Induction cetuximab, XXXX , and @entity3003 followed by chemoradiation with cetuximab, @entity1311 , and @entity3003 for @entity5 : a phase II ECOG-ACRIN trial (E2303).

@entity1 @entity137 @entity986 @entity5 @entity3003 @entity1311 @entity204 @entity213
BACKGROUND: E2303 evaluated cetuximab, @entity1311 , and @entity3003 used as induction therapy and concomitant with radiation therapy in @entity1 with stage III/IV @entity213 ( @entity213 ) determining pathologic complete response (CR), event-free survival (EFS), and @entity137 . @entity1 AND METHODS: @entity1 with resectable stage III/IV @entity213 underwent induction therapy with planned primary site restaging biopsies (at week 8 in clinical complete responders and at week 14 if disease persisted). Chemoradiation (CRT) began week 9. If week 14 biopsy was negative, @entity1 completed CRT (68-72 Gy); otherwise, resection was carried out. @entity986 protein expression status was correlated with response/survival. RESULTS: Seventy-four @entity1 were enrolled; 63 were eligible. Forty-four (70%) were free of surgery to the primary site, progression, and death 1-year post-treatment. Following induction, 41 (23 CR) underwent week 8 primary site biopsy and 24 (59%) had no @entity5 (pathologic CR). Week 14 biopsy during chemoradiation (50 Gy) in 34 (15 previously positive biopsy; 19 no prior biopsy) was negative in 33. Thus 90% of eligible @entity1 completed CRT. Overall survival and EFS were 78% and 55% at 3 years, respectively. Disease progression in 23 @entity1 (37%) was local only in 10 (16%), regional in 5 (8%), local and regional in 2 (3%), and distant in 5 @entity1 (8%). There were no treatment-related @entity204 . @entity137 was primarily hematologic or radiation-related. @entity986 AQUA score was not associated with response/survival. CONCLUSIONS: Induction cetuximab, @entity1311 , and @entity3003 followed by the same drug CRT is safe and induces high primary site response and promising survival. CLINICAL TRIALS NUMBER: NCT 00089297.
