Iressa® Confirmed Effective for Elderly with Non-Small Cell

[RandyW]

Iressa® Confirmed Effective for Elderly with Non-Small Cell Lung Cancer

Researchers from Japan have reported that Iressa® (gefitinib) is effective and well tolerated for initial treatment of elderly patients with non-small cell lung cancer (NSCLC). The details of this study were published in the October, 2008 issue of the Journal of Thoracic Oncology.1

Oral Iressa® is approved in the U.S. as a single-agent treatment for patients with advanced NSCLC who have failed platinum- and taxane-based treatment. Iressa® is a selective inhibitor of epidermal growth factor receptor-tyrosine kinase. Epidermal growth factor receptor is expressed, overexpressed, or dysregulated in many human solid tumors, including NSCLC. Activation of this receptor is believed to promote tumor growth by blocking apoptosis and by increasing cell proliferation, adhesion and invasive capacity, and motility. Responsive lung tumors are likely to be adenocarcinomas or bronchio-alveolar carcinomas and occurred more frequently in non-smokers and women. Responses also occur more frequently in patients with specific mutations of epidermal growth factor receptor (EGFR).

Palliative treatment of elderly patients with advanced NSCLC is often associated with severe chemotherapy related toxicities. The major benefit of Iressa for treatment of NSCLC may be its ability to produce responses as a single agent in refractory patients without toxic side effects. Iressa is not marrow toxic but does cause nausea, vomiting, diarrhea, rash, acne, and dry skin. In the recent Italian trial Iressa was found to be effective in older patients with relapsed advanced NSCLC (see first item of related news). The major side effects did not appear to be different than in younger patients and these researchers concluded that Iressa was a safe drug for the palliative treatment of elderly patients with NSCLC. However, data on the effects of Iressa for initial treatment of advanced NSCLC is limited.

The current study involved 49 patients with untreated advanced NSCLC who were 75 years of age or older (median age of 80 years). Forty of the 49 patients had adenocarcinoma and 32 were female. The response rate was 25% and the one-year survival was 50%. Skin rash was the most common side effect. Five of 7 patients with EGFR mutations had a partial response. These authors concluded, “Gefitinib monotherapy is effective and relatively well-tolerated in chemotherapy-naïve elderly patients with advanced NSCLC.”

Comments: This is further evidence that single agent Iressa can provide significant palliation in some elderly patients with advanced NSCLC.

Related News:

Gefitinib (Iressa®) Well Tolerated in Elderly Patients with NSCLC (01/15/2004)

Iressa® Active and Well Tolerated in Advanced NSCLC Patients With EGFR Mutations (10/30/2006)

Iressa® Effective in Initial Treatment of Subset of Lung Cancer Patients (07/16/2006)

Reference:

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1Ebi N, Semba H, Tokunaga SJI, et al. A phase II trial of gefitinib monotherapy in chemotherapy-naive patients 75 years or older with advanced non-small cell lung cancer. Journal of Thoracic Oncology 2008;3:1166-1171.

[gpawelski]

Performance status is a standard functional classification in oncology research and practice. Poor performance status is an important determinant of clinical outcomes in cancer patients. It is a measure of how disabled you are, or how severe your symptoms are. Specific numeric scales are used (Karnofsky Status). This is not the same as prognosis. Someone who has just had major surgery may have a very poor performance status, but an excellent prognosis. Conversely, many patients with early metastatic disease will have no symptoms and an excellent performance status, but the long term prognosis can be very poor.

The role of chemotherapy in patients with a poor PS and metastatic NSCLC compared with those with early-stage and locally advanced NSCLC has been addressed. Several different approaches have been studied, including the role of single-agent chemotherapy, platinum-based doublets, nonplatinum-containing doublets, and molecularly targeted therapies (like Iressa). Cisplatin-based doublet chemotherapy has been largely eschewed for the population who have a performance status of 2 (PS2). Nevertheless, the increasing study of PS2 patients with advanced NSCLC has coincided with a growing array of treatment options that are generally less challenging in terms of potential toxicity than cisplatin doublet combinations.

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