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 Cytotoxic agents
Head and Neck Cancers
Therapy
Biological therapy
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

Abstract

Aim

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.

Methods

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.

Results

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.

Conclusions

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.

Disclosure

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.