Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naïve advanced non-small cell lung cancer

Langer, C. J., O'Byrne, Kenneth J., Socinski, M. A., Mikhailov, S. M., Leśniewski-Kmak, K., Smakal, M., Ciuleanu, T. E., Orlov, S. V., Dediu, M., Heigener, D., Eisenfeld, A. J., Sandalic, L., Oldham, F. B., Singer, J. W., & Ross, H. J. (2008) Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naïve advanced non-small cell lung cancer. Journal of Thoracic Oncology, 3(6), pp. 623-630.

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INTRODUCTION: Performance status (PS) 2 patients with non-small cell lung cancer (NSCLC) experience more toxicity, lower response rates, and shorter survival times than healthier patients treated with standard chemotherapy. Paclitaxel poliglumex (PPX), a macromolecule drug conjugate of paclitaxel and polyglutamic acid, reduces systemic exposure to peak concentrations of free paclitaxel and may lead to increased concentrations in tumors due to enhanced vascular permeability.

METHODS: Chemotherapy-naive PS 2 patients with advanced NSCLC were randomized to receive carboplatin (area under the curve = 6) and either PPX (210 mg/m/10 min without routine steroid premedication) or paclitaxel (225 mg/m/3 h with standard premedication) every 3 weeks. The primary end point was overall survival.

RESULTS: A total of 400 patients were enrolled. Alopecia, arthralgias/myalgias, and cardiac events were significantly less frequent with PPX/carboplatin, whereas grade ≥3 neutropenia and grade 3 neuropathy showed a trend of worsening. There was no significant difference in the incidence of hypersensitivity reactions despite the absence of routine premedication in the PPX arm. Overall survival was similar between treatment arms (hazard ratio, 0.97; log rank p = 0.769). Median and 1-year survival rates were 7.9 months and 31%, for PPX versus 8 months and 31% for paclitaxel. Disease control rates were 64% and 69% for PPX and paclitaxel, respectively. Time to progression was similar: 3.9 months for PPX/carboplatin versus 4.6 months for paclitaxel/carboplatin (p = 0.210).

CONCLUSION: PPX/carboplatin failed to provide superior survival compared with paclitaxel/carboplatin in the first-line treatment of PS 2 patients with NSCLC, but the results with respect to progression-free survival and overall survival were comparable and the PPX regimen was more convenient. © 2008International Association for the Study of Lung Cancer.

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ID Code: 65177
Item Type: Journal Article
Refereed: No
Additional URLs:
Keywords: CT-2103, Non-small cell lung cancer, Paclitaxel poliglumex, PPX, PS 2, Toxicity, carboplatin, paclitaxel, adult, advanced cancer, aged, alopecia, arthralgia, article, cancer control, cancer staging, cancer survival, cardiotoxicity, clinical trial, combination chemotherapy, controlled study, drug efficacy, febrile neutropenia, female, human, hypersensitivity reaction, infection, infestation, lung non small cell cancer, major clinical study, male, myalgia, nausea and vomiting, neuropathy, neutropenia, phase 2 clinical trial, phase 3 clinical trial, priority journal, quality of life, thrombocytopenia, treatment response, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Disease-Free Survival, Follow-Up Studies, Humans, Lung Neoplasms, Middle Aged, Neoplasm Staging, Polyglutamic Acid, Retrospective Studies, Survival Rate, Treatment Outcome, United States
DOI: 10.1097/JTO.0b013e3181753b4b
ISSN: 1556-0864
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: Copyright 2008 Lippincott Williams & Wilkins
Deposited On: 06 Dec 2013 02:20
Last Modified: 11 Mar 2014 23:56

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