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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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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