PRECEDENT: A randomized phase II trial comparing EC145 and pegylated liposomal doxorubicin (PLD) in combination, versus PLD alone, in subjects with platinum-resistant ovarian cancer

Autor: R. W. Naumann, J. T. Symanowski, S. A. Ghamande, N. Y. Gabrail, L. Gilbert, M. G. Teneriello, G. Sutton, C. Lovejoy, R. A. Messmann
Rok vydání: 2010
Předmět:
Zdroj: Journal of Clinical Oncology. 28:LBA5012b-LBA5012b
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2010.28.18_suppl.lba5012b
Popis: LBA5012b Background: EC145, a conjugate of folic acid and desacetylvinblastine hydrazide binds with high affinity to the folate receptor (FR), found on > 90% of epithelial ovarian cancers. This abstract reports interim data on an international randomized, phase II study of EC145 + PLD compared with PLD alone, in women with platinum-resistant ovarian cancer. An independent Data Safety Monitoring Board (DSMB) has conducted a prespecified interim analysis on PFS and safety with results reported herein. Methods: Women ≥ 18 with ECOG PS of 0-2 and ≤ 2 prior systemic cytotoxic regimens were randomized to receive EC145 (2.5 mg IV weeks 1 and 3) + PLD (50 mg/m2 IBW IV q 28 days) or PLD (50 mg/m2 IBW IV q 28 days) alone until progression or death. Results: The interim analysis occurred after the 46th event out of a planned study total of 95 progressions or deaths. Demographic characteristics at screening such as age, cancer type, residual tumor after debulking, prior therapy, CA-125 and time from diagnosis were balanced between arms. RECIST mean sum tumor length was longer for the combination arm (122.7 mm vs. 81.3 mm). There was no statistical difference between study arms with regard to total adverse events, serious adverse events, or the number of subjects reporting at least one treatment-emergent drug-related serious adverse event resulting in discontinuation. The Table displays the results of the interim analysis of PFS. At the interim, there is also a trend toward benefit in overall survival for the combination arm with HR = 0.425 (p value of 0.064). Conclusions: Results indicate a greater than doubling in median PFS for women with platinum-resistant ovarian cancer receiving EC145 and PLD over those receiving PLD alone. These interim data suggest that EC145 and PLD is the first combination to show a statistically significant delay in progression-free survival over standard therapy in women with platinum-resistant ovarian cancer. [Table: see text] [Table: see text]
Databáze: OpenAIRE
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