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Positive Phase III Results Reported for Abraxane (Paclitaxel) in Metastatic Pancreatic Cancer
Positive results have been reported from the phase III Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound [nab-paclitaxel]; Celgene International Sàrl) in combination with gemcitabine (Gemzar, Eli Lilly). The new findings were reported online in the New England Journal of Medicine.
The MPACT trial was an open-label randomized study of 861 previously untreated patients with metastatic pancreatic cancer in North America, Europe, and Australia.
The patients were randomly assigned to treatment with nab-paclitaxel and gemcitabine (n = 431) or gemcitabine alone (n = 430). Patients in the nab-paclitaxel/gemcitabine group received nab-paclitaxel as an intravenous (IV) infusion over 30 to 40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an IV infusion over 30 to 40 minutes at a dose of 1,000 mg/m2 given on days 1, 8, and 15 of each 28-day cycle. In the comparator treatment group, gemcitabine monotherapy was administered at a dose of 1,000 mg/m2 given weekly for 7 weeks followed by a 1-week rest period in cycle 1. In cycle 2 and onwards, gemcitabine was administered on days 1, 8, and 15 of a 28-day cycle. The study’s primary endpoint was overall survival (OS).
The median OS was 8.5 months in the nab-paclitaxel/gemcitabine group compared with 6.7 months in the gemcitabine group (hazard ratio [HR] for death, 0.72; P P P