Background Nab-paclitaxel was approved for the treatment of metastatic adenocarcinoma of pancreas (mPAC), as a first treatment in combination with gemcitabine
Purpose To evaluate the effectiveness and safety of nab-paclitaxel in patients with mPAC in a real-world setting.
Material and methods Retrospective observational study of mPAC patients treated with nab-paclitaxel 125 mg/m2+gemcitabine (March 2013 to September 2018). Variables: age, sex, ECOG, treatment line, number of cycles and dose reduction. Efficacy endpoints: progression-free survival (PFS) and overall survival (OS). For safety profile assessment, adverse effects (AE) that forced a dose reduction or treatment suspension were collected, also hospital recovering caused by nab-paclitaxel toxicity.
Results Thirty-six patients were included, 56% males. Average age: 64±10 years. Thirty-three per cent started with ECOG 0% and 67% with ECOG≥1. The treatment lines were: first (47%), second (36%) and ≥third (17%). The average number of cycles was 3.7±2. The median duration of treatment was 16 weeks (95% CI: 11 to 22). The median OS was 36 weeks (95% CI: 24 to 47), data for 33% of the patients was censored. The median PFS (mPFS) was 20 weeks (95% CI: 11 to 30). mPFS was compared in different groups: 33 weeks versus 20 in the first line compared to second or later lines (p=0.443) and 24 weeks versus 20 in ECOG 0 patients compared to ECOG≥1 (p=0.295).
Dose reduction was performed in 72% of patients. Causes: neurotoxicity (38%), blood toxicity (58%), poor tolerance to previous cycles (8%) and bad performance (3%). Sixty-one per cent of patients were hospitalised because of nab-paclitaxel toxicity and nine had to discontinue treatment because of neurotoxicity (n=3), blood toxicity (n=2), performance worsening (n=3) and hepatic toxicity (n=1).
Conclusion The results obtained in our study are consistent with the ones obtained in the pivotal trial: mOS 36 versus 34 weeks, mPFS 20 versus 22 weeks, duration of treatment 16 versus 16 weeks. The results of PFS seem to be better when nab-paclitaxel is used as a first line and in patients with ECOG 0, but the differences are not statistically significant (p=0.443, p=0.295). A bigger sample would be needed to confirm all results. The AE described were similar to those published in the literature.
References and/or acknowledgements No conflict of interest.
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