Κυριακή 26 Ιουνίου 2016

ROBOTIC PROSTATECTOMY PREVAILS?

The long-running debate about which surgical method is best for removing a cancerous prostate is over, a urologic surgeon declares in an editorial published in the July issue of the Journal of Urology.
"Robotic prostatectomy has superior or at least equal oncologic efficacy and complication rates compared to open prostatectomy," writes Michael O. Koch, MD, from the Indiana University School of Medicine in Indianapolis. "I believe the most current literature supports that view and this debate should finally be put to rest."
Dr Koch presents himself as an impartial judge, saying that he has "substantial surgical experience with both techniques."
Dr Koch's editorial, partially entitled the "End of the Controversy," accompanies a study that prompted his declaration and compares the rival procedures.
In the population-based cohort study, researchers from the University of Chicago, led by Shane Pearce, MD, identified patients treated for nonmetastatic prostate cancer in 2010 or 2011 from the National Cancer Data Base. Of these men, 73,131 underwent robotic assisted laparoscopic prostatectomy and 23,804 underwent open radical prostatectomy.
Compared with open prostatectomy, robotic prostatectomy was "independently associated with clinically meaningful reductions in positive surgical margins," the primary outcome of the study, Dr Pearce and his colleagues conclude.
The same held true for the secondary outcomes of postoperative radiation therapy and 30-day mortality. The oncologic benefit was primarily in patients with organ-confined disease.
Specifically, in a propensity-matched cohort analysis, robotic prostatectomy was shown to reduce the risk for positive surgical margins (odds ratio [OR], 0.88; P < .01), the use of radiation therapy (OR, 0.71; P < .01), and 30-day mortality (OR, 0.28; P < .01).
Notably, the protective effect of robotic prostatectomy for positive surgical margins was found only in patients with pT2 disease (OR, 0.85; P < .01).
"There was no difference in positive surgical margin rates for patients with pT3 disease, suggesting that tumor biology rather than surgical approach dictates the margin status when extraprostatic extension is present," the researchers report.
They found "similar results" with multivariable regression analysis.
Positive surgical margins were used as the primary outcome because data on biochemical recurrence are not available in the National Cancer Data Base, Dr Pearce explained. But margins are a risk factor for biochemical recurrence and influence decisions on postoperative radiation and systemic therapy; they can also negatively affect disease-specific mortality. In short, they are an important oncologic measure.
Dr Pearce said that the prostatectomy debate has dissolved, as well as resolved.
"In my opinion, the controversy has slowly fizzled away over the last 10 years, as the robotic approach to radical prostatectomy has become the most common surgical approach throughout US academic centers and community hospitals," he told Medscape Medical News.
The robotic approach has consistently shown advantages, such as less blood loss, shorter hospital stays, and decreased morbidity, Dr Pearce said.
"With more recent studies suggesting improved oncologic outcomes with the robotic approach, there are very few potential advantages to the open approach, aside from possible cost savings," he added.
There will never be a randomized controlled trial of the two techniques, so the evidence will not improve much in the future, Drs Pearce and Koch point out. Studies of administrative databases are as good as it gets, they both say, but they also acknowledge a potential for bias.
In his editorial, Dr Koch says it is possible that robotic surgery was performed more often at high-volume centers, which could account for its superior results.
But he then makes a remarkable assertion.
"It really doesn't matter. The conclusion that robotic prostatectomy as currently performed in the United States has superior oncologic results to open prostatectomy as it is currently being done is inescapable, despite the reason for that difference," he writes.
What About the Cost?
The cost of the two techniques was not addressed in the study, and Dr Pearce said he is unaware of any cost-effectiveness comparison studies.
But Dr Koch addresses the issue in his editorial.
He cites a recent study of the all-payer premier hospital database, which showed that robotic prostatectomy is associated with an additional $4528 for the 90-day period after surgery (Eur UrolPublished online February 10, 2016). However, for the highest-volume surgeons, this additional expense was much lower — only $1990. That range of additional costs is justified by the reduction in morbidity for patients, the authors of that study conclude.
Dr Koch agrees. Given the as good or better oncologic outcomes and the reduction in complications, he says that "in 2016 any small incremental expense justifies its use."
No direct or indirect commercial incentive is associated with the study. Dr Koch has disclosed no relevant financial relationships.
J Urol. 2016;196: 9-10, 76-81. EditorialAbstract

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