July 27, 2011

Tarceva Outperforms Chemotherapy for Initial Treatment of Lung Cancer with an Mutation


Among patients with advanced non-small cell lung cancer that tests positive for a mutation in the EGFR gene, initial treatment with the targeted therapy Tarceva® (erlotinib) produces better outcomes and fewer serious side effects than chemotherapy.  These results were published in Lancet Oncology.

Lung cancer remains the leading cause of cancer death in the United States and abroad, highlighting the importance of finding more effective approaches to treatment.

As cancer research has evolved, it’s become apparent that the specific characteristics of a tumor can have a profound effect on the behavior of the cancer and its response to particular treatments. In the case of non-small cell lung cancer (NSCLC), for example, mutations in the EGFR (epidermal growth factor receptor) gene may influence whether the cancer responds to the EGFR-targeted drugs Tarceva and Iressa® (gefitinib).

Tarceva is currently approved for the treatment of advanced NSCLC after initial treatment has failed, or as maintenance therapy after chemotherapy. Iressa has restricted availability in the US (it’s only available to patients who have previously shown a response to the drug).

These drugs are also being evaluated in the initial treatment of advanced NSCLC, and studies in newly diagnosed patients have suggested that cancers that contain a mutation in the EGFR gene are more likely to respond to Tarceva and Iressa. Among people with NSCLC, EGFR mutations are most common in people of Asian ethnicity, women, never-smokers, and those with a type of lung cancer known as adenocarcinoma.

To compare Tarceva with chemotherapy for the initial treatment of advanced NSCLC that tests positive for an EGFR mutation, researchers in China conducted a study among 165 patients with Stage IIIB or Stage IV NSCLC. Half the patients were treated with Tarceva and half were treated with combination chemotherapy consisting of Gemzar® (gemcitabine) and carboplatin.

  • Treatment with Tarceva substantially delayed cancer progression. Median survival without cancer progression was 13.1 months among patients treated with Tarceva and 4.6 months among patients treated with chemotherapy.
  • Serious side effects were also less common in the Tarceva group.

These results suggest that for patients with advanced NSCLC that tests positive for an EGFR mutation, initial treatment with Tarceva is more effective and better tolerated than chemotherapy. Tarceva has not yet been approved by the U.S. Food and Drug Administration for this purpose, but patients with newly diagnosed NSCLC may wish to talk with their doctor about whether EGFR testing may be appropriate. Testing for EGFR mutations may not be recommended for all patients with NSCLC. Some groups of patients—such as those with squamous cell NSCLC—are less likely than others to have an EGFR mutation.

Reference: Zhou C, Wu Y-L, Chen G et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicentre, open-label, randomized, phase 3 study. Lancet Oncology. Early online publication July 22, 2011.

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