title: Efficacy of second-line erlotinib in patients postprogression of first-line chemotherapy in head and neck cancers.
abstract: BACKGROUND
  Oral tyrosine kinase inhibitor (gefitinib and erlotinib) have been used in the palliative treatment of head and neck cancers with limited success. In this report, we aim to quantify the symptomatic benefit, progression-free survival (PFS) and overall survival (OS) when erlotinib is given as second-line treatment in Head and neck cancers.
  
  
  METHODS
  This was a post-hoc retrospective analysis of a randomized study comparing metronomic chemotherapy with cisplatin. A patient who progressed on chemotherapy and had a PS0-2 were offered second-line chemotherapy. Patients who had received erlotinib (150 mg PO OD) as second line treatment were selected for this analysis. Erlotinib was discontinued in case of either progression of disease or if the patient had intolerable side effects. Patient were monitored 1-week after the start of erlotinib and subsequently at monthly intervals. The toxicity was recorded in accordance with CTCAE version 4.02 (NCI,USA) and the response were graded in accordance with RECIST version 1.1. All of these patients were followed-up till death.
  
  
  RESULTS
  Twenty-three patients were identified. The median age of these patients at the start of the second line was 47 years (interquartile range 40.5-51.75 years). The primary site of distribution was oral cavity primary in 17 patients (77.3%) and nonoral cavity primary in 05 (22.7%) patients. The immediate last chemotherapy regimen received was cisplatin in 9 patients (40.9%) and metronomic chemotherapy in 13 patients (59.1%). Symptomatic benefits post second-line erlotinib was seen in 18 patients (81.8%). The most common adverse events (any grade) seen were anemia in 20 patients (90.9%), rash in 10 patients (45.5%) and diarrhea in 7 patients (31.8%).The best radiological response documented were a partial response in 04 patients (19.2%). The median estimated PFS and OS were 110 days (95% confidence interval [CI]: 61-175 days) and 156 days (95% CI: 126-185 days) respectively.
  
  
  CONCLUSIONS
  Erlotinib single agent has promising activity in the second line and needs to be explored in future studies.
authors.forename: V
authors.initials: V
authors.lastname: Patil
authors.forename: A
authors.initials: A
authors.lastname: Karpe
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors.forename: V
authors.initials: V
authors.lastname: Noronha
authors.forename: A
authors.initials: A
authors.lastname: Joshi
authors.forename: V
authors.initials: V
authors.lastname: Muddu
authors.forename: A
authors.initials: A
authors.lastname: Bhattacharjee
authors.forename: S
authors.initials: S
authors.lastname: Dhumal
authors.forename: K
authors.initials: K
authors.lastname: Prabhash
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000069347:Erlotinib Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D000069347:Erlotinib Hydrochloride