Oral versus pulse intravenous cyclophosphamide: a retrospective analysis of adverse events in a high infectious diseases burdened setting
Thesis (MMed) -- Stellenbosch University, 2014.
ENGLISH ABSTRACT: Background Cyclophosphamide (CPM) is still considered to be the first line treatment of many life-threatening autoimmune conditions. It does however carry significant risk for severe adverse events especially infections. At present CPM is either administered as a daily oral dose (DOC) or as an intravenous pulse (PIVC). There is uncertainty regarding the safety profiles of either regimen in high infectious diseases burdened settings. Objective To compare the frequency and nature of adverse events related to the use of DOC and PIVC in a high infectious diseases burdened setting. Methods A retrospective cohort of all patients treated from 1 January 2008 to 31 May 2013 with CPM for autoimmune diseases at Tygerberg Academic Hospital was studied comparing DOC and PIVC. Disease characteristics and occurrence of major adverse events of participants in each group was compared. Results A total of 134 (92 DOC and 42 PIVC) participants were included. Participants in the DOC group were treated for longer (174 vs. 101 days, p<0.01) and with higher cumulative doses (17 276 mg vs. 3 327 mg p<0.01). Risk for infection was similar in both groups although 6 vs. 0 (p=0.18) participants in the DOC group died due to leukopaenic sepsis. Nadir leukocyte counts were also lower in the DOC group (median 3.8 x 10⁹/l vs. 5.3 x 10⁹/l, p=0.02). Conclusion Infection rates in both groups were similar. DOC was, however, associated with longer treatment duration, greater cumulative CPM doses and more severe leukopaenia. If resources allow and available literature provides support for efficacy, consideration should be given to greater use of PIVC.