The role of NKTR-102 in women with platinum resistant/refractory ovarian cancer and failure on pegylated liposomal doxorubicin (PLD)
| Autor: | Ignace Vergote, Luc Dirix, Linda R. Duska, Carol Zhao, Agustin A. Garcia, G. G. Rao, J. P. Micha, Christine Gennigens, Vincent Armenio, J. West, G. J. S. Rustin, L. K. Masuoka, Daniel Lewis Spitz, C. H. Pippitt, Abraham C. F. Leung, Graham Dark, Christopher J. Poole, Emad Ibrahim, Nicholas S. Reed |
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| Rok vydání: | 2011 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 29:5047-5047 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 5047 Background: NKTR-102, a topoisomerase-I inhibitor-polymer conjugate with markedly reduced peak concentrations and a continuous concentration profile, demonstrated broad antitumor activity per RECIST in a phase I study. The original phase 2 study in platinum-resistant/refractory ovarian cancer showed a 21% confirmed objective response rate (ORR) (RECIST; Vergote, ASCO 2010). Methods: 71 pts with platinum resistant/refractory ovarian cancer (PROC) were originally randomized to NKTR-102 IV at a dose of 145 mg/m2 q14d vs. q21d. In addition to being resistant/refractory to platinum, 33 pts in this analysis (16/q14d; 17/q21d) had also progressed on prior PLD. 6 of these 33 pts were platinum-refractory (progression within 28 days of last platinum dose). Eligible pts had ECOG PS 0-1, adequate renal, hepatic, and marrow function. The primary endpoint was ORR per RECIST; secondary endpoints included PFS, OS and safety. Results: For the 33 PROC pts pre-treated with PLD, median age was 59; ECOG PS 0/1 was 46%/54... |
| Databáze: | OpenAIRE |
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