Phase II trial of neoadjuvant docetaxel (T), cisplatin (P), and cetuximab (E) followed by concurrent radiation (X), P, and E in locally advanced head and neck cancer (HNC)

• DOI: 10.1200/jco.2008.26.15_suppl.6002
• Publication Date: 2017-02-24T07:33:44Z
• Authors: A. E. Argiris; M. K. Gibson; D. E. Heron; R. P. Smith; R. L. Ferris; S. Y. Lai; S. W. Kim; B. F. Branstetter; J. T. Johnson; J. R. Grandis
• Keywords: Carboplatin; Chemoradiotherapy

6002 Background: We incorporated E, a chimeric IgG1 monoclonal antibody against the epidermal growth factor receptor, into induction therapy and subsequent chemoradiotherapy of HNC. Methods: Patients (pts) had previously untreated, stage III/IV squamous cell or undifferentiated carcinoma HN, ECOG PS 0–1, adequate laboratory parameters. Induction consisted T 75 mg/m² day 1, P E 250 days 1,8, 15 (after an initial dose 400 on cycle 1), repeated every 21 x 3 cycles, with prophylactic antibiotics. Subsequently, pts received 70 Gy (2 Gy/day) concurrent 30 weekly, followed by maintenance for 6 months. Sample size was 39 pts; target overall response rate (ORR) to TPE: 80%. Results: From 1/06 10/07, were enrolled: median age 52 (21–74); male: 34; IV: 35; primary site: oropharynx, 23; larynx, 5; hypopharynx, 3, oral cavity, 3; nasopharynx, unknown, 2. 36 all cycles TPE discontinued treatment due infusion reactions 1 complications); 34 XPE 7 weekly doses; 2 switched carboplatin. In 37 evaluable using RECIST, ORR 32/37 (86%); CR 2, PR 30, SD in primary, 19/26 (73%) clinical exam 13/22 (59%) PET. After (n=28), 100%; 8, 20; 22/22 (100%) 19/22 (86%) underwent neck dissection presumed residual disease; 2/3 pCR. With follow-up 12 months (3–23), 4 progressed (3 local, distant); pt salvage surgery remains disease free. died (1 myocardial infarction progression). Serious toxicities during included grade (G) 3/4 neutropenia, 8/20; neutropenic fever, 4; G infection, anemia, 2; thrombocytopenia, 1; hypomagnesemia, 3/1; rash, mucositis, diarrhea, During (n=30): 15; dermatitis, 8/1; 5/6; 7; Conclusions: has manageable substantial activity Early survival results are promising. Author Disclosure Employment Leadership Consultant Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bristol-Myers Squibb