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. (October 2021)

• Record Type: Journal Article
• Authors: Guo, Ye; Luo, Yi; Zhang, Qingyuan; Huang, Xiaoming; Li, Zhengdong; Shen, Liangfang; Feng, Jifeng; Sun, Yan; Yang, Kunyu; Ge, Minghua; Zhu, Xiaodong; Wang, Lin; Liu, Yanyan; He, Xiaohui; Bai, Chunmei; Xue, Kai; Zeng, Yan; Chang, XinYing; Chen, Wenfeng; Lin, Tongyu
• Is Part Of: European journal of cancer. Volume 156(2021)
• Page Start: 35
• Page End: 45
• Publication Date: 2021-10
• Subjects: Cetuximab -- China -- EXTREME -- First-line -- Recurrent and/or metastatic squamous cell carcinoma of the head and neck; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2021.06.039
• Languages: English
• ISSNs: 0959-8049

Abstract

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. Highlights: The EXTREME regimen is a standard-of-care first-line treatment option for R/M SCCHN. The Asia–Pacific region has the most cases of head and neck cancers in the world. CHANGE-2 evaluated 1L cetuximab plus CT in Chinese patients with R/M SCCHN. Treatment with cetuximab plus CT was effective and safe. These results led to the approval of cetuximab plus CT in China for R/M SCCHN.