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Itraconazole and Amphotericin B To Treat Fungal Infections in Patients with Cancer Who Are Receiving Chemotherapy FREE

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The summary below is from the full report titled “Intravenous and Oral Itraconazole versus Intravenous Amphotericin B Deoxycholate as Empirical Antifungal Therapy for Persistent Fever in Neutropenic Patients with Cancer Who Are Receiving Broad-Spectrum Antibacterial Therapy. A Randomized, Controlled Trial.” It is in the 18 September 2001 issue of Annals of Internal Medicine (volume 135, pages 412-422). The authors are M Boogaerts, DJ Winston, EJ Bow, G Garber, AC Reboli, AP Schwarer, N Novitzky, A Boehme, E Chwetzoff, K De Beule, and the Itraconazole Neutropenia Study Group.


Ann Intern Med. 2001;135(6):S39. doi:10.7326/0003-4819-135-6-200109180-00005
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What is the problem and what is known about it so far?

When patients with cancer receive chemotherapy (drugs used to kill cancer cells), normal cells in the bone marrow are often temporarily damaged or destroyed. Since the bone marrow produces cells that fight infection (white blood cells, or leukocytes), chemotherapy often increases susceptibility to infection. These infections are usually due to bacteria or fungi. It is often difficult to determine which organism has caused infection. Fungi are difficult to treat and often cause fatal complications, unless treatment is started early or before infection starts. Patients with low white blood cell counts due to chemotherapy and suspected fungal infection usually receive amphotericin B. Although 43% to 72% of these patients improve while taking this drug, bad side effects occur in 35% to 82%. An effective, less toxic, alternative treatment would be helpful.

Why did the researchers do this particular study?

To determine whether itraconazole is as good as amphotericin B in treating possible fungal infections in patients with cancer who are receiving chemotherapy.

Who was studied?

384 patients with cancers of the blood (from 10 countries) who had received chemotherapy. Patients had to have fever, a low white blood cell count, and at least 3 days of previous antibiotic therapy.

How was the study done?

Patients were assigned to receive amphotericin B or itraconazole. Amphotericin B was given intravenously. Itraconazole was first given intravenously and then by mouth. Treatment outcome was considered good if fever disappeared and the white blood cell count became high enough to ward off infection. Treatment failure occurred if the patient had progressive fungal infection, died of any cause after 3 days of therapy, had continued fever, or needed to change therapy because of poor response or side effects. The two drugs were judged equivalent if the difference in response to treatment was no larger than 15%.

What did the researchers find?

Treatment was successful in 47% of patients receiving itraconazole and 38% receiving amphotericin B. Eleven percent of patients taking itraconazole and 14% of those taking amphotericin B died. Significantly fewer patients who took itraconazole (19%) than those who took amphotericin B (38%) had to stop therapy because it had toxic effects. However, 19 patients taking itraconazole but only 1 patient taking amphotericin B had to change medications because of continuing fever. Itraconazole had fewer side effects than amphotericin B.

What are the limitations of the study?

Three quarters of patients in both groups had received oral antifungal drugs to prevent fungal infections before the study began. Both the researchers and the patients knew which drug was being given, and this may have affected some judgments. Since specific fungus infections were not confirmed by the laboratory, the researchers cannot be certain that one drug is more effective than the other in treating a particular fungal infection.

What are the implications of the study?

Itraconazole appears as effective as amphotericin B in cancer patients at risk for fungal infections during chemotherapy. It also has fewer side effects and can be given orally after initial intravenous therapy.

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