Phase II Study of Cetuximab in Combination with Docetaxel in Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck after Platinum-Containing Therapy: A Multicenter Study of the Arbeitsgemeinschaft Internistische Onkologie

Abstract

Background: Cetuximab and docetaxel have single-agent activity in squamous cell carcinoma of the head and neck (SCCHN). The efficacy of their combination was evaluated in platinum-pretreated patients with recurrent and/or metastatic SCCHN. Patients and Methods: A total of 84 patients were treated with docetaxel 35 mg/m² weekly for a maximum of 6 cycles and concomitant cetuximab 250 mg/m² weekly until disease progression or unacceptable toxicity. The primary endpoint was the objective response rate and secondary endpoints included the response rate in relation to platinum sensitivity, progression-free survival (PFS), overall survival (OS) and toxicity. Results: Nine (11%) patients achieved a partial response and 34 (40%) stable disease, resulting in a disease control rate of 51%. Response to treatment was 49% in previously platinum-sensitive and 50% in previously platinum-resistant disease. The median PFS was 3.1 months and the median OS 6.7 months. The most common grade 3 or 4 adverse events were mucositis (8%), pneumonia (8%), fatigue (8%) and skin reactions (14%). Sepsis occurred in 3 patients. Conclusion: Cetuximab plus docetaxel is an active treatment regimen with moderate toxicity in SCCHN patients. However, no superiority in comparison with monotherapy could be shown. Responsiveness and survival were independent of previous platinum sensitivity.

Advanced Squamous Cell Carcinoma of the Head and Neck: The Current Role of Cetuximab

“…Knoedler et al [40] evaluated 84 patients treated with docetaxel at 35 mg/m 2 weekly for 6 cycles with CTX at conventional doses, until progression or unacceptable toxicity. Eleven percent achieved PR and 40% SD, for a disease control rate of 51%.…”

Palliative treatment standards for head and neck squamous cell carcinoma

“…Clinical trials have not been able to establish standards for palliative treatment. In the setting of refractory disease after first-line therapy, many different protocols proved to be comparably effective including monochemotherapy, poly-chemotherapy, and best supportive care alone [6,8,17]. Only a minority of treatment centers acknowledge clinical trial participation as their institutional treatment standard.…”

“…Usually, the standard imaging interval in palliative clinical trials for HNSCC is 6 weeks or imaging in the case of clinical suspicion of disease progression [1,2,6,8,14,16]. For clinical trials, the need for predefined imaging time points is evident, but in the clinical setting standardized restaging during palliative treatment seems to be debatable.…”

Baseline caspase activity predicts progression free survival of temsirolimus-treated head neck cancer patients

“…Surgery or radiochemotherapy (RCT) remain the mainstay of treatment for patients with localised disease, although long-term survival remains poor in these patients [2,3]. Palliative chemotherapy is considered a standard of care in case of relapse or metastatic disease (R/M) occurs [4,5]. Subsequent treatment remains undefined after the failure of 1st line chemotherapy, and often consists of methotrexate or taxane therapy.…”

“…Subsequent treatment remains undefined after the failure of 1st line chemotherapy, and often consists of methotrexate or taxane therapy. Current approaches are associated with an objective response rate (ORR) of less than 10% and an overall survival (OS) of 6-8 months in these patients [3,5].…”