Background Pancreatic cancer remains a highly fatal and difficult-to-treat disease. Nab-paclitaxel (nab-P), an albumin-bound formulation of paclitaxel, appears to decrease levels of cytidine deaminase, which is the primary gemcitabine catabolic enzyme; this probably increases sensitivity to gemcitabine (GEM) when these agents are combined. This combination is used off label.
Purpose To evaluate the safety of GEM plus nab-P used off label in patients with metastatic pancreatic ductal adenocarcinoma (PDA). To compare the incidence of adverse events (AEs) with clinical trial results.
Materials and methods Retrospective observational study from January 2011–October 2012. The inclusion criteria were all patients with PDA who received GEM 1000 mg/m2 followed by nab-P at 100 mg/m2 weekly for 3 weeks of a 4-week cycle. The information was extracted from patients’ medical records and from pharmacy service records. Variables: demographics, previous treatment, dosage reduction and toxicity. AEs were graded according to NCI CTCAE v4.
Results Eighteen patients with PDA were identified (61% males). The median age was 63 (range 41–80) years. Site of metastatic disease: liver (33%), bone (33%), abdomen/peritoneal (28%), lung (17%) and liver only (11%). Two patients were not assessed for response due to early clinical progression and poor tolerance. No grade 4 toxicity was observed. Grade 1 toxicity represented 42.0% of all ARs, 40.7% were grade 2 and 17.3% grade 3. The most common treatment-related AEs of any grade were fatigue (94% vs. clinical trial 94%), anaemia (66% vs. clinical trial 95%), thrombocytopenia (56% vs. clinical trial 65%), nausea (56% vs. clinical trial 45%), diarrhoea (50% vs. clinical trial 25%), neutropenia (45% vs. clinical trial 85%), vomiting (39% vs. clinical trial 15%), leukopenia (33% vs. clinical trial 90%). Ten patients (56%) required dosage reduction. The causes were thrombocytopenia (50%), fatigue (30%), neutropenia (10%) and pancytopenia (10%).
Conclusions All adverse events observed were reported in the clinical trial. These patients require close monitoring during treatment.
No conflict of interest.
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