Cetuximab plus platinum-based chemotherapy in head and neck Squamous Cell Carcinoma: a retrospective study in a single Comprehensive European Cancer Institution

Background: The use of cetuximab in combination with platinum (P) plus 5-fluorouracil (F) has previously been demonstrated to be effective in the treatment of metastatic squamous cell cancer of head and neck (SCCHN). We investigated the efficacy and outcome of this protocol as a first-line treatment for patients with recurrent or metastatic disease. We evaluated overall-survival (OS), progression-free-survival (PFS), overall response rate (ORR) and the treatment toxicity profile in a retrospective cohort. Patients and Methods: This study enrolled 121 patients with untreated recurrent or metastatic SCCHN. The patients received PF+ cetuximab every 3 weeks for a maximum of 6 cycles. Patients with stable disease who received PF+ cetuximab continued to receive cetuximab until disease progressed or unacceptable toxic effects were experienced, whichever occurred first. Results: The median patient age was 53 (37-78) years. The patient cohort was 86.8% male. The addition of cetuximab to PF in the recurrent or metastatic setting provided an OS of 11 months (Confidential Interval, CI, 95%, 8.684-13.316) and PFS of 8 months (CI 95%, 6.051-9.949). The disease control rate was 48.9%, and the ORR was 23.91%. The most common grade 3 or 4 adverse events in the PF+ cetuximab regimen were febrile neutropenia (5.7%), skin rash (3.8%) and mucosistis (3.8%). Conclusions: The results of this study suggest that cetuximab plus platinum-fluorouracil chemotherapy is a good option for systemic treatment in advanced SSCHN patients. This regimen has a well-tolerated toxicity profile.info:eu-repo/semantics/publishedVersio

Grade 3 and/or grade 4 adverse effects observed according to CTCAE version 4.0.

<p><b>Abbreviations</b>: CTCAE, Common Terminology Criteria for Adverse Events. 5FU, 5-fluourouracil.</p

Characteristics of patients treated with platinum in combination with 5-FU plus cetuximab.

<p><b>Abbreviations</b>: ECOG PS, eastern cooperative oncology group performance status; 5-FU, 5-fluourouracil.</p

Show PFS of all patient treated with platinum +5-FU +cetuximab (A); and stratified by platinum (B): carboplatin +5-FU+cetuximab versus cisplatin +5-FU+cetuximab.

<p>Analysis was performed using log-rank test. Abbreviations: PFS stands for progression-free-survival; C stands for platinum (carboplatin or cisplatin); 5-FU stands for 5-fluourouracil.</p

Treatment characteristics after 3 or 6 cycles of platinum, 5-fluourouracil and cetuximab.

<p><b>Abbreviations</b>: PF, platinum (cisplatin or carboplatin) and 5-fluourouracil.</p>+<p>Include patients who have not image assessment before cycle 3 due to toxicities issues.</p>*<p>ORR refers to overall response rate and includes complete response and partial response, according to RECIST criteria.</p>***<p>ORR+stable disease.</p>**<p>Median.</p

Show OS survival of all patients treated with platinum +5-FU+cetuximab (A); and stratified by platinum (B): carboplatin +5-FU+cetuximab versus cisplatin +5-FU+cetuximab.

<p>Analysis was performed using log-rank test. Abbreviations: OS stands for overall-survival; C stands for platinum (carboplatin or cisplatin); 5-FU stands for 5-fluourouracil.</p

Treatment characteristics according to platinum used for CF+ cetuximab.

<p><b>Abbreviations</b>: PF, platinum (cisplatin or carboplatin) and 5-fluourouracil.</p>+<p>ORR refers to overall response rate and includes complete response and partial response.</p>++<p>Disease control rate includes complete response, partial response and stable disease.</p>*<p>Qui square test.</p>**<p>Median.</p>***<p>Mann-Whitney U Test.</p