987O - Cetuximab (C), fluorouracil (F) and cisplatin (P) alone or with docetaxel (D) for recurrent/metastatic (RM) head and neck cancer (HNSCC). Final ana...

Date 27 September 2014
Event ESMO 2014
Session Head and neck cancer
Topics Anti-Cancer Agents & Biologic Therapy
Head and Neck Cancers
Presenter Maren Knoedler
Citation Annals of Oncology (2014) 25 (suppl_4): iv340-iv356. 10.1093/annonc/mdu340
Authors M. Knoedler1, T.C. Gauler2, A. Dietz3, V. Grünwald4, J. Stoehlmacher-Williams5, S. Knipping6, M. Schroeder7, O. Guntinas-Lichius8, N. Frickhofen9, H. Lindemann10, R. Fietkau11, B. Haxel12, C. Junghanß13, G. Maschmeyer14, M. Zipfel15, P. Martus16, U. Keilholz17
  • 1Medical Oncolog, University Cancer Center Leipzig (UCCL), 04103 - Leipzig/DE
  • 2Medical Oncology, West German Cancer Center, University Hospital Essen, Essen/DE
  • 3Head And Neck Surgery, Universitatsklinikum Leipzig, 04103 - Leipzig/DE
  • 4Clinic For Hematology, Hemostasis, Oncology, Hannover Medical School, 30625 - Hannover/DE
  • 5Oncology, University Hospital Dresden, Dresden/DE
  • 6Head And Neck Surgery, Städtisches Klinikum Dessau, 06847 - Dessau-Roßlau/DE
  • 7Medical Oncology, KKD Katolisches Klinikum Duisburg, DE-47166 - Duisburg/DE
  • 8Clinic For Ear, Nose And Throat, Universitätsklinikum Jena, Jena/DE
  • 9Hematology, Medical Oncology, Palliativ Care, HSK Dr. Horst Schmidt KlinikInternal Medicin 3, DE-65199 - Wiesbaden/DE
  • 10Hematology And Medical Onclogy, Kath. Krankenhaus Hagen gem. GmbH
St.-Marien-Hospital, Hagen/DE
  • 11Radiotherapy, University Hospital Erlangen, Erlangen/DE
  • 12Head And Neck Surgery, University Hospital Mainz, Mainz/DE
  • 13Hematology And Medical Onclogy, University Hospital Rostock, Rostock/DE
  • 14Hematology And Medical Onclogy, Klinikum Erst von Bergmann, Potsdam/DE
  • 15Hematology And Medical Onclogy, University Hospital Bonn, Bonn/DE
  • 16Biostatistics, Charité University Hospital, Berlin/DE
  • 17Medical Oncology, Charité Comprehensive Cancer Center, Berlin/DE



Analysis of a trial investigating, whether TPFC would be feasible and superior to PFC in patients with RM-HNSCC without limiting comorbidities, based on the findings, that D in addition to PF in induction treatment and C in addition to PF in RM disease both improved outcome in HNSCC. The first analysis was presented at ASCO 2014; here we present the final analysis.


180 patients were assigned 1:1 to receive either (arm A) P 40 mg/sqm, D 40 mg/sqm, F 2000 mg/sqm days 1 + 8, C 400/250 mg/sqm days 1, 8, 15 q3w or (arm B) standard PFC (P 100 mg/sqm day 1, F 1000 mg/sqm days 1-4, C 400/250 mg/sqm days 1, 8, 15) q3w. Chemotherapy was continued for a maximum of 6 cycles in absence of disease progression or limiting toxicity, followed by C maintenance (500 mg/sqm q2w). Because of excessive toxicity (gastrointestinal and infections) in arm A, P was reduced to 30 and F to 1000 mg/sqm after 20 patients/arm.


Median follow-up was 2 years. Toxicity was similar in both arms, with a rate of grade 4 toxicities of 21.3% vs. 30.8% of patients in arms A vs. B. 11.2% vs. 6.6% potentially treatment related deaths were observed in arms A vs. B. Median PFS A vs. B was 5.4 vs. 5.0 mo (HR 0.79, p = 0.375), median OS was 9.8 vs. 9.7 mo (HR 1.39, p = 0.993) and response rates were 38.2% vs. 31.9%, respectively.


Despite of the previously described advantage of both components D and C in treatment of HNSCC, the four-drug regimen was not associated with improved median PFS or OS. The efficacy data of the CeFCiD trial are comparable with the results in the EXTREME trial.


M. Knoedler: Financial support for conducting this trial by Merck GmbH and Sanofi Aventis for conducting this trial; T. Gauler, A. Dietz, V. Grünwald, J. Stoehlmacher-Williams, O. Guntinas-Lichius and G. Maschmeyer: Merck Serono; U. Keilholz: Merck Serono and Sanofi Aventis. All other authors have declared no conflicts of interest.