Published online Feb 24, 2022. doi: 10.5306/wjco.v13.i2.147
Peer-review started: June 22, 2021
First decision: July 16, 2021
Revised: August 4, 2021
Accepted: January 17, 2022
Article in press: January 17, 2022
Published online: February 24, 2022
Processing time: 245 Days and 11.3 Hours
The targeted therapy cetuximab in combination with 5-fluorouracil and platinum-based chemotherapy (the EXTREME regimen) has shown substantial efficacy for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). However, a new strategy combining platinum, taxanes, and cetuximab (the TPEx regimen) has demonstrated similar efficacy with a more favorable toxicity profile in clinical trials.
There is scarce evidence outside randomized clinical trials including patients treated with TPEx scheme.
To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study.
This retrospective multicenter cohort study included patients with histologically confirmed recurrent or metastatic SCCHN treated with first-line TPEx at five medical centers in Argentina between January 1, 2017, and April 31, 2020. Chemotherapy consisted of four cycles of docetaxel, cisplatin, and cetuximab followed by cetuximab maintenance therapy. Clinical outcomes and toxicity profiles were collected from medical charts. Treatment response was assessed by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Among the 24 patients included, the majority of patients (83.3%) received at least four chemotherapy cycles in the initial phase. The overall response rate was 62.5%, and 3 patients achieved a complete response (12.5%). The median time to response was 2.4 mo (95%CI: 1.3-3.5). With a median follow-up of 12.7 mo [95% confidence interval (CI): 8.8-16.6), the median progression-free survival (PFS) was 6.9 mo (95%CI: 6.5-7.3), and the overall survival rate at 12 mo was 82.4%. Patients with documented tumor response showed a better PFS than those with disease stabilization or progression [8.5 mo (95% CI: 5.5-11.5) and 4.5 mo (95%CI: 2.5-6.6), respectively; P = 0.042]. Regarding the safety analysis, two-thirds of patients reported at least one treatment-related adverse event, and 25% presented grade 3 toxicities. Of note, no patient experienced grade 4 adverse events.
TPEx was a well-tolerated regimen in our population, showing a lower incidence of grade 3-4 adverse events than previously reported. PFS was comparable to those of recently reported clinical trials using the same treatment scheme. We observed a higher overall response rate compared to the previous results in phase 2 trials.
This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.