Background Nab-paclitaxel is approved for first-line treatment of patients with metastatic pancreatic cancer (mCP).
Purpose To evaluate the efficacy and safety of treatment with nab-paclitaxel and gemcitabine in patients with mCP.
Material and methods Retrospective observational study of mCP patients treated with nab-paclitaxel and gemcitabine during the past 5 years. Collected variables: age, sex, ECOG, adjuvant chemotherapy, treatment line, dose reduction and adverse events (AE). Efficacy endpoints were progression-free survival (PFS) and overall survival (OS) obtained by the Kaplan–Meier method. Adverse effects (AE) were collected for safety profile assessment. Descriptive statistical analysis was performed using the SPSS Statistics program V22.0.
Results Forty-seven patients (30 men and 17 women) were included. The median age was 59 years (29–82). At the beginning of the treatment, more than 80% presented ECOG 0–1: 23.4% had received previous adjuvant chemotherapy (gemcitabine and/or fluoropyrimidines). They were treated with nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 on days 1, 8 and 15 every 28 days. In 89.4% of the patients it was prescribed as first-line treatment. Dose reduction was performed in 68.1%. The median duration of treatment was 4.5 months (0.5–22.9), with four long survivors (longer than 15 months). The median PFS was 9.1 months (95% CI 8.36 to 9.73) and the median OS was 9.11 months (95% CI 4.0 to 14.2). Eighty-three per cent of patients (n=39) had AE of some grade and 17% (n=8) of grade 3–4. The most common AE were: asthaenia (n=17), neutropaenia (n=16), thrombocytopaenia (n=15), neuropathy (n=13), alopecia (n=5), diarrhoea (n=7), mucositis (n=3), vomiting (n=3), oedema (n=3) and dermatitis (n=2). These were grade 3–4: neutropaenia (n=7), thrombocytopaenia (n=4), mucositis (n=1), alopecia (n=1) and neuropathy (n=1). The causes of treatment discontinuation were mainly due to progression in 42.6% and deterioration of general health in 29.8%. At the end of the study, five patients continued treatment.
Conclusion The PFS obtained in our study is greater than those described in the pivotal trial MPACT or CA046. This difference may be due to the four patients with a considerably longer treatment than the average and a small sample. Regarding OS, there are no significant differences with the pivotal trial. The AE described were similar to those published in the literature
Reference and/or acknowledgements BMC Cancer 2016;16:817.
No conflict of interest.
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