Cetuximab: a standard approach to the first-line treatment of recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck

Bernier, Jacques

doi:10.1007/s12156-009-0026-3

Cited by 3 publications

(1 citation statement)

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“…Median OS was 10.1 months ( vs 7.4 months with chemotherapy alone, P =0.04) and median PFS was 5.6 months ( vs 3.3 months with chemotherapy alone, P <0.001) (Vermorken et al , 2008). This increase in OS time of 2.7 months was a significant advance in the treatment of SCCHN, but novel approaches are urgently required to further improve survival (Bernier, 2009). …”

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Phase I/II trial of cilengitide with cetuximab, cisplatin and 5-fluorouracil in recurrent and/or metastatic squamous cell cancer of the head and neck: findings of the phase I part

et al. 2011

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Background:Novel therapies are needed to improve the poor prognosis of patients with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN).Methods:ADVANTAGE is a phase I/II, multicentre study evaluating the integrin inhibitor cilengitide combined with cetuximab and platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN. The phase I part tested cilengitide (500, 1000 and 2000 mg) twice weekly with standard doses of cetuximab, cisplatin and 5-fluorouracil.Results:Ten patients (9 male, 1 female; median 56 years old) were included in the phase I part. No dose-limiting toxicities (DLTs: grade 3/4 toxicities in the first 3 weeks as defined per protocol) or deaths occurred. The most common adverse events (AEs) were constipation, rash, nausea, anorexia and fatigue. Cilengitide-related grade 3/4 AEs, all of which occurred after the DLT observation period, were anaemia, angioedema, asthenia, mucosal inflammation, nausea and vomiting (one event per category). Best overall tumour response was partial response (PR) for 4 out of 10 patients and stable disease (SD) for 6 out of 10 patients across all cohorts. Disease control rate (complete response, PR and SD) was 100%.Conclusion:Cilengitide combined with cetuximab and platinum-based chemotherapy was well tolerated. No DLTs or unexpected AEs were observed. Cilengitide 2000 mg was considered safe and was selected for the subsequent randomised phase II part assessing progression-free survival.

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Phase I/II trial of cilengitide with cetuximab, cisplatin and 5-fluorouracil in recurrent and/or metastatic squamous cell cancer of the head and neck: findings of the phase I part

et al. 2011

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Treatment of the Elderly Head and Neck Cancer Patient

Horiot

Aapro

2011

Head and Neck Cancer

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Spotlight on Cetuximab in Squamous Cell Carcinoma of the Head and Neck†

Frampton

2011

BioDrugs

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Cetuximab (Erbitux®) is a chimeric monoclonal antibody directed against the human epidermal growth factor receptor (EGFR). EGFR is overexpressed and/or upregulated in most squamous cell carcinomas of the head and neck (SCCHN); this overexpression is associated with more aggressive disease and poorer prognosis. In the EU, cetuximab is approved in combination with radiation therapy for the treatment of locally advanced SCCHN and in combination with platinum-based chemotherapy for the treatment of recurrent and/or metastatic SCCHN. In randomized, open-label, multinational, phase III clinical trials, cetuximab plus radiotherapy significantly improved the duration of locoregional control (primary endpoint) compared with radiotherapy alone in patients with locally advanced SCCHN, while cetuximab plus first-line platinum-based chemotherapy significantly improved overall survival (primary endpoint) compared with first-line platinum-based chemotherapy alone in patients with recurrent and/or metastatic SCCHN. The efficacy benefits of cetuximab-based combination therapy were achieved without an adverse impact on patients' health-related quality of life. In addition, cetuximab had an acceptable tolerability profile when added to radiotherapy or platinum-based chemotherapy; in particular, it did not exacerbate the toxicities commonly associated with these other treatment modalities. Cetuximab-related adverse events, which include skin rash, hypomagnesemia and infusion-related reactions, are mostly mild to moderate in severity and manageable. Thus, cetuximab-based combination therapy is a valuable treatment option in patients with SCCHN. In the setting of locally advanced, unresectable disease, cetuximab plus radiotherapy offers an alternative approach to the current standard of care, namely platinum-based chemotherapy plus radiotherapy (chemoradiotherapy). Based on informal comparisons, cetuximab plus radiotherapy appears to be at least as effective as chemoradiotherapy and, moreover, less toxic; however, formal comparisons of these regimens are required before their relative efficacy and tolerability can be conclusively determined. In the setting of recurrent and/or metastatic SCCHN, cetuximab plus platinum-based chemotherapy provides a first-line treatment of choice for fit patients in whom palliative chemotherapy is indicated.

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Cetuximab: a standard approach to the first-line treatment of recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck

Cited by 3 publications

References 53 publications

Phase I/II trial of cilengitide with cetuximab, cisplatin and 5-fluorouracil in recurrent and/or metastatic squamous cell cancer of the head and neck: findings of the phase I part

Phase I/II trial of cilengitide with cetuximab, cisplatin and 5-fluorouracil in recurrent and/or metastatic squamous cell cancer of the head and neck: findings of the phase I part

Treatment of the Elderly Head and Neck Cancer Patient

Spotlight on Cetuximab in Squamous Cell Carcinoma of the Head and Neck†

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