The comparison of the therapeutic equivalence of Oxaliplatin-RONC ® (branch “Naukoprofi” of N.N. Blokhin RCRC) and Eloxatin® (Aventis Pharma LTD, Great Britain) in mFOLFOX6 combination as a first line of chemotherapy in patients with metastatic colorectal cancer

Автор: Kolomeytseva Alina Andreevna, Kopachevskaia Svetlana Vasilevna, Orel Nadezhda Fedorovna, Gorbunova Vera Andreevna, Eskina Tatyana Yurevna, Fedyanin Mikhail Yurevich, Manzyuk Lyudmila Valentinovna, Snegovoy Anton Vladimirovich, Scriabina Ludmila Sergeevna, Mukhametshina Guzel Zinnurovna, Odintsova Anastasia Sergeevna, Trusilova Elena Vladimirovna, Mukhametgaleeva Farida Khaydarovna, Sehina Olga Viktorovna, Vakhabova Yulia Vjacheslavovna, Dobrova Natalia Valerievna, Chernoglazova Ekaterina Valerievna

Журнал: Злокачественные опухоли @malignanttumors

Рубрика: Собственные исследования

Статья в выпуске: 4 (20), 2016 года.

Бесплатный доступ

The combination of fluoropyrimidines with oxaliplatin is one of the standard first line chemotherapy of metastatic colorectal cancer (mCRC). In Russian cancer research center was performed a full cycle of production the drug Oxaliplatin-RONC®, showed equivalence to Eloxatin® in vitro and in vivo. The main purpose of this study was to evaluate the therapeutic equivalence of Oxaliplatin-RONC ® and Eloxatin® in mFOLFOX6 combination as a first line of chemotherapy in patients with mCRR. The second purpose was to compare the safety of drugs. A total of 59 patients were enrolled in the study. Patients were assigned in a 1:1 ratio to receive up to 9 cycles of mFOLFOX6 with Oxaliplatin-RONC® or Eloxatin®; cycles were repeated every 14 days. 30 patients were randomly assigned to Oxaliplatin-RCRC® and 29 to Eloxatin®. The objective response rate was 46,67% in the Oxaliplatin-RONC® group and 37,93% in the Eloxatin® group (р (non inferiority)=0,046); 97,5% CI,-0,16-0,33). The median progression-free survival was 6,9 months in the Oxaliplatin-RONC® group, as compared with 7 months in the Eloxatin® group (P=0.571). The median of duration response rate was 5,5 months in the Oxaliplatin-RONC® and 6,2 months in the Eloxatin® group (p=0.8). The incidence of adverse events grade 3 or 4 was comparable in groups. Oxaliplatin-RONC® and Eloxatin® in the mFOLFOX6 combination showed comparable efficacy and safety in patients with mCRC.

Еще

Короткий адрес: https://sciup.org/140222670

IDR: 140222670   |   DOI: 10.18027/2224-5057-2016-4-58-67

Статья научная