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- Title
Metformin plus lrinotecan in patients with refractory colorectal cancer: a phase 2 clinical trial.
- Authors
Bragagnoli, Arinilda Campos; Araujo, Raphael L. C.; Ferraz, Mauricio Wagner; dos Santos, Lucas Vieira; Abdalla, Kathia Cristina; Comar, Fabiana; Santos, Florinda Almeida; Oliveira, Marco Antonio; Carvalheira, José Barreto Campello; Cárcano, Flávio Mavigner; da Silveira Nogueira Lima, João Paulo
- Abstract
<bold>Background: </bold>Patients with refractory colorectal (CRC) cancer have few treatment options. This trial tests the combination of metformin and irinotecan in this setting.<bold>Methods: </bold>A phase 2 single-arm trial was conducted, patients received metformin 2500 mg orally a day plus irinotecan 125 mg/m2 intravenously weekly D1 and D8 every 21 days. The primary endpoint was the disease control rate according to the Response Evaluation Criteria in Solid Tumors version 1.1 at 12 weeks.<bold>Results: </bold>Between December 2015 and January 2018, 41 patients were enrolled. Seventeen patients (41%) met the primary endpoint of disease control in 12 weeks; hence, the study was deemed positive. The median progression-free survival was 3.3 months (CI 95%, 2.0-4.5 months), and the median overall survival was 8.4 months (CI 95%, 5.9-10.8 months). Both mutation RAS status and disease control at 12 weeks impacted overall survival in the multivariate model (HR 2.28, CI 95%, 1.12-4.7, p = 0.02; and HR 0.21, CI 95%, 0.08-0.5, p = 0.001, respectively). The most common adverse event was diarrhoea (29.2% grade 3).<bold>Conclusions: </bold>In this trial, metformin plus irinotecan demonstrated disease control in patients with refractory CRC. Further trials with optimised diarrhoea control are needed to confirm these results.
- Subjects
THERAPEUTIC use of antineoplastic agents; SURVIVAL; RESEARCH; CLINICAL trials; RESEARCH methodology; CANCER relapse; PROGNOSIS; MEDICAL cooperation; EVALUATION research; COLORECTAL cancer; COMPARATIVE studies; METFORMIN; LONGITUDINAL method
- Publication
British Journal of Cancer, 2021, Vol 124, Issue 6, p1072
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-020-01208-6