Cetuximab approved for first-line treatment of head and neck cancer in Europe

Source: www.docguide.com Author: staff The European Commission has approved a new indication for the use of cetuximab (Erbitux) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The approval is based primarily upon the results of the Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer (EXTREME) study, published in the September issue of the New England Journal of Medicine. The EXTREME study established that adding cetuximab to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate. Patients treated with cetuximab plus chemotherapy experienced the following improvements, compared with chemotherapy alone: · Median overall survival increase of nearly 3 months (10.1 vs 7.4 months; P = .04), equating to a 20% reduction in the risk of death (hazard ratio [HR]: 0.80) during the study period · 70% increase in median progression-free survival (5.6 vs 3.3 months; P < .001) · 80% relative increase in response rate (36% vs 20%; P < .001) The most commonly reported side effect with cetuximab is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with cetuximab; about half of these reactions are severe. Note: 1. Source: Merck

2008-12-01T18:50:38-07:00December, 2008|Oral Cancer News|

High rate of severe radiation dermatitis during radiation therapy with concurrent cetuximab in head and neck cancer: Results of a survey in EORTC institutes

Source: Radiother Oncol, October 30, 2008 Author: Christian Giro et al. Objective: Examination of the rate of grade III or grade IV radiation dermatitis during treatment of head and neck cancer (HNC) with radiotherapy (RT) and concurrent cetuximab in EORTC centres. Materials and Method: A questionnaire was sent to all members of the EORTC Radiation Oncology Group and Head and Neck Group (111 institutions) to evaluate the widespread use of cetuximab and radiotherapy in HNC and to estimate the frequency of grades III and IV skin reactions in the radiation portals associated with this protocol. Co-morbidities, RT schedules and co-medications were also recorded. Results: We received responses from 28 institutions in 11 countries. A total of 125 HNC patients from 15 institutions were treated with cetuximab and concurrent RT. Information about the skin reactions was available from 71 patients. Of these 36 had no grade III/IV adverse effects in the RT field, 15 had a grade III and 20 had grade IV radiation dermatitis. No detectable relation of grades III and IV radiation dermatitis with co-morbidities such as liver insufficiency or renal dysfunction was found. Conclusion: According to the results of the questionnaire, grade III/IV radiation dermatitis is observed in 49% of HNC patients treated with cetuximab and concurrent RT. A systematic clinical monitoring of cutaneous side effects during RT plus cetuximab is advised to ensure the safety of this protocol. Authors: Christian Giro, Bernhard Berger, Edwin Bolke, I Frank Ciernik, Frederic Duprez, Laura Locati, Sophie Maillard, Mahmut Ozsahin, Raphael [...]

2008-11-16T11:29:22-07:00November, 2008|Oral Cancer News|

Platinum-based chemotherapy plus cetuximab in head and neck cancer

Source: New England Journal of Medicine, Volume 359:1116-1127, September 11, 2008, Number 11 Authors: Jan B. Vermorken, M.D., Ph.D. et al. Background: Cetuximab is effective in platinum-resistant recurrent or metastatic squamous-cell carcinoma of the head and neck. We investigated the efficacy of cetuximab plus platinum-based chemotherapy as first-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck. Methods: We randomly assigned 220 of 442 eligible patients with untreated recurrent or metastatic squamous-cell carcinoma of the head and neck to receive cisplatin (at a dose of 100 mg per square meter of body-surface area on day 1) or carboplatin (at an area under the curve of 5 mg per milliliter per minute, as a 1-hour intravenous infusion on day 1) plus fluorouracil (at a dose of 1000 mg per square meter per day for 4 days) every 3 weeks for a maximum of 6 cycles and 222 patients to receive the same chemotherapy plus cetuximab (at a dose of 400 mg per square meter initially, as a 2-hour intravenous infusion, then 250 mg per square meter, as a 1-hour intravenous infusion per week) for a maximum of 6 cycles. Patients with stable disease who received chemotherapy plus cetuximab continued to receive cetuximab until disease progression or unacceptable toxic effects, whichever occurred first. Results: Adding cetuximab to platinum-based chemotherapy with fluorouracil (platinum–fluorouracil) significantly prolonged the median overall survival from 7.4 months in the chemotherapy-alone group to 10.1 months in the group that received chemotherapy plus cetuximab (hazard [...]

2008-09-11T08:55:37-07:00September, 2008|Oral Cancer News|
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