The targeted agent Sutent® (sunitinib) provides superior quality of life compared with interferon alfa for patients with advanced renal cell carcinoma (RCC). These results were recently published in the August 1, 208 issue of Journal of Clinical Oncology.
Sutent is an oral kinase inhibitor of fms-like tyrosine kinase 3 (Flt3), Kit, VEGF, and PDGF receptors that is currently in clinical trials for treatment of a variety of malignancies. It produces anticancer effects through targeted mechanisms that include anti-angiogenesis, as well as direct killing of the cancer cell. In Phase I-II studies, Sutent demonstrated anti-tumor and anti-angiogenic activity in RCC, as well as other solid tumors. In January 2006 the U.S. Food and Drug Administration (FDA) approved the use of Sutent for the treatment of gastrointestinal stromal tumors (GIST) that had progressed after Gleevec® (imatinib mesylate) and for advanced RCC.
To compare Sutent with interferon in the initial treatment of metastatic RCC, researchers conducted a Phase III clinical trial among 750 patients. Patients were assigned to receive either Sutent or interferon.
Initial results from this study, published in 2007, indicated that patients treated with Sutent experienced significantly longer progression-free survival than patients treated with interferon. At the 2008 ASCO meeting, researchers provided updated results from this study; these updated results confirmed the benefits of Sutent that were reported previously:
- Progression-free survival was 11 months among patients treated with Sutent compared with five months among patients treated with interferon.
- Responses occurred in 47% of patients treated with Sutent compared with 12% of patients treated with interferon.
- Overall survival was 26.4 months among patients treated with Sutent compared with 21.8 months among patients treated with interferon. This result did not meet the criteria for statistical significance.
The most common serious (grade 3 or 4) adverse events among patients treated with Sutent were high blood pressure, fatigue, diarrhea, and hand-foot syndrome. The most common serious adverse events among patients treated with interferon were fatigue and loss of appetite. These results provided additional evidence that Sutent improves outcomes among patients with metastatic kidney cancer.
Researchers involved in the above summarized trial have now reported the comparison of quality of life between the two groups of patients. Three questionnaires were used to compare quality of life (QOL) among patients:
- The Functional Assessment of Cancer Therapy–Kidney Symptom Index–15 item (FKSI-15)
- The Functional Assessment of Cancer Therapy–General (FACT-G)
- The EuroQol Group's EQ-5D self-report questionnaire
The FKSI-15 questionnaire relates to issues including: lack of energy, fatigue, pain, bone pain, weight loss, shortness of breath, cough, fever, and blood in the urine (hematuria); the FACT-G questionnaire includes physical well-being [PWB], social/family well-being, emotional well-being, and functional well-being; the EQ-5D questionnaire relates to five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
QOL scores were all significantly improved across all three questionnaires among patients treated with Sutent compared with those treated with interferon-alfa.
The researchers concluded: “Sunitinib provides superior QOL compared with [interferon alfa] in [metastatic] RCC patients.”
Related News:
Study Confirms Efficacy of Sutent® for Initial Treatment of Metastatic Renal Cell Cancer (06/04/2008)
Sutent® Linked with Heart Problems (1/11/2008)
Sutent® Improves Progression-Free Survival Over Interferon in Kidney Cancer (1/18/2007)
Multicenter Trial Confirms Effectiveness of Sutent® for Treatment of Metastatic Renal Cell Carcinoma (6/23/2006)
Sutent® Approved by FDA for Treatment of Renal Cell Carcinoma and Gastrointestinal Stromal Tumor (4/4/2006)
Reference: Cella D, Li J, Cappelleri J, et al. Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a Phase III randomized trial. Journal of Clinical Oncology. 2008:26; 3763-3769.
