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Journal of the American Academy of Dermatology
Volume 74, n° 6
pages 1077-1085 (juin 2016)
Doi : 10.1016/j.jaad.2016.01.019
accepted : 13 January 2016
Original Articles

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
 

Gaël Deplanque, MD, PhD a, , Radj Gervais, MD b, Alain Vergnenegre, MD, PhD c, Lionel Falchero, MD d, Pierre-Jean Souquet, MD e, Jean-Michel Chavaillon, MD f, Bruno Taviot, MD g, Ghislaine Fraboulet, MD h, Hakim Saal, MD i, Caroline Robert, MD, PhD j, Olivier Chosidow, MD, PhD k
on behalf of

CYTAR investigators

a Swiss Cancer Center Lausanne, Lausanne, Switzerland 
b Centre Régional de Lutte Contre le Cancer Baclesse, Caen, France 
c Hopital Du Cluzeau, Limoges, France 
d Centre Hospitalier de Villefranche, Villefranche sur Saône, France 
e Centre Hospitalier Lyon-Sud, Pierre Bénite, France 
f Centre Hospitalier D'Antibes, Antibes, France 
g Centre Médical N. De Pontoux, Chalon Sur Saône, France 
h Centre Hospitalier René Dubos, Pontoise, France 
i Laboratoires Roche, Boulogne-Billancourt, France 
j Institut Gustave Roussy, Villejuif, France 
k Hôpital Henri Mondor, Créteil, France 

Reprint requests: Gaël Deplanque, MD, PhD, Département d'Oncologie, Service d'Oncologie Médicale, Bureau BH 09/737, Rue du Bugnon 46, CH-1011 Lausanne, Switzerland.Département d'OncologieService d'Oncologie MédicaleBureau BH 09/737, Rue du Bugnon 46LausanneCH-1011Switzerland
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.

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.

The full text of this article is available in PDF format.

Key words : doxycycline, erlotinib, folliculitis, non-small-cell lung cancer, rash

Abbreviations used : AE, CI, CONSORT, CTCAE, CYTAR, DI, ECOG, EGFR, NCI, NSCLC, OS, PFS, QoL, TEAE



 Supported by Roche.
 Disclosure: Dr Deplanque has received research funds from Roche. Mr Vergnenegre has received research funds from Chugai, Boehringer, Lilly, Roche, and AstraZeneca; and is a consultant for MSD, AstraZeneca, and Roche. Mr Souquet has received honoraria from Roche, Lilly, AstraZeneca, Pfizer, and Amgen. Mr Saal is a salaried employee of Roche. Ms Robert is a consultant for BMS, Roche, GSK, Merck, and Novartis. Mr Chosidow is a consultant for Roche. Mr Gervais, Mr Falchero, Mr Chavaillon, Mr Taviot, and Mr Fraboulet have no conflicts of interest to declare.



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