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

L. Paz-Ares, Helen J Ross, M. O'Brien, A. Riviere, U. Gatzemeier, J. Von Pawel, E. Kaukel, L. Freitag, W. Digel, H. Bischoff, R. García-Campelo, N. Iannotti, P. Reiterer, I. Bover, J. Prendiville, A. J. Eisenfeld, F. B. Oldham, B. Bandstra, J. W. Singer, P. Bonomi

Research output: Contribution to journalArticle

119 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1608-1613
Number of pages6
JournalBritish Journal of Cancer
Volume98
Issue number10
DOIs
StatePublished - May 20 2008
Externally publishedYes

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docetaxel
Non-Small Cell Lung Carcinoma
Therapeutics
Febrile Neutropenia
Alopecia
Survival
paclitaxel poliglumex

Keywords

  • Docetaxel
  • Lung cancer
  • Poliglumex

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer. / Paz-Ares, L.; Ross, Helen J; O'Brien, M.; Riviere, A.; Gatzemeier, U.; Von Pawel, J.; Kaukel, E.; Freitag, L.; Digel, W.; Bischoff, H.; García-Campelo, R.; Iannotti, N.; Reiterer, P.; Bover, I.; Prendiville, J.; Eisenfeld, A. J.; Oldham, F. B.; Bandstra, B.; Singer, J. W.; Bonomi, P.

In: British Journal of Cancer, Vol. 98, No. 10, 20.05.2008, p. 1608-1613.

Research output: Contribution to journalArticle

Paz-Ares, L, Ross, HJ, O'Brien, M, Riviere, A, Gatzemeier, U, Von Pawel, J, Kaukel, E, Freitag, L, Digel, W, Bischoff, H, García-Campelo, R, Iannotti, N, Reiterer, P, Bover, I, Prendiville, J, Eisenfeld, AJ, Oldham, FB, Bandstra, B, Singer, JW & Bonomi, P 2008, 'Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer', British Journal of Cancer, vol. 98, no. 10, pp. 1608-1613. https://doi.org/10.1038/sj.bjc.6604372
Paz-Ares, L. ; Ross, Helen J ; O'Brien, M. ; Riviere, A. ; Gatzemeier, U. ; Von Pawel, J. ; Kaukel, E. ; Freitag, L. ; Digel, W. ; Bischoff, H. ; García-Campelo, R. ; Iannotti, N. ; Reiterer, P. ; Bover, I. ; Prendiville, J. ; Eisenfeld, A. J. ; Oldham, F. B. ; Bandstra, B. ; Singer, J. W. ; Bonomi, P. / Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer. In: British Journal of Cancer. 2008 ; Vol. 98, No. 10. pp. 1608-1613.
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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.",
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AU - Riviere, A.

AU - Gatzemeier, U.

AU - Von Pawel, J.

AU - Kaukel, E.

AU - Freitag, L.

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