In conclusion, a novel taxane formulation, Genexol-PM,
which is a CrEL-free paclitaxel formulated with a polymeric
micelle, was safely administered without HSRs and showed a
favorable toxicity profile. The major DLTs were neuromuscular
toxicity and myelosuppression, and the recommended phase II
dosage for Genexol-PM was determined to be 300 mg/m2 for
3 h once every 3 weeks. Genexol-PM displayed the pharmacokinetics
characteristic of CrEL-free paclitaxel. Of note, Genexol-
PM permits the delivery of a higher paclitaxel dose. The
achievement of higher paclitaxel dose without additional toxicity
may suggest that this CrEL-free novel taxane formulation is
likely to replace the current paclitaxel formulation. Phase II
studies with Genexol-PM are currently underway for patients
with advanced breast and non-small cell lung cancers.