Gaël Deplanque1, Radj Gervais2, Alain Vergnenegre3, Lionel Falchero4, Pierre-Jean Souquet5, Jean-Michel Chavaillon6, Bruno Taviot7, Ghislaine Fraboulet8, Hakim Saal9, Caroline Robert10, Olivier Chosidow11. 1. Swiss Cancer Center Lausanne, Lausanne, Switzerland. Electronic address: gael.deplanque@chuv.ch. 2. Centre Régional de Lutte Contre le Cancer Baclesse, Caen, France. 3. Hopital Du Cluzeau, Limoges, France. 4. Centre Hospitalier de Villefranche, Villefranche sur Saône, France. 5. Centre Hospitalier Lyon-Sud, Pierre Bénite, France. 6. Centre Hospitalier D'Antibes, Antibes, France. 7. Centre Médical N. De Pontoux, Chalon Sur Saône, France. 8. Centre Hospitalier René Dubos, Pontoise, France. 9. Laboratoires Roche, Boulogne-Billancourt, France. 10. Institut Gustave Roussy, Villejuif, France. 11. Hôpital Henri Mondor, Créteil, France.
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 witherlotinib 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. LIMITATIONS: The open-label design of the study and the duration of the treatment with doxycycline are limitations. CONCLUSION:Doxycycline did not reduce the incidence of erlotinib-induced folliculitis, but significantly reduced its severity.
RCT Entities:
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. LIMITATIONS: The open-label design of the study and the duration of the treatment with doxycycline are limitations. CONCLUSION:Doxycycline did not reduce the incidence of erlotinib-induced folliculitis, but significantly reduced its severity.
Authors: Bernd Tischer; Martina Bilang; Matthias Kraemer; Philippe Ronga; Mario E Lacouture Journal: Support Care Cancer Date: 2017-11-07 Impact factor: 3.603