Gefitinib (ZD1839) Monotherapy as a Salvage Regimen for Previously Treated Advanced Non-Small Cell Lung Cancer

Abstract

Purpose: A worldwide compassionate-use program has enabled >42,000 patients with advanced non-small cell lung cancer (NSCLC) to receive gefitinib treatment. Here we report the outcome of gefitinib therapy in patients who enrolled in the "Iressa" Expanded Access Program at the Samsung Medical Center.Experimental Design: Patients with advanced or metastatic NSCLC who had progressed after prior systemic chemotherapy and for whom no other treatment option was available were eligible to receive gefitinib treatment as part of the Expanded Access Program. A post hoc assessment of potential prognostic factors for response and survival was performed by multivariate analysis.Results: All 111 evaluable patients had stage IV disease; most patients had a baseline performance status of 2 [n ‫؍‬ 52 (47%)] or 3 [n ‫؍‬ 18 (16%)] and had received >2 prior chemotherapy regimens (56%). The objective response rate was 26%, the disease control rate (measured over >8 weeks) was 40%, and the 1-year survival rate was 44%. Adenocarcinoma histology was associated with better response and disease control rates, and a performance status of 0 -2 was also associated with a better disease control rate. Both of these factors, as well as female gender, were significantly associated with longer survival. Gefitinib was well tolerated; the most common adverse event was grade 1 skin rash.Conclusions: Gefitinib demonstrated significant antitumor activity and a favorable tolerability profile in this series of NSCLC patients with poor prognosis.

Phase III Trial of Two Versus Four Additional Cycles in Patients Who Are Nonprogressive After Two Cycles of Platinum-Based Chemotherapy in Non–Small-Cell Lung Cancer

“…Because it is well known that EGFR TKIs are more effective in Asian patients, 16,21,22 the potential survival impact of salvage therapy may be an important confounding factor that influenced OS after disease progression in the present study.…”

Mutation in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor Is a Predictive and Prognostic Factor for Gefitinib Treatment in Patients with Non–Small Cell Lung Cancer

“…However, accumulated clinical evidence strongly suggests that ethnic/geographic factors play an important role in the response of patients to gefitinib treatment. This is based on the high response rates reported exclusively from countries in the Asia Pacific region, including Taiwan (12,20,21). Although the similarity of high response rates (f30%) among each independent group in this region was quite convincing, most of these data came from observational studies with no supporting molecular analyses.…”

Gender aspects in chronic myeloid leukemia: long-term results from randomized studies

“…4,5,[7][8][9][10][11][13][14][15][16][17]30 Reports of a male survival advantage in cancer patients are rare. 31 The better survival of women with malignant diseases might just reflect their better general longevity, an earlier disease stage at diagnosis or a more favorable risk profile.…”

“…Recent examples are outcome in ischemic and nonischemic heart disease [1][2][3] and in solid neoplastic disorders such as malignant melanoma, [4][5][6] non-small-cell lung cancer treated with gefitinib and tipifarnib, [7][8][9] surgically treated colorectal cancer, 10 esophageal carcinoma, 11 renal cell carcinoma 12 and soft tissue sarcoma. 13,14 Gender differences in survival have been reported also in hematological malignancies such as Hodgkin's disease, 15 acute myeloid leukemia, 16 and childhood acute lymphoblastic leukemia.…”