Variabilidad en la actividad y los resultados de la evaluación de nuevos medicamentos por las comisiones de farmacia y terapéutica de los hospitales en España

Objective: To analyse the relationship between doses of gemcitabine-carboplatin (GEM-CARBO) administered and incidence and level of haematological and renal toxicity, and the adherence to the treatment in patients with non-small cell lung cancer. Methods: Retrospective study which lasted for 37 months. We were able to obtain the minimum set of data needed to carry out the follow-up with the help of Farmis-Oncofarm® software and the medical and pharmacotherapeutic records. The haematological toxicity was assessed in accordance with the Common Toxicity Criteria 3.0. Renal toxicity was evaluated using serum creatinine levels and creatinine clearance. Results: Thirty-one patients were included in the study who were administered a total of 122 cycles. There was a 34.0% and 30.8% incidence of anaemia and grade 3 neutropaenia, respectively. There was also a 3.8% and 7.7% incidence of grade 3 and grade 4 thrombocytopaenia, respectively. No cases of renal toxicity were found. 65.0% of patients received more than 85.0% of the planned theoretical dosage of carboplatin and 58% of patients received more than 85.0% of the planned theoretical dosage of gemcitabine. Administration was delayed in 18.0% of the cycles prescribed. Conclusions: The indication and prescription of the GEM-CARBO regimen was adjusted in accordance with solid scientific evidence, but its haematological toxicity limited its use and made it difficult to maintain the dose intensity foreseen in the study. This compromised the effectiveness of the treatment.