Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: A Randomized Multicenter Phase II Trial of the North-Eastern German Society...

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Zeitschriftentitel:	Journal of Clinical Oncology
Personen und Körperschaften:	Sehouli, Jalid, Stengel, Dirk, Harter, Philipp, Kurzeder, Christian, Belau, Antje, Bogenrieder, Thomas, Markmann, Susanne, Mahner, Sven, Mueller, Lothar, Lorenz, Ralf, Nugent, Andreas, Wilke, Jochen, Kuznik, Andreas, Doering, Gabriele, Wischnik, Arthur, Sommer, Harald, Meerpohl, Hans-Gerd, Schroeder, Willibald, Lichtenegger, Werner, Oskay-Oezcelik, Guelten
In:	Journal of Clinical Oncology, 29, 2011, 2, S. 242-248
Format:	E-Article
Sprache:	Englisch
veröffentlicht:	American Society of Clinical Oncology (ASCO)
Schlagwörter:	Cancer Research Oncology

Details
Zusammenfassung:	<jats:sec><jats:title>Purpose</jats:title><jats:p> Weekly administration of topotecan (Tw) is less toxic and widely considered a better treatment option than conventional 5-day therapy (Tc) in women with platinum-resistant recurrent ovarian cancer. We conducted a randomized phase II trial (TOWER [Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer]) to better define the ratio between benefits and risks with either treatment approach. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients were randomly assigned to two independent two-stage protocols of Tw (4 mg/m<jats:sup>2</jats:sup>/wk administered on days 1, 8, and 15) or Tc (1.25 mg/m<jats:sup>2</jats:sup>/d on days 1 to 5). We evaluated risk ratios (RRs) for the primary end point of clinical benefit (complete response, partial response, and stable disease), the duration of progression-free survival (PFS) and overall survival (OS), associated hazard ratios (HRs), and RRs of toxicity with 95% CIs. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In total, 194 patients were randomly assigned at 54 centers to Tw (n = 97) or Tc (n = 97). Clinical benefit was observed in 36 of 76 (47%; 95% CI, 36% to 59%) Tw and 46 of 80 (58%; 95% CI, 46% to 68%) Tc patients (RR, 1.21; 95% CI, 0.90 to 1.64; P = .205). Patients in the Tw group had a slightly shorter PFS (HR, 1.29; 95% CI, 0.96 to 1.76) but similar OS (HR, 1.04; 95% CI, 0.74 to 1.45) compared with Tc. Tw was associated with significantly lower risks of anemia (RR, 0.35; 95% CI, 0.16 to 0.79), neutropenia (RR, 0.38; 95% CI, 0.23 to 0.65), and thrombocytopenia (RR, 0.23; 95% CI, 0.09 to 0.57). </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> With regard to effectiveness in terms of response and PFS, Tc remains the standard of care in patients with platinum-resistant recurrent ovarian cancer. However, comparable OS rates and a favorable toxicity profile make Tw another viable treatment option in this setting. </jats:p></jats:sec>
Umfang:	242-248
ISSN:	0732-183X 1527-7755
DOI:	10.1200/jco.2009.27.8911