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Phase I and pharmacokinetic study of nab-paclitaxel, nanoparticle albumin-bound paclitaxel, administered weekly to Japanese patients with solid tumors and metastatic breast cancer
Cancer Chemotherapy and Pharmacology, 08/25/2011
Clinical Article
Ando M et al. – Weekly administration of nab-paclitaxel was well tolerated up to 100 mg/m2 by heavily pretreated patients. For MBC patients, 150 mg/m2 nab-paclitaxel as a first-line therapy was well tolerated. Dose reduction due to neuropathy allows multiple cycles of treatment.
Methods- Phase I study, patients with advanced solid tumors received nab-paclitaxel at dose levels of 80–125 mg/m2 as 30-min infusions once a week for 3 weekly doses repeated every 4 weeks
- In tolerability study, patients received 150 mg/m2 nab-paclitaxel
- Blood samples at first dose of nab-paclitaxel collected for pharmacokinetic analysis
- 15 patients were treated for median of 5 cycles in phase I study
- MTD was 125 mg/m2; dose-limiting toxicity was neutropenia requiring skipping of the second or third weekly administration in the first cycle
- In tolerability study, 6 patients were treated for median of 6 cycles; no intolerable toxicities observed in first cycle
- Grade 3 sensory and motor neuropathy observed in 4 and 1 patients, respectively
- Ocular toxicities observed in 2 patients (keratopathy and macular hole)