Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials
Abstract Background This analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic p...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-09-01
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| Series: | BMC Urology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12894-018-0387-7 |
| _version_ | 1819018634237837312 |
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| author | Neil M. Schultz Neal D. Shore Simon Chowdhury Laurence H. Klotz Raoul S. Concepcion David F. Penson Lawrence I. Karsh Hongbo Yang Bruce A. Brown Arie Barlev Scott C. Flanders |
| author_facet | Neil M. Schultz Neal D. Shore Simon Chowdhury Laurence H. Klotz Raoul S. Concepcion David F. Penson Lawrence I. Karsh Hongbo Yang Bruce A. Brown Arie Barlev Scott C. Flanders |
| author_sort | Neil M. Schultz |
| collection | DOAJ |
| description | Abstract Background This analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic progression-free survival, or no prostate-specific antigen progression at 1 and 2 years following treatment initiation. Methods Clinical event rates were obtained from the STRIVE (NCT01664923) and TERRAIN (NCT01288911) trials, and the number needed to treat was the inverse of the absolute rate difference between the event rates of enzalutamide and bicalutamide. The 95% Confidence Interval of the number needed to treat was derived from the 95% Confidence Interval of the event rate difference. Results Using STRIVE data (patients with metastatic disease: n = 128 enzalutamide; n = 129 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer with progression-free survival were 2.0 and 2.8, respectively; with radiographic progression-free survival, 2.6 and 3.0, respectively; and without prostate-specific antigen progression, 1.8 and 2.4, respectively. Using TERRAIN data (n = 184 enzalutamide; n = 191 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with progression-free survival were 4.3 and 3.7, respectively; with radiographic progression-free survival, 10.0 and 2.8, respectively; and without prostate-specific antigen progression, 2.1 and 3.2, respectively. Conclusions The combined data from TERRAIN and STRIVE demonstrated that treating chemotherapy-naïve metastatic castration-resistant prostate cancer with enzalutamide leads to more patients without clinical progression at 1 and 2 years than with bicalutamide. Trial registration STRIVE (NCT01664923; registration date: August 10, 2012) and TERRAIN (NCT01288911; registration date: February 1, 2011). |
| first_indexed | 2024-12-21T03:22:32Z |
| format | Article |
| id | doaj.art-ac2303e9cda546ff9696e315c7ef9767 |
| institution | Directory Open Access Journal |
| issn | 1471-2490 |
| language | English |
| last_indexed | 2024-12-21T03:22:32Z |
| publishDate | 2018-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Urology |
| spelling | doaj.art-ac2303e9cda546ff9696e315c7ef97672022-12-21T19:17:40ZengBMCBMC Urology1471-24902018-09-011811910.1186/s12894-018-0387-7Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trialsNeil M. Schultz0Neal D. Shore1Simon Chowdhury2Laurence H. Klotz3Raoul S. Concepcion4David F. Penson5Lawrence I. Karsh6Hongbo Yang7Bruce A. Brown8Arie Barlev9Scott C. Flanders10Astellas Pharma, Inc.Carolina Urologic Research CenterGuy’s, King’s, and St. Thomas’ HospitalsSunnybrook Health Sciences Centre, University of TorontoUrology Associates, P.CVanderbilt University Medical CenterThe Urology Center of ColoradoAnalysis Group, Inc.Astellas Pharma, Inc.Medivation, Inc.Astellas Pharma, Inc.Abstract Background This analysis estimated the number needed to treat with enzalutamide versus bicalutamide to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer who would obtain clinical benefit regarding progression-free survival, radiographic progression-free survival, or no prostate-specific antigen progression at 1 and 2 years following treatment initiation. Methods Clinical event rates were obtained from the STRIVE (NCT01664923) and TERRAIN (NCT01288911) trials, and the number needed to treat was the inverse of the absolute rate difference between the event rates of enzalutamide and bicalutamide. The 95% Confidence Interval of the number needed to treat was derived from the 95% Confidence Interval of the event rate difference. Results Using STRIVE data (patients with metastatic disease: n = 128 enzalutamide; n = 129 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with chemotherapy-naïve metastatic castration-resistant prostate cancer with progression-free survival were 2.0 and 2.8, respectively; with radiographic progression-free survival, 2.6 and 3.0, respectively; and without prostate-specific antigen progression, 1.8 and 2.4, respectively. Using TERRAIN data (n = 184 enzalutamide; n = 191 bicalutamide) comparing enzalutamide with bicalutamide at 1 and 2 years, the numbers needed to treat to achieve one additional patient with progression-free survival were 4.3 and 3.7, respectively; with radiographic progression-free survival, 10.0 and 2.8, respectively; and without prostate-specific antigen progression, 2.1 and 3.2, respectively. Conclusions The combined data from TERRAIN and STRIVE demonstrated that treating chemotherapy-naïve metastatic castration-resistant prostate cancer with enzalutamide leads to more patients without clinical progression at 1 and 2 years than with bicalutamide. Trial registration STRIVE (NCT01664923; registration date: August 10, 2012) and TERRAIN (NCT01288911; registration date: February 1, 2011).http://link.springer.com/article/10.1186/s12894-018-0387-7EnzalutamideBicalutamideMetastatic castration-resistant prostate cancerNumber needed to treat |
| spellingShingle | Neil M. Schultz Neal D. Shore Simon Chowdhury Laurence H. Klotz Raoul S. Concepcion David F. Penson Lawrence I. Karsh Hongbo Yang Bruce A. Brown Arie Barlev Scott C. Flanders Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials BMC Urology Enzalutamide Bicalutamide Metastatic castration-resistant prostate cancer Number needed to treat |
| title | Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials |
| title_full | Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials |
| title_fullStr | Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials |
| title_full_unstemmed | Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials |
| title_short | Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials |
| title_sort | number needed to treat analysis of clinical progression in patients with metastatic castration resistant prostate cancer in the strive and terrain trials |
| topic | Enzalutamide Bicalutamide Metastatic castration-resistant prostate cancer Number needed to treat |
| url | http://link.springer.com/article/10.1186/s12894-018-0387-7 |
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