Source: DGNews  |  Posted 4 years ago

By Shazia Qureshi

PARIS, FRANCE -- February 8, 2008 -- Treatment with sorafenib and low-dose interferon alpha-2a resulted in a clinical benefit rate of about 80% in patients with metastatic renal cell carcinoma in a study presented here at the 19th International Congress on Anti-Cancer Treatment (ICACT).

The results of this randomised, prospective, phase 2 trial were presented here on February 5 by lead author Sergio Bracarda, MD, Specialist in Medical Oncology and Urology, Santa Maria della Misericordia Hospital, Perugia, Italy.

The researchers randomised 100 patients with metastatic renal cell carcinoma (with a clear-cell component of 50% or higher) to one of two study arms, each with a different dosing schedule of interferon alpha-2a. The median age of patients was 63 years (range 34-80 years), and 29% of all patients were women. All patients had previously undergone a nephrectomy and they had no cerebral metastases.

All patients were given 400 mg of sorafenib twice daily. Patients assigned to study arm A (n = 51) were given 9 MU of interferon alpha-2a subcutaneously 3 times a week. Patients in arm B (n = 49) received 3 MU of interferon-alpha-2a subcutaneously 5 times a week. In both groups, interferon treatment was started 7 days after the start of sorafenib treatment.

The results showed that an objective response was observed in 17.6% of patients in arm A and 34.7% of patients in arm B (P =.05). In arm A, 47.1% of patients achieved stable disease, compared with 44.9% of patients in arm B. Taken together, Dr. Bracarda said, there was a clinical benefit rate of 64.7% in arm A and 79.6% in arm B (P =.09).

The researchers found that in study arm A, the median progression-free survival was 7.9 months. It was 8.5 months in study arm B (P =.21).

The most commonly occurring severe adverse effects included hypophosphataemia, skin rash, fatigue, diarrhoea, leukopaenia, and thrombocytopenia.

Dr. Bracarda said that while sorafenib plus interferon is a combination that is currently used to treat metastatic renal cell carcinoma, the use of low-dose interferon with sorafenib is a new treatment option that shows good clinical benefit and good tolerability.

[Presentation title: Sorafenib in Combination With Interferon-alpha-2a for Metastatic Renal Cell Carcinoma: Results From a Randomized Prospective Phase II Trial of Two Different Treatment Schedules (RAPSODY; GOIRC Study 0681). Abstract OR 18]