1. Seven-Month Prostate-Specific Antigen Is Prognostic in Metastatic Hormone-Sensitive Prostate Cancer Treated With Androgen Deprivation With or Without Docetaxel.
- Author
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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, and Sweeney CJ
- Subjects
- Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Databases, Factual, Docetaxel adverse effects, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasms, Hormone-Dependent blood, Neoplasms, Hormone-Dependent mortality, Neoplasms, Hormone-Dependent pathology, Prostatic Neoplasms blood, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Randomized Controlled Trials as Topic, Retrospective Studies, Time Factors, Treatment Outcome, Androgen Antagonists administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Docetaxel administration & dosage, Kallikreins blood, Neoplasms, Hormone-Dependent drug therapy, Prostate-Specific Antigen blood, Prostatic Neoplasms drug therapy
- Abstract
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.
- Published
- 2018
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