BJU International, December 2012, Vol.110(11b), pp.E575-E582
To purchase or authenticate to the full-text of this article, please visit this link: http://onlinelibrary.wiley.com/doi/10.1111/j.1464-410X.2012.11286.x/abstract Byline: Jatinder Goyal(1)(*), Philipp Nuhn(1)(2)(*), Peng Huang(1), Prachi Tyagi(1), Daniel Oh(1), Michael A. Carducci(1), Mario A. Eisenberger(1), Emmanuel S. Antonarakis(1) Keywords: prostate cancer; chemotherapy; clinical trial; metastatic castration-resistant prostate cancer; docetaxel; overall survival Study Type - Prognosis (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Previous studies have reported better outcomes in cancer patients that enrolled in clinical trials, suggesting that trial participation in itself might be beneficial. We investigated the potential positive effect of clinical trial participation on survival outcomes of patients with metastatic castration-resistant prostate cancer who were treated with first-line docetaxel-containing chemotherapy. After accounting for potential baseline inequalities, participation in a clinical trial itself was associated with significantly longer overall survival in these patients. OBJECTIVE To study differences in baseline characteristics and outcomes of patients with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line docetaxel-containing chemotherapy on prospective clinical studies (trial participants) versus those receiving this therapy outside of a clinical study (non-participants). PATIENTS AND METHODS Records from 247 consecutive chemotherapy-naive patients who were treated with docetaxel-containing chemotherapy for mCRPC at a single high-volume centre from 1998 to 2010 were reviewed. All patients received docetaxel either as clinical trial participants (n= 142; 11 separate studies) or as non-participants (n= 105). Univariable and multivariable Cox regression models predicted overall survival after chemotherapy initiation. RESULTS There was no significant difference between trial participation and non-participation with respect to patient age, type of primary treatment, tumour grade or clinical stage. Multivariable analyses showed a significantly lower risk of all-cause mortality (hazard ratio 0.567; P= 0.027) among trial participants vs non-participants. CONCLUSIONS Patients that were treated with docetaxel for mCRPC showed a significantly longer overall survival when enrolled in a clinical trial. Improved survival in trial participants may reflect the better medical oversight typically seen in patients enrolled in trials, more regimented follow-up schedules, or a positive effect on caregivers' attitudes because of greater contact with medical services. With the retrospective nature of this analysis and the small study population, prospective studies are needed to validate the present findings and to further investigate the relationship between clinical trial participation and outcomes. Author Affiliation: (1)Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University, Baltimore, MD, USA (2)Department of Urology, Ludwig-Maximilians-Universitat, Munich, Germany Correspondence: (*) Emmanuel S. Antonarakis, Prostate Cancer Research Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, 1650 Orleans Street, CRB1-1M45, Baltimore, MD 21231, USA. e-mail: firstname.lastname@example.org Article Note: (*) These authors contributed equally to this study. Accepted for publication 23 March 2012 CAPTION(S): Supporting info item Testosterone levels and percentage of biopsy affected by tumour. Linear regression between the variables testosterone and percentage of tumour representation in the biopsy sample is displayed (P 0.01). In our centre, the tumour burden in the biopsy is expressed as the percentage of tumour in each prostatic lobe, ranging from 〉0% to 100%. Thus, the percentage of tumour represented in the biopsy adding the two prostatic lobes ranges from 〉0% to 200%. Testosterone levels and progression risk. Tumours were subclassified depending on their D'Amico risk of progression: low risk, PSA 10, DRE [less than or equal to] T2a and Gleason score [less than or equal to]6; intermediate risk, PSA 10-20, DRE = T2b and Gleason score 7; high risk, PSA 〉 20 or DRE a[yen] T2c or Gleason score a[yen]8. Low risk, testosterone 470 [+ or -] 171 ng/dL; intermediate risk, testosterone 445 [+ or -] 151 ng/dL; high risk, testosterone 365 [+ or -] 162 ng/dL; P= 0.03.
Prostate Cancer ; Chemotherapy ; Clinical Trial ; Metastatic Castration‐Resistant Prostate Cancer ; Docetaxel ; Overall Survival