Background Intrathecal administration of methotrexate, cytarabine and hydrocortisone (i.e. triple intrathecal therapy) is commonly used to treat and prevent central nervous system (CNS) involvement in leukaemias and lymphomas. The dose, volume and method of preparation and administration of intrathecal chemotherapy are highly variable in clinical practice. Thus, the standardisation of the preparation of the triple intrathecal therapy (TIT) is recommended.
Purpose To describe the incidence and severity of adverse events (AEs) due to standardised TIT in adult patients.
Material and methods Prospective observational study performed from January 2013 to June 2014 of adult patients treated with standard TIT (methotrexate 12 mg, cytarabine 30 mg and hydrocortisone 20 mg, in a final volume of 8 ml and pH and osmolarity values 7–7.5 and 280–310 mOsm/kg, respectively). The severity of AEs was classified according to Common Terminology Criteria for Adverse Events (CTCAE) grade.
Results Twenty patients, 5 female and 15 male, median age 50 years, were included. Median monitoring time: 8.5 [1.5–19] months. The most common diagnoses were non-Hodgkin’s lymphoma (59%), acute lymphoblastic leukaemia (30%) and acute myeloid leukaemia (15%). TIT was administered via lumbar puncture in all patients, and the indication was prophylaxis of CNS involvement in 19 patients. During the study period, 56 TIT treatments were administered (2.8 TIT/patient). Seven patients (36%) showed any adverse events (AEs). AEs occurred in 30% of administrations: headache (23.2%), vomiting (17.9%), dizziness (5.4%), back pain (3.6%), paresthesias (1.8%) and orthostatic hypotension (1.8%). All AEs were acute; the median time of onset was 26 [1–72] h and the median duration of event 48 [1–720] h. The severity was: 22.6% grade 1, 74.2% grade 2 and 3.2% grade 3. All toxicities resolved.
Conclusion The incidence of mild and moderate AEs associated with TIT is relatively frequent, headache being the most common AE such as described in the literature. No long-term toxicities were observed. Therefore, the TIT shows an acceptable toxicity profile.
CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf [Internet]. Available from: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf
ReferenceNo conflict of interest.
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