42nd Annual Meeting: Sunitinib Superior to Interferon-a in Metastatic Kidney Cancer

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Speaker: Robert J. Motzer, MD, Attending Physician, Memorial-Sloan Kettering Cancer Center, New York, New York

Sunitinib maleate (Sutent, Pfizer), an oral tyrosine kinase inhibitor that targets a number of kinase enzymes (including vascular endothelial growth factor receptor [VEGFR]), demonstrated a statistically significant improvement in progression­free survival and objective response rate when compared with interferon-a (Roferon, Roche) as first-line therapy in patients with metastatic renal cell cancer (MRCC).

Although the standard treatment for kidney cancer is either interferon-a or interleukin-2 (Proleukin, Chiron), both of which are immune therapies, the two treatment approaches are associated with a low response rate. On the basis of two recent phase 2 trials of sunitinib monotherapy, the Food and Drug Administration (FDA) approved the drug as a second-line treatment for advanced renal cell cancer, the most common type of kidney cancer. tadalis sx

With these findings in mind, a phase 3, international, randomized trial was conducted to compare sunitinib and inter-feron-a as a first-line systemic therapy for patients with MRCC. A total of 750 patients with advanced clear-cell MRCC and no previous chemotherapy were randomly assigned to receive either sunitinib 50 mg orally once daily for four weeks, followed by two weeks off, in six-week cycles, or interferon-a, given as a subcutaneous injection of 99 million international units (MU) three times weekly in six-week cycles.

The primary endpoint of the trial was progression-free survival. Secondary endpoints included objective response rate, overall survival, and ADEs.

Median progression-free survival, as assessed by a third-party independent review, was 47.3 weeks with sunitinib and 24.9 weeks with interferon-a. The objective response rate was 35.7% with sunitinib and 8.8% with interferon-a.

The study was conducted from August 2004 to October 2005. As of June 2006, 632 patients (85%) were alive; 49 sunitinib patients died (13%), and 65 patients in the interferon-a arm died (17.3%).

HPV Vaccine Shows Benefits in Preventing Vaginal and Vulvar Cancers

Speaker: Jorma Paavonen, MD, Professor and Chief Physician, Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland

Quadrivalent human papillomavirus (HPV) L1 virus-like particle (VLP) vaccine (Gardasil, Merck & Co.) prevented types HPV 16-related and HPV 18-related vaginal and vulvar high-grade precancerous lesions for at least two years after immunization. These findings support the prophylactic efficacy of the vaccine in preventing HPV 16-related and HPV 18-related vaginal and vulvar cancers.
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Initially, the vaccine had been developed to target four strains of HPV: HPV 16 and 18 are linked to cervical cancer, and HPV 6 and 11 cause anogenital warts. On June 6, 2006, the FDA approved the vaccine for the prevention of HPV-related cervical cancer.

This study, called FUTURE II, combined data from the clinical trials evaluating the HPV vaccine in 18,150 women from North and South America, Europe, and Asia. The women received either quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine or placebo. Vaccinations were given on day one and at the second and sixth months. Genital tract specimens were obtained on day one and at 6- to 12-month intervals thereafter, for a maximum of 48 months.

Cytologic and histologic examinations and tests to detect HPV were conducted at a centrally located laboratory. Biopsy specimens were HVP-typed. In the per-protocol analysis, women received three doses of vaccine and had no major protocol violations; they were HPV 16-seronegative or HPV 18-seronegative on day one and HPV 16-negative or HPV 18 DNA-negative on day one through the seventh month.

The primary endpoint of the study was the impact of the vaccine on the rates of HPV 16-related and 18-related vulvar intraepithelial neoplasia (VIN) grade 2 or 3 and vaginal intra-epithelial neoplasia (VaIN) grade 2 or 3.
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In the per-protocol analysis, after an average of 18 months of follow-up, the vaccine was 100% effective in preventing HPV 16-related or 18-related VIN grade 2 or 3 or VaIN grade 2 or 3. There were 10 cases of high-grade vulvar or vaginal lesions in the placebo group and none in the group of women given the HPV vaccine.

In the modified intent-to-treat (mITT) group (women who received one or more doses of HPV vaccine and were HPV 16-seronegative or HPV 18-seronegative at day one according to serologic and DNA testing), after an average of two years, 24 women taking placebo had histologically confirmed HPV 16-related or 18-related VIN grade 2 or 3 or VaIN grade 2 or 3. No viral infections were observed for the women who had received at least one or more doses of HPV vaccine.
Overall, protection with the HPV vaccine was 100%.