title: Induction cetuximab, paclitaxel, and carboplatin followed by chemoradiation with cetuximab, paclitaxel, and carboplatin for stage III/IV head and neck squamous cancer: a phase II ECOG-ACRIN trial (E2303).
abstract: BACKGROUND
  E2303 evaluated cetuximab, paclitaxel, and carboplatin used as induction therapy and concomitant with radiation therapy in patients with stage III/IV head and neck squamous cell carcinoma (HNSCC) determining pathologic complete response (CR), event-free survival (EFS), and toxicity.
  
  
  METHODS
  Patients with resectable stage III/IV HNSCC 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, patients completed CRT (68-72 Gy); otherwise, resection was carried out. p16 protein expression status was correlated with response/survival.
  
  
  RESULTS
  Seventy-four patients 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 tumor (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 patients completed CRT. Overall survival and EFS were 78% and 55% at 3 years, respectively. Disease progression in 23 patients (37%) was local only in 10 (16%), regional in 5 (8%), local and regional in 2 (3%), and distant in 5 patients (8%). There were no treatment-related deaths. Toxicity was primarily hematologic or radiation-related. p16 AQUA score was not associated with response/survival.
  
  
  CONCLUSIONS
  Induction cetuximab, paclitaxel, and carboplatin followed by the same drug CRT is safe and induces high primary site response and promising survival.
  
  
  BACKGROUND
  NCT 00089297.
authors.affiliation: Department of Surgery, Landmark Medical Center, Woonsocket. Electronic address: hwanebo@chartercare.org.
authors.forename: H J
authors.initials: HJ
authors.lastname: Wanebo
authors.affiliation: Department of Biostatistics & Computational Biology, Dana Farber Cancer Institute, Boston.
authors.forename: J
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia.
authors.forename: B A
authors.initials: BA
authors.lastname: Burtness
authors.affiliation: Department of Surgery, Fox Chase Cancer Center, Philadelphia.
authors.forename: J A
authors.initials: JA
authors.lastname: Ridge
authors.affiliation: Department of Biostatistics & Computational Biology, Dana Farber Cancer Institute, Boston.
authors.forename: M
authors.initials: M
authors.lastname: Ghebremichael
authors.affiliation: Department of Radiation Oncology, University of Alabama, Birmingham.
authors.forename: S A
authors.initials: SA
authors.lastname: Spencer
authors.affiliation: Department of Medicine, Yale University, New Haven.
authors.forename: D
authors.initials: D
authors.lastname: Psyrri
authors.affiliation: Department of Medicine, Yale University, New Haven.
authors.forename: E
authors.initials: E
authors.lastname: Pectasides
authors.affiliation: Department of Medicine, Yale University, New Haven.
authors.forename: D
authors.initials: D
authors.lastname: Rimm
authors.affiliation: Department of Medical Oncology, John H. Stroger Hospital of Cook County, Chicago.
authors.forename: F R
authors.initials: FR
authors.lastname: Rosen
authors.affiliation: Department of Medical Oncology, Porter Memorial Hospital, Denver.
authors.forename: M R
authors.initials: MR
authors.lastname: Hancock
authors.affiliation: Department of Medicine, University of Miami, Miami.
authors.forename: K A
authors.initials: KA
authors.lastname: Tolba
authors.affiliation: Department of Medical Oncology, Johns Hopkins University and Sidney Kimmel Comprehensive Cancer Center, Baltimore, USA.
authors.forename: A A
authors.initials: AA
authors.lastname: Forastiere
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage*; D000068818:Cetuximab; D059248:Chemoradiotherapy; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D004847:Epithelial Cells / Q000187:drug effects / Q000473:pathology; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D017239:Paclitaxel; D000068818:Cetuximab
keywords: cetuximab; chemoradiation; head–neck; induction chemotherapy