IRESSA SUMMARY
IRESSA®
(gefitinib)
TABLETS
IRESSA® (gefitinib tablets) contain 250 mg of gefitinib and are available as brown film-coated tablets for daily oral administration.
IRESSA is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
The effectiveness of IRESSA is based on objective response rates (see CLINICAL PHARMACOLOGY — Clinical Studies section). There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Results from two large, controlled, randomized trials in first-line treatment of non-small cell lung cancer showed no benefit from adding IRESSA to doublet, platinum-based chemotherapy. Therefore, IRESSA is not indicated for use in this setting.
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NEWS HIGHLIGHTSMedia Articles Related to Iressa (Gefitinib)
Iressa as Good as Chemotherapy for Lung Cancer
Source: MedicineNet Neutropenia Specialty [2008.11.24]
Title: Iressa as Good as Chemotherapy for Lung Cancer
Category: Health News
Created: 11/22/2008 2:00:00 AM
Last Editorial Review: 11/24/2008
ASCO Releases Updated Treatment Guidelines For Patients With Stage 4 Non-Small Cell Lung Cancer
Source: Lung Cancer News From Medical News Today [2009.11.17]
New recommendations on the use of chemotherapy to treat patients with stage 4 non-small cell lung cancer (NSCLC) were issued today by the American Society of Clinical Oncology (ASCO). The evidence-based clinical practice guideline indicates a patient's physical age should not determine the cancer treatment he/she is given.
In Non-Small Cell Lung Cancer PET Imaging Before Radiation Not Ideal For Determining Boost Radiation Doses
Source: Lung Cancer News From Medical News Today [2009.11.04]
Positron emission tomography (PET) imaging of non-small cell lung cancer prior to receiving radiation therapy should not be the basis for determining areas that may benefit from higher doses of radiation, according to research presented by investigators at Thomas Jefferson University Hospital at the 51st ASTRO Annual Meeting (Abstract #2583/B-186).
What Are The Real Benefits Versus Risks Of Preventative Brain Radiation For Patients With Non-small Cell Lung Cancer?
Source: Lung Cancer News From Medical News Today [2009.11.03]
Patients with non-small cell lung cancer treated with preventative brain radiation (called prophylactic cranial irradiation or PCI), significantly decrease their risk of developing brain metastases (cancer spread in the brain) by more than 50 percent (from 18 percent to 8 percent), compared to th
PET Imaging Response A Prognostic Factor After Thoracic Radiation Therapy For Lung Cancer
Source: Lung Cancer News From Medical News Today [2009.11.07]
A rapid decline in metabolic activity on a PET scan after radiation therapy for non-small cell lung cancer is correlated with good local tumor control, according to a study presented by researchers at Thomas Jefferson University Hospital at the 51st ASTRO Annual Meeting. In addition, the researchers also found that the higher the metabolic activity and tumor size on a PET scan before treatment, the more likely a patient is to die from lung cancer.
Published Studies Related to Iressa (Gefitinib)
Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. [2009.09.03]
BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer... CONCLUSIONS: Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. (ClinicalTrials.gov number, NCT00322452.) 2009 Massachusetts Medical Society
Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: results from a two-part, double-blind, randomized phase ii study. [2009.05.20]
PURPOSE: Vandetanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR) signaling. In this two-part phase II study, the efficacy and safety of vandetanib was compared with that of gefitinib, an inhibitor of EGFR signaling... CONCLUSION: The primary efficacy objective was achieved, with vandetanib demonstrating a significant prolongation of PFS versus gefitinib. Vandetanib 300 mg/d is currently being evaluated as a monotherapy in two randomized phase III studies in advanced NSCLC.
Randomized phase II study of gefitinib compared with placebo in chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status. [2009.05.01]
PURPOSE: To compare gefitinib with placebo in chemotherapy naive patients with advanced non-small-cell lung cancer (NSCLC) and poor performance status... CONCLUSION: There was no statistically significant difference in PFS, OS, and ORRs after treatment with gefitinib or placebo, in the overall population; improvements in QOL and symptoms were similar in both groups. Tolerability profile of gefitinib was consistent with previous studies. PFS was statistically significantly improved for gefitinib-treated patients with EGFR FISH-positive tumors.
Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected]. [2009.04.10]
PURPOSE: To compare survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with gefitinib 250 or 500 mg/day or standard methotrexate... CONCLUSION: In patients with recurrent or metastatic SCCHN, while responses with gefitinib were seen, neither gefitinib 250 nor 500 mg/day improved overall survival compared with methotrexate. With the exception of tumor hemorrhage-type events with gefitinib, the adverse event profiles were generally consistent with those previously observed.
Epidermal growth factor receptor expression analysis in chemotherapy-naive patients with advanced non-small-cell lung cancer treated with gefitinib or placebo in combination with platinum-based chemotherapy. [2009.03]
PURPOSE: Two large, randomized, placebo-controlled trials (IRESSA NSCLC Trial Assessing Combination Therapy; INTACT 1 and 2) in non-small-cell lung cancer (NSCLC) failed to show survival benefit for gefitinib (IRESSA) in combination with first-line platinum-based chemotherapy. Epidermal growth factor receptor (EGFR) staining was assessed retrospectively in relation to survival response to gefitinib in combination with chemotherapy... CONCLUSIONS: While some previous studies indicate that higher EGFR expression correlates with poor survival, our analyses provide statistically significant evidence that the combination of EGFR expression and growth pattern is a strong prognostic indicator for improved survival within this setting. The effects of membrane staining and growth pattern are still significant when adjusting for mutation.
Clinical Trials Related to Iressa (Gefitinib)
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer [Active, not recruiting]
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia [Active, not recruiting]
The purpose of this study is to determine how effective, and to what extent, Iressa is in the
treatment of acute myelogenous leukemia.
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment [Active, not recruiting]
The purpose of this study is to provide gefitinib treatment to patients who, on completion or
closure of other gefitinib clinical studies, were either receiving placebo treatment, or are
continuing on the same dose and regimen of gefitinib established in their preceding study,
for as long as the patients continue to derive benefit.
Open-Label Extension of Other SZ1839 (Iressa) Trials [Completed]
A trial to assess patients who have been treated with Iressa in a previous clinical trial and
may benefit from continued treatment with Iressa.
First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia [Active, not recruiting]
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet
chemotherapy given as first line treatment in terms of progression free survival in selected
NSCLC patients.
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