Resumen de The use of nanoparticle albumin-bound paclitaxel in cancer
Irene Escribano Valenciano, Susana Cortijo Cascajares, José Manuel Caro Teller, M. P. Goyache-Goñi, Ana Fernández Vázquez, José Miguel Ferrari Piquero
Objective: To analyse the use and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in cancer patients treated in a tertiary hospital.
Method: An observational retrospective study of nab-paclitaxel indications was carried out during 59 months (between February 2009, when nab-paclitaxel was included in our Hospital Drug Formulary, and December 2013). Patients were identified using the electronic prescription software Oncofarm®. Information was obtained from electronic clinical records and prescriptions. The following data were collected: sex, age, diagnosis, dose and frequency, use in combination or as monotherapy, treatment duration, previous treatment with paclitaxel, adverse events and reasons for discontinuation.
Results: 160 patients were included in the study, (79.4% women), with a mean age of 61 years (SD: 12.5). The mean dose prescribed was 195.6 mg (SD: 70.3). Twenty-five patients were enrolled in clinical trials, but out of them, 85 patients were diagnosed of breast cancer and 50 patients suffered other neoplasias. Considering the overall population treated, nab-paclitaxel monotherapy was administered to 87 patients and 73 received it in combination with other antineoplastic drugs. The degree of adequacy to label obtained was 45.2%. The median duration of nab-paclitaxel treatment was 13.3 weeks (range: 8-22 weeks). Reasons for nab-paclitaxel discontinuation were progression disease (107 patients), toxicity (16) and fever of unknown origin (1). Mild toxicity (such as alopecia, fatigue and grade 1-2 gastrointestinal toxicity) was reported from the entire population treated with nab-paclitaxel in our study. Excluding those toxicities, most common adverse events were: neuropathy (33.1% of patients), neutropenia (12.5%), onycholysis (10.6%), anaemia (9.4%) and mucositis (8.8%). Elevated transaminases were observed in four patients, febrile neutropenia in two patients, acute kidney disease in one patient and a hypersensitivity reaction in another one.
Conclusions: The global degree of adequacy to label observed in our study was lower than the obtained in other antineoplastic drugs studies. We found less incidence of neuropathy, neutropenia and febrile neutropenia than those reported in other nab-paclitaxel clinical trials, but similar grade 3 neuropathy.
Considering that more than a half of nab-paclitaxel prescriptions were off-label uses, our data show the need to develop pharmacotherapeutic monitoring programs in order to guarantee the rational and cost-effective use of nab-paclitaxel
