Purpose: An open-label, matched-pair (by diagnosis, stage of disease, age, and gender) pilot clinical trial was conducted to test whether the combined administration of the medical nutriment MSC (Avemar) with cytotoxic drugs and the continued administration of MSC on its own help to reduce the incidence of treatment-related febrile neutropenia in children with solid cancers compared with the same treatments without MSC.
Methods: Between December 1998 and May 2002, 22 patients (11 pairs) were enrolled in this study. At baseline, the staging of the tumors was the same in each pair (mostly pTNM = T2N0M0), with the exception of two cases in which patients in the MSC group had worse prognoses (metastasis at baseline). There were no significant differences in the average age of the patients, the length of treatment time (MSC) or follow-up, the number of patients with central venous catheters, the number of chemotherapy cycles, the frequency of preventive counterneutropenic interventions, or the type and dosage of antibiotic and antipyretic therapy used in the two groups.
Results: During the treatment (follow-up) period, there was no progression of the malignant disease, whereas at end-point the number and frequency of febrile neutropenic events significantly differed between the two groups: 30 febrile neutropenic episodes (24.8%) in the MSC group versus 46 (43.4%) in the control group (Wilcoxon signed rank test, P < 0.05).
Conclusions: The continuous supplementation of anticancer therapies with the medical nutriment MSC helps to reduce the incidence of treatment-related febrile neutropenia in children with solid cancers.
From *Second Department of Pediatrics, School of Medicine, Semmelweis University, Budapest, Hungary; †Biometric Unit, School of Medicine, Semmelweis University, Budapest, Hungary; and ‡Jewish University, Budapest, Hungary.
Received for publication March 4, 2004;
accepted July 29, 2004.
This work was supported by BIO-00098/2000 from the Hungarian Government.
Dr. Babosa is deceased.
Reprints: Miklós Garami, MD, Head, Pediatric Oncology, Second Department of Pediatrics, School of Medicine, Semmelweis University, Tűzoltó u. 7-9, Budapest, Hungary, H-1094 (e-mail: firstname.lastname@example.org).