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The role of gefitinib in lung cancer treatment
1Division of Medical Oncology, Vrije Universiteit Medical Center, Amsterdam, The Netherlands. g.giacconne@vumc.nl
Abstract:
Gefitinib (Iressa) is a novel targeted therapy that inhibits the tyrosine kinase activity of the epidermal growth factor receptor by competitively blocking the ATP binding site. In preclinical studies gefitinib has shown potent activity in a number of tumor models, including several lung cancer cell lines and xenografts. Two large randomized Phase II studies (IDEAL 1 and IDEAL 2) in pretreated non-small cell lung cancer reported a response rate approaching 20% in second-line patients and approximately 10% in those pretreated with two or more chemotherapy regimens. The median survival in these two studies approached 6-8 months. As a first-line therapy, gefitinib has been assessed in combination with two different chemotherapy regimens in two large randomized studies (INTACT 1 and INTACT 2). Both studies failed to show an improvement in survival on a total patient accrual of >1000 patients in each study. Other end points (e.g., time to progression and response rate) were also not improved by the addition of gefitinib. Additional studies are indicated to assess the possible role of gefitinib in the maintenance of patients who received chemotherapy or chemoradiotherapy. Studies investigating gefitinib as first-line monotherapy are also required.
Insights
Gefitinib (Iressa), a targeted therapy for lung cancer, showed modest response rates in pretreated patients. However, it did not improve survival as a first-line treatment when combined with chemotherapy.
Area of Science:
- Oncology
- Pharmacology
- Molecular Biology
Background:
- Gefitinib (Iressa) is a targeted therapy inhibiting epidermal growth factor receptor (EGFR) tyrosine kinase activity.
- Preclinical studies demonstrated potent anti-tumor activity in various lung cancer models.
- Previous Phase II studies (IDEAL 1, IDEAL 2) showed response rates of ~20% and ~10% in pretreated non-small cell lung cancer (NSCLC).
Purpose of the Study:
- To evaluate gefitinib's efficacy as a first-line therapy in non-small cell lung cancer (NSCLC).
- To assess gefitinib's role in combination with chemotherapy regimens.
- To determine overall survival and other endpoints in NSCLC patients.
Main Methods:
- Two large randomized Phase II studies (IDEAL 1, IDEAL 2) evaluated gefitinib in pretreated NSCLC patients.
- Two large randomized Phase I/II studies (INTACT 1, INTACT 2) assessed gefitinib in combination with chemotherapy as first-line treatment.
- Patient accrual exceeded 1000 patients in the INTACT studies.
Main Results:
- In pretreated NSCLC, gefitinib yielded response rates of approximately 20% (second-line) and 10% (third-line or later).
- Median survival in the IDEAL studies was 6-8 months.
- The INTACT studies showed no improvement in overall survival, time to progression, or response rate when gefitinib was added to first-line chemotherapy.
Conclusions:
- Gefitinib demonstrated activity in pretreated NSCLC but did not improve survival as a first-line treatment in combination with chemotherapy.
- Further research is needed to explore gefitinib's potential in maintenance therapy or as first-line monotherapy for NSCLC.
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