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Targeted drugs for mRCC effective in first-line treatment
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The oral, multi-kinase angiogenesis inhibitors pazopanib and sunitinib demonstrated similar effectiveness in controlling metastatic renal cell carcinoma, according to results of the COMPARZ trial.
Pazopanib (Votrient, GlaxoSmithKline) and sunitinib (Sutent, Pfizer) are targeted drugs available for first-line treatment of metastatic renal cell carcinoma (mRCC). Although sunitinib is considered the standard treatment, results of previous trials suggest pazopanib has similar efficacy with fewer adverse events, according to background information in the study.
In the COMPARZ trial — a randomized, open label, phase 3 trial — researchers compared the efficacy, safety and tolerability of the two drugs.
Robert J. Motzer, MD, medical oncologist at Memorial-Sloan Kettering Cancer Center, and colleagues enrolled 1,110 patients with clear cell mRCC.
The researchers randomly assigned patients to 800 mg of pazopanib daily (n=557) or 50 mg sunitinib once daily (n=553). Treatment was in 6-week cycles (4 weeks on, 2 weeks off).
PFS served as the primary endpoint.
Study results showed similar PFS for patients assigned to pazopanib (10.5 months) and sunitinib (10.2 months; HR=0.998; 95% CI, 0.898-1.219). Median OS also was similar between the two study arms (28.4 months for pazopanib vs. 29.3 months for sunitinib; HR=0.91; 95% CI, 0.76-1.08).
“The trial showed that pazopanib had similar efficacy (non-inferiority) compared to sunitinib in first-line treatment of mRCC,” Motzer said in a press release.
The researchers also evaluated other secondary endpoints, including response, OS, safety and quality of life.
The results suggested improved tolerability for pazopanib over sunitinib, Motzer said.
Researchers found statistically significant differences in 11 of the 14 quality-of life-subsets — such as fatigue, diarrhea and skin sores — all of which favored pazopanib.
Maria De Santis, MD, a medical oncologist with Kaiser Franz Josef-Spital in Vienna and chair of the ESMO 2012 genitourinary program track, said the results were “urgently awaited.”
“The COMPARZ trial allows us to define a standard option in the front-line treatment of renal cell carcinoma, because it was proven that pazopanib is non-inferior to sunitinib,” De Santis said in a press release. “In addition, being treated with pazopanib, patients experienced fewer troublesome side-effects and an increased quality of life.”
For more information:
Motzer JM. Abstract #LBA8_PR. Presented at: 2012 European Society for Medical Oncology Congress; Sept. 28 – Oct. 2, 2012; Vienna, Austria.
Disclosure: The researchers report lecture fees or research funding from, advisory or employment relationships with, or stock ownership in GlaxoSmithKline, Pfizer, Novartis, Genentech, Aveo, Bayer and Onyx.