Phase II Study of Sunitinib Administered in a Continuous Once-Daily Dosing Regimen in Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Abstract

Sunitinib 37.5 mg, administered on a continuous once-daily dosing regimen, has a manageable safety profile as second-line mRCC therapy, providing flexible dosing, which can be explored in combination studies.

Alternate sunitinib schedules in patients with metastatic renal cell carcinoma

“…In this study, individual investigators were able to dose escalate patients with mild nonhematologic and mild-to-moderate hematologic AEs during the first 8 weeks of study to 50 mg/day. Sixteen patients were discontinued from this study because of AEs, and dosing was reduced to 25 mg/day in 46 patients due to grade 3/4 AEs [13]. Barrios et al conducted a phase II study testing 37.5 mg CDD in 119 treatment naïve patients.…”

Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer

“…Although CDD and Schedule 4/2 have not been compared head-to-head in one trial, subsequent trials of sunitinib using a CDD schedule in patients with RCC and with GIST indicate that this regimen is well tolerated, associated with broadly similar clinical activity to Schedule 4/2, and provides flexibility in dosing schedule (GIST: median PFS 34 weeks and 24 weeks for sunitinib on CDD and Schedule 4/2, respectively; RCC: median PFS 8.2 months for both sunitinib on CDD and Schedule 4/2) (Motzer et al, 2006(Motzer et al, , 2007George et al, 2007George et al, , 2009Escudier et al, 2009). Here we report the efficacy and safety of sunitinib 37.5 mg per day given as a CDD schedule in an additional cohort of patients, after failure of a platinum-based regimen.…”

Reply: Predictive factors for severe toxicity of sunitinib in unselected patients with advanced renal cell cancer

“…We agree that dose escalation needs to be considered in patients without side effects when aiming for a tumour response. The probability of a greater response and survival increases with higher drug exposure in metastatic renal cell cancer, although the survival of patients treated with lower sunitinib doses on a continuous daily base overlaps with that of patients treated with standard dosing (Escudier et al, 2009). The two cases mentioned by Dr Rezaei Kalantari are indeed interesting, because dose reduction was initially required because of a series of side effects.…”