Background In phase 1, 2 and 3 trials of nab-paclitaxel, substantial clinical activity was noted in patients with advanced pancreatic cancer.
We conducted an observational study to assess the effectiveness and safety of this therapy in real clinical practice.
Purpose To analyse the effectiveness and safety of metastatic pancreatic cancer treated with nab-paclitaxel. To compare overall survival (OS) with the results published in the literature.
Material and methods An ambipective, multicentre, observational study was carried out in a third level hospital.
Inclusion criteria were: patients diagnosed with metastatic pancreatic cancer treated with nab-paclitaxel plus gemcitabine since the drug was included in the hospital´s service.
The variables collected were: age, sex, weight (kg), size (cm), body surface (m²), pancreatic tumour location, site of metastatic disease, number of metastatic diseases, ECOG at baseline and after TAC, level of carbohydrate antigen 19.9 (CA 19.9), level of GPT, GOT, bilirubin and serum haemoglobin, neutrophil counts and adverse events grade 3 or higher.
The principal effectiveness endpoint was OS.
OS was analysed with the Kaplan-Meier method with SPSS software.
Data were obtained by the pharmacy dispensation program (ATHOS) and clinical charts.
Results 28 patients were included from March 2012 to August 2015. 50% were male, with a mean age of 62 ± 2 years.
ECOG at baseline was 1 in 65% and 0 in 27% of patients. The most frequent pancreatic tumour location was the pancreas´s head, and the most frequent metastatic site was the liver.
Mean CA 19.9, GPT, GOT, bilirubin, serum haemoglobine and neutrophil levels were 11, 250.41, 33.31, 0.71,122 and 5.7, respectively.
Most often reported adverse events grade 3 or higher were: fatigue (2.4%), diarrhoea (2.4%), sickness (2.4) and alopecia (11%). 4.8% of patients developed more than one adverse event.
The mean OS was 13.18 (95% CI 7.1 to 19.3) months.
Conclusion Metastatic pancreatic patients benefited from treatment with nab-paclitaxel in terms of OS. Nab-paclitaxel was well tolerated overall.
No conflict of interest.
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