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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
First-line cisplatin, docetaxel, and cetuximab for patients with recurrent or metastatic head and neck cancer: A multicenter cohort study
Agustín Falco, Mariano Leiva, Albano Blanco, Guido Cefarelli, Andrés Rodriguez, Juan Melo, Federico Cayol, Manglio Miguel Rizzo, Alejandro Sola, Hernán Rodríguez Montani, Matías Chacon, Diego Enrico, Federico Waisberg
Agustín Falco, Mariano Leiva, Department of Medical Oncology, Head and Neck Unit, Alexander Fleming Cancer Institute, Buenos Aires 1428, Argentina
Albano Blanco, Guido Cefarelli, Andrés Rodriguez, Matías Chacon, Diego Enrico, Federico Waisberg, Department of Medical Oncology, Alexander Fleming Cancer Institute, Buenos Aires 1426, Argentina
Juan Melo, Federico Cayol, Department of Medical Oncology, Hospital Italiano de Buenos Aires, Buenos Aires 1199, Argentina
Manglio Miguel Rizzo, Department of Medical Oncology, Hospital Universitario Austral, Pilar 1629, Argentina
Alejandro Sola, Department of Medical Oncology, Fundación Centro Oncológico de Integración Regional, Mendoza 5500, Argentina
Hernán Rodríguez Montani, Department of Medical Oncology, Hospital Italiano Rosario; Sanatorio de la Mujer, Rosario 2001, Argentina
Author contributions: Falco A provided the study concept and designed the study; Falco A, Leiva M, Blanco A, Cefarelli G, Enrico D, and Waisberg F contributed to the data acquisition and quality control of data; Falco A, Leiva M, Blanco A, Enrico D, and Waisberg F contributed to the data analysis and interpretation; all authors contributed to manuscript preparation and editing and have read and approved the manuscript.
Institutional review board statement: The study was reviewed and approved for publication by the Institutional Review Board of each center according to the Argentinian ethical norms and regulations for multicenter studies.
Informed consent statement: Patients were not required to give their informed consent for this study because the analysis used anonymous data lacking patient names, addresses, dates of birth, wards, bed numbers, and hospital numbers and other private information.
Conflict-of-interest statement: All the authors have no conflicts of interest related to the manuscript.
STROBE statement: The authors have read the STROBE Statement, and the manuscript was prepared and revised according to the STROBE Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Agustín Falco, MD, Staff Physician, Department of Medical Oncology. Head and Neck Unit, Alexander Fleming Cancer Institute, Cramer 1180, Buenos Aires 1428, Argentina.
afalco@alexanderfleming.org
Received: June 22, 2021
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
ARTICLE HIGHLIGHTS
Research background
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.
Research motivation
There is scarce evidence outside randomized clinical trials including patients treated with TPEx scheme.
Research objectives
To evaluate the safety and efficacy of the TPEx scheme as first-line therapy in advanced SCCHN in a multicenter cohort study.
Research methods
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).
Research results
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.
Research conclusions
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.
Research perspectives
This regimen may be considered an attractive therapeutic strategy due to its simplified administration, decreased total number of chemotherapy cycles, and treatment tolerability.
