THE COMPARISON OF THE THERAPEUTIC EQUIVALENCE OF OXALIPLATINRONC® (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
https://doi.org/10.18027/2224-5057-2016-4-58-67
Abstract
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 OxaliplatinRCRC® and 29 to Eloxatin®.
The objective response rate was 46,67% in the OxaliplatinRONC® 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 OxaliplatinRONC® 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.
About the Authors
A. А. Kolomeytseva
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Kolomeytseva Alina Andreevna – MD, PhD, senior Researcher, Chemotherapy Department, Moscow
S. V. Kopachevskaia
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Kopachevskaia Svetlana Vasil’evna – PhD, deputy Director of N. N. Blokhin Russian Cancer Research Center, Director of Research and Production Branch of “N.N. Blokhin Russian Cancer Research Center” , Moscow
Russian Federation
Kopachevskaia Svetlana Vasil’evna – PhD, deputy Director of N. N. Blokhin Russian Cancer Research Center, Director of Research and Production Branch of “N.N. Blokhin Russian Cancer Research Center” , Moscow
N. F. Orel
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Orel Nadezhda Fedorovna – MD, PhD, DSc, leading Researcher, Chemotherapy Department, Moscow
V. A. Gorbunova
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Gorbunova Vera Andreevna – MD, PhD, DSc, professor, head of Chemotherapy Department, Moscow
T. Y. Eskina
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Eskina Tatyana Yur’evna – head of drug registration, branch “Naukoprofi”, Moscow
M. Y. Fedyanin
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Fedyanin Mikhail Yur’evich – MD, PhD, oncologist, Department of Clinical Pharmacology and Chemotherapy, Moscow
L. V. Manzyuk
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Manzyuk Lyudmila Valentinovna – MD, PhD, DSc, professor, head of Department of studying of new anticancer drugs department, Moscow
A. V. Snegovoy
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Snegovoy Anton Vladimirovich – MD, PhD, senior researcher, Department of studying of new anticancer drugs, Moscow
L. S. Scriabina
Altai Regional Oncology Center
Russian Federation
Russian Federation
Scriabina Ludmila Sergeevna – MD, PhD, head of Сhemotherapy Department, Altai region, Barnaul
G. Z. Mukhametshina
Republican Clinical Oncology Center
Russian Federation
Mukhametshina Guzel Zinnurovna – MD, PhD, head of Chemotherapy Department № 1, Kazan
Russian Federation
Mukhametshina Guzel Zinnurovna – MD, PhD, head of Chemotherapy Department № 1, Kazan
A. S. Odintsova
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Odintsova Anastasia Sergeevna – MD, PhD, oncologist, Chemotherapy Department, Moscow
E. V. Trusilova
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Trusilova Elena Vladimirovna – MD, PhD, Researcher, Chemotherapy Department, Moscow
F. H. Mukhametgaleeva
Republican Clinical Oncology Center
Russian Federation
Russian Federation
Mukhametgaleeva Farida Khaydarovna – MD, oncologist, Chemotherapy Department, Kazan
O. V. Sehina
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Sehina Olga Viktorovna – researcher, Department of Clinical Pharmacology and Chemotherapy, Moscow
Y. V. Vakhabova
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Vakhabova Yulia Vjacheslavovna – MD, PhD, oncologist, Department of Chemotherapy and Combined Methods of Treatment Malignant Tumors, Moscow
N. V. Dobrova
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Dobrova Natalia Valerievna – MD, PhD, senior researcher Department of Chemotherapy and Combined Methods of Treatment Malignant Tumors, Moscow
E. V. Chtrnoglazova
N.N. Blokhin Russian Cancer Research Center
Russian Federation
Russian Federation
Chernoglazova Ekaterina Valerievna – MD, PhD, researcher, Department of Chemotherapy and Combined Methods of Treatment Malignant Tumors, Moscow
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Review
For citations:
Kolomeytseva A.А., Kopachevskaia S.V., Orel N.F., Gorbunova V.A., Eskina T.Y., Fedyanin M.Y., Manzyuk L.V., Snegovoy A.V., Scriabina L.S., Mukhametshina G.Z., Odintsova A.S., Trusilova E.V., Mukhametgaleeva F.H., Sehina O.V., Vakhabova Y.V., Dobrova N.V., Chtrnoglazova E.V. THE COMPARISON OF THE THERAPEUTIC EQUIVALENCE OF OXALIPLATINRONC® (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. Malignant tumours. 2016;(4):58-67. (In Russ.) https://doi.org/10.18027/2224-5057-2016-4-58-67
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