March 8, 2009

Iressa® Equivalent to Taxotere® for Previously Treated NSCLC


Iressa® Equivalent to Taxotere® for Previously Treated NSCLC

Iressa® (gefitinib) is equivalent to Taxotere® (docetaxel) in patients with previously treated non–small cell lung cancer (NSCLC) and is also associated with lower rates of treatment-related adverse events, according to the results of a study published in the November 22, 2008 issue of the Lancet.[1]

Lung cancer remains the greatest cause of cancer-related deaths in the world. In the United States, it causes more deaths than breast cancer, colorectal cancer, and prostate cancer combined. Non–small cell lung cancer (NSCLC) accounts for roughly 85% of all lung cancers; “non–small cell” refers to the type of cell within the lung where the cancer originated. In advanced NSCLC cancer has spread outside the lung; standard therapy for this stage of disease includes chemotherapy. However, chemotherapy is often difficult to tolerate. Another approach to treatment utilizes agents targeted specifically against cancer cells; these targeted agents may have fewer side effects.

Iressa is an oral agent that is targeted specifically against the human epidermal growth factor receptor (EGFR). EGFR is a protein that is found on the surface of cells and is involved in cellular growth, spread, and replication. Cancerous cells often overexpress EGFR or have mutations within EGFR, leading to uncontrolled growth or spread of the cancer cells. Iressa binds to EGFR and halts or reduces its effects on cancer cells.

The Iressa NSCLC Trial Evaluating Response and Survival versus Taxotere, or INTEREST Trial, was a multicenter Phase III trial involving 1,466 patients with locally advanced or metastatic NSCLC who had been previously treated with one or more platinum-based regimens of chemotherapy. The patients were randomly assigned to receive Iressa or Taxotere. The primary objective of the study was to compare the overall survival between the two groups and to establish the non-inferiority of Iressa, as well as the superiority of Iressa, in patients with a high EGFR gene-copy number.

The results of the study did indeed indicate that Iressa is not inferior to Taxotere; the median overall survival for the Iressa group was 7.6 months compared with 8 months for the Taxotere group. However, Iressa did not prove superior in the group with high EGFR gene-copy numbers. Secondary endpoints of the study included quality of life, safety, and tolerability. Iressa was associated with lower rates of treatment-related adverse events than Taxotere and patients in the Iressa group reported a higher quality of life. The most common side effects of Iressa were acne and diarrhea, whereas the most common side effects of Taxotere were neutropenia, weakness, and hair loss.

The researchers concluded that Iressa produces equivalent results to Taxotere and is a valid treatment for previously treated patients with advanced NSCLC.


[1] Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-small call lung cancer (INTEREST): A randomized phase III trial. Lancet. 2008; 372: 1809-1818.

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