The standard first-line treatment option for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) is cetuximab, platinum, and fluorouracil.
However, according to the GORTEC study first published online this week in the journal Annals of Oncology, cetuximab, docetaxel, and cisplatin (TPEx) regimen as first-line treatment for HNSCC showed positive activity.
The multicenter, phase 2 study included fifty-four patients with confirmed HNSCC, performance status with less than or equal to 1, and under 71 years of age. All patients were given the TPEx regimen.
The patients were given G-CSF after each chemotherapy cycle for prophylaxis and cetuximab every two weeks after the end of the treatment cycle for maintenance therapy.
Results showed that the primary endpoint, objective response rate, was met with 44.4% (95% CI: 30.9, 58.6). Moreover, the median overall survival was 14 months (95% CI: 11.3, 17.3) and progression-free survival was 6.2 months (95% CI: 5.4, 7.2).
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The most common grade 3 and 4 adverse events were skin rash (16.6%) and non-febrile neutropenia (20.4%). The fatal adverse events were pulmonary embolism and infection, which lead to three deaths.