Long-term follow-up of 3-month neoadjuvant hormone therapy before radical prostatectomy in a randomized trial Journal Article

   

Authors:	Yee, D. S.; Lowrance, W. T.; Eastham, J. A.; Maschino, A. C.; Cronin, A. M.; Rabbani, F.
Article Title:	Long-term follow-up of 3-month neoadjuvant hormone therapy before radical prostatectomy in a randomized trial
Abstract:	Objective To report our long-term follow-up of an institutional randomized prospective trial of radical prostatectomy (RP) with or without a 3-month course of neoadjuvant hormone therapy (NHT), which results in pathological downstaging, but generally no reduction in biochemical recurrence (BCR) on early follow-up (at 3 years). Patients and methods From December 1992 to June 1996, 148 patients with clinically localized prostate cancer were randomized to RP only or 3 months of goserelin acetate and flutamide before RP. BCR was defined as a detectable serum prostate specific antigen level (>0.1 ng/mL) at least 6 weeks after surgery, with a confirmatory increase. Results The median follow-up for BCR-free patients was 8 years. There was no significant difference in BCR-free probabilities between groups (P = 0.7). The BCR-free probability at 7 years was 78% for patients undergoing RP only and 80% for patients undergoing NHT and RP (difference of 2%; 95% confidence interval, CI, 12-16%). A Cox regression showed no significant relationship between NHT and BCR (hazard ratio 1.16; 95% CI, 0.56-2.39, P = 0.7). Overall, two patients had local recurrence and six developed metastases, and were evenly distributed among the RP only and NHT groups. Conclusion Although our study was not originally powered to detect differences in BCR, there was no overall benefit in BCR-free probability, local recurrence or metastasis with 3 months of NHT at 8 years of follow-up. Pending evidence of improvement in patient outcomes, NHT before RP appears to be unjustified outside of clinical trials. © 2009 BJU International.
Keywords:	adult; controlled study; human tissue; treatment outcome; aged; middle aged; cancer surgery; major clinical study; clinical trial; cancer recurrence; multimodality cancer therapy; cancer adjuvant therapy; neoadjuvant therapy; cancer staging; follow up; lymph node metastasis; cancer diagnosis; diagnostic accuracy; prospective study; prostate specific antigen; controlled clinical trial; neoplasm recurrence, local; randomized controlled trial; antineoplastic combined chemotherapy protocols; cancer mortality; prostate cancer; cancer invasion; prostatic neoplasms; goserelin; prostate; antigen specificity; prostatectomy; epidemiologic methods; neoplasm metastasis; hormonal therapy; flutamide; biochemistry; hormones
Journal Title:	BJU International
Volume:	105
Issue:	2
ISSN:	1464-4096
Publisher:	Wiley Blackwell
Date Published:	2010-01-01
Start Page:	185
End Page:	190
Language:	English
DOI:	10.1111/j.1464-410X.2009.08698.x
PUBMED:	19594741
PROVIDER:	scopus
PMCID:	PMC2807908
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-74049164745&partnerID=40&md5=0f6c905338b15b05dba71774651ce3f0
Notes:	--- - "Cited By (since 1996): 4" - "Export Date: 20 April 2011" - "CODEN: BJINF" - "Source: Scopus"

https://synapse.mskcc.org/synapse/works/has_related_data_chk/5401