COMBINATION CHEMOTHERAPY OF ADVANCED NON-SMALL-CELL LUNG CANCER BY DRUGS PACLITAXEL AND CARBOPLATIN: AN OPEN PROSPECTIVE CLINICAL TRIAL


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Abstract

The article presents the results of an open, prospective clinical trial aimed at assessing the safety and efficacy of Taxacad® and carboplatin in combination chemotherapy of patients with advanced non-small-cell lung cancer. Study patients have received a combination of Taxacad®
(175 mg/m2 as a 3-hour intravenous infusion) and carboplatin (at a dose corresponding to AUC = 6). Cycles of chemotherapy were performed with an interval of 21 days. Six cycles of chemotherapy were planned. The study enrolled 88 patients, 78 of which were included in the analysis of the effectiveness of treatment. Enrolled patients have received 1 to 9 courses of chemotherapy according to the planned scheme. The safety profile of drug combinations used corresponded with data obtained in international studies. Grade III-IV anemia was observed in 4,5 % of patients, grade III-IV leukopenia - in 6,8 %, grade III-IV neutropenia - 35,6 %; III-IV grade thrombocytopenia and liver and renal toxicity was not observed. According to the efficacy analysis (n = 78), partial response rate was 25,6 %, stabilization rate - 44,9 %, progression was observed in 29,5 % of patients. The median time to progression was 4,2 months. Data show that the results of the use of generic drugs Carboplatin and Taxacad®
manufactured by CJSC BIOCAD are consistent with the literature on efficacy and safety of the original drugs.

References

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