FDA Approved Drug, Sunitinib can Prevent Recurrence of Advanced Renal Cell Cancer

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Highlights:

• Sunitinib has been granted approval by the US FDA to reduce the risk of recurrence of renal cell carcinoma following surgery in adult patients at a high risk of recurrence
• Sunitinib appears to improve disease-free survival in these patients
• Its use is, however, associated with several side effects and reduced quality of life.

The U.S. Food and Drug Administration (FDA) has approved the use of the kinase inhibitor sunitinib to prevent the recurrence of kidney cancer in adults at a high risk of recurrence after the surgical removal of the diseased kidney.

The approval was based on the results of the S-TRAC clinical trial conducted on 615 patients with renal cell cancer who had undergone surgery for removal of the affected kidney and were at a high risk of recurrence. The patients were adults diagnosed with clear cell renal cell carcinoma at stage 3 or higher and/or had spread of the cancer to the regional lymph nodes. Some patients received sunitinib on a 4-weekly schedule with a break of two weeks in between, for a total duration of 1 year. Others received placebo for comparison. The scientists found that:

• Patients who received sunitinib had a longer median duration of disease-free survival of 6.8 years as compared to 5.6 years in the placebo group
• At three years, 64.9% in the sunitinib group and 59.5% in the placebo group were disease free, as defined in the study.
• At five years following the treatment, 59.3% patients in the sunitinib group and 51.3% in the placebo group were disease free
• Serious adverse events of grade 3 or higher occurred in 63.4% patients in the sunitinib group and 21.7% in the placebo group. The patients on sunitinib had a lower quality of life while on the treatment as compared to those on the placebo group.

About Sunitinib

Sunitinib is already being used for certain cases of gastrointestinal stromal tumors advanced renal cell carcinoma, and advanced pancreatic neuroendocrine tumors. It acts as a kinase inhibitor in addition to acting on several receptors that promote the growth of cancer cells.

‘The US FDA has approved sunitinib in adult patients who have undergone surgical removal of their kidney affected with renal cell cancer and are at a high risk for recurrence.’

As for other anticancer medications, sunitinib is also associated with several and sometimes serious adverse effects. It carries the risk of severe liver damage, which could even progress to liver failure and death. Other serious adverse effects include cardiovascular issues like heart failure, heart attack, abnormal heart rhythms and high blood pressure, skin reactions like necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis, blood-related disorders like bleeding and formation of small clots that reduce platelet counts, low blood sugar levels, loss of protein through the urine, thyroid problems, damage to the jaw bone, and problems with wound healing. The breakdown of the cancer cells by the treatment can result in a condition called tumor lysis syndrome. It should not be used in pregnant women.

About Renal Cell Carcinoma

Renal cell carcinoma is the most common type of kidney cancer. The chances of survival at 5 years are 53% in patients with spread of cancer to the local areas around the kidney (stage 3 cancer), and just 8% in those whom the cancer has spread to distant sites. Though patients who receive treatment early have good outcomes, up to 40% patients with advanced cancer have a relapse following surgical removal of the diseased kidney.

References:

1. FDA expands approval of Sutent to reduce the risk of kidney cancer returning - (https:www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585657.htm)
2. Ravaud A et al. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med 2016; 375:2246-2254

Source: Medindia

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