Is it necessary to add anti-angiogenic therapy to chemotherapy in patients with metastatic colorectal cancer and BRAF mutation? The systematic review and meta-analysis results

Федянин, М. Ю.; Полянская, Е. М.; Эльснукаева, Х. Х.-М.; Трякин, А. А.; Pokataev, I.; Ignatova, Ekaterina; Сергеев, Ю. С.; Bulanov, A.; Тюляндин, С. А.

doi:10.18027/2224-5057-2020-10-2-3

Cited by 3 publications

(2 citation statements)

References 19 publications

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“…The study confirmed poor prognosis of the CMS4 subtype (RR = 1.7, P = 0.021) and revealed that addition of cetuximab worsened patient survival for the CMS1 subtype ( P = 0.037)[ 74 ]. We could explain these results with fibroblast enrichment of the CMS1 subtype tumors, which decrease cetuximab activity due to the secretion of IL-16A and TGF-β[ 69 , 70 ]. These results might indicate low efficacy of cetuximab for the CMS1 subtype or bevacizumab high efficacy in the CALGB/SWOG 80405 study.…”

Section: Molecular Genetic Subtypes Of Colon Cancermentioning

confidence: 99%

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Clinical significance of molecular subtypes of gastrointestinal tract adenocarcinoma

Ignatova¹,

Козлов²,

Иванов³

et al. 2022

WJGO

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Adenocarcinomas of the gastrointestinal tract (esophagus, stomach, and colon) represent a heterogeneous group of diseases with distinct etiology, clinical features, treatment approaches, and prognosis. Studies are ongoing to isolate molecular genetic subtypes, perform complete biological characterization of the tumor, determine prognostic groups, and find predictive markers to the effectiveness of therapy. Separate molecular genetic classifications were created for esophageal adenocarcinoma [The Cancer Genome Atlas (TCGA)], stomach cancer (TCGA, Asian Cancer Research Group), and colon cancer (Colorectal Cancer Subtyping Consortium). In 2018, isolation of TCGA molecular genetic subtypes for adenocarcinomas of the gastrointestinal tract (esophagus, stomach, and colon) highlighted the need for further studies and clinical validation of subtyping of gastrointestinal adenocarcinomas. However, this approach has limitations. The aim of our work was to critically analyze integration of molecular genetic subtyping of gastrointestinal adenocarcinomas in clinical practice.

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Section: Molecular Genetic Subtypes Of Colon Cancermentioning

confidence: 99%

“…On the other hand, the CMS1 subtype is usually observed in right-sided tumors, which usually have BRAF gene mutations[ 61 ]. The addition of anti-angiogenic drugs in the first-line or second-line therapy significantly increases the survival of patients with BRAF mutations[ 57 , 70 ].…”

Section: Molecular Genetic Subtypes Of Colon Cancermentioning

confidence: 99%

Clinical significance of molecular subtypes of gastrointestinal tract adenocarcinoma

Ignatova¹,

Козлов²,

Иванов³

et al. 2022

WJGO

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Toxicity and efficacy of biosimilar bevacizumab in the second-line therapy for metastatic colon cancer in routine clinical practice: results of an independent observational study

Федянин

Моисеенко

Лядова

et al. 2021

Onkol. koloproktol.

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Objective: to compare the efficacy and tolerability of second‑line chemotherapy with original bevacizumab (Avastin) and biosimilar bevacizumab produced by “Biocad” (Avegra) in patients with metastatic colon cancer.Materials and methods. This retrospective observational study included patients with metastatic colon cancer treated in 9 clinics in the Russian Federation. Inclusion criteria were as follows: metastatic or locally advanced colon cancer and second‑line therapy with bevacizumab (Avastin or Avegra). The primary outcome measure was overall survival (OS). Secondary outcome measures included progression‑free survival (PFS), disease control rate (DCR), and incidence of adverse events associated with antiangiogenic therapy.Results. We identified 209 patients with metastatic colon cancer who received second‑line therapy with biosimilar bevacizumab (n = 37; 17.7 %) or original bevacizumab (n = 90; 43 %) or no targeted therapy (n = 82; 39.3 %) between 2014 and 2018. Patients in these three groups were matched for their main prognostic characteristics. The DCR was 59.5 % in the group of biosimilar bevacizumab, 58.9 % in the group of original bevacizumab, and 50 % in the control group (without targeted therapy). PFS was 6 months in the chemotherapy group and 8 months in the groups of bevacizumab (hazard ratio (HR) 0.77; 95 % confidence interval (CI) 0.65–0.91; p = 0.002); the difference in PFS between patients receiving biosimilar bevacizumab and original bevacizumab was insignificant (HR 1.3; 95 % CI 0.81–2.1; р = 0.3). Median OS was 16 months in the chemotherapy group, 30 months in the biosimilar bevacizumab group, and 20 months in the original bevacizumab group (HR 0.89; 95 % CI 0.72–1.1; р = 0.3). We observed a tendency to longer OS in patients receiving biosimilar bevacizumab (HR 0.44; 95 % CI 0.17–1.1; р = 0.08). Bevacizumab‑ associated toxicity was limited to arterial hypertension and was registered in 4 patients with only one patient who developed grade III hypertension.Conclusions. There was no significant difference in PFS between patients receiving biosimilar and original drug, while OS was higher in the group of biosimilar bevacizumab. Both medicines demonstrated similar toxicity. Therapy with biosimilar bevacizumab ensured lower incidence of hypertension and proteinuria compared to the original drug. An additional prospective observational study assessing the efficacy and tolerability of biosimilar bevacizumab in colon cancer patients is needed.

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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

et al. 2021

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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 (2887) years. Patients had an ECOG performance status of 01, 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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Is it necessary to add anti-angiogenic therapy to chemotherapy in patients with metastatic colorectal cancer and BRAF mutation? The systematic review and meta-analysis results

Cited by 3 publications

References 19 publications

Clinical significance of molecular subtypes of gastrointestinal tract adenocarcinoma

Clinical significance of molecular subtypes of gastrointestinal tract adenocarcinoma

Toxicity and efficacy of biosimilar bevacizumab in the second-line therapy for metastatic colon cancer in routine clinical practice: results of an independent observational study

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

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