Objective:

To analyse the effectiveness and safety of oral antineoplastic drugs (ANEOs) that are authorized in special situations in a third-level hospital and to compare the results obtained with the clinical evidence used for this authorization.

Method:

Descriptive observational and retrospective study. We included all adult patients who started treatment with ANEO in special situations during the year 2016. We collected demographic, treatment-related and clinical variables (overall survival (OS), progression-free survival (PFS)). Adverse reactions and detected interactions were collected. An unadjusted comparison was made between the results of the available evidence and those of the study patients.

Results:

34 patients were treated, 50% were men, the median age was 58 years (38-80) and they presented ECOG 1 in 64.7%.

Most of the treated patients were diagnosed with advanced colorectal cancer, treated with trifluridine-tipiracil, followed by palbociclib in breast cancer, obtaining results similar to those of the evidence. The median PFS was 2.8 months (95% CI 0.8-4.8) and the 8-month SG (95% CI 3.4-12.5) for all patients.

26% of patients required dose reduction because of treatment toxicity. We found 13 interactions, which affected 15 patients, only two of category X.

Conclusions:

The effectiveness of ANEO in special situations in our center is similar to that of available evidence. The impact on survival is low and adverse effects are common.