1298P - Analysis of erlotinib-related skin toxicities from Japanese post-marketing surveillance (POLARSTAR) in 9,909 non-small-cell lung cancer (NSCLC) pati...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Complications/Toxicities of Treatment
Non-Small Cell Lung Cancer
Presenter Yoshio Kiyohara
Authors Y. Kiyohara1, N. Yamazaki2, A. Seki3, M. Fukuoka4
  • 1Dermatology Division, Shizuoka Cancer Center, 411-8777 - Nagaizumi, Shizuoka/JP
  • 2Department Of Dermatologic Oncology, National Cancer Center Hospital, 104-0045 - Tsukiji, Chuo-ku, Tokyo/JP
  • 3Pharmacovigilance Department, CHUGAI PHARMACEUTICAL CO., LTD., 103-8324 - Muromach, Chuo-ku, Tokyo/JP
  • 4Medical Oncology, Izumi Municipal HospitalCancer Center, JP-589-8511 - Izumi City/JP



Skin toxicities (rash) are the most common adverse reaction associated with erlotinib. Most cases of rash are mild or moderate using appropriate rash management (RM). RM is very important for keeping good QOL during erlotinib treatment. Though steroids are commonly used as RM, the precise efficacy and the appropriate way of administration have not yet been fully established. Establishment of appropriate management of rash is necessary to continue erlotinib treatment for obtaining maximum benefit. In this surveillance, we analyzed RM in clinical practice from 9,909 NSCLC pts.


From Dec 2007 to Oct 2009, all recurrent/advanced NSCLC pts in Japan treated with erlotinib were enrolled into this surveillance. The observation period was 12 months and all adverse events were collected. Erlotinib related rash, interventions for the symptoms and outcomes of the interventions were analyzed.


A total of 9,909 pts were evaluated. Rash was occurred in 67.4 % (6,674) pts. Grade 1 / 2 / 3 of rash was observed (26.8 %, 32.4 %, and 7.2 %). Frequency and the median time to onset from erlotinib administration to per each acneiform rash, dry skin, and paronychia were 60.9 %, 9.0 days, 7.4 %, 16.0 days, and 6.6 %, 34.0 days, respectively. The most common RM was steroids in 75.0 % of acneiform rash. In the patients who were treated with steroids for their acneiform rash, more than 75 % of them started steroids within 4 days from onset date. Median time from steroids start to recovery in pts whose steroids were started after 0-1 days / 2-6 days / 7-13 days / 14-20 days/ 21 days or later from rash observed were 35.0 days / 39.0 days/ 40.0 days/ 64.0 days/ 103.5 days, respectively. In the patients who are initiated from medium potency of steroids for their rash, 32.4 % pts are required to change stronger potency steroids, and median time to recovery of them was 71.5 days. On the otherhand, Median time to recovery from rash onset was 40.0 days in the pts who were initiated with steroids of strong or strongest potency.


Earlier initiation of management for rash with more than strong topical steroids achieves faster improvement.


Y. Kiyohara: Chugai, Takeda, Merck Serono,Bristol-Myers Squibb, GlaxoSmithKline:advisory board.

N. Yamazaki: Chugai, Takeda, Merck Serono,Bristol-Myers Squibb, GlaxoSmithKline: advisory board, Chugai: corporate-sponsored research.

All other authors have declared no conflicts of interest.