Safety and treatment patterns of multikinase inhibitors in patients with metastatic renal cell carcinoma at a tertiary oncology center in Italy

Abstract

BackgroundMultikinase inhibitors (MKIs) sunitinib and sorafenib have become a standard of care for metastatic renal cell carcinoma (mRCC). This study assessed safety and treatment patterns for these agents in a real-world clinical practice setting in Italy.MethodsA retrospective medical record review was performed at a tertiary oncology center in Italy. The study included MKI-naïve non-trial patients ≥18 years old, with a histological diagnosis of mRCC, and who received sunitinib or sorafenib as first MKI during 9/2005-7/2008. Data were collected on adverse events (AEs), treatment modifications (discontinuations, interruptions, dose changes), and reasons for these modifications.Results145 patients were included; 85 received sunitinib and 60 received sorafenib as first-line MKI. Median treatment duration was 6.6 (sunitinib) and 5.8 (sorafenib) months. 97.6% and 70.0% of patients receiving sunitinib and sorafenib, respectively, experienced ≥1 AE; 27.1% and 31.7% had ≥1 grade 3/4 AE. The most common any grade AE for sunitinib was fatigue/asthenia (81.2%), followed by mucositis/stomatitis (58.8%) and decreased taste sensation (42.4%), while for sorafenib this was fatigue/asthenia (43.3%) followed by hand-foot syndrome (38.3%) and diarrhea (31.7%). Treatment discontinuation, interruption, and dose reduction due to AEs occurred in 11.8%, 23.5%, and 30.6%, respectively, of patients receiving sunitinib, and 5.0%, 23.3%, and 36.7%, respectively, of patients receiving sorafenib.ConclusionsIn this retrospective study, most patients experienced ≥1 AE during first-line MKI treatment. AEs were reported frequently and resulted in treatment modifications in 40% of patients receiving sunitinib and 45% of patients receiving sorafenib. These results suggest a need for additional effective and more tolerable treatments for mRCC.

SWITCH: A Randomised, Sequential, Open-label Study to Evaluate the Efficacy and Safety of Sorafenib-sunitinib Versus Sunitinib-sorafenib in the Treatment of Metastatic Renal Cell Cancer

“…In the present study, more patients reached second-line therapy on protocol in the So-Su compared with the Su-So arm (57% vs 42%; p < 0.01). This is consistent with data from other studies suggesting that patients receiving sorafenib early in the treatment sequence are more likely to receive subsequent therapies than those receiving first-line sunitinib (34-38% for sorafenib vs 16-18% for sunitinib) [26,27]. The reasons for this difference are not clear.…”

Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients

“…Although grade 1 and 2 AE might have been underreported, a high proportion (39.6%) of patients experienced grade 3 or higher AEs. In our series, the rates of grade ≥3 fatigue, nausea, vomiting, and diarrhea are higher than those previously reported in both controlled and non-controlled studies (Table-4) (8)(9)(10)(11)(12). The high proportion of serious AE might be explained by the broader eligibility criteria.…”

Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first‐line sunitinib: a medical chart review across ten centers in five European countries

“…This study, which relied on data from medical charts from 291 treatment-na€ ıve patients across five countries in Europe, contributes to the growing body of knowledge regarding the tolerability and management of side effects for patients receiving first-line anti-angiogenic agents for the treatment of advanced RCC [4,5,[7][8][9][10][11][12][13][14][15]. The findings Includes all patients with at least 1 AE during the respective AE observation period.…”