The N.N. Petrov Research and Development Institution of Oncology (Saint-Petersburg) has prepared an interim report on clinical study of REFNOT: Comparative randomized study of REFNOT combined with chemotherapy in the FEC mode, REFNOT combined with Ingaron and FEC chemotherapy, and FEC chemotherapy only in treatment of regional and metastatic breast cancer (phase II/III). The Institution oncologists reached a conclusion based on the results of the research: the FEC chemotherapy with REFNOT produced higher effecton the female patientsas compared to the reference group (FEC chemotherapy only).
The study of REFNOT titled “Comparative randomized study of REFNOT combined with chemotherapy in FEC mode, REFNOT combined with Ingaron and FEC chemotherapy, and FEC chemotherapy only in treatmentof regional and metastatic breast cancer (phase II/III)” was an open label controlled randomized clinical study.
Study purpose: to compare the effectiveness of FEC chemotherapy and REFNOT product combined with FEC chemotherapy in treatment of regional and metastatic breast cancer. The study was conducted in the N.N. Petrov Federal State University Research and Development Institute of Oncology of the Ministry of Healthcare and Social Development of the Russian Federation. The primary investigator was the director of the institute, an associate member of the Russian Academy of Sciences, professor V.F. Semiglazov.
111 patients with breast cancer were included. The oncologists have established, that after 6 courses of chemotherapy,full or partial regress of the tumor has been observed in 55% of patients in the reference group and 62.1% patients after chemotherapy combined with REFNOT. After 6 courses of chemotherapy, tumor progress has been observed only in patients from the reference group.
Based on the results of the research, the oncologists have reached a conclusion that chemotherapy combined with REFNOT was more effective for patients compared to the reference group. Good tolerability of REFNOT should also be duly noted, as there were no additional adverse effects of combined therapy in the studied population.
Date: January 2009
The study of REFNOT titled “Comparative randomized study of REFNOT combined with chemotherapy in FEC mode, REFNOT combined with Ingaron and FEC chemotherapy, and FEC chemotherapy only in treatmentof regional and metastatic breast cancer (phase II/III)” was an open label controlled randomized clinical study.
Study purpose: to compare the effectiveness of FEC chemotherapy and REFNOT product combined with FEC chemotherapy in treatment of regional and metastatic breast cancer. The study was conducted in the N.N. Petrov Federal State University Research and Development Institute of Oncology of the Ministry of Healthcare and Social Development of the Russian Federation. The primary investigator was the director of the institute, an associate member of the Russian Academy of Sciences, professor V.F. Semiglazov.
111 patients with breast cancer were included. The oncologists have established, that after 6 courses of chemotherapy,full or partial regress of the tumor has been observed in 55% of patients in the reference group and 62.1% patients after chemotherapy combined with REFNOT. After 6 courses of chemotherapy, tumor progress has been observed only in patients from the reference group.
Based on the results of the research, the oncologists have reached a conclusion that chemotherapy combined with REFNOT was more effective for patients compared to the reference group. Good tolerability of REFNOT should also be duly noted, as there were no additional adverse effects of combined therapy in the studied population.
Date: January 2009