ArticleESMO gastrointestinal oncology2025
Regorafenib and metronomic capecitabine, cyclophosphamide, and aspirin in refractory metastatic colorectal cancer: results from the REPROGRAM-01 single-arm phase II trial.
Article in ESMO gastrointestinal oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04534218 (Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II), which is not on this map. Not yet cited in PubMed.
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Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II
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Abstract
Background: Treatment of chemotherapy-resistant metastatic colorectal cancers (mCRCs) is still an unmet medical need. Combining regorafenib, an antiangiogenic multikinase inhibitor with metronomic chemotherapy and aspirin may enhance efficacy to circumvent the tumor microenvironment and offer better clinical outcomes. REPROGRAM-01 was a signal-seeking phase II study assessing the efficacy and safety of multimodal metronomic chemotherapy combined with regorafenib (NCT04534218). Patients and methods: mCRC patients involved were previously exposed to conventional chemotherapies, bevacizumab, anti-epidermal growth factor receptor (anti-EGFR) if Results: Forty-eight patients were included. No unexpected serious adverse event was reported and 10 patients discontinued regorafenib for toxicity. The most common grade 3 and 4 toxicities involved palmoplantar erythrodysesthesia (14.6%), diarrhea (6.3%), hypertension (4.2%), and lymphopenia (4.2%). The best ORR was 4.2% [95% confidence interval (CI) 0.8% to 12.5%]. The trial was negative on the primary endpoint aiming to achieve an ORR of 15%, compared with 4% for null hypothesis. Median PFS and OS were 4.7 months (95% CI 3.7-5.9 months) and 9.5 months (95% CI 7.2-14.9 months), respectively. The PFS rates at 6 months and 12 months were 32.5% and 6.5%, respectively. A decrease of NPY methylated circulating tumor DNA >50% occurred in 16 out of the 26 assessable patients, leading to a median PFS of 5.5 months (95% CI 3.7-9.5 months) versus 3.6 (95% CI 1.8-9.6 months). A median PFS of 7.2 months (95% CI 3.7-11.6 months) was achieved in patients with decreasing angiopoietin-2 (ANG2) levels compared with 3.9 months (95% CI 1.3-19.4 months) in ANG2 nonresponding patients. Conclusions: According to the REPROGRAM-01 study, combining multimodal metronomic chemotherapy with regorafenib would double the number of patients who could benefit from regorafenib treatment without increasing toxicities.
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