title: Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomized phase II trial.
abstract: OBJECTIVE
  The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Cetuximab-radiotherapy is superior to radiotherapy alone in this population, validating epidermal growth factor receptor (EGFR) as a target. Erlotinib is a small-molecule inhibitor of EGFR. Adding EGFR inhibition to standard cisplatin-radiotherapy may improve efficacy.
  
  
  METHODS
  Patients with locally advanced SCCHN were randomly assigned to receive cisplatin 100 mg/m(2) on days 1, 22, and 43 combined with 70 Gy of radiotherapy (arm A) or the same chemoradiotherapy with erlotinib 150 mg per day, starting 1 week before radiotherapy and continued to its completion (arm B). The primary end point was complete response rate (CRR), evaluated by central review. The secondary end point was progression-free survival (PFS). Available tumors were tested for p16 and EGFR by fluorescent in situ hybridization.
  
  
  RESULTS
  Between December 2006 and October 2011, 204 patients were randomly assigned. Arms were well balanced for all patient characteristics including p16, with the exception of more women on arm A. Patients on arm B had more rash, but treatment arms did not differ regarding rates of other grade 3 or 4 toxicities. Arm A had a CRR of 40% and arm B had a CRR of 52% (P = .08) when evaluated by central review. With a median follow-up time of 26 months and 54 progression events, there was no difference in PFS (hazard ratio, 0.9; P = .71).
  
  
  CONCLUSIONS
  Erlotinib did not increase the toxicity of cisplatin and radiotherapy in patients with locally advanced HNSCC but failed to significantly increase CRR or PFS.
authors: University of Washington, Seattle Cancer Care Alliance, 825 Eastlake Ave E MS G4-940, Seattle, WA 98109, USA. rgmart@u.washington.edu
authors: Renato G
authors: RG
authors: Martins
authors: Upendra
authors: U
authors: Parvathaneni
authors: Julie E
authors: JE
authors: Bauman
authors: Anand K
authors: AK
authors: Sharma
authors: Luis E
authors: LE
authors: Raez
authors: Michael A
authors: MA
authors: Papagikos
authors: Furhan
authors: F
authors: Yunus
authors: Brenda F
authors: BF
authors: Kurland
authors: Keith D
authors: KD
authors: Eaton
authors: Jay J
authors: JJ
authors: Liao
authors: Eduardo
authors: E
authors: Mendez
authors: Neal
authors: N
authors: Futran
authors: David X
authors: DX
authors: Wang
authors: Xiaoyu
authors: X
authors: Chai
authors: Sarah G
authors: SG
authors: Wallace
authors: Melissa
authors: M
authors: Austin
authors: Rodney
authors: R
authors: Schmidt
authors: D Neil
authors: DN
authors: Hayes
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000235:genetics / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000235:genetics; D000069347:Erlotinib Hydrochloride; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006258:Head and Neck Neoplasms / Q000235:genetics / Q000473:pathology / Q000628:therapy*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D008297:Male; D010146:Pain / Q000139:chemically induced; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors; D002945:Cisplatin