Cetuximab (C), fluorouracil (F), and cisplatin (P) alone or with docetaxel (D) for recurrent/metastatic (RM) head and neck cancer (HNSCC): First analysis of AIO trial # 1108.

6018 Background: This trial was 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 question was, whether TPFC would be feasible and superior to PFC in patients with RM-HNSCC without limiting comorbidities. Methods: In an open-label randomized multicenter trial, 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). Primary endpoint was PFS. Results: Accrual was completed in Nov 2013. A planned safety analysis had revealed excessive toxicity (gastrointestinal and infections) in arm A, necessitating an amendment with reduction of P to 30 and F to 1000 mg/sqm after 20 patients/...