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

URN to cite this document:

urn:nbn:de:bvb:355-epub-408745 Copy

DOI to cite this document:

10.5283/epub.40874 Copy

Knoedler, M. ; Gauler, T. C. ; Gruenwald, V. ; Matzdorff, A. ; Schroeder, M. ; Dietz, A. ; Jordan, W.-O. ; Arnold, B. ; Hennemann, Burkhard ; Keilholz, Ulrich

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Date of publication of this fulltext: 21 Oct 2019 09:12

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Details

Item type:	Article
Open Access Type:	Alliance-/National licence
Journal or Publication Title:	Oncology
Publisher:	Karger
Volume:	84
Page Range:	pp. 284-289
Date:	2013
Additional Information (public):	OA-Komponente aus Allianzlizenz
Institutions:	Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie)
Identification Number:	Value Type 10.1159/000345453 DOI
Keywords:	Cetuximab, Disease control rate, Docetaxel, Platinum sensitivity, Squamous cell carcinoma of the head and neck
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	40874

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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 ...

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.

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