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Cisplatin based chemotherapy treatment regimens have long been a standard treatment for Stage IV non small cell lung cancer. The chemotherapy agent vinorelbine was previously approved by the Food and Drug Administration for the treatment of non small cell lung cancer because it improved survival of patients with Stage IV disease. A clinical trial was designed to compare the chemotherapy combination of cisplatin and vinorelbine to cisplatin chemotherapy alone for the initial treatment of Stage IV non small cell lung cancer. The results of this National Cancer Institute sponsored direct comparison were recently published.

In this clinical trial, 432 patients with predominantly Stage IV non small cell lung cancer were treated with either cisplatin chemotherapy alone or the combination of cisplatin and vinorelbine chemotherapy and directly compared. Both chemotherapy treatments were well tolerated with similar side effects except for neutropenia. Neutropenia was more common in the cisplatin /vinorelbine chemotherapy treatment, occurring in approximately 4 out of 5 patients. In this clinical trial, patients treated with cisplatin and vinorelbine were 2 times more likely to experience a significant decrease in the size of their cancer and survived almost twice as long from the initiation of treatment with a 1 year survival rate of 36% compared to 20% for cisplatin alone. This clinical trial demonstrated that the combination chemotherapy regimen of cisplatin and vinorelbine was well tolerated and superior to cisplatin alone for the treatment of Stage IV non small cell lung cancer. This treatment strategy is now being compared to other combination chemotherapy regimens. (Journal of Clinical Oncology, Vol 16, No 7, pp 2459-2465, 1998)

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