MINOAS: A Single-arm Translational Phase II Trial of FOLFIRI Plus Aflibercept as First-line Therapy in Unresectable, Metastatic Colorectal Cancer

Matikas, Alexios; Souglakos, John; Katsaounis, Panagiotis; Κotsakis, Athanasios; Kouroupakis, Panagiotis; Pantazopoulos, Nikolaos; Kentepozidis, Nikolaos; Nikolaidi, Adamantia; Messaritakis, Ippokratis; Tzovara, Ioanna; Hatzidaki, Dora; Prinarakis, Efthymis; Georgoulias, Vassilis

doi:10.1007/s11523-019-00647-3

Cited by 11 publications

(25 citation statements)

References 34 publications

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“…There was one toxic death due to sepsis. Grade 3/4 AEs included neutropenia (16.1%), diarrhea (19.4%), hypertension (12.9%), asthenia (9.7%), proteinuria (3.2%) and bowel perforation (3.2%) [21].…”

Section: European and Us Studiesmentioning

confidence: 99%

Safety of Aflibercept in Metastatic Colorectal Cancer: A Literature Review and Expert Perspective on Clinical and Real-World Data

Muro

Salinardi

Singh

et al. 2020

Cancers

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Background: Metastatic colorectal cancer (mCRC) represents a substantial health burden globally and an increasing challenge in Asian countries. Treatment options include chemotherapy plus a vascular endothelial growth factor (VEGF) inhibitor (such as bevacizumab, aflibercept or ramucirumab), or anti-epidermal growth factor receptor (EGFR) therapies. Aflibercept, a recombinant fusion protein, has been approved for treatment of mCRC in combination with FOLFIRI for patients whose disease progresses during or after treatment with an oxaliplatin-containing regimen, based on its efficacy and tolerability profile in clinical trials. This report aims to provide an overview of both clinical and real-world evidence and experience on the use of aflibercept in routine clinical practice, with a focus on European, American and Asian populations. Methods: A literature search was conducted in PubMed (on 28th February 2019) using the search terms ("aflibercept") and ("Colorectal"OR"CRC") to identify publications containing information on aflibercept-containing regimens. Results: The adverse events (AE) profile was similar between geographical locations. Across trials, real-world and retrospective studies, grade ≥ 3 hypertension and proteinuria were amongst the most frequently reported AEs. Conclusions: The safety profile of aflibercept is generally manageable and comparable across various geographic locations.

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Section: European and Us Studiesmentioning

confidence: 99%

Safety of Aflibercept in Metastatic Colorectal Cancer: A Literature Review and Expert Perspective on Clinical and Real-World Data

Muro

Salinardi

Singh

et al. 2020

Cancers

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“…Aflibercept addition to mFOLFOX for six cycles, followed by maintenance and oxaliplatin reintroduction at progression, gained PFS 9.3 months (33). Aflibercept/FOLFIRI reached ORR 61.3% and PFS 8.4 months (34). Aflibercept/FOLFIRI for 12 cycles followed by aflibercept maintenance gained ORR 46.6%, PFS 8.4 months, and OS 20.9 months (35).…”

Section: Discussionmentioning

confidence: 99%

Relevance of Pharmacogenomics and Multidisciplinary Management in a Young-Elderly Patient With KRAS Mutant Colorectal Cancer Treated With First-Line Aflibercept-Containing Chemotherapy

et al. 2020

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Intensive oncological treatment integrated with resection of metastases raised the clinical outcome of metastatic colorectal cancer (MCRC). In clinical practice, complex evaluation of clinical (age, performance status, comorbidities), and biological (tumoral genotype, pharmacogenomic) parameters addresses tailored, personalized multidisciplinary treatment strategies. Patients with MCRC unsuitable for first-line intensive medical treatments are prevalent and showed worse clinical outcome. After progression to oxaliplatin-based chemotherapy, aflibercept/FOLFIRI significantly improved clinical outcome, even if no survival benefit was reported in adjuvant fast relapsers by aflibercept addition. The case reported a young-elderly (yE) patient with KRAS mutant colorectal cancer rapidly progressing to adjuvant chemotherapy, unfit owing to comorbidities, with multiple pharmacogenomic alterations, who gained long-term survival in clinical practice by multidisciplinary treatment strategy consisting of first-line and re-introduction of aflibercept-containing chemotherapy and two-stage lung metastasectomies. Case presentation: A 71-years-old yE patient, unfit for intensive oncological treatments owing to Cumulative Illness Rating Scale (CIRS) stage secondary, affected by KRAS c.35 G>T mutant colorectal cancer, rapidly progressing with lung metastases after adjuvant XelOx chemotherapy, reached long-term survival 66 months with no evidence of disease after first-line and re-introduction of tailored, modulated aflibercept (4 mg/kg) d1,15-irinotecan (120 mg/m 2) d1,15-5-fluorouracil (750 mg/m 2 /day) dd1-4, 15-18; and secondary radical bilateral two-stage lung metastasectomies. Safety profile was Conclusions: In clinical practice, a complex management evaluating clinical parameters and RAS/BRAF genotype characterizing an individual patient with MCRC, particularly elderly and/or unfit owing to comorbidities, is required to properly address tailored, multidisciplinary medical and surgical treatment strategies, integrated with careful monitoring of superimposing toxicity syndromes, also related to pharmacogenomic alterations, to gain optimal activity, and long-term efficacy.

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“…In ing studies fulfilled the eligibility criteria and were included in the meta-analysis, including three randomized controlled trials [15][16][17] and seven single-arm clinical trials. [18][19][20][21][22][23][24] The literature review and identification process were shown in Figure 1. The meta-analysis evaluated the efficacy and toxicity of the aflibercept plus chemotherapy regimen for a total of 2049 patients with mCRC across ten clinical studies.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…The meta-analysis evaluated the efficacy and toxicity of the aflibercept plus chemotherapy regimen for a total of 2049 patients with mCRC across ten clinical studies. [15][16][17][18][19][20][21][22][23][24] The age of the patients ranged from 18.2 to 86 years, with a male predominance (59.49%). Baseline clinical characteristics of these patients were summarized in Table 1.…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

Efficacy and safety of aflibercept plus chemotherapy in metastatic colorectal cancer: A systematic review and PRISMA‐Compliant single‐arm Meta‐Analysis of noncomparative clinical studies and randomized controlled trials

Reyila

et al. 2022

Clinical Pharmacy Therapeu

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What is known and Objective Aflibercept, a recombinant protein designed to suppress the vascular endothelial growth factor (VEGF) signalling pathway, has been used in patients with metastatic colorectal cancer (mCRC). We conducted the first meta‐analysis to systematically review the efficacy and safety of aflibercept in mCRC. Methods PubMed Central/Medline, Embase and cochrane library were systematically searched for randomized controlled trials and single‐arm clinical trials on aflibercept plus chemotherapy for the treatment of mCRC through 9 September 2021. Results Ten studies comprising 2049 patients met the inclusion criteria. The pooled estimate rates were 16.0% for 12mPFS, 64.4% for 12mOS, 32.5% for ORR, 83.5% for DCR, while the rates of III/IV AEs rate were 80.2% respectively. The pooled estimate rates were 16.8% for III/IV diarrhoea, 22.3% for III/IV hypertension, 29.5% for III/IV neutropenia, 7.3% for III/IV proteinuria and 8.6% for III/IV oral mucositis. Conclusions Analysis of data from randomized controlled trials(RCT) and single‐arm clinical trials confirmed the good efficacy of aflibercept plus chemotherapy in mCRC, while the safety of the treatment is concerning.

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MINOAS: A Single-arm Translational Phase II Trial of FOLFIRI Plus Aflibercept as First-line Therapy in Unresectable, Metastatic Colorectal Cancer

Cited by 11 publications

References 34 publications

Safety of Aflibercept in Metastatic Colorectal Cancer: A Literature Review and Expert Perspective on Clinical and Real-World Data

Safety of Aflibercept in Metastatic Colorectal Cancer: A Literature Review and Expert Perspective on Clinical and Real-World Data

Relevance of Pharmacogenomics and Multidisciplinary Management in a Young-Elderly Patient With KRAS Mutant Colorectal Cancer Treated With First-Line Aflibercept-Containing Chemotherapy

Efficacy and safety of aflibercept plus chemotherapy in metastatic colorectal cancer: A systematic review and PRISMA‐Compliant single‐arm Meta‐Analysis of noncomparative clinical studies and randomized controlled trials

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