Randomized Phase III Trial Comparing Single-Agent Paclitaxel Poliglumex (CT-2103, PPX) with Single-Agent Gemcitabine or Vinorelbine for the Treatment of PS 2 Patients with Chemotherapy-NaЇve Advanced Non-small Cell Lung Cancer

Abstract

Background: Patients with advanced non-small cell lung cancer (NSCLC) and impaired performance status (PS 2) have limited life expectancies and decreased tolerance for drug-induced toxicities. Current treatment guidelines indicate that PS 2 patients benefit from systemic therapy. Further refinement of treatment in these patients requires reduction of treatment-associated toxicities while maintaining or improving efficacy. Paclitaxel poliglumex (PPX), a macromolecular polymer– drug conjugate of paclitaxel and poly-Lglutamic acid, may enhance the therapeutic index of paclitaxel.