The US Food and Drug Administration (FDA) has approved sunitinib malate (Sutent, Pfizer) for the adjuvant treatment of renal cell carcinoma in patients who are at high-risk of disease recurrence after a nephrectomy.
“This is the first adjuvant treatment approved for patients with renal cell carcinoma, which is significant because patients with this disease who have a nephrectomy are often at high risk of the cancer returning,” said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press statement.
“There is now an approved therapy for patients who previously did not have options to potentially reduce cancer recurrence,” he added.
An oral therapy, sunitinib was previously approved in 2006 for the treatment of advanced renal cell carcinoma. It is an antiangiogenic therapy that acts as a vascular endothelial growth factor (VEGF) pathway inhibitor.
The new approval is based on results from the Sunitinib as Adjuvant Treatment for Patients at High Risk of Recurrence of Renal Cell Carcinoma Following Nephrectomy (S-TRAC) Trial. The results were presented last year at the European Society for Medical Oncology (ESMO) Congress and simultaneously published in 2016 in The New England Journal of Medicine.
Participating patients had locoregional renal-cell carcinoma (tumor stage 3 or higher, regional lymph-node metastasis, or both) on the basis of modified University of California Los Angeles Integrated Staging System (UISS) criteria.
In the phase 3 randomized trial, which was sponsored by Pfizer, the 5-year rate of disease-free survival was 59.3% in the sunitinib group and 51.3% in the placebo group.
The median duration of disease-free survival was 6.8 years in the sunitinib group and 5.6 years in the placebo group (hazard ratio, 0.76; P=0.03), according the published results.
Disease-free survival was the primary outcome and was defined as tumor recurrence, the occurrence of metastasis or a secondary cancer or death.
Patients received sunitinib (50 mg per day) on a 4-weeks-on, 2-weeks-off schedule for 1 year. The efficacy data listed here were from a blinded independent central review.
Dose reductions related to adverse events were more frequent in the sunitinib group than in the placebo group (34.3% vs. 2%) and so were dose interruptions (46.4% vs. 13.2%) and discontinuations (28.1% vs. 5.6%).
Grade 3 or 4 adverse events were more common with sunitinib (48.4% for grade 3 events and 12.1% for grade 4 events) than placebo (15.8% and 3.6%, respectively). No deaths were attributed to toxicities.
The common side effects of sunitinib include fatigue, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia, dyspepsia, and thrombocytopenia, according to the FDA.
The results from S-TRAC were in contrast to another trial in the adjuvant setting, ASSURE, which, as reported by Medscape Medical News, showed that neither sorafenib (Nexavar, Bayer) nor sunitinib prolonged disease-free survival (DFS) in patients with resected, locally advanced renal cell carcinoma.
Women who are pregnant should not take sunitinib because it is teratogenic.
The labeling for sunitinib contains a boxed warning to alert healthcare professionals and patients about the risk of severe hepatoxicity, which may result in liver failure or death.
Sunitinib is also previously approved for the treatment of certain patients with gastrointestinal stromal tumors and for patients with pancreatic neuroendocrine tumors (NETs).
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