Cargando…
Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T
BACKGROUND: Sipuleucel-T has demonstrated improved overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC). This analysis examined the effect of sipuleucel-T on time to disease-related pain (TDRP) and time to first use of opioid analgesics (TFOA) in mCRPC using data...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160816/ https://www.ncbi.nlm.nih.gov/pubmed/24957547 http://dx.doi.org/10.1038/pcan.2014.21 |
_version_ | 1782334450026151936 |
---|---|
author | Small, E J Higano, C S Kantoff, P W Whitmore, J B Frohlich, M W Petrylak, D P |
author_facet | Small, E J Higano, C S Kantoff, P W Whitmore, J B Frohlich, M W Petrylak, D P |
author_sort | Small, E J |
collection | PubMed |
description | BACKGROUND: Sipuleucel-T has demonstrated improved overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC). This analysis examined the effect of sipuleucel-T on time to disease-related pain (TDRP) and time to first use of opioid analgesics (TFOA) in mCRPC using data pooled from three randomized phase III studies in men with asymptomatic or minimally symptomatic mCRPC (D9901 (NCT00005947), D9902A (NCT01133704), D9902B (IMPACT; NCT00065442)). METHODS: Four-hundred and twenty-eight asymptomatic patients were analyzed for TDRP; 737 patients were analyzed for TFOA. Pain status was collected using logs adjudicated by blinded, independent reviewers. Opioid use for cancer-related pain was identified from medically reviewed reports of concomitant medication. Disease-related pain was defined as pain post enrollment. TDRP and TFOA were analyzed using the Kaplan–Meier method and Cox regression. RESULTS: Treatment with sipuleucel-T was not associated with a significant difference in TDRP (hazard ratio (HR)=0.819; 95% confidence interval (CI): 0.616–1.089; P=0.170; median TDRP 5.6 months for sipuleucel-T and 5.3 months for control, respectively), although 39.3% of sipuleucel-T-treated patients and 18.9% of control patients were pain-free at 12 months. However, there was a significant delay in TFOA with sipuleucel-T (HR=0.755; 95% CI: 0.579–0.985; P=0.038). Median TFOA for sipuleucel-T was 12.6, and 9.7 months for control, with 50.6% and 43.1% opioid-free at 12 months, respectively. Kaplan–Meier curves for both end points began to diverge at 6 months. CONCLUSIONS: Sipuleucel-T was associated with longer TFOA but not significantly longer TDRP. Both end points demonstrated evidence of a delayed treatment effect, consistent with an active immunotherapy. |
format | Online Article Text |
id | pubmed-4160816 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-41608162014-09-22 Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T Small, E J Higano, C S Kantoff, P W Whitmore, J B Frohlich, M W Petrylak, D P Prostate Cancer Prostatic Dis Original Article BACKGROUND: Sipuleucel-T has demonstrated improved overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC). This analysis examined the effect of sipuleucel-T on time to disease-related pain (TDRP) and time to first use of opioid analgesics (TFOA) in mCRPC using data pooled from three randomized phase III studies in men with asymptomatic or minimally symptomatic mCRPC (D9901 (NCT00005947), D9902A (NCT01133704), D9902B (IMPACT; NCT00065442)). METHODS: Four-hundred and twenty-eight asymptomatic patients were analyzed for TDRP; 737 patients were analyzed for TFOA. Pain status was collected using logs adjudicated by blinded, independent reviewers. Opioid use for cancer-related pain was identified from medically reviewed reports of concomitant medication. Disease-related pain was defined as pain post enrollment. TDRP and TFOA were analyzed using the Kaplan–Meier method and Cox regression. RESULTS: Treatment with sipuleucel-T was not associated with a significant difference in TDRP (hazard ratio (HR)=0.819; 95% confidence interval (CI): 0.616–1.089; P=0.170; median TDRP 5.6 months for sipuleucel-T and 5.3 months for control, respectively), although 39.3% of sipuleucel-T-treated patients and 18.9% of control patients were pain-free at 12 months. However, there was a significant delay in TFOA with sipuleucel-T (HR=0.755; 95% CI: 0.579–0.985; P=0.038). Median TFOA for sipuleucel-T was 12.6, and 9.7 months for control, with 50.6% and 43.1% opioid-free at 12 months, respectively. Kaplan–Meier curves for both end points began to diverge at 6 months. CONCLUSIONS: Sipuleucel-T was associated with longer TFOA but not significantly longer TDRP. Both end points demonstrated evidence of a delayed treatment effect, consistent with an active immunotherapy. Nature Publishing Group 2014-09 2014-06-24 /pmc/articles/PMC4160816/ /pubmed/24957547 http://dx.doi.org/10.1038/pcan.2014.21 Text en Copyright © 2014 Macmillan Publishers Limited http://creativecommons.org/licenses/by/3.0/ This work is licensed under a Creative Commons Attribution 3.0 Unported License. The images or other third party material in this article are included in the article's Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/3.0/ |
spellingShingle | Original Article Small, E J Higano, C S Kantoff, P W Whitmore, J B Frohlich, M W Petrylak, D P Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T |
title | Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T |
title_full | Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T |
title_fullStr | Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T |
title_full_unstemmed | Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T |
title_short | Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T |
title_sort | time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-t |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4160816/ https://www.ncbi.nlm.nih.gov/pubmed/24957547 http://dx.doi.org/10.1038/pcan.2014.21 |
work_keys_str_mv | AT smallej timetodiseaserelatedpainandfirstopioiduseinpatientswithmetastaticcastrationresistantprostatecancertreatedwithsipuleucelt AT higanocs timetodiseaserelatedpainandfirstopioiduseinpatientswithmetastaticcastrationresistantprostatecancertreatedwithsipuleucelt AT kantoffpw timetodiseaserelatedpainandfirstopioiduseinpatientswithmetastaticcastrationresistantprostatecancertreatedwithsipuleucelt AT whitmorejb timetodiseaserelatedpainandfirstopioiduseinpatientswithmetastaticcastrationresistantprostatecancertreatedwithsipuleucelt AT frohlichmw timetodiseaserelatedpainandfirstopioiduseinpatientswithmetastaticcastrationresistantprostatecancertreatedwithsipuleucelt AT petrylakdp timetodiseaserelatedpainandfirstopioiduseinpatientswithmetastaticcastrationresistantprostatecancertreatedwithsipuleucelt |