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Harshman LC , Chen YH , Liu G , Carducci MA , Jarrard D , Dreicer R , Hahn N , Garcia JA , Hussain M , Shevrin D , Eisenberger M , Kohli M , Plimack ER , Cooney M , Vogelzang NJ , Picus J , Dipaola R , Sweeney CJ
Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel
J Clin Oncol. 2018 Feb 1;36(4) :376-382
PMID: 29261442    PMCID: PMC5805480   
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Purpose We evaluated the relationship between prostate-specific antigen (PSA) and overall survival in the context of a prospectively randomized clinical trial comparing androgen-deprivation therapy (ADT) plus docetaxel with ADT alone for initial metastatic hormone-sensitive prostate cancer. Methods We performed a landmark survival analysis at 7 months using the E3805 Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) database ( ClinicalTrials.gov identifier: NCT00309985). Inclusion required at least 7 months of follow-up and PSA levels at 7 months from ADT initiation. We used the prognostic classifiers identified in a previously reported trial (Southwest Oncology Group 9346) of PSA </= 0.2, > 0.2 to 4, and > 4 ng/mL. Results Seven hundred nineteen of 790 patients were eligible for this subanalysis; 358 were treated with ADT plus docetaxel, and 361 were treated with ADT alone. Median follow-up time was 23.1 months. On multivariable analysis, achieving a 7-month PSA </= 0.2 ng/mL was more likely with docetaxel, low-volume disease, prior local therapy, and lower baseline PSAs (all P </= .01). Across all patients, median overall survival was significantly longer if 7-month PSA reached </= 0.2 ng/mL compared with > 4 ng/mL (median survival, 60.4 v 22.2 months, respectively; P < .001). On multivariable analysis, 7-month PSA </= 0.2 and low volume disease were prognostic of longer overall survival (all P < 0.01). The addition of docetaxel increased the likelihood of achieving a PSA </= 0.2 ng/mL at 7 months (45.3% v 28.8% of patients on ADT alone). Patients on ADT alone who achieved a 7-month PSA </= 0.2 ng/mL had the best survival and were more likely to have low-volume disease (56.7%). Conclusion PSA </= 0.2 ng/mL at 7 months is prognostic for longer overall survival with ADT for metastatic hormone-sensitive prostate cancer irrespective of docetaxel administration. Adding docetaxel increased the likelihood of a lower PSA and improved survival.
1527-7755 Harshman, Lauren C Chen, Yu-Hui Liu, Glenn Carducci, Michael A Jarrard, David Dreicer, Robert Hahn, Noah Garcia, Jorge A Hussain, Maha Shevrin, Daniel Eisenberger, Mario Kohli, Manish Plimack, Elizabeth R Cooney, Matthew Vogelzang, Nicholas J Picus, Joel Dipaola, Robert Sweeney, Christopher J ECOG-ACRIN 3805 Investigators UG1 CA189829/CA/NCI NIH HHS/United States P50 CA180995/CA/NCI NIH HHS/United States U10 CA180802/CA/NCI NIH HHS/United States U10 CA180821/CA/NCI NIH HHS/United States U10 CA180801/CA/NCI NIH HHS/United States U10 CA180795/CA/NCI NIH HHS/United States U10 CA180847/CA/NCI NIH HHS/United States U10 CA180790/CA/NCI NIH HHS/United States U10 CA180820/CA/NCI NIH HHS/United States U10 CA180833/CA/NCI NIH HHS/United States U10 CA180794/CA/NCI NIH HHS/United States U10 CA180867/CA/NCI NIH HHS/United States U10 CA180888/CA/NCI NIH HHS/United States U10 CA180853/CA/NCI NIH HHS/United States Comparative Study Journal Article Randomized Controlled Trial Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't United States J Clin Oncol. 2018 Feb 1;36(4):376-382. doi: 10.1200/JCO.2017.75.3921. Epub 2017 Dec 20.