Tarceva® Has Significant Activity as Initial Treatment for E

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According to results recently published in the Journal of Clinical Oncology, treatment with the single agent Tarceva® (erlotinib) is active and well tolerated when used as initial therapy for patients 70 years of age or older with advanced non–small cell lung cancer who have not received prior chemotherapy.

Lung cancer remains the leading cause of cancer deaths in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 75–80% of all lung cancers. Advanced NSCLC refers to cancer that has spread from the lung to other sites in the body. Because long-term survival for patients with advanced NSCLC remains suboptimal, treatment is aimed at extending the duration of survival for patients while maintaining an optimal quality of life.

Elderly patients often cannot tolerate standard treatment including chemotherapy and radiation therapy, particularly if they have other existing medical conditions. Furthermore, patients may not wish to receive additional chemotherapy or radiation therapy if they have already undergone treatment with these modalities and have experienced a cancer recurrence.

Tarceva is a targeted agent that may be used for treatment of patients with NSCLC that has stopped responding to prior therapies. It works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication and when mutated or altered, excessive replication of cells can occur. Tarceva reduces the uncontrolled replication and growth of cancer cells by blocking mutated EGFR pathways. Study results have indicated that patients with specific mutations and/or disease characteristics may respond better to Tarceva than patients without these mutations and characteristics. Research continues to determine specifically which patients may derive the greatest benefit from treatment with Tarceva. Furthermore, Tarceva is not associated with the side effects of chemotherapy and/or radiation therapy, giving some patients who are not eligible for standard therapies because of their side effects an effective treatment alternative.

Researchers from the Dana-Farber Cancer Center recently conducted a clinical trial to further evaluate Tarceva in the treatment of elderly patients with advanced NSCLC. This trial included 80 patients with a median age of 75 years. Forty percent of patients had received prior surgery and/or radiation therapy; however, no patients had received prior chemotherapy.

Partial regression of cancer (partial response) occurred in 10% of patients.

41% of patients had a stabilization of their disease for at least two months.

The median survival time was nearly 11 months.

At one year nearly half (46%) of patients were still alive.

At two years nearly 20% of patients were still alive.

All patients with EGFR mutations achieved a partial response or disease stabilization and had improved survival over patients without EGFR mutations.

The researchers concluded that treatment with Tarceva appears to be an effective treatment choice for some patients with NSCLC, particularly those with EGFR mutations. Further research is needed to clearly identify which patients will gain optimal benefit from Tarceva. The researchers stated, “Erlotinib merits consideration for further investigation as a first-line therapeutic option in elderly patients.”

Reference: Jackman DM, Yeap BY, Lindeman NI, et al. Phase II clinical trial of chemotherapy-naïve patients >70 years of age treated with erlotinib for advanced non-small-cell lung cancer. Journal of Clinical Oncology. 2007;25:760-766.