Preliminary analysis of ECOG 3303: Concurrent radiation (RT), cisplatin (DDP) and cetuximab (C) in unresectable, locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN).

6006 Background: Randomized trials and meta-analyses have demonstrated therapeutic superiority for concurrent platinum-based chemoradiation vs. RT alone in unresectable LA-SCCHN. More recently, Bonner et al (NEJM, 2006) reported a survival advantage for (C) plus RT vs RT alone. We report toxicity and response data from an ECOG trial of concurrent chemo-RT and C in LA-SCCHN.,Unresectable, newly diagnosed patients with LA-SCCHN, PS 0-1 and adequate physiologic indices received C 400 mg/m d1, then 250 mg/m Q wk, in combination with definitive RT (70 Gy/2Gy/d x 7 wks) starting d 15 and DDP 75 mg/m days 15, 36 and 57. In the absence of disease progression (PD) or untoward toxicity, pts could continue C weekly for > 6 mos.,69 pts were accrued between 12/21/04 and 7/20/06. 5 were ineligible; 3 never started treatment. Of the remaining 61, median age was 56 (range 42-79); 85% were male, 44% PS 0; 61% had < 5% weight loss. 98% were Stage IV: 43% T4; 75% N2, 15% N3. Most common primary sites included base of tongue (34%), tonsil (21%) and other oropharynx (13%). 87% received all planned doses of C prior to and concurrent with DDP-RT. 74% received all 3 doses of cisplatin; 93% received > 2 doses. 3 pts (5%) were switched to carboplatin. Median RT dose was 70 Gy. 8 pts (13%) received < 50 Gy. 41 (67%) received maintenance therapy with C; 19 (31%) completed > 6 mos. 10 pts (16%) proved inevaluable for response. Three (5%) had PD; 31% had stable disease; 23% and 25% had CR and PR respectively. One clearly attributable Grade (gr) 5 event (neutropenic fever) was recorded. Among 65 evaluable pts, 97% had gr >3 toxicity, including neutropenia in 17 (26%), fatigue in 15 (23%), acneiform rash in 18 (28%), and radiation dermatitis in 10 (15%). Gr ≥3 mucositis was registered in 35 (54%); Gr ≥3 hyponatremia in 13 (20%). Two late Gr 4 toxicities were observed; (1) laryngeal edema, (2) pain in larynx/pharynx.,Weekly C225, in combination with concurrent DDP and full dose RT, is feasible in fit pts with unresectable LA-SCCHN. Unique toxicities included acneiform rash and possible increase in Gr ≥3 mucositis. Longer follow-up is needed for determination of local-regional control and survival endpoints. [Table: see text].