A Double-Blind, Randomized Comparison Study between Zytux™ vs MabThera® in Treatment of CLL with FCR Regimen: Non-Inferiority Clinical Trial

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Abstract

Background: Chronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux™ in comparison to MabThera ^® in treatment of CLL.

Materials and Methods: Seventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux™, and group B was treated with MabThera ^®. A non-inferiority margin of 20% for the primary outcome was defined to examine the similarity between Zytux™ and MabThera ^®.

Results: Baseline demographic characteristics showed no statistically signiﬁcant difference between the two groups.

The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux™ demonstrated a similar profile of adverse reactions in comparison to MabThera ^®. Moreover, the overall response rate was 88% and 89% for Zytux™ and MabThera ^®, respectively (CI -0.17, 0.18).

Conclusion: Results showed non-inferiority of Zytux™ in terms of efficacy and adverse events as a biosimilar version of MabThera ^®.

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Most cited references 23

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EUROCARE-4. Survival of cancer patients diagnosed in 1995-1999. Results and commentary.

Milena Sant, Claudia Allemani, Mariano Santaquilani … (2009)

EUROCARE-4 analysed about three million adult cancer cases from 82 cancer registries in 23 European countries, diagnosed in 1995-1999 and followed to December 2003. For each cancer site, the mean European area-weighted observed and relative survival at 1-, 3-, and 5-years by age and sex are presented. Country-specific 1- and 5-year relative survival is also shown, together with 5-year relative survival conditional to surviving 1-year. Within-country variation in survival is analysed for selected cancers. Survival for most solid cancers, whose prognosis depends largely on stage at diagnosis (breast, colorectum, stomach, skin melanoma), was highest in Finland, Sweden, Norway and Iceland, lower in the UK and Denmark, and lowest in the Czech Republic, Poland and Slovenia. France, Switzerland and Italy generally had high survival, slightly below that in the northern countries. There were between-region differences in the survival for haematologic malignancies, possibly due to differences in the availability of effective treatments. Survival of elderly patients was low probably due to advanced stage at diagnosis, comorbidities, difficult access or lack of availability of appropriate care. For all cancers, 5-year survival conditional to surviving 1-year was higher and varied less with region, than the overall relative survival.

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Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia.

Maher Albitar, M Detry, Michael Andreeff … (2005)

Fludarabine and cyclophosphamide (FC), which are active in treatment of chronic lymphocytic leukemia (CLL), are synergistic with the monoclonal antibody rituximab in vitro in lymphoma cell lines. A chemoimmunotherapy program consisting of fludarabine, cyclophosphamide, and rituximab (FCR) was developed with the goal of increasing the complete remission (CR) rate in previously untreated CLL patients to >/= 50%. We conducted a single-arm study of FCR as initial therapy in 224 patients with progressive or advanced CLL. Flow cytometry was used to measure residual disease. Results and safety were compared with a previous regimen using FC. The median age was 58 years; 75 patients (33%) had Rai stage III to IV disease. The CR rate was 70% (95% CI, 63% to 76%), the nodular partial remission rate was 10%, and the partial remission rate was 15%, for an overall response rate of 95% (95% CI, 92% to 98%). Two thirds of patients evaluated with flow cytometry had less than 1% CD5- and CD19-coexpressing cells in bone marrow after therapy. Grade 3 to 4 neutropenia occurred during 52% of courses; major and minor infections were seen in 2.6% and 10% of courses, respectively. One third of the 224 patients had >/= one episode of infection, and 10% had a fever of unknown origin. FCR produced a high CR rate in previously untreated CLL. Most patients had no detectable disease on flow cytometry at the end of therapy. Time to treatment failure analysis showed that 69% of patients were projected to be failure free at 4 years (95% CI, 57% to 81%).

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Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia.

Constantine Tam, Susan O'Brien, William Wierda … (2008)

Early results of the fludarabine, cyclophosphamide, and rituximab (FCR) regimen in 224 patients showed that it was highly active as initial therapy of chronic lymphocytic leukemia. In this report, we present the final results of all 300 study patients at a median follow up of 6 years. The overall response rate was 95%, with complete remission in 72%, nodular partial remission in 10%, partial remission due to cytopenia in 7%, and partial remission due to residual disease in 6%. Two patients (< 1%) died within 3 months of starting therapy. Six-year overall and failure-free survival were 77% and 51%, respectively. Median time to progression was 80 months. Pretreatment characteristics independently associated with inferior response were age 70 years or older, beta2-microglobulin twice the upper limit of normal (2N) or more, white cell count 150 x 10(9)/L or more, abnormal chromosome 17, and lactate dehydrogenase 2N or more. No pretreatment characteristic was independently associated with decreased complete remission duration. The risk of late infection was 10% and 4% for the first and second years of remission, respectively, and less than 1.5% per year for the third year onward. In a multivariate analysis of patients receiving fludarabine-based therapy at our center, FCR therapy emerged as the strongest independent determinant of survival.

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Author and article information

Journal

Journal ID (nlm-ta): Int J Hematol Oncol Stem Cell Res

Journal ID (iso-abbrev): Int J Hematol Oncol Stem Cell Res

Journal ID (publisher-id): IJHOSCR

Title: International Journal of Hematology-Oncology and Stem Cell Research

Publisher: Tehran University of Medical Sciences, Hematology-Oncology and Stem Cell Transplantation Research Center (Tehran, Iran )

ISSN (Print): 2008-3009

ISSN (Electronic): 2008-2207

Publication date (Print): 1 April 2018

Volume: 12

Issue: 2

Pages: 84-91

Affiliations

[1 ]Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran

[2 ]Department of Internal Medicine, Hematology and Medical Oncology Ward, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran

[3 ]Pediatric Growth and Development Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran

[4 ]Clinic of Hematology and Oncology, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran

[5 ]AJA Cancer Research Center (ACRC), AJA University of Medical Sciences, Tehran, Iran

[6 ]Division of Hematology and Medical Oncology, Emam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran

[7 ]Department of Internal Medicine, Persian Gulf Tropical Medicine Research Center, Bushehr University of Medical Sciences, Bushehr, Iran

[8 ]Research Department, Mahak’s Pediatric Cancer Treatment and Research Center, Tehran, Iran

[9 ]Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

[10 ]School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Author notes

Corresponding Author: Dr. Mohammad Faranoush, Pediatric Growth and Development Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran. Tel: 0989121590517. E-mail: faranoush47@ 123456gmail.com

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Publisher ID: IJHOSCR-12-84

PMC ID: 6141434

PubMed ID: 30233768

SO-VID: 7b72dcae-9b45-4d03-8466-a88a8cd944cd

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This is an Open Access article distributed under the terms of the Creative Commons Attribution License, ( http://creativecommons.org/licenses/by/3.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

A Double-Blind, Randomized Comparison Study between Zytux™ vs MabThera® in Treatment of CLL with FCR Regimen: Non-Inferiority Clinical Trial

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Most cited references 23

EUROCARE-4. Survival of cancer patients diagnosed in 1995-1999. Results and commentary.

Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia.

Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia.

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