A phase II study of BAY 43–9006 in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal cancer (NPC)

5566 Background: Bay 43–9006, a novel bi-aryl urea, is a potent inhibitor of kinases of Raf-1 (C-Raf) and B-Raf which are critical members of the RAS/RAF/MEK/ERK signalling pathway. In addition, Bay 43–9006 inhibits other pro-angiogenic protein tyrosine kinases, including VEGFR-2/3 and PDGFR-β. Overexpression of these signal transduction and angiogenic markers has been associated with poor prognosis in epithelial malignancies. We conducted a phase II study to examine the efficacy of Bay 43–9006 in advanced HNSCC and NPC. Methods: Patients (pts) with advanced HNSCC and NPC with measurable disease, no more than one prior chemotherapy regimen for recurrent and/or metastatic disease, performance status (PS) ECOG 0–2, and adequate organ functions were eligible. Bay 43–9006 was administered orally at 400 mg BID on a continuous basis, in 28-day cycles. Responses were evaluated every 8 weeks according to RECIST criteria. Results: Seventeen patients have been enrolled to date (9m/8f). Median age was 59 years (range 46 - 77); 82% had PS 0 or 1 and 18% PS 2; 65% HNSCC and 35% NPC; 11 pts had received prior chemotherapy, 3 had received prior erlotinib and 16 had received prior radiation therapy. All pts were evaluable for toxicity and 10 for response assessment to date. Six pts (60%) (4 HNSCC and 2 NPC) had stable disease ranging from 3 to 6 cycles, and 4 pts (40%) had progressive disease. A total of 36 cycles had been administered (median number/patient: 2; range 1–6). No grade 4 toxicity was seen. Main haematological toxicity was grade 3 lymphopenia in 5 (29%) pts. Common grade 3 non-hematological toxicity included hyponatremia in 4 (24%), dyspnea in 3 (18%), and non-specific pain in 3 (18%) pts. Grade 1/2 non-hematolgical toxicity included fatigue in 15 (88%), hypertension in 6 (35%), hand-foot syndrome in 6 (35%) and skin rash in 3 (18%) pts respectively. One pt died of intracranial tumoral hemorrhage, deemed to be unlikely related to treatment. Conclusions: Bay 43–9006 was well tolerated. Although no objective response was seen to date in this group of heavily pretreated patients, over half of the evaluable patients had achieved tumor stabilization. Further trial accrual is ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer

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