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Gefitinib in the treatment of advanced non-small-cell lung cancer
1Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Germany. dr.martin.reck@web.de
Abstract:
Most patients with non-small-cell lung cancer (NSCLC) present with advanced disease and their long-term prognosis remains poor, even after platinum-based chemotherapy. EGF receptor (EGFR)-targeted therapies, such as gefitinib, have been subject to comprehensive clinical development. Several Phase II and III trials have evaluated the clinical efficacy of gefitinib as monotherapy in pretreated patients with advanced NSCLC, as well as both monotherapy and combined with chemotherapy in chemo-naive patients. A Phase III trial in heavily pretreated advanced NSCLC patients, 90% of whom were refractory, demonstrated some improvement in survival with gefitinib compared with placebo; however, the difference was not statistically significant in the overall population. A second large Phase III trial in patients with pretreated advanced NSCLC (INTEREST) demonstrated the noninferiority of gefitinib in comparison with docetaxel for overall survival together with an improved quality of life and tolerability profiles. As a result, gefitinib is expected to have a large impact in the management of pretreated patients with NSCLC.
Insights
Gefitinib shows promise for advanced non-small-cell lung cancer (NSCLC) patients, particularly those pretreated. While not significantly improving survival in all refractory cases, it offers comparable survival to docetaxel with better quality of life.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced non-small-cell lung cancer (NSCLC) has a poor prognosis, even with chemotherapy.
- Epidermal Growth Factor Receptor (EGFR) targeted therapies are a focus in NSCLC treatment.
Purpose of the Study:
- To evaluate the clinical efficacy of gefitinib in advanced NSCLC patients.
- To compare gefitinib with chemotherapy and placebo in pretreated and chemo-naive NSCLC patients.
Main Methods:
- Phase II and III clinical trials were conducted.
- Gefitinib was assessed as monotherapy and in combination with chemotherapy.
- Comparisons included placebo and docetaxel in pretreated advanced NSCLC patients.
Main Results:
- A Phase III trial showed a non-statistically significant survival improvement with gefitinib versus placebo in refractory patients.
- The INTEREST trial demonstrated gefitinib's noninferiority to docetaxel for overall survival.
- Gefitinib offered improved quality of life and tolerability compared to docetaxel.
Conclusions:
- Gefitinib is a viable treatment option for pretreated advanced NSCLC patients.
- The drug offers comparable survival benefits to docetaxel with enhanced patient tolerability and quality of life.
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