Phase Ii Trial Of Sunitinib In Patients With Recurrent And/Or Metastatic Squamous Cell Carcinoma Of The Head And Neck (Scchn)

6064 Background: Sunitinib is an oral multitargeted tyrosine kinase inhibitor against RET, VEGFR, PDGFR, and c-KIT. We conducted a phase II trial to evaluate the tolerability and efficacy of sunitinib in metastatic and/or recurrent SCCHN patients. Methods: Patients who had received no more than two prior regimens were eligible and, depending on ECOG performance status (PS), were entered into either Cohort A (PS0–1) or Cohort B (PS2). Sunitinib was administered in 6-week cycles at 50mg daily for 4 weeks followed by 2 weeks off. Primary endpoints were objective tumor response and tolerability for Cohorts A and B, respectively. Results: Twenty-two patients were accrued (Cohort A - 15 pts, Cohort B - 7 pts). Median age in cohort 1 and 2 were 56 and 61 years, respectively. Grade 3/4 hematologic toxicities encountered were lymphopenia (18%), neutropenia (14%) and thrombocytopenia (9%). Fatigue and anorexia were the most common non-hematologic toxicities. Grade 3/4 fatigue occurred in 23% of pts. Vascular complications included hypertension (5pts), epistaxis (3pts), pulmonary hemorrhage (2pts), gastrointestinal hemorrhage (2pts) and tumor hemorrhage (1pt). Four patients were not evaluable for tumor response (Cohort A - 3pts, Cohort B - 1pt). In cohort A, out of the 12 evaluable patients, one partial response was observed and 3 pts attained disease stabilization. In cohort B, no objective tumor responses were observed but 2 pts attained disease stabilization in 6 evaluable pts. Dose reduction was required in 5pts. In Cohort B, 2pts required dose reduction for grd 3 fatigue and grd 3 nausea. Median follow-up was 10 weeks. Median time to progression for cohort A and B were 9 and 11 weeks, respectively. Median overall survival for cohort A and B were 21 and 19 weeks, respectively. Conclusions: Although sunitinib was well tolerated in PS 0–2 patient, efficacy parameters in cohort A were not met at interim analysis and the study was closed to accrual. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration National Institutes of Health