Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer
Autor: | P. Reiterer, J. von Pawel, N Iannotti, Isabel Bover, A. Riviere, Jack W. Singer, B. Bandstra, Philip Bonomi, Luis Paz-Ares, U. Gatzemeier, Mary O'Brien, Helen J. Ross, R García-Campelo, Lutz Freitag, Fred B. Oldham, W. Digel, E. Kaukel, Helge Bischoff, J Prendiville, Amy J. Eisenfeld |
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Jazyk: | angličtina |
Rok vydání: | 2008 |
Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Lung Neoplasms Paclitaxel medicine.medical_treatment Antineoplastic Agents Docetaxel Neutropenia Gastroenterology Drug Administration Schedule chemistry.chemical_compound Internal medicine Carcinoma Non-Small-Cell Lung Clinical Studies medicine poliglumex Humans Lung cancer Adverse effect Aged Neoplasm Staging Aged 80 and over Chemotherapy business.industry Patient Selection Middle Aged medicine.disease Antineoplastic Agents Phytogenic Surgery lung cancer Treatment Outcome Oncology chemistry Paclitaxel Poliglumex Polyglutamic Acid Quality of Life Female Taxoids business Febrile neutropenia medicine.drug |
Zdroj: | British Journal of Cancer |
ISSN: | 1532-1827 0007-0920 |
Popis: | 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 (P0.001) and febrile neutropenia (P=0.006). Grade 3 or 4 neuropathy (P0.001) 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%, P0.001). 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. |
Databáze: | OpenAIRE |
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