A phase II study of dose-escalation of regorafenib for patients with previously treated metastatic colorectal cancer – DEREGULATE study - Trial in progress

Abstract

management of metastatic colorectal cancer remains the best significantly improves overall 5-year survival. There are two wellapproaches of surgical treatment of patients with synchronous colorecsis. The former includes synchronous resection of the colorectal priresection of the liver metastases and the latter is a staged h. However, at present the issue of feasibility and effectiveness of ions for metastatic liver lesions in patients with synchronous metacancer (SMCLC) is negotiated and remains uncertain. This study the surgical outcomes and survival benefit between synchronous of the colorectal liver metastases. of 144 patients with colorectal cancer and synchronous liver metastases 2008-2017. There were two groups of patients. Fifty-eight A were undergone synchronous liver and colon resection whereas from group B -staged resection of colon and liver, respectively. 3-year survival in group A with synchronous resections was 41% and 50% (h>0.001). There were no significant differences in overall level of ons in the groups A and B after surgical stages finishing, and 36.1%(n ¼ 52), respectively (h>0.001). Shorter duration of the in the group A -316.3 (610.3) min in comparison with the 18.3) min (h<0.001). Patients after staged resection stayed longer in bed-days, then those who undergone synchronous resections -(p < 0.001) provided with shorter recovery terms in post-operative of our research has indicated necessity of the development of difch in SMCLC surgical treatment. Subsequent research should be study of prognosis factors and criteria for patients' selection for surgiassessment of economic efficacy and patients' life quality.

Optimizing Regorafenib Dosing and Patient Management in Colorectal Cancer in Latin America: Perspectives from Argentina

“…Recent results from the randomized, phase II REARRANGE study provide additional support to first‐cycle flexible dosing by demonstrating numerical improvements in relevant AEs including fatigue, HFSR, and hypertension without negatively impacting efficacy with a lower starting dose of 120 mg/day in Cycle 1 [19]. A single‐arm, phase II, dose escalation study (DEREGULATE) of regorafenib (80 mg/day starting dose with escalation considered every 2 weeks during the course of treatment) in Japanese patients with mCRC is ongoing [20]. These findings have the potential to change treatment practice by offering physicians an alternative strategy that may help mitigate toxicities and ensure continued treatment.…”