• V A Miller.
• Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
• Semin. Oncol. 1997 Aug 1; 24 (4 Suppl 14): S14-15-S14-17.

AbstractWe undertook a phase I/II study of the combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and vinorelbine in the treatment of unresectable or metastatic non-small cell lung cancer (NSCLC). Nineteen patients with unresectable NSCLC received a combination of docetaxel 50 mg/m2 and vinorelbine 15 to 45 mg/m2 every 2 weeks. All patients received prophylactic granulocyte-colony stimulating factor 5 microg/kg/d and corticosteroids. The incidence of hematologic toxicity with this dosing schedule was low; only 2.5% of treatment cycles were complicated by febrile neutropenia. The maximum tolerated dose has not been reached. It is concluded that using this schedule, a combination of docetaxel and vinorelbine can be administered in combination, together with granulocyte-colony stimulating factor, with a low risk of associated hematologic toxicity. Further dose escalation is needed to determine the maximum tolerated dose of the combination. A partial response was observed in five patients (26%; 95% confidence interval, 15% to 57%), and nine (47%) patients showed stable disease. Based on these preliminary results, the combination of these two drugs appears to have antitumor activity against NSCLC and warrants continued study.

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