Cetuximab, fluorouracil (5-FU), cisplatin, and docetaxel as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Interim results of a randomized phase II clinical trial (CeFCiD).

Medientyp: E-Artikel

Titel: Cetuximab, fluorouracil (5-FU), cisplatin, and docetaxel as first-line treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Interim results of a randomized phase II clinical trial (CeFCiD)

Beteiligte: Knoedler, Maren; Dietz, Andreas; Gauler, Thomas Christoph; Gruenwald, Viktor; Stoehlmacher, Jan; Knipping, Stephan; Guntinas-Lichius, Orlando; Frickhofen, Norbert; Schroeder, Michael; Maschmeyer, Georg; Rethwisch, Volker; Haxel, Boris; Keilholz, Ulrich

Erschienen: American Society of Clinical Oncology (ASCO), 2013

Sprache: Englisch

DOI: 10.1200/jco.2013.31.15_suppl.e17021

ISSN: 1527-7755; 0732-183X

Schlagwörter: Cancer Research ; Oncology

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Beschreibung: e17021 Background: This study investigates efficacy and toxicity of docetaxel added to cetuximab, cisplatin and 5-FU for patients with R/M SCCHN. We here report a planned second interim analysis to compare response rates between arms in order to decide on continuing to full accrual. Methods: Inclusion criteria were: stage III/IV R/M SCCHN and ECOG 0-1. Patients were randomized to arm A: cetuximab (standard dose) plus a maximum of 6 cycles of docetaxel (40 mg/m², day 1+8), cisplatin (40 mg/m², day 1+8) and 5-FU (2000 mg/m², day 1+8) or to arm B: cetuximab (standard dose), cisplatin (100 mg/m², day 1) and 5-FU (1000 mg/m², day 1-4). Treatment was administered until progression or intolerability. The endpoint of this analysis was RR. Results: A first interim analysis for toxicity after treatment of 20 patients per arm revealed more hematologic and gastrointestinal grade III/IV toxicities in the experimental arm. Therefore dose reductions of cisplatin from 40 to 30 mg/m² and 5-FU from 2,000 to 1,000 mg/m² had been introduced. A secondary toxicity analysis with 40 patients per arm observed reduced treatment related toxicities. Currently 100 patients could be assessed for response: arm A: 82 % male, median age 58 years, arm B: 82 % male, median age 60 years. Best overall RR was 41 % (3 CR, 18 PR) in arm A compared to 45 % (4 CR, 19 PR) in arm B. The DCR was 75 % in arm A and 80 % in arm B. Conclusions: After introducing dose reductions toxicity is manageable. Comparable response rates were seen in both arms. CeFCiD continues per protocol for evaluation of the primary endpoint PFS. Enrollment is estimated to be completed in Aug 2013. Clinical trial information: CeFCiD-1108.

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