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Lancet oncol: Comparison of two first-line chemotherapy regimens for patients with recurrent/metastatic head and neck squamous cell carcinoma!

 Last Update: 2021-03-19
 Source: Internet
 Author: User

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A phase 2 trial of the TPEx chemotherapy regimen (Docetaxel-platinum-cetuximab) showed that patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) have a median overall survival of up to 14 months.

This study aims to compare the efficacy and safety of the PTEx regimen and the standard EXTRNE regimen (platinum-fluorouracil-cetuximab) in such patients.

This is a multi-center, open-label, randomized phase 2 trial conducted in 68 centers in France, Spain, and Germany, recruiting 18-70 years of age with histologically confirmed recurrence/metastatic disease that cannot be cured HNSCC patients were randomly divided into two groups 1:1.

From October 10, 2014 to November 29, 2017, a total of 541 patients were recruited and randomly divided into two groups: 271 in the TPEx group and 270 in the EXTREME group.

Kaplan-Meier estimation of overall survival and progression-free survival

The median follow-up time of TPEx group and EXTREME group were 34.

At the deadline, 209 and 218 patients in the TPEx group and EXTREME group had died.

Subgroup analysis of overall survival and progression-free survival

214 (81%) of the 263 patients in the TPEx group and 246 (93%) of the 265 patients in the EXTREME group had adverse events of grade 3 or higher during chemotherapy.

infection

In summary, although the trial did not reach its primary endpoint, and the overall survival of the TPEx group was not significantly improved compared to the EXTREME group, the TPEx regimen has good safety.

The TPEx program may provide an alternative to the standard first-line treatment EXTREME program for patients with relapsed/metastatic HNSCC

Original source:

Joel Guigay, et al.

org/10.
1016/S1470-2045(20)30755-5" target="_blank" rel="noopener">Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial leave a message here

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