Friday, January 26, 2007

Latest Cancer News

Noxavil® May be Superior for Prevention of Fungal Infections in Cancer Patients
According to two articles recently published in the New England Journal of Medicine, the anti-fungal agent Novaxil® (posaconazole) may be superior to other anti-fungals in cancer patients who are at a high risk for developing a fungal infection.

Fungal infections are responsible for a significant number of deaths among some cancer patients who undergo treatment associated with a drastic reduction in the amount of immune cells in their body (immunosuppressive therapy). These types of treatments, particularly high-dose therapy, leave patients susceptible to infection with bacteria, viruses, or fungus.

Furthermore, patients suffering from a condition referred to as graft-versus-host disease (GVHD)—a potential complication of a stem cell transplant—are often treated with agents that suppress the immune system. Even slight infections can quickly develop into life-threatening situations in these patients. Researchers continue to evaluate ways to prevent or reduce the severity of infections for these patients.

The first trial reported in the New England Journal of Medicine included 600 patients with graft-versus-host disease (GVHD) who were receiving therapy that suppressed their immune system. Patients were assigned to treatment with either Novaxil or Diflucan® (fluconazole), both anti-fungal agents, for the prevention of fungal infections.[1]

Invasive fungal infections (infections that spread throughout the body) occurred in 5.3% of patients treated with Novaxil, compared to 9% of patients treated with Diflucan.
Infection with aspergillosis (a common and potentially life-threatening type of fungal infection) occurred in 2.3% of patients treated with Novaxil, compared with 7% of patients treated with Diflucan.
The risk of death from fungal infections was just 1% among patients treated with Novaxil, compared with 4% among patients treated with Diflucan.
The researchers concluded that Novaxil appears to be superior to Diflucan in preventing fungal infections and more effectively reduces deaths caused by fungal infections among patients with GVHD who are receiving immunosuppressive therapy.

The second trial reported in the New England Journal of Medicine included patients with acute myelogenous leukemia or myelodysplastic syndrome who had low levels of immune cells (neutropenia) and were considered to be at a high risk of developing invasive fungal infections. This trial included approximately 600 patients who received anti-fungal therapy with either Novaxil or Diflucan or Sporanox® (itraconazole). Patients were treated with anti-fungal agents at the beginning of each chemotherapy cycle to reduce the risk of a fungal infection until they either achieved a complete disappearance of cancer and immune cell levels were restored to normal or they developed a fungal infection.[2]

Development of an invasive fungal infection occurred in 2% of patients in the Novaxil group, and 8% of patients in the Diflucan or Sporanox group.
Invasive aspergillosis occurred in only 1% of patients in the Novaxil group, compared with 7% of patients in the Diflucan or Sporanox group.
Survival was significantly improved among patients in the Novaxil group compared with those in the Diflucan or Sporanox group.
Serious side effects were reported in 6% of patients in the Novaxil group and 2% of patients in the Diflucan or Sporanox group.
The researchers from this trial concluded that Novaxil appears superior to Diflucan and Sporanox in preventing invasive fungal infections among patients with neutropenia who are undergoing chemotherapy.

Results from both of these trials indicate that Novaxil may be the anti-fungal of choice for cancer patients at a high risk of developing invasive fungal infections. However, it is important for all patients to discuss with their physician their individual risks and benefits of treatment with any anti-fungal agent.

References:

[1] Ullmann A, Lipton J, Vesole D, et al. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. New England Journal of Medicine. 2007; 356:335-347.

[2] Cornely O, Maertens J, Winston D, et al. Posaconazole vs. fluconazole or itraconazole prophylaxis in patietns with neutropenia. New England Journal of Medicine. 2007; 356:348-359.