Abstract :
[en] Epidermal growth factor receptor tyrosine kinase inhibitors represent a new
treatment option for patients with advanced nonsmall cell lung cancer (NSCLC). This
retrospective study examined to what extent previous clinical trial experience matches largescale
Western community implementation of this treatment.
In the Belgian expanded access programme, the data from 513 patients with advanced or
metastatic NSCLC, not suitable for further chemotherapy and receiving oral gefitinib 250 mg?day-1
until disease progression, death or unacceptable toxicity, were analysed.
The median (range) duration of gefitinib treatment was 2.3 months (0.0–32.7). Its use was
predominantly in second- or third-line treatment. The overall response and disease control rates
were 8.9 and 41.2%, respectively. In univariate analysis, response was more common in females
and never-smokers. In multivariate analysis, female sex was the only significant predictive factor
(odds ratio (OR) (95% confidence interval (CI)) 0.329 (0.129–0.839)). Symptom improvement was
reported in 108 patients of whom 32 (29.6%) had an objective response, 66 (61.1%) experienced
disease stabilisation and 10 (9.3%) progressed. Gefitinib was well tolerated; only 7.8% of the
patients reported grade 3 or 4 toxicity. The overall median survival was 4.7 months, with a 1-yr
survival rate of 21%. Survival was strongly influenced by a better performance status (PS) (good
PS: hazard ratio (HR) (95%CI) 0.110 (0.077–0.157)) and adenocarcinoma with bronchioloalveolar
carcinoma features histology (HR (95%CI) 0.483 (0.279–0.834)).
In conclusion, the activity of gefitinib was confirmed in the present large Western community
implementation study. Response, present in a small subgroup, led to a rewarding survival and
could be predicted by sex only. Baseline performance status and adenocarcinoma with
bronchioloalveolar carcinoma features histology were significant factors for survival.
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