Optimal strength and timing of steroids in the management of erlotinib-related skin toxicities in a post-marketing surveillance study (POLARSTAR) of 9909 non-small-cell lung cancer patients.

Background: Skin toxicities, such as rash, are the most common adverse reactions associated with erlotinib. Steroids are a key treatment option for rash management; however, optimal timing of administration and selection of steroid strength have not been fully established. In this surveillance study of Japanese non-small-cell lung cancer (NSCLC) patients treated with erlotinib, rash management using topical steroids was analyzed in routine clinical practice.

Methods: From December 2007 to October 2009, all recurrent/advanced NSCLC patients in Japan treated with erlotinib were enrolled into this study (POst-Launch All-patient Registration Surveillance in TARceva). The observation period was 12 months, and data for all adverse events were collected. Erlotinib-related rash, interventions for the symptoms, and outcomes of the interventions were analyzed.

Results: A total of 9909 patients were evaluated. Rash occurred in 67.4 % of patients; grade 1, 2, and 3 rash were observed in 26.8 %, 32.4 %, and 7.2 % of patients, respectively. The most common management strategy was topical steroids in 75.0 % of patients with rash. Regardless of rash grade, earlier initiation of steroids resulted in quicker recovery. In those for whom topical steroids were initiated more than 21 days after rash onset, median recovery time was more than 100 days regardless of rash grade, compared with those treated before rash onset, whose median time to recovery was 35-51 days, depending on rash grade. Median time to recovery of rash in the group initiated on medium-rank steroids then changed to strong-rank steroids was 47, 98, and 103 days for those with grade 1, 2, and 3 rash, respectively, compared with 39, 53, and 73 days median recovery for grade 1, 2, and 3 rash, respectively, in patients initiated on strong-rank steroids.

Conclusion: Earlier initiation of topical steroids for the management of rash with strong or higher-rank steroids could achieve faster improvement.