Background Adverse drug reactions (ADRs) are especially important with antineoplastic drugs because of their implications on patients’ health and quality of life.

Purpose To study the epidemiology, clinical features, diagnosis and pharmacology of ADRs detected in hospitalised patients treated with antineoplastic drugs.

Materials and Methods Analytical observational study (2011). We included all patients receiving cancer treatment. Study variables were: sociodemographic characteristics (age, sex), clinical (diagnostic, stage) and ADRs. The analysis was epidemiological: ADRs conducted (cumulative incidence, CI), clinical: (physiological system affected, type, duration, production mechanism, frequency, severity), pharmacological: (drug, administration, cycle) and diagnostic: (causality, chronological sequence).

Results 125 patients (mean age 51 years), 68% male, 32% female, 90% comorbidities. The most common diagnoses were lymphoma (28%), specifically non-Hodgkin’s Lymphoma (11%), acute lymphoblastic leukaemia (9%), acute myeloid leukaemia (6%) mainly in advanced stages (68%). We detected a total of 170 ADRs with antineoplastic agents (28% CI). Physiological systems primarily affected were: blood (89%), digestive system (23%). The most common ADR was cytopenia (49%) specifically febrile neutropenia (37%). The duration was <7 days (75%) and >7 days (25%). ADRs were mostly produced in a dose-dependent way (85%), were very common (94%) and according to severity were: lethal (2%), severe (5%), moderate (73%), mild (19%). The drugs involved were: cytarabine, methotrexate, idarubicin, carmustine, cisplatin by intravenous administration (97%) and during first treatment cycles: cycle 1 (53%), cycle 2 (23%). 92% of the ADRs are tested and produced after drug administration (99%). In 60% and 19% of cases the measure was the continuation and discontinuation of antineoplastic therapy, respectively. In cases of re-exposure, the emergence of drug ADRs was positive in 45% of patients and in the disappearance of ADRs discontinuation was positive in 92%.

Conclusions The incidence of ADRs was high, the majority of ADRs were well known, moderate and positive outcome according to the measurements. It would be better to understand the ADRs as it can help develop other strategies to reduce their impact on the safety of cancer treatments in the first cycles.

No conflict of interest.