Effectiveness and safety of Regorafenib in elderly patients with metastatic colorectal cancer / 中华老年医学杂志

ABSTRACT

Objective:To analyze the dosing, efficacy and safety of Regorafenib in elderly patients with metastatic colorectal cancer.Methods:Clinical data of 40 elderly patients with advanced colorectal cancer treated with regorafenib from June 2018 to October 2019 at Beijing Hospital were collected.The dosing, effectiveness and safety of regorafenib were retrospectively analyzed.The primary endpoint was overall survival(OS).Results:A total of 40 elderly patients were enrolled in this study, including 25 males and 15 females, with a median age of 66 years.The initial dose of Regorafenib was 80 mg, and the maintenance dose was 80 mg in 14(35.0%)patients, 120 mg in 20(50.0%)patients and 160 mg in 6(15.0%)patients.Thirty-one patients were treated with Regorafenib and 9 patients were given a combination therapy including Regorafenib.The objective response rate(ORR)was 2.5%(1 case), and the disease control rate(DCR)was 45.0%(18 cases). The median progression free survival(PFS)was 2.2 months(95% CI 2.1-4.0)and the median OS was 8.8 months(95% CI 7.1-11.2). There was no significant difference in PFS or OS in different maintenance dose groups( P<0.05). Patients who received 120 mg Regorafenib as a maintenance dose showed longest survival with a median OS of 9.8 months(95% CI 6.9-14.0). There was no difference in median OS between the Regorafenib group and the combination therapy group( χ2=0.1, P>0.05). Grade 3 and 4 adverse reactions occurred in 11 patients(27.5%). Common adverse reactions were hand-foot skin reaction, fatigue, hypertension, diarrhea, elevated transaminase levels and proteinuria. Conclusions:Regorafenib offers a good survival benefit for elderly patients with advanced colorectal cancer who failed to respond to standard therapy.The dosing strategy, starting with a low dose of Regorafenib and escalating gradually as tolerance builds up, is recommended for elderly patients, when both efficacy and safety are considered.The proportion of patients who can tolerate 120 mg Regorafenib as a maintenance dose is high with relatively long overall survival, indicating it is appropriate for the elderly.