GEMCITABINE IS AN ACTIVE NEW AGENT IN PREVIOUSLY UNTREATED EXTENSIVE SMALL-CELL LUNG-CANCER (SCLC) - A STUDY OF THE NATIONAL-CANCER-INSTITUTE-OF-CANADA CLINICAL-TRIALS GROUP

Background: The new pyrimidine antimetabolite Gemcitabine has shown pr eclinical efficacy in a number of solid tumour lines and acceptable to xicity in phase I trials. As part of an ongoing effort to identify act ive new agents in small cell lung cancer, the NCIC Clinical Trials Gro up studied Gemcitabine in previously untreated patients with extensive disease. Patients and Methods: Twenty-nine newly diagnosed patients w ith untreated extensive small cell lung cancer and at least one bidime nsionally measurable site received Gemcitabine as a 30 minute intraven ous infusion weekly x 3 every 4 weeks. The starting dose was 1000 mg/m l/week in the first 17 patients and 1250 mg/m2/week in the remainder. Patients were reevaluated for response every 4 weeks. Those failing to respond after 2 cycles of therapy were to be offered standard chemoth erapy. Results: Of the 29 patients entered, all were evaluable for tox icity and 26 for response. One complete and 6 partial responses were s een giving a response rate of 27% (95% CI: 11%-47%). Median response d uration was 12.5 weeks and the median survival of the entire populatio n was 12 months. Toxic effects were mild to moderate: in particular se rious myelosuppression was uncommon. Conclusions: Gemcitabine is activ e in previously untreated small cell lung cancer in doses which produc e little toxicity. Combination studies of Gemcitabine with other agent s active in this disease are warranted.