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MINOAS: A Single-arm Translational Phase II Trial of FOLFIRI Plus Aflibercept as First-line Therapy in Unresectable,
Alexios Matikas1, John Souglakos1, Panagiotis Katsaounis1
1Hellenic Oncology Research Group (HORG), 55 Lombardou St, 11474, Athens, Greece.
Background:
FOLFIRI/aflibercept is approved as a second-line treatment in metastatic colorectal cancer (mCRC) but there are limited data for its use as a first-line treatment.
Objective:
To investigate the activity and safety of first-line FOLFIRI/aflibercept in mCRC, as well as to prospectively evaluate biomarkers of early response to treatment.
Patients And Methods:
MINOAS was a phase II trial that aimed to evaluate the activity and toxicity of first-line FOLFIRI/aflibercept in mCRC. The primary endpoint was objective response rate (ORR). The secondary endpoints were toxicity, progression-free survival (PFS), overall survival (OS), and the evaluation of CEACAM-positive circulating tumor cells (CTC) and diffusion-weighted (DW)-MRI as biomarkers.
Results:
Thirty-one patients were enrolled and 259 chemotherapy cycles were administered. At the time of the preplanned interim analysis, all patients had discontinued treatment and the ORR was 61.3%, crossing the activity threshold for trial discontinuation. Median PFS was 8.4 months (95% CI 7.8-9.0). Median OS had not been reached. There was one toxic death due to sepsis; grade 3/4 adverse events included neutropenia (n = 5), diarrhea (n = 6), hypertension (n = 4), asthenia (n = 3), proteinuria (n = 1), and bowel perforation (n = 1). Retaining CTC-negative status predicted better OS compared to continuous detection of CTCs (p = 0.015). Early decrease of the apparent diffusion coefficient (ADC) in DW-MRI was associated with an objective response.
Conclusion:
The activity and safety of first-line FOLFIRI/aflibercept merit further evaluation in randomized studies. CLINICALTRIALS.
Gov Registration Number:
NCT02624726.
Insights
First-line FOLFIRI/aflibercept shows promising activity in metastatic colorectal cancer (mCRC), with a 61.3% objective response rate. Further randomized studies are warranted to confirm its efficacy and safety in this patient population.
Area of Science:
- Oncology
- Medical Research
- Clinical Trials
Background:
- FOLFIRI/aflibercept is an established second-line treatment for metastatic colorectal cancer (mCRC).
- Limited data exist regarding its efficacy and safety as a first-line therapy for mCRC.
Purpose of the Study:
- To evaluate the activity and safety of first-line FOLFIRI/aflibercept in patients with mCRC.
- To prospectively assess biomarkers, including circulating tumor cells (CTCs) and diffusion-weighted magnetic resonance imaging (DW-MRI), for early response prediction.
Main Methods:
- A phase II trial (MINOAS) enrolled 31 patients with mCRC.
- The primary endpoint was objective response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS), overall survival (OS), CTC analysis, and DW-MRI.
- Patients received FOLFIRI plus aflibercept as first-line treatment.
Main Results:
- The interim analysis revealed an ORR of 61.3%, exceeding the threshold for trial discontinuation.
- Median PFS was 8.4 months; median OS was not reached.
- Key adverse events included neutropenia and diarrhea; one toxic death occurred.
- Negative CTC status and early decrease in apparent diffusion coefficient (ADC) on DW-MRI were associated with improved outcomes.
Conclusions:
- First-line FOLFIRI/aflibercept demonstrates significant activity and a manageable safety profile in mCRC.
- Biomarkers such as CTC status and DW-MRI may predict treatment response.
- Further investigation in randomized clinical trials is recommended.
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