Медицинский совет (Dec 2019)
Results of using 3-component regimen TEGOXIRI (tegafur, oxaliplatin, irinotecan) ± Leucovorin in patients with advanced colorectal cancer
Abstract
Introduction. Colorectal cancer (CRC) holds leading positions in the cancer incidence and mortality patterns worldwide. In this regard, the study of new effective drugs and development of new treatment regimens for advanced CRC is receiving priority attention today.Objective of the study: develop a new 3-component chemotherapy (CT) regimen based on the combination of oxaliplatin (oxa)/irinotecan (iri)/tegafur (Ftorafur®) ± Leucovorin, study its efficacy and safety in the first-line therapy for advanced CRC; assess the feasibility of its use in the outpatient setting.Materials and methods. The study included patients with advanced CRC, who had not previously received drug therapy for disseminated disease. In this study, all patients received first-line CT therapy based on a combination of: oxa/iri/tegafur (Ftorafur®) ± Leucovorin. The researchers developed and studied 2 CT regimens. CT regimen in subgroup I: iri (150 mg/m2 BSA intravenous (IV) infusion, 90-minute infusion, Day 1) + oxa (100 mg/m2 BSA IV infusion, 2-hour infusion, Day 1) + tegafur (Ftorafur ®) (1200 mg (400 mg TID), per os, daily, Days 1–14) + Leucovorin 50 mg TID, 15–20 minutes before taking tegafur, daily, Days 1–14. The next course starts from Day 22. CT regimen in subgroup II: iri (150 mg/m2 BSA intravenous (IV) infusion, 90-minute infusion, Days 1 and 15) + oxa (100 mg/m2 BSA IV infusion, 2-hour infusion, Days 1 and 15) + tegafur (Ftorafur®) (1200 mg (400 mg TID), per os, daily, Days 1–14). The interval between the courses is 14 days. The next course starts from Day 29. The researchers assessed the immediate and long-term results of treatment and safety of two above-mentioned first-line therapy chemotherapy regimens for advanced CRC.Results. The study included 30 patients with advanced CRC, 6 of whom received 3-week СТ regimen (subgroup I), 24 patients received 2-week regimen (subgroup II). In subgroup I, 4 (66.7%) patients achieved partial regression (PR) of metastases, 2 (33.3%) patients achieved long-term stable disease (SD ≥ 6 months). Thus, the disease control (PR + SD ≥6 months) was achieved in 100% of cases. The median progression-free survival (PFS) in this subgroup was 9.53 months; the median overall survival (OS) was 13.60 months. In subgroup II, PR was reported in 13/23 (56.5%) patients, of which 4 (17.4%) were radically operated. SD ≥6 months was achieved in 6 (26.1%) patients. Thus, the disease control (PR + SD ≥6 months) was achieved in 82.6% of cases. The median progression-free survival (PFS) in this subgroup was 8.73 months; the median overall survival (OS) was 17.24 months. In the general group of patients, who received therapy regimens I and II, the disease control was 86.2% (PR-58.6%; SD ≥6 months was 27.6%); median PFS was 9.57 months; median OS was 16.8 months. Conclusions. Data resulting from our study suggest that the combination of oxa, iri, and tegafur (Ftorafur®) ± Leucovorin is effective and safe 3-component first-line CT regimen for advanced CRC, which is easy for use in outpatient setting.
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