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Type of surgical approach-open or robot assisted-appears to have no effect on specific clinical outcomes in patients undergoing radical prostatectomy for high-risk prostate cancer, nor does the procedure influence the pathway subsequent therapy might follow, according to a recent study.
New Orleans-Type of surgical approach-open or robot assisted-appears to have no effect on specific clinical outcomes in patients undergoing radical prostatectomy for high-risk prostate cancer, nor does the procedure influence the pathway subsequent therapy might follow, according to a recent study.
Univariate and multivariate analysis of 215 patients undergoing one or the other procedure between May 2006 and June 2010 showed that a number of clinical factors were more suggestive of subsequent therapeutic paths than surgical approach.
“A lot of patients coming to MD Anderson go on to clinical trials for high-risk prostate cancer. There seemed to be numerous postoperative treatment pathways, and we wanted to characterize those patterns in light of introducing the robotic platform in 2006 to this group,” senior author John Davis, MD, told Urology Times.
A flow chart created from the study’s data shows patients pursuing a number of differing clinical avenues subsequent to their surgery. There were as many as 30 unique pathways characterizing steps of their treatment choices, responses, and subsequent observation versus more treatments such as radiation and/or androgen deprivation.
“The take-home message is that while surgery alone was employed in 59% of cases, there is no standard pathway for postoperative management,” said Dr. Davis, associate professor of urology at MD Anderson Cancer Center, Houston, of the study, which was presented at the 2013 World Congress of Endourology and SWL in New Orleans.
“And it is not as if everyone got some form of radiation therapy. Some noted during our presentation that these patients are all high risk and are likely to need some form of adjuvant radiation. Actually, we found very little straight adjuvant radiation applied-less than 5%. These cases were completed before the AUA and ASTRO released new guidelines that put more emphasis on adjuvant radiation in patients with extra-prostatic disease, seminal vesical invasions, or positive margins,” said Dr. Davis.
Using either approach, however, the chart reflects that some patients appear cured by surgery alone, and others by surgery plus radiation. On the other hand, approximately a quarter of each surgical group had positive lymph nodes, and their subsequent management often led to hormonal therapy. Significant follow-up will be required to learn more about these latter outcomes.
Of the 215 patients in the retrospective analysis of multiple surgeons at a tertiary cancer hospital, 91 underwent an open procedure and 124 underwent a robotic procedure. High-risk cancer was defined according to D’Amico criteria: having two of three factors-PSA >20.0 ng/mL, Gleason 8-10, and clinical stage T2c or greater. Biochemical failure was defined as PSA ≥0.2 ng/mL. Median follow-up was 4.7 years. The team used the Clavien-Dindo system to classify postoperative complications at 30 days follow-up.
Surgery type doesn’t affect recurrence
“We did a univariate and multivariate analysis. Neither open nor robotic surgery affected the outcome-biochemical occurrence. The rate of high-grade (3-5) Clavien complications between procedures was within 2%,” Dr. Davis told Urology Times.
Clavien complications (≥3) appeared in four patients (4.4%) following an open procedure and in eight (6.5%) following a robotic procedure.
Univariate analysis showed that pathologic stage (p<.001), positive surgical margins (HR: 2.21, 1.5-3.4), pathologic N1 (HR: 3.6, 2.3-5.4), and number of high-risk features (2-2.6, 1.77-4.59 vs. 3-6.8, 1.7-17) were predictors of biochemical failure.
On multivariate analysis, predictors of biochemical failure were preoperative PSA (HR: 1.02, 1.01-1.04), pathologic Gleason score (4+3 [p=.15, 8, 9]), administration of preoperative hormones (p=.03), pathologic stage (3a, p=.3; 3b, p=.05; 4, p=.01), and positive node status (pN1, HR: 1.98, 1.20-3.27).
The variety of predictors and post-surgical therapeutic courses were a reflection of the heterogeneity of high-risk prostate cancer, Dr. Davis said. His team concluded that it is unlikely that a standardized approach to the disease will be established given the inconsistency of clinical and biologic outcomes. Nevertheless, surgery, be it open or robotic, is a viable first step, they said.UT
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