Clinical Study

British Journal of Cancer (2008) 98, 1608–1613. doi:10.1038/sj.bjc.6604372 www.bjcancer.com
Published online 13 May 2008

Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer

L Paz-Ares1, H Ross2, M O'Brien3, A Riviere4, U Gatzemeier5, J Von Pawel6, E Kaukel7, L Freitag8, W Digel9, H Bischoff10, R García-Campelo11, N Iannotti12, P Reiterer13, I Bover14, J Prendiville15, A J Eisenfeld16, F B Oldham16, B Bandstra16, J W Singer16 and P Bonomi17

  1. 1Hospital Universitario 12 de Octubre, Servicio de Oncología Médica, Madrid 28041, Spain
  2. 2Earle A. Chiles Research Institute, Portland, OR 97213, USA
  3. 3Royal Marsden Hospital, London SW3 6JJ, UK
  4. 4Centre François Baclesse, Centre de Lutte Contre le Cancer de Caen, Caen 14076, France
  5. 5Krankenhaus Grosshansdorf, Grosshansdorf 22927, Germany
  6. 6Asklepios-Fachkliniken Munchen Gauting, Gauting 82131, Germany
  7. 7Allgemeines Krankenhaus Harburg, Hamburg 21075, Germany
  8. 8Lungenklinik Hemer, Hemer 58675, Germany
  9. 9Universitatsklinikum Freiburg, Freiburg 79106, Germany
  10. 10Department of Radiology, Thoraxklinik Heidelberg GmbH, Heidelberg 69126, Germany
  11. 11Juan Canalejo University Hospital, Servicio de Oncología Médica, La Coruña 15006, Spain
  12. 12Hem-Onc Associates of The Treasure Coast, Port St. Lucie, FL 34952, USA
  13. 13Masarykova Nemocnice, Ústí nad Labem 401 13, Czech Republic
  14. 14Hospital San Llàtzer, Palma de Mallorca 07198, Spain
  15. 15Guy's Hospital, Medical Oncology and Breast Unit, London SE1 9RT, UK
  16. 16Cell Therapeutics Inc., Seattle, WA 98119, USA
  17. 17Rush University Medical Center, 1725 West Harrison Street, Chicago, IL 60612, USA

Correspondence: Dr P Bonomi, E-mail: Philip_Bonomi@rush.edu

Received 17 September 2007; Revised 27 February 2008; Accepted 3 March 2008; Published online 13 May 2008.

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Abstract

Paclitaxel poliglumex (PPX), a macromolecule drug conjugate linking paclitaxel to polyglutamic acid, reduces systemic exposure to peak concentrations of free paclitaxel. Patients with non-small-cell lung cancer (NSCLC) who had received one prior platinum-based chemotherapy received 175 or 210 mg m-2 PPX or 75 mg m-2 docetaxel. The study enrolled 849 previously treated NSCLC patients with advanced disease. Median survival (6.9 months in both arms, hazard ratio=1.09, P=0.257), 1-year survival (PPX=25%, docetaxel=29%, P=0.134), and time to progression (PPX=2 months, docetaxel=2.6 months, P=0.075) were similar between treatment arms. Paclitaxel poliglumex was associated with significantly less grade 3 or 4 neutropenia (P<0.001) and febrile neutropenia (P=0.006). Grade 3 or 4 neuropathy (P<0.001) was more common in the PPX arm. Patients receiving PPX had less alopecia and did not receive routine premedications. More patients discontinued due to adverse events in the PPX arm compared to the docetaxel arm (34 vs 16%, P<0.001). Paclitaxel poliglumex and docetaxel produced similar survival results but had different toxicity profiles. Compared with docetaxel, PPX had less febrile neutropenia and less alopecia, shorter infusion times, and elimination of routine use of medications to prevent hypersensitivity reactions. Paclitaxel poliglumex at a dose of 210 mg m-2 resulted in increased neurotoxicity compared with docetaxel.

Keywords:

lung cancer, poliglumex, docetaxel