Email this article Multicenter prospective observational post-approval study of safety and efficacy of bevacizumab (Avegra®, BIOCAD) in patients with metastatic colorectal cancer in real world practice: APOLLON-11 and SOYUZ-APOLLON
- Authors: Tryakin A.A.1, Fedyanin M.Y.1, Moiseenko F.V.2,3, Mironov O.V.4, Stroyakovskiy D.L.5, Sokolov N.I.6, Orlova S.A.7, Mantsyrev E.O.8, Sultanbaev A.V.9, Teterich A.A.10, Babina K.G.11, Yukalchuk D.Y.12, Borzyanitsa S.M.13, Isyangulova A.Z.7, Saidullaeva A.F.14, Chernova Y.A.15, Bobrova E.A.16, Fadeeva N.V.8, Chobanu D.Y.17
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Affiliations:
- Blokhin National Medical Research Center of Oncology
- Saint Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology)
- Petrov National Medicine Research Center of Oncology
- Tambov Regional Oncological Clinical Dispensary
- Moscow City Oncology Hospital №62
- Botkin Hospital
- Republican Clinical Oncological Dispensary
- Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
- Regional Oncological Clinical Dispensary
- Belgorod Oncological Dispensary
- Volgograd Regional Clinical Oncological Dispensary
- Regional Oncological Dispensary
- Rappoport Kuzbass Clinical Oncological Dispensary
- Tver Regional Clinical Oncological Dispensary
- Tomsk Regional Oncological Dispensary
- Loginov Moscow Clinical Scientific Center
- JSC "BIOCAD"
- Issue: Vol 23, No 4 (2021)
- Pages: 695-702
- Section: CLINICAL ONCOLOGY
- URL: https://journals.rcsi.science/1815-1434/article/view/100136
- DOI: https://doi.org/10.26442/18151434.2021.4.201307
- ID: 100136
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Abstract
Aim. To evaluate the safety and efficacy of long-term continuous use of Avegra® BIOCAD (international nonproprietary name – INN: bevacizumab) as a targeted therapy in patients with metastatic colorectal cancer in real-world practice.
Materials and methods. The paper presents the interim results of a multicenter prospective observational post-approval study of the safety and efficacy of Avegra® BIOCAD (INN: bevacizumab) combined with chemotherapy in patients with metastatic colorectal cancer. Inclusion criteria: histology verified diagnosis of metastatic colorectal cancer; therapy with bevacizumab (by JSC BIOCAD, Russia) to all patients included in the study, as part of real-world clinical practice, at a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with standard cytotoxic regimens (FOLFOX 6, XELOX, etc.). The main safety criteria are the incidence of adverse reactions to bevacizumab and the rate of treatment withdrawal due to the development of adverse reactions to bevacizumab. Additional criteria are objective response rate (complete and partial response to therapy), disease control rate (ORR and stable disease), and rate of disease progression.
Results. At the time of the interim analysis, 441 patients with metastatic colorectal cancer in 28 research centers of the Russian Federation (Moscow, Saint Petersburg and regional clinics) were included in the study. Median age of patients is 62 (28–87) years. Patients had an ECOG performance status of 0–1, with a median follow-up of 7.3 months. After the therapy, the disease control rate was 79.5%. The median PFS was 8 months (95% CI 7.04 to 9.00). The median OS was not reached. Toxicity associated with bevacizumab manifested predominantly as arterial hypertension (3%), diarrhea (1,1%) and asthenia (0.9%). Nine (2.1%) SARs were observed; three (0.6%) of them (COVID-19, intestinal obstruction, multiple organ failure) resulted in mortality. The obtained results are well consistent with the previously known bevacizumab safety profile characteristics.
Conclusion. The interim analysis results confirm the favorable safety profile and high efficacy of Avegra® BIOCAD (INN: bevacizumab) combined with standard cytotoxic regimens (FOLFOX, XELOX, etc.) as first-line therapy in patients with metastatic colorectal cancer. The real-world data for ORR and PFS are comparable with clinical trials results. At the time of the interim analysis publication, the study is ongoing. Final conclusions on the safety and efficacy of bevacizumab (by JSC BIOCAD, Russia), will be made after the study is completed.
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##article.viewOnOriginalSite##About the authors
Alexey A. Tryakin
Blokhin National Medical Research Center of Oncology
Author for correspondence.
Email: atryakin@mail.ru
ORCID iD: 0000-0003-2245-214X
D. Sci. (Med.)
Russian Federation, MoscowMikhail Yu. Fedyanin
Blokhin National Medical Research Center of Oncology
Email: fedianinmu@mail.ru
ORCID iD: 0000-0001-5615-7806
D. Sci. (Med.)
Russian Federation, MoscowFedor V. Moiseenko
Saint Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology); Petrov National Medicine Research Center of Oncology
Email: moiseenkofv@gmail.com
ORCID iD: 0000-0003-2544-9042
D. Sci. (Med.)
Russian Federation, Saint PetersburgOleg V. Mironov
Tambov Regional Oncological Clinical Dispensary
Email: fedianinmu@mail.ru
Department Head
Russian Federation, TambovDaniil L. Stroyakovskiy
Moscow City Oncology Hospital №62
Email: d.stroiakovski@icloud.com
ORCID iD: 0000-0003-1973-1092
Cand. Sci. (Med.)
Russian Federation, MoscowNikolai Iu. Sokolov
Botkin Hospital
Email: atryakin@mail.ru
Cand. Sci. (Med.)
Russian Federation, MoscowSvetlana A. Orlova
Republican Clinical Oncological Dispensary
Email: lana.orlova_84@mail.ru
Department Head
Russian Federation, CheboksaryEvgenii O. Mantsyrev
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Email: atryakin@mail.ru
Cand. Sci. (Med.)
Russian Federation, ChelyabinskAlexander V. Sultanbaev
Regional Oncological Clinical Dispensary
Email: rkodrb@yandex.ru
ORCID iD: 0000-0003-0996-5995
Cand. Sci. (Med.)
Russian Federation, UfaAntonina A. Teterich
Belgorod Oncological Dispensary
Email: atryakin@mail.ru
Department Head
Russian Federation, BelgorodKseniia G. Babina
Volgograd Regional Clinical Oncological Dispensary
Email: atryakin@mail.ru
Department Head
Russian Federation, VolgogradDenis Yu. Yukalchuk
Regional Oncological Dispensary
Email: atryakin@mail.ru
oncologist
Russian Federation, AngarskStanislav M. Borzyanitsa
Rappoport Kuzbass Clinical Oncological Dispensary
Email: atryakin@mail.ru
oncologist
Russian Federation, KemerovoAlina Z. Isyangulova
Republican Clinical Oncological Dispensary
Email: atryakin@mail.ru
oncologist, chemotherapist
Russian Federation, KazanAleksandra F. Saidullaeva
Tver Regional Clinical Oncological Dispensary
Email: atryakin@mail.ru
oncologist
Russian Federation, TverYuliia A. Chernova
Tomsk Regional Oncological Dispensary
Email: atryakin@mail.ru
oncologist
Russian Federation, TomskElvira A. Bobrova
Loginov Moscow Clinical Scientific Center
Email: bobrovaelvira@yandex.ru
oncologist
Russian Federation, MoscowNatalia V. Fadeeva
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
Email: 89048082445@mail.ru
Cand. Sci. (Med.)
Russian Federation, ChelyabinskDmitrii Yu. Chobanu
JSC "BIOCAD"
Email: atryakin@mail.ru
Medical Advisor
Russian Federation, Saint PetersburgReferences
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