987OCETUXIMAB (C), FLUOROURACIL (F) AND CISPLATIN (P) ALONE OR WITH DOCETAXEL (D) FOR RECURRENT/METASTATIC (RM) HEAD AND NECK CANCER (HNSCC). FINAL ANALYSIS OF AIO TRIAL # 1108 - CEFCID.

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. Grunwald, 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.