ASCO Abstracts are now available online...
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Meeting: 2005 ASCO Annual Meeting
Category: Lung Cancer
SubCategory: Non-Small Cell Lung Cancer
PPX/carboplatin in NSCLC
Abstract No: 7230
Author(s): J. J. Nemunaitis, N. Leighl, W. Miller, Y. Cormier, A. Bernareggi, F. Oldham
Abstract:
Background: PPX (XYOTAX), a macromolecular drug conjugate that links paclitaxel with biodegradable polymer, poly-L-glutamic acid, is water soluble and can be administered as a 10 minute infusion. Eliminating the need for CremophorEL reduces the risk of hypersensitivity reactions, even without premedication. Preclinical and clinical findings show that PPX is relatively stable in plasma; more than 95% of paclitaxel in circulation is present as the inactive conjugate, reducing systemic exposure to high concentrations of free paclitaxel. The antitumor activity of single agent PPX in chemotherapy naïve high-risk patients with NSCLC has been previously reported. In addition, PPX has been successfully combined with standard doses of cisplatin and carb. This multicenter, open label study evaluates the safety and efficacy of PPX in a standard doublet regimen for 1st line treatment of NSCLC.
Methods: PPX (210 mg/m2) was administered as a short (10-20 minute) IV infusion followed carb (AUC 6) q3w to chemotherapy-naïve patients (pts) with performance status (PS) 0-2. Pts were treated for up to 6 cycles. Safety was assessed using NCI CTC (v 2). Efficacy assessments were done after every 2nd cycle using RECIST. Plasma samples were collected for pharmacokinetic (PK) assessment of PPX.
Results: 74 pts were treated. The median age was 64 (range 32-85). 53% of pts were male. 14% of pts had PS2. Of the 60 pts with efficacy assessment following cycle 2, 9 pts (15%) had partial response and 24 pts (40%) had stable disease as the best response. Adverse event (AE) data are available for 40 pts (see table). No hypersensitivity reactions were observed. Detailed PK data will be presented.
Conclusions: Preliminary data suggest that PPX (210 mg/m2) in combination with carb (AUC 6) is active as 1st line treatment for NSCLC. PPX demonstrates easily manageable toxicities and is generally well tolerated.
Selected AEs (n=40)
Grade 1/2 Grade 3 Grade 4
Neutropenia 0 5 10
Thrombocytopenia 3 2 0
Febrile neutropenia 0 2 2
Anemia 5 5 2
Alopecia 10 - -
Neuropathy 13 2 0
Gastrointestinal 22 6 1
Fatigue 17 3 1
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