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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: | , , , , , , , , , , , , , , , , , , , |
| In: | Journal of Clinical Oncology, 29, 2011, 2, S. 242-248 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Society of Clinical Oncology (ASCO)
|
| Schlagwörter: |
| author_facet |
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 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 |
|---|---|
| author |
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 |
| spellingShingle |
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 Journal of Clinical Oncology 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 of Gynecological Oncology Ovarian Cancer Study Group Cancer Research Oncology |
| author_sort |
sehouli, jalid |
| spelling |
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 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2009.27.8911 <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> 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 of Gynecological Oncology Ovarian Cancer Study Group Journal of Clinical Oncology |
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American Society of Clinical Oncology (ASCO), 2011 |
| imprint_str_mv |
American Society of Clinical Oncology (ASCO), 2011 |
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American Society of Clinical Oncology (ASCO) |
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Journal of Clinical Oncology |
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| title |
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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_unstemmed |
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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_full |
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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_fullStr |
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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_full_unstemmed |
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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_short |
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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_sort |
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 of gynecological oncology ovarian cancer study group |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1200/jco.2009.27.8911 |
| publishDate |
2011 |
| physical |
242-248 |
| description |
<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> |
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| author | 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 |
| author_facet | 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, 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 |
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| description | <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> |
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| spelling | 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 0732-183X 1527-7755 American Society of Clinical Oncology (ASCO) Cancer Research Oncology http://dx.doi.org/10.1200/jco.2009.27.8911 <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> 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 of Gynecological Oncology Ovarian Cancer Study Group Journal of Clinical Oncology |
| spellingShingle | 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, Journal of Clinical Oncology, 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 of Gynecological Oncology Ovarian Cancer Study Group, Cancer Research, Oncology |
| title | 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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_full | 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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_fullStr | 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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_full_unstemmed | 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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_short | 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 of Gynecological Oncology Ovarian Cancer Study Group |
| title_sort | 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 of gynecological oncology ovarian cancer study group |
| title_unstemmed | 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 of Gynecological Oncology Ovarian Cancer Study Group |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1200/jco.2009.27.8911 |