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EXTREME regimen (chemotherapy [CT; cisplatin/carboplatin and 5-fluorouracil]) combined with cetuximab is the standard first-line for patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M SCCHN) ( 1L) Therapies, and are supported by international guidelines
.
The CHANGE-2 trial is a randomized phase 3 clinical trial led by Professor Lin Tongyu from the Cancer Center of Sun Yat-sen University.
It evaluates an improved CT scheme (both chemotherapeutic doses are reduced) combined with cetuximab versus CT alone The effectiveness and safety of the program as the first-line therapy for Chinese R/M SCCHN patients
.
The test patients were randomized to receive 6 courses of CT + cetuximab followed by cetuximab until the disease progressed, or CT regimen alone
.
The primary endpoint is progression-free survival (PFS) as assessed by the independent review committee (IRC)
Progression-free survival and overall survival of the two groups of patients
Progression-free survival and overall survival of the two groups of patientsIn total, a total of 243 patients were randomly divided into two groups: 164 in the CT+cetuximab combination group and 79 in the CT group
.
The median PFS of the CT+cetuximab combination group and the CT group were 5.
The median PFS of the CT+cetuximab combination group and the CT group were 5.
The occurrence of common adverse reactions in the two groups
The occurrence of common adverse reactions in the two groupsThe most common grade 3-4 adverse reactions requiring emergency treatment occurred in 61.
3% and 48.
7% of the combined group and CT group, respectively
.
In summary, the results of the CHANGE-2 trial show that adding cetuximab to the improved platinum/5-fluorouracil regimen can significantly improve the median PFS, median OS and ORR of patients with R/M SCCHN, and it has not It has caused new or unexpected safety issues, confirming that CT combined with cetuximab can be used as a safe and effective first-line treatment for R/M SCCHN patients in China
.
.
CT combined with cetuximab can be used as a safe and effective first-line treatment for R/M SCCHN patients in China
Original source:
Guo Ye,Luo Yi,Zhang Qingyuan et al.
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 in this message