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Journal of Biomedicine and Biotechnology
Volume 2011 (2011), Article ID 185646, 5 pages
http://dx.doi.org/10.1155/2011/185646
Research Article

Intermittent Chemotherapy and Erlotinib for Nonsmokers or Light Smokers with Advanced Adenocarcinoma of the Lung: A Phase II Clinical Trial

1Institute of Oncology, Zaloska 2, 1000 Ljubljana, Slovenia
2School of Medicine, University of maribor, Slomskov trg 15, 2000 Maribor, Slovenia
3University Hospital for Pulmonary and Allergic Diseases, Golnik, Slovenia

Received 31 October 2010; Accepted 21 February 2011

Academic Editor: Tony Mok

Copyright © 2011 Matjaz Zwitter et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Intermittent application of chemotherapy and tyrosine kinase inhibitors may avoid antagonism between the two classes of drugs. This hypothesis was tested in a Phase II clinical trial. Patients and Methods. Eligible patients were nonsmokers or light smokers, chemo-naïve, with metastatic adenocarcinoma of the lung. Treatment: 4 to 6 cycles of gemcitabine 1250 mg/m2 on days 1 and 4, cisplatin 75 mg/m2 on day 2, and erlotnib 150 mg daily on days 5–15, followed by erlotinib as maintenance. Results. 24 patients entered the trial. Four pts had grade 3 toxicity. Complete remission (CR) and partial remission (PR) were seen in 5 pts and 9 pts, respectively (response rate 58%). Median time to progression (TTP) was 13.4 months and median overall survival (OS) was 23 months. When compared to patients with negative or unknown status of EGFR mutations, 8 patients with EGFR gene activating mutations had significantly superior experience: 4 CR and 4 PR, with median TTP 21.5 months and OS 24.2 months ( 𝑃 < . 0 5 ). Conclusions. Intermittent schedule with gemcitabine, cisplatin and erlotinib has mild toxicity. For patients who are positive for EGFR gene activating mutations, this treatment offers excellent response rate, time to progression and survival.