Initial Clinical Study Of nabPaclitaxel

The results of the first phase 1 study in patients with advanced solid tumors demonstrated that nab-paclitaxel could be given safely every three weeks without premedication (10). The first three patients were given infusions over three hours. Since no hypersensitivity reactions were observed, the remainder of the patients received treatment with a shorter infusion time (30 minutes). No acute hypersensitivity reactions occurred at either infusion rate at doses ranging from 135 to 375 mg/m2.

Hematologic toxicity was dose dependent, but mild and not cumulative. The median absolute neutrophil count nadir (x109/L) ranged from 2.22 to 0.96. Febrile neutropenia was uncommon and no septic deaths were reported. The median platelet count nadir (x 109/L) ranged from 173 to 204. One patient received a platelet transfusion. The investigators concluded that hematologic toxicity was less than expected and that it did not substantially effect dose and treatment decisions during the trial.

Most nonhematologic toxicities were grade 1 or 2, with no grade 4 toxicities. Nausea, vomiting, and muscle and joint aches were most common. The maximum tolerated dose of nab-paclitaxel was 300 mg/m2 with dose-limiting toxicities (sensory neuropathy, stomatitis, and superficial keratopathy) occurring at 375 mg/m2. The maximum tolerated dose was substantially higher (approximately 50%) than a typical solvent-based paclitaxel dose of 175 mg/m2.

0 0

Post a comment