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Annals of Oncology Advance Access published online on February 22, 2005
Annals of Oncology, doi:10.1093/annonc/mdi157
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© 2005 European Society for Medical Oncology
Received October 20, 2004
Revised December 27, 2004
Accepted January 4, 2005

Original article

Skin rash and good performance status predict improved survival with gefitinib in patients with advanced non-small cell lung cancer

M. K. Mohamed 1, S. Ramalingam 1, Y. Lin 2, W. Gooding 2, and C. P. Belani 1*

1 Division of Hematology-Oncology, University of Pittsburgh School of Medicine, USA
2 Biostatistics Facility, University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA

* To whom correspondence should be addressed.
C. P. Belani, E-mail: belanicp{at}upmc.edu


  Abstract

Background: Gefitinib (Iressa®) is active as a single agent in the treatment of select patients with recurrent non-small cell lung cancer (NSCLC). The clinical characteristics of patients treated with gefitinib on an Expanded Access Program (EAP) at our institution identified predictive variables associated with better outcome.

Patients and methods: Patients (n=199) with advanced NSCLC were treated with gefitinib (250 mg) upon progression with chemotherapy. Baseline patient characteristics were: median age, 69 years; males, 57%; adenocarcinoma, 56%.

Results: Partial responses were noted in two patients (1%) and disease stabilization in 66 (35%) patients. The median survival (MS) was 5.9 months [95% confidence interval (CI) 4.1-7.1] and median time to progression was 3 months (95% CI 2.0-3.0). The predictive factors analyzed were gender, skin rash, diarrhea, tumor histology and performance status (PS). Patients who developed skin rash (any grade) had MS of 10.8 months versus 4.0 months for those without rash (P <0.0001, log rank test). Patients with PS 0, 1 and 2 had MS of 8.4, 6.2 and 2.8 months, respectively (P <0.0002). The other factors did not impact survival.

Conclusions: Occurence of skin rash and baseline PS of 0/1 were associated with improved survival with gefitinib for recurrent NSCLC patients at our institution.

Keywords: gefitinib; non-small cell lung cancer; performance status; skin rash.
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