title: Doxycycline for prevention of erlotinib-induced rash in patients with non-small-cell lung cancer (NSCLC) after failure of first-line chemotherapy: A randomized, open-label trial.
abstract: BACKGROUND
  Rash is a common epidermal growth factor receptor inhibitor-induced toxicity that can impair quality of life and treatment compliance.
  
  
  OBJECTIVE
  We sought to evaluate the efficacy of doxycycline in preventing erlotinib-induced rash (folliculitis) in patients with non-small-cell lung cancer.
  
  
  METHODS
  This open-label, randomized, prospective, phase II trial was conducted in 147 patients with locally advanced or metastatic non-small-cell lung cancer progressing after first-line chemotherapy, randomized for 4 months with erlotinib alone 150 mg/d per os (control arm) or combined with doxycycline 100 mg/d (doxycycline arm). Incidence and severity of rash, compliance, survival, and safety were assessed.
  
  
  RESULTS
  Baseline characteristics of the 147 patients were well balanced in the intent-to-treat population. Folliculitis occurred in 71% of patients in the doxycycline arm and 81% in the control arm (P = .175). The severity of folliculitis and other skin lesions was lower in the doxycycline arm compared with the control arm. Other adverse events were reported at a similar frequency across arms. There was no significant difference in survival between treatment arms.
  
  
  CONCLUSIONS
  The open-label design of the study and the duration of the treatment with doxycycline are limitations.
  
  
  CONCLUSIONS
  Doxycycline did not reduce the incidence of erlotinib-induced folliculitis, but significantly reduced its severity.
authors.affiliation: Swiss Cancer Center Lausanne, Lausanne, Switzerland. Electronic address: gael.deplanque@chuv.ch.
authors.forename: Gaël
authors.initials: G
authors.lastname: Deplanque
authors.affiliation: Centre Régional de Lutte Contre le Cancer Baclesse, Caen, France.
authors.forename: Radj
authors.initials: R
authors.lastname: Gervais
authors.affiliation: Hopital Du Cluzeau, Limoges, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Vergnenegre
authors.affiliation: Centre Hospitalier de Villefranche, Villefranche sur Saône, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Falchero
authors.affiliation: Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Souquet
authors.affiliation: Centre Hospitalier D'Antibes, Antibes, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Chavaillon
authors.affiliation: Centre Médical N. De Pontoux, Chalon Sur Saône, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Taviot
authors.affiliation: Centre Hospitalier René Dubos, Pontoise, France.
authors.forename: Ghislaine
authors.initials: G
authors.lastname: Fraboulet
authors.affiliation: Laboratoires Roche, Boulogne-Billancourt, France.
authors.forename: Hakim
authors.initials: H
authors.lastname: Saal
authors.affiliation: Institut Gustave Roussy, Villejuif, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Robert
authors.affiliation: Hôpital Henri Mondor, Créteil, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chosidow
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D004318:Doxycycline / Q000627:therapeutic use*; D000069347:Erlotinib Hydrochloride / Q000009:adverse effects* / Q000627:therapeutic use; D005076:Exanthema / Q000139:chemically induced / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000069347:Erlotinib Hydrochloride; D004318:Doxycycline
keywords: doxycycline; erlotinib; folliculitis; non-small-cell lung cancer; rash