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Three Factors Influence Prognosis of Advanced Non-small Cell Lung Cancer Treated with Gefitinib

Gefitinib demonstrated anti-tumour activity and was associated with a longer survival period in women with advanced non-small cell lung cancer during an open label, expanded access program, say researchers. This improved survival was associated with 3 independent factors.

Through the expanded access program, "we were able to further characterize the efficacy of gefitinib," in a heterogeneous patient population with advanced non-small cell lung cancer, report oncologist Pasi A. Jänne, MD, and colleagues of the Lowe Center for Thoracic Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, United States. Gefitinib is an epidermal growth factor receptor (EGFR) inhibitor.

The investigators 3 significant independent factors that were associated with the improved survival were: female gender, good performance status (0/1), and adenocarcinoma histopathology. The latter was unexpected because "squamous cell carcinomas more frequently express EGFR than adenocarcinomas." The development of skin toxicity as a prognostic variable approached, but did not reach, statistical significance (P = .088).

The patients studied were ineligible for admission to phase 2 studies because of poor performance status, number and type of prior chemotherapy regimens, or the quality of life score required for entry. The present objective was to provide information on their response that might be useful to practicing oncologists using the drug outside the strict clinical trial setting.

Two hundred consecutive patients with advanced NSCLC were enrolled, receiving oral gefitinib, 250 mg per day. The drug was administered continuously until there was evidence of undue toxicity or of disease progression. Patients had previously received a median of 2 chemotherapy regimens (range 0-6 regimens). Of the patients enrolled, 23 died from disease progression before treatment was initiated, and 5 withdrew their consent for participation.

The 172 treated patients took gefitinib for a median of 2.3 months (range 0.5-22 months). The duration of treatment in the 105 women was significantly longer than in the 95 men: a median of 2.0 months (range 0-22+ months) vs. a median of 1.5 months (range 0-11 months, P = .0069).

Of the 172 patients evaluable for efficacy, 4.1% (95% CI; 1.7-8.2%) experienced a partial response and 34.9% had stable disease as their best response. A total of 154 patients were evaluable for toxicity; 8 experienced grade 3/4 toxicity; 2 patients discontinued therapy for grade 3 rash, and 1 patient for grade 3 nausea.

The duration of gefitinib therapy differed significantly according to the patients' performance status (PS) (P < .0001). In 25 patients with a PS of 0 it was 4.5 months (range 1- 22.0 months); in 101 patients with a PS of 1 it was 2.5 months (range 0-15.0 months); in 47 patients with a PS of 2 it was 1.5 months (range 0-8.0 months), and in 17 patients with PS of 3 it was 1.5 months (range 0-3.0 months).

Median survival for all patients was 4.5 months (95% CI; 4.1-4.9 months); 29% survived for 1 year. A total of 27 patients are continuing on study, 19 women and 8 men whose median duration of gefitinib treatment is 7.5 months (range 4-22.0 months). Ten patients (5%) have received the drug for greater than or equal to 12 months.

The authors conclude that gefitinib demonstrates anti-tumour activity in a heterogeneous population of NSCLC patients who were treated in the expanded access study. Findings need to be further validated in additional clinical studies.


Lung Cancer 2004 May;44:2:221-30 "Outcomes of patients with advanced non-small cell lung cancer treated with gefitinib (ZD1839, 'Iressa') on an expanded access study"

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