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| |  ECCO: Taxotere Monotherapy Increases Survival In Lung Cancer Patients VIENNA, AUSTRIA -- September 15, 1999 -- Monotherapy with the chemotherapeutic agent Taxotere® (docetaxel) represents an effective first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC), researchers reported at the tenth meeting of the European Congress of Clinical Oncology (ECCO). The data, from a phase III trial, showed that patients with metastatic or unresectable localized NSCLC who were randomized to single-agent therapy with docetaxel had a significantly better survival at 20 months than patients who were assigned to receive best supportive care. Patients treated with docetaxel, a taxane, had a significantly greater improvement in pain and dyspnoea, and also required significantly fewer pain and other tumor-related medications. "Historically, patients with metastatic or unresectable localized NSCLC have a poor prognosis, with palliation the only achievable treatment goal," said Professor Kazimierz Roszkowski, lead investigator of the trial and General Director of the Institute for Tuberculosis and Lung Diseases in Warsaw, Poland. "Our study suggests that docetaxel given alone can dramatically improve outcome, with survival benefits still present at 20 months." The 207 patients enrolled in the trial received either docetaxel, 100 mg/m2, given as a one-hour infusion on day one and repeated every three weeks or best supportive care. Best supportive care is one of the options in treating patients with advanced NSCLC and refers to measures aimed at maintaining patient comfort, including nutritional support and control of symptoms such as nausea, vomiting, pain, and dyspnoea (shortness of breath). Participants in the trial had not received prior chemotherapy and were not allowed to undergo chemotherapy or other systemic anticancer therapy during the study period. The two treatment groups were similar with respect to demographic characteristics such as age and gender and clinical characteristics such as performance status and tumor stage. Overall survival was significantly improved in docetaxel-treated patients compared with control patients, and the difference between the two groups became more pronounced over time. The estimated survival rates were 25 percent for the docetaxel group and 16 percent for the control group at 12 months. The survival rates at 20 months were 12 percent and zero percent for the two groups, respectively. The differences between the two groups at the 20-month and 12-month time points were statistically significant. Patients treated with docetaxel also had a statistically significant improvement in median time to disease progression (12.6 weeks for docetaxel-treated patients compared with 8.9 weeks for control patients). The overall response rate in the docetaxel group was 20 percent. The overall response rate is the sum of the complete and partial response rates. A complete response is defined as a complete disappearance of clinical and x-ray signs of the cancer, while a partial response refers to a 50 percent or greater decrease in measurable tumor size. During the study period, 69 percent of control and 40 percent of docetaxel patients required morphine-like medications, and 61 percent of control and 32 percent of docetaxel patients needed other analgesics. Significantly fewer docetaxel patients needed other tumor-related medications, including palliative radiotherapy. A significantly higher percentage of the docetaxel-treated patients received systemic anti-infective drugs, either prophylactically or therapeutically, during their treatment. Tolerance was good. Only three percent of the patients experienced febrile neutropenia (low white blood cell count) and six percent did experience infections.
Lung Cancer Worldwide, lung cancer is the second leading cause of cancer-related deaths. Although the incidence of lung cancer in men has leveled off, the incidence in women continues to increase. Among women, lung cancer now exceeds breast cancer as the number one cause of cancer-related deaths. At present, patients with metastatic NSCLC have relatively limited treatment options. Only 25 percent of patients have tumors that are operable. The majority of patients are treated with radiation therapy and/or chemotherapy, and still with best supportive care.
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