Platinum‐based chemotherapy plus cetuximab first‐line for Asian patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results of an open‐label, single‐arm, multicenter trial

Abstract

Background. The purpose of this study was to assess the efficacy, safety, and pharmacokinetics of cisplatin-based chemotherapy plus cetuximab as first-line treatment in Chinese and Korean patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Methods. Patients (n 5 68) received cetuximab weekly plus 3-week cycles of cisplatin/5-fluorouracil (5-FU) chemotherapy for up to 6 cycles. The primary endpoint was overall response rate. Results. The overall response rate was 55.9%, including 2 complete responses (CRs). Median overall survival (OS) was 12.6 months and median progression-free survival (PFS) was 6.6 months. Grade 3/4 adverse events (AEs) were reported in 41 (60.3%) patients. The safety profile was in line with previous clinical experience. The pharmacokinetic profile was in line with that observed with cetuximab in white and Japanese patients. Conclusion. The efficacy, safety, and pharmacokinetic findings from this study support the use of first-line platinum-based chemotherapy plus cetuximab in Chinese and Korean patients with recurrent and/or metastatic SCCHN (ClinicalTrials.gov NCT01177956).

Prognostic score in patients with recurrent or metastatic carcinoma of the head and neck treated with cetuximab and chemotherapy

“…Importantly, patients with a Karnofsky performance score lower than 70 and patients that had received chemotherapy as part of treatment for locally advanced disease during the last 6 months were primarily excluded from the phase III trial by Vermorken et al If more stringent inclusion criteria regarding ECOG and systemic treatment free interval of at least 6 months are applied to our patients, results are in line with previously published data. [7, 20–22] Furthermore, patients with a Karnofsky score below 80 did not benefit from the addition of cetuximab to chemotherapy in the study published by Vermorken et al[7] This suggests, that patient selection is very important to avoid intensive and potentially toxic treatment in patients with little chance for benefit. However, a standardized tool to identify these patients was not available so far.…”

Salivary duct carcinoma treated with cetuximab-based targeted therapy: A case report

“…3A), and systemic treatment similar to the regimen used in the EXTREME trial was initiated (22,23). The regimen comprised cetuximab every 7 days (120-min intravenous infusion of a 400-mg/m 2 initial dose, followed by weekly 60-min infusions of 250 mg/m 2 ) together with 3-week cycles of cisplatin (240-min intravenous infusion of 80 mg/m 2 on day 1) and 5-FU chemotherapy (24-h continuous infusion of 800 mg/m 2 per day on days 1-5) (22,23). This treatment was previously found to be well-tolerated, with mild adverse events, including grade 1 skin rash, dermatitis acneiform and paronychia, and grade 2 hypomagnesemia.…”

Consenso multidisciplinario y multiinstitucional de la utilidad del cetuximab en el tratamiento de los pacientes con carcinoma epidermoide de cabeza y cuello

“…La tasa de respuesta global fue del 36%, la tasa de control de la enfermedad fue del 88%, la SVLP de 4.1 meses y la SG de 14.1 meses. Con el mismo protocolo, Guo, et al 27 exploraron la adición de CTX a QT basada en CDDP y 5-FU en 68 pacientes asiáticos. La tasa de respuesta global fue del 55.9%, incluyendo dos respuestas completas.…”