorouracil]) plus cetuximab is a standard-of-care first-line (1L) treatment for patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), as supported by international guidelines. The phase III CHANGE-2 trial assessed the efficacy and safety of a modified CT regimen (with a reduced dose of both components) and cetuximab versus CT for the 1L treatment of Chinese patients with R/M SCCHN.

METHODS:

Patients were randomised to receive up to six cycles of CT plus cetuximab followed by cetuximab maintenance until progressive disease or CT alone. The primary end-point was the progression-free survival (PFS) time assessed by the independent review committee (IRC).

RESULTS:

Overall, 243 patients were randomised (164 to CT plus cetuximab; 79 to CT). The hazard ratios for PFS by IRC and overall survival (OS) were 0.57 (95% CI: 0.40-0.80; median: 5.5 versus 4.2 months) and 0.69 (95% CI: 0.50-0.93; median: 11.1 versus 8.9 months), respectively, in favour of CT plus cetuximab. The objective response rates (ORR) by IRC were 50.0% and 26.6% with CT plus cetuximab and CT treatment, respectively. Treatment-emergent adverse events of maximum grade 3 or 4 occurred in 61.3% (CT plus cetuximab) and 48.7% (CT) of patients.

CONCLUSIONS:

CHANGE-2 showed an improved median PFS, median OS and ORR with the addition of cetuximab to a modified platinum/5-fluorouracil regimen, with no new or unexpected safety findings, thereby confirming CT plus cetuximab as an effective and safe 1L treatment for Chinese patients with R/M SCCHN.

CLINICAL TRIAL REGISTRATION NUMBER:

NCT02383966.

• Authors: Ye Guo, Yi Luo, Qingyuan Zhang, Xiaoming Huang, Zhengdong Li, Liangfang Shen, Jifeng Feng, Yan Sun, Kunyu Yang, Minghua Ge, Xiaodong Zhu, Lin Wang, Yanyan Liu, Xiaohui He, Chunmei Bai, Kai Xue, Yan Zeng, XinYing Chang, Wenfeng Chen, Tongyu Lin
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 156 Pg. 35-45 (10 2021) ISSN: 1879-0852 [Electronic] England
• PMID: 34418665 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antineoplastic Agents, Immunological
• Carboplatin
• Cetuximab
• Cisplatin
• Fluorouracil

Topics

• Aged
• Antineoplastic Agents, Immunological (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (therapeutic use)
• Cetuximab (adverse effects, therapeutic use)
• China
• Cisplatin (therapeutic use)
• Female
• Fluorouracil (therapeutic use)
• Head and Neck Neoplasms (drug therapy, mortality, pathology)
• Humans
• Male
• Middle Aged
• Neoplasm Recurrence, Local
• Progression-Free Survival
• Squamous Cell Carcinoma of Head and Neck (drug therapy, mortality, secondary)
• Time Factors