Efficacy and tolerability of a low-dose, 2-week administration of sunitinib followed by a week rest (2/1 schedule) for metastatic renal cell carcinoma: a single center experience of six cases

Abstract

BackgroundSunitinib, an oral multitarget tyrosine kinase inhibitor and standard first-line treatment for metastatic renal cell carcinoma (mRCC), is generally administered on a 6-week schedule (4 weeks on/2 weeks off). However, drug toxicity often leads to temporary treatment interruption, resulting in reduced treatment efficacy. In this report, we investigated whether sunitinib administration of at a dose of 25 mg/day in a 2-weeks-on/1-week-off cycle would reduce the incidence of drug-related side effects while maintaining drug efficacy.FindingsA total of six patients with mRCC were orally administered sunitinib at a dose of 25 mg/day in a 2-weeks-on/1-week-off regimen until intolerable toxicities occurred. All enrolled patients were assessed for toxicity and response. The median treatment period was 24 months (range, 9–40 months). Objective responses were as follows: disease stabilization of >6 months was achieved in all patients. The most important toxicities were neutropenia, fatigue, and proteinuria, but all were controlled.ConclusionsOral sunitinib at 25 mg/day in a 2-weeks-on/1-week-off regimen to Japanese patients can avoid drug-related toxicities while achieving the same dose intensity as a 6-week schedule. Because these data were derived from a small number of patients, future prospective studies of modified sunitinib administration schedules are warranted.

Efficacy and Safety of Regorafenib With 2/1 Schedule for Patients ≥ 75 Years With Metastatic Colorectal Cancer (mCRC) After Failure of 2 Lines of Chemotherapy

“…A small study showed a better toxicity profile for sunitinib in a 2-weeks-on/1-week-off regimen compared with the conventional 4/2 schedule, while maintaining the standard dose intensity. 17 Moreover, a large retrospective analysis reported a better tolerability and no decrease in efficacy for the patients with metastatic renal cell cancer who switched from the standard 4/2 to the modified 2/1 schedule of sunitinib owing to adverse events. 18 Despite the encouraging results of our analysis, the small size of the population is a limitation that prevents us from drawing general conclusions.…”

Sunitinib maleate administration before percutaneous CT-guided cryoablation for large renal cell carcinoma: A case report

“…Further studies are needed to confirm whether combined treatment of sunitinib maleate administration and CA is effective in other cases. Second, although we used a modified regimen of sunitinib maleate administration previously reported [8] , [9] , [10] , the appropriate regimen of sunitinib maleate administration before CA remains is unknown. Also, the proper timing of performing CA after the last sunitinib maleate administration is not established.…”

“…This CT finding was considered to correspond to poor embolic effects of TAE. Therefore, we administered sunitinib maleate before CA based on the literature previously published [8] , [9] , [10] . The regimen was 37.5 mg/day of sunitinib maleate for 2 weeks, with a rest of 1 week.…”

The impact of the national centralized drug procurement on the use of original and generic targeted anti- tumor drugs in Hohhot, China: an interrupted time-series analysis

“…Clinical studies have demonstrated that sunitinib has a considerably high occurrence rate of adverse reactions [25], while its optimal dosage and treatment cycle remain controversial [26,27]. Furthermore, the dosages recommended of sunitinib by international guidelines for Asian populations were lacking [28][29][30]. The side-effect pro le of the original and generic sunitinib has not been shown to differ clinically.…”