Source: Urology  |  Posted 5 years ago

By Jill Stein

PARIS, FRANCE -- February 8, 2007 -- Sunitinib malate (Sutent) produces larger improvements in quality of life than interferon-alfa in patients with metastatic renal cell carcinoma, investigators reported here at the 18[^]th[] International Congress on Anti-Cancer Treatment (ICACT).

Joseph C. Cappelleri, PhD, director, biostatistics division, Global Research and Development, Pfizer Inc, Groton, Connecticut, presented the results of quality of life analyses from a recent phase 3 trial in a presentation on February 8[^]th.[]

In a previous analysis of data from this study, researchers found that sunitinib was associated with significantly increased progression-free survival compared with interferon-alfa in patients with metastatic renal cell carcinoma (N Engl J Med 2007;356(2):115-124).

In the present quality of life analysis, the researchers used both repeated measures mixed-effects models (MEM) and pattern-mixture models (PMM) to test the robustness of treatment effect on health-related quality of life (HRQoL).

The study included 750 patients who were randomized to treatment with either sunitinib in repeated 6-week cycles of 50 mg/day administered orally for 4 weeks followed by 2 weeks off treatment or subcutaneous interferon-alfa 3 times weekly on non-consecutive days at 3 MU per dose during the first week, 6 MU per dose the second week, and 9 MU per dose thereafter.

Quality of life was measured by the Functional Assessment of Cancer Therapy - General and Kidney Symptom Index, and with the EuroQol Group's EQ-5D self-report questionnaire. Higher scores denoted better outcomes for all endpoints. Patients completed questionnaires on days 1 and 28 of each cycle. Data were analyzed for up to 9 cycles of sunitinib treatment.

For all HRQoL endpoints, the overall post-randomization least-square means estimated by MEM favored sunitinib (all P <.01).

Also, the results from the PMM were generally consistent with the results from the repeated measures MEM.

"Overall, the results demonstrate that sunitinib outperforms alfa-interferon in providing important quality of life improvements in metastatic renal cell carcinoma," Dr. Cappelleri commented. "This is important because it means that sunitinib confers benefit beyond an improved progression-free survival."

Sunitinib malate is an oral, multi-targeted receptor tyrosine kinase inhibitor with both anti-tumor and anti-angiogenic effects.

Sunitinib has shown activity against a variety of tumors and has been approved in several countries for the treatment of imatinib-resistant or -intolerant gastrointestinal stromal tumors and for advanced and/or metastatic renal cell carcinoma.

The study was sponsored by Pfizer.

[Presentation title: Effects of Sunitinib Versus Interferon Alfa on Health-Related Quality of Life in Patients with Metastatic Renal Cell Carcinoma: Comparing the Results of Mixed-Effects and Pattern-Mixture Models. Abstract Number 325]