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Title: Consolidation Docetaxel After Chemoradiotherapy Encouraging In Non-Small Cell Lung Cancer

"Consolidation Docetaxel After Chemoradiotherapy Encouraging In Non-Small Cell Lung Cancer"

SAN ANTONIO, TX -- May 15, 2003 -- The use of the taxane docetaxel (Taxotere®) after standard chemotherapy with cisplatin/etoposide plus radiotherapy produces high survival rates in patients with Stage IIIB non-small cell lung cancer (NSCLC), according to a study published in the May 15 issue of the Journal of Clinical Oncology (JCO). The SWOG-9504 study led by David R. Gandara, M.D. of the Southwest Oncology Group (SWOG) found that nearly 40 percent of patients remained alive at the three-year follow-up. The median survival was 26 months and the progression-free survival was 16 months, all of which surpass the results seen in a prior SWOG study (SWOG-9019) published last year in the JCO, where identical concurrent chemoradiotherapy was followed by two additional cycles of cisplatin/etoposide instead of consolidation docetaxel. "These results suggest that the incorporation of consolidation therapy using docetaxel into this treatment regimen may improve lung cancer patients' chances for longer survival," said David R. Gandara, M.D., chair of the SWOG Lung Committee and professor of medicine and director of clinical research at the University of California Davis Cancer Center. "In Stage IIIB NSCLC, patients typically have both bulky local-regional cancer and a high rate of occult distant micrometastases undetectable by current scanning techniques. To think about curing such a patient with Stage IIIB disease, both of these compartments, local disease and distant disease, must be controlled. The SWOG-9504 regimen was designed to address both local-regional disease by employing full dose platinum-based chemotherapy together with concurrent thoracic radiation, followed by full doses of docetaxel to eradicate distant micrometastases, in a concept we refer to as taxane sequencing. Docetaxel is the most effective drug when given in the second-line therapy of NSCLC, and our approach moves it forward into the first-line setting." The Phase II study included 83 patients with newly diagnosed primary bronchogenic (originating in the air passages of the lungs) Stage IIIB non-small cell lung cancer (NSCLC) that was too extensive to be cured by surgery. The median age of the patients in the study was 60 years. Sixty-one patients were men, and 22 were women. In Stage IIIB NSCLC, the primary tumor has invaded surrounding organs or there is extensive lymph node involvement, or both. All patients received cisplatin, 50 mg/m2, administered intravenously on days 1 and 8, and etoposide, 50 mg/m2, administered intravenously each day for five days. The chemotherapy treatment was repeated four weeks later. On the first day of chemotherapy, patients started radiotherapy, which continued for five days a week for six weeks. Consolidation docetaxel, 75 to 100 mg/m2, was administered intravenously starting about four weeks after the completion of chemoradiotherapy, and the treatment was repeated every 21 days for three cycles. Concurrent chemoradiotherapy was reasonably well tolerated. Side effects during consolidation docetaxel treatment included esophagitis and neutropenia (low white blood cells). Most severe episodes of neutropenia occurred during escalation of the docetaxel dose to 100 mg/m2. Since recent studies suggest that 75 mg/m2 is equally effective and less toxic than 100 mg/m2, further studies of this regimen are using 75 mg/m2 during all three consolidation courses. Two patients died of radiation-related pneumonitis. A large Phase III Intergroup study (S0023) using this regimen followed by randomization to maintenance therapy with the epidermal growth factor inhibitor ZD1839 or placebo is currently underway. The patients involved in this study who receive placebo will serve as a confirmatory group to validate the results of the SWOG-9504 trial. About Lung Cancer Lung cancer is the second most common cancer in the United States. It is also the number one cause of cancer death among men and women, having surpassed breast cancer as the number one cancer killer of women. Lung cancer claims approximately 155,000 lives each year, accounting for 28 percent of all cancer deaths. Seventy five to 80 percent of all lung cancer diagnoses in the United States are NSCLC, making it the most common type of lung cancer. At present, most patients with locally advanced (Stage III) disease have few treatment options. Only 25 percent are suitable for surgery, and most other patients are treated with combinations of chemotherapy and/or radiation therapy. SOURCE: Southwest Oncology Group

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