Background Paclitaxel albumin bound nanoparticles (nab-Paclitaxel) is indicated for the treatment of metastasic pancreatic adenocarcinoma (MPA). In clinical trials, nab-Paclitaxel plus gemcitabine (n-PG) significantly improved clinical outcomes. However, n-PG induced peripheral neuropathy and myelosuppression.
Purpose To analyse the adverse events (AE) related to the combination n-PG in the treatment of MPA in clinical practice.
Material and methods Retrospective observational study of all patients with MPA who received n-PG from January 2014 to October 2015.
The information was obtained from electronic medical records (IANUS), pharmacotherapy records (Silicon) and the software for pharmaceutical validation of chemotherapy treatments (Oncofarm-Farmis).
Data collected: age, gender, performance status (PS), relevant comorbidities and treatment duration. Safety assessment: AE were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.
Results We included 15 patients with MPA treated with n-PG. Median age was 61.7 ± 9.8 years and 9 (60.0%) were male. At baseline, 11 (73.3%) patients had PS1, 3 (20.0%) PS2 and 1 (6.7%) PS3.
The most common comorbidities were: hypertension (26.7%), diabetes (20.0%), dyslipidaemia (20.0%), gastritis (20.0%) and alcohol consumption (20.0%).
62 cycles were administrated (median 4 ± 2 cycles/patient) and treatment duration was 104 ± 70 days. In 11 (73.3%) patients the treatment was discontinued due to: progression of disease 6 (54.5%), AE 2 (18.2%), worsening of PS 1 (9.1%), death 1 (9.1%) and patient decision 1 (9.1%).
Patients experienced 72 AE (4.8 AE/patient). The most frequent AE were: anaemia 13 (86.7%), asthenia 10 (66.7%), neutropenia 8 (53.3%), nausea and/or vomiting 7 (46.7%), diarrhoea 7 (46.7%), hepatotoxicity 6 (40.0%), thrombocytopenia 4 (26.7%), dysgeusia 3 (20.0%) and peripheral neuropathy 3 (20.0%).
Rates of toxicity were: 15 (20.8%) grade 1, 17 (23.6%) grade 2, 9 (12.5%) grade 3 and 1 (1.4%) grade 4. The rest of the AE were not classified.
The dose was modified in 4 (26.7%) patients and administration was delayed in 8 (53.3%) patients.
Conclusion The main AE were anaemia, asthenia and neutropenia. The majority of AE were grade 1–2. Similar findings have been reported in clinical trials.
Overall, the treatment was well tolerated, with only a small number of discontinuations.
No conflict of interest.
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