1. A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients.
- Author
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Lee, Valerie, Parkinson, Rose, Zahurak, Marianna, Cope, Leslie, Cercek, Andrea, Verheul, Henk, Gootjes, Elske, Lenz, Heinz Josef, Iqbal, Syma, Jones, Peter, Baylin, Stephen, Rami, Vandna, Ahuja, Nita, El Khoueiry, Anthony, and Azad, Nilofer S.
- Subjects
IRINOTECAN ,COLORECTAL cancer ,METASTASIS ,PROGRESSION-free survival ,REGORAFENIB - Abstract
DNA methyltransferase inhibitors (DNMTi) have demonstrated benefit in reversing resistance to systemic therapies for several cancer types. In a phase II trial of guadecitabine and irinotecan compared to regorafenib or TAS‐102 in pts with advanced mCRC refractory to irinotecan. Patients with mCRC refractory to irinotecan were randomized 2:1 to guadecitabine and irinotecan (Arm A) vs standard of care regorafenib or TAS‐102 (Arm B) on a 28‐day cycle. Between January 15, 2016 and October 24, 2018, 104 pts were randomized at four international sites, with 96 pts undergoing treatment, 62 in Arm A and 34 in Arm B. Median overall survival was 7.15 months for Arm A and 7.66 months for Arm B (HR 0.93, 95% CI: 0.58–1.47, P =.75). The Kaplan–Meier rates of progression free survival at 4 months were 32% in Arm A and 26% in Arm B. Common ≥Grade 3 treatment related adverse events in Arm A were neutropenia (42%), anemia (18%), diarrhea (11%), compared to Arm B pts with neutropenia (12%), anemia (12%). Guadecitabine and irinotecan had similar OS compared to standard of care TAS‐102 or regorafenib, with evidence of target modulation. Clinical trial information: NCT01896856. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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