PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer.
| Autor: | Naumann RW; R. Wendel Naumann and James T. Symanowski, Levine Cancer Institute, Carolinas Medical Center, Charlotte, NC; Robert L. Coleman, MD Anderson Cancer Center, University of Texas, Houston; Michael G. Teneriello, Texas Oncology, Austin, TX; Robert A. Burger, Fox Chase Cancer Center, Philadelphia, PA; Edward A. Sausville, Greenebaum Cancer Center, University of Maryland, Baltimore, MD; Elzbieta Kutarska, Centrum Onkologii Ziemi Lubelskiej, Lubland; Elzbieta Nowara, Instytut im. Marii Skłodowskiej-Curie, Gliwice, Poland; Sharad A. Ghamande, Georgia Health Sciences University, Augusta, GA; Nashat Y. Gabrail, Gabrail Cancer Center, Canton, OH; Stephen E. DePasquale, Chattanooga's Program in Women's Oncology, Chattanooga, TN; Lucy Gilbert, McGill University Health Centre, Montreal, Quebec, Canada; Robert H. Gersh, Cancer Care Northwest, Spokane, WA; Wael A. Harb, Horizon Oncology Research, Lafayette; Chandra D. Lovejoy, Christopher P. Leamon, David E. Morgenstern, and Richard A. Messmann, Endocyte, West Lafayette, IN; Panagiotis A. Konstantinopoulos, Beth Israel Deaconess Medical Center; and Richard T. Penson, Dana-Farber Cancer Center, Massachusetts General Hospital, Boston, MA., Coleman RL, Burger RA, Sausville EA, Kutarska E, Ghamande SA, Gabrail NY, Depasquale SE, Nowara E, Gilbert L, Gersh RH, Teneriello MG, Harb WA, Konstantinopoulos PA, Penson RT, Symanowski JT, Lovejoy CD, Leamon CP, Morgenstern DE, Messmann RA |
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| Jazyk: | angličtina |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2013 Dec 10; Vol. 31 (35), pp. 4400-6. Date of Electronic Publication: 2013 Oct 14. |
| DOI: | 10.1200/JCO.2013.49.7685 |
| Abstrakt: | Purpose: Vintafolide (EC145) is a folic acid-desacetylvinblastine conjugate that binds to the folate receptor (FR), which is expressed on the majority of epithelial ovarian cancers. This randomized phase II trial evaluated vintafolide combined with pegylated liposomal doxorubicin (PLD) compared with PLD alone. The utility of an FR-targeted imaging agent, (99m)Tc-etarfolatide (EC20), in selecting patients likely to benefit from vintafolide was also examined. Patients and Methods: Women with recurrent platinum-resistant ovarian cancer who had undergone ≤ two prior cytotoxic regimens were randomly assigned at a 2:1 ratio to PLD (50 mg/m(2) intravenously [IV] once every 28 days) with or without vintafolide (2.5 mg IV three times per week during weeks 1 and 3). Etarfolatide scanning was optional. The primary objective was to compare progression-free survival (PFS) between the groups. Results: The intent-to-treat population comprised 149 patients. Median PFS was 5.0 and 2.7 months for the vintafolide plus PLD and PLD-alone arms, respectively (hazard ratio [HR], 0.63; 95% CI, 0.41 to 0.96; P = .031). The greatest benefit was observed in patients with 100% of lesions positive for FR, with median PFS of 5.5 compared with 1.5 months for PLD alone (HR, 0.38; 95% CI, 0.17 to 0.85; P = .013). The group of patients with FR-positive disease (10% to 90%) experienced some PFS improvement (HR, 0.873), whereas patients with disease that did not express FR experienced no PFS benefit (HR, 1.806). Conclusion: Vintafolide plus PLD is the first combination to demonstrate an improvement over standard therapy in a randomized trial of patients with platinum-resistant ovarian cancer. Etarfolatide can identify patients likely to benefit from vintafolide. |
| Databáze: | MEDLINE |
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