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Data Presented at ASCO 2016 Builds upon Foundation of Abraxane Plus Gemcitabine as a First-Line Treatment in Patients with Metastatic Pancreatic Cancer

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Additional Relevant Details An Italian multi-center real-life retrospective analysis highlighted outcomes of 122 patients who received first-line ABRAXANE plus gemcitabine followed by second-line treatment. (Abstract #4124 - Giordano). Second line treatments included FOLFOX/XELOX (45%). FOLFIRI (22%), FOLFIRINOX (18%), and other single agent therapies (15%). Median overall survival for patients receiving a second-line therapy following ABRAXANE plus gemcitabine was 13.5 months (95% CI 12.659-14.341), compared with 6.8 months for patients (99 patients) receiving BSC (95% CI 5.567-8.033), p < 0.0001. Also of note in the research presented at ASCO were two studies evaluating ABRAXANE plus gemcitabine in patients who exhibited elevated bilirubin levels, a common disease effect in metastatic pancreatic cancer. These studies provide insight into this patient population, which was excluded from the Phase III study of ABRAXANE plus gemcitabine.
In one observational interim analysis (Abstract #e15739 - zur Hausen), 20 (of 219) patients with a mean bilirubin level of 4.4 mg/dl (1.5-12.9) at baseline were followed for up to 4 cycles of ABRAXANE plus gemcitabine and methods of hyperbilirubinaemia were assessed. The mean bilirubin level of these patients dropped to 1.8 mg/dl (0.35-14.1; p=0.031) by the 2nd cycle. There were 14 (70%) patients that started treatment with a standard dosage and 6 (30%) that started with a reduced dose. Grade 3 or 4 toxicities were seen in 70 percent of patients with the most common being leukopenia, anemia and fever (each 20%).An additional analysis of 29 patients (Abstract #e15717 - Pelzer) examined safety and survival with ABRAXANE/Gemcitabine in patients with elevated total bilirubin levels (≥ 1.2 to > 5 x ULN).Administration of ABRAXANE in patients with hepatic impairment should be performed with caution. Patients with hepatic impairment may be at increased risk of toxicity, particularly from myelosuppression; such patients should be closely monitored for development of profound myelosuppression. According to the prescribing information, ABRAXANE is not recommended in patients who have total bilirubin > 5 x ULN or AST > 10 x ULN.Multiple studies evaluated real-world comparative effectiveness and economic evaluations of first-line metastatic pancreatic treatments.An independent, retrospective, Canadian comparative effectiveness analysis of ABRAXANE plus gemcitabine, FOLFIRINOX, and gemcitabine alone (Abstract #6561 - Wang) in five British Columbia cancer centers found the median overall survival of these treatments was 8.5 months for ABRAXANE plus gemcitabine (n=59), 7.8 months for FOLFIRINOX (n=59) and 3.1 months for gemcitabine alone. The analysis noted that patients receiving FOLFIRINOX were significantly younger (p < 0.001), had better performance status (p < 0.001) and had less disease burden at presentation (p=0.049), compared with ABRAXANE plus gemcitabine. Treatment discontinuation due to toxicities occurred in 36% of patients receiving FOLFIRINOX, 17% of patients receiving ABRAXANE plus gemcitabine and 23% of patients receiving gemcitabine alone.
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Jun 04, 2016
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Related Keywords Metastatic Pancreatic Cancer, Abraxane, Paclitaxel Protein-bound Particles, Gemcitabine