Objectives: In this pilot randomized clinical trial the preventive effects of weekly granulocyte colonystimulating factor (GCSF) injection for patients with central nervous system (CNS) tumors receiving craniospinalirradiation were assessed with regard to risk of treatment interruption.
Methods: We randomized 40 CNS cancerpatients into two groups (20 patients each), the first receiving GCSF prevention therapy before weekly craniospinalradiotherapy and the control group without this prophylaxis. The main outcome was whether GCSF preventivetherapy decreased the rate of interruption of radiotherapy because of leucopenia and thrombocytopenia. Weused t -test, and chi-square test statistics to compare the quantitative and qualitative outcomes.
Results: therewere no significant differences in platelets and WBC loss between the treatment and control groups. Treatmentinterruption was lower in weekly GCSF therapy group (35%), compared to the control group (55%), althoughthe difference was not statistically significant (P value 0.2). While 8 patients (40%) also received GCSF therapydue to leucopenia in the control group only one patient reached a critical level and needed GCSF therapy becauseof irradiation complications (p-value 0.02). Among those who received naodjuvant chemotherapy (8 patientsin each group), among the GCSF prevention group only in one (12%) we had to interrupt radiotherapy, ascompared to 6 in the control group due to WBC loss.
Conclusion: Weekly GSCF injections among CNS tumorpatients receiving craniospinal therapy may decrease treatment interruption. A larger study with longer followupis now needed to confirm our results.