(RxWiki News) Currently, there’s no standard of care to treat kidney cancer that has spread to other parts of the body. A phase ll trial involving an existing drug may change that.
This is good news as the medication may offer patients with this form of kidney cancer new treatment options.
"Research clinical trials."
Bernard Escudier, MD, head of the French Group of Immunotherapy and chairman of the Genitourinary tumor board at the Institut Gustave Roussy in Villejuif, France, and colleagues in France, Germany, Italy, Spain, Poland and the UK worked with 92 patients with late-stage papillary kidney cancer.
Accounting for 15 percent of kidney cancer cases, papillary kidney cancer is five times more common in men than in women. Clear cell renal carcinoma is the more common type of kidney cancer.
Alexander Kutikov, MD, associate professor of urologic surgical oncology at Fox Chase Cancer Center in Philadelphia, PA, told dailyRx News, “Most investigations of targeted therapy have focused on patients with clear cell renal cell carcinoma, as clear cell RCC represents the vast majority of patients with advanced disease.”
Afinitor is already used to treat pancreas, kidney (advanced renal cell carinoma), brain and breast cancers. The medication targets a protein called mTOR (mammalian target of rapamycin) that regulates cell growth processes. Afinitor is known as an mTOR inhibitor.
Patients were enrolled in the RAPTOR (RAD001 in Advanced Papillary Tumor Program in Europe) study, which began in July 2009. Most of the participants were white males, and the average age was 60 years old.
None of the participants had received systemic treatment (chemotherapy) for their disease.
Participants took 10 mg of Afinitor by mouth once a day until the disease progressed or side effects became intolerable.
This study looked at progression-free survival (PFS) – the time during which a disease does not get worse.
Participants were divided into three groups – safety, which included all study members, intention-to-treat (ITT) – 83 participants and Per Protocol (PP) – 63 members.
Because PFS can be difficult to judge, this study used two evaluation methods. Local review was performed by scientists at the study sites. Central review was conducted by an independent group.
Study results varied based on the review methodology.
In the PP group, the six-month PFS rate was 58.7 percent according to local review and 34.9 percent per central review.
Median PFS in the PP group was 7.8 months per local review and 3.9 months per central review.
Median PFS in the ITT group was 7.6 months per local review and 3.7 months per central review.
Median overall survival was 21 months in the ITT group and 20 months in the PP group.
Serious adverse events included weakness, fatigue and anemia. More than a quarter (27.2 percent) of the participants had to leave the study due to adverse events.
“These [study] data add to further evidence that mTOR inhibitors, in this case everolimus, have clinically relevant activity in patients with advanced papillary disease.”
Results from this study were presented at the 2013 European Cancer Congress (ECC2013). Before publication in a peer-reviewed journal, all research is considered preliminary.
A number of the authors have financial ties with various pharmaceutical companies.