For bladder cancer patients undergoing radical cystectomy, robot-assisted laparoscopy with intracorporeal urinary diversion (ICUD) was associated with better survival and fewer serious complications compared with open surgery, a Swedish population-based study found.
Examining all radical cystectomies for bladder cancer in the nation from 2011 to 2018, a propensity score-matched analysis found estimated 5-year overall survival rates of 61.4% with the robotic approach versus 57.7% with open surgery.
This difference represented a relative 29% lower all-cause mortality risk over the study's 47 months of median follow-up (HR 0.71, 95% CI 0.56-0.89, P=0.004), according to researchers led by Ashkan Mortezavi, MD, of University Hospital Basel in Switzerland, who shared their findings in JAMA Network Open.
While complication rates at 90 days were similar between groups (51% for each), robot-assisted laparoscopic surgery was associated with a lower risk of Clavien-Dindo grade III or higher complications (17.2% vs 23.9%; OR 0.62, 95% CI 0.43-0.87, P=0.009), a difference driven primarily by fewer lymphoceles, cardiovascular and respiratory complications, and events in the abdominal wall or stoma.
Multiple randomized trials have now demonstrated similar rates of complications and oncologic outcomes with robot-assisted laparoscopy versus open surgery. In the randomized RAZOR trial, for example, the 2-year progression-free survival rate was 72.3% with robotic cystectomy and 71.6% with open cystectomy (P=0.001 for noninferiority).
But the patients in these trials almost exclusively underwent extracorporeal urinary diversion (ECUD) rather than ICUD, "leaving the question concerning the risks and benefits of a fully minimal-invasive intracorporeal technique unanswered," the authors explained.
The practice became routine in Sweden in 2004, and in the study nearly all the patients who underwent robot-assisted laparoscopy received ICUD (94.2%), with the remaining receiving ECUD.
"It has been proposed that ICUD might have potential benefits in terms of decreased fluid loss, further reduced EBL [estimated blood loss], and quicker return to bowel function," noted Mortezavi and co-authors.
In their study, robotic cystectomy with ICUD was significantly associated with lower estimated blood loss versus open surgery (median 150 mL vs 700 mL, P<0.001) and with a reduced likelihood of intraoperative transfusions (OR 0.05, 95% CI 0.03-0.08, P<0.001).
Median operating time was similar with the two approaches (320-323 minutes), but patients who underwent robotic laparoscopy had a shorter median length of stay (9 vs 13 days, P<0.001), and a greater number of lymph nodes removed (median 20 vs 14 nodes, P<0.001).
Likelihood of rehospitalization at 90 days, however, was greater with the robotic approach (OR 1.28, 95% CI 1.02-1.60, P=0.03), and this was not connected to broader implementation of protocols for enhanced recovery after surgery.
"We hypothesize that the higher rate of infectious complications in the [robot-assisted laparoscopic surgery] cohort, which in many cases make intravenous antibiotics necessary based on local guidelines, may have attributed to this finding," wrote Mortezavi and colleagues.
While the high-grade complication rate in the open surgery group was similar to what has been described among comparable open-surgery cohorts, the researchers highlighted that the rate in the robotic group was lower than what has been reported with ECUD in the past (22-35%).
"However," they cautioned, "owing to the technically more challenging nature of ICUD, a higher complication rate at the beginning of the learning curve, as observed in this study, has to be taken into consideration."
Comparing robotic surgeries performed in 2011-2014 with those performed in 2015-2018, they found that Clavien-Dindo grade III or greater complications were higher earlier on but significantly declined by the later time point (OR 0.62, 95% CI 0.43-0.90, P=0.01).
Using the Swedish National Register of Urinary Bladder Cancer and the population-based Cause of Death Register, the researchers looked at every patient (N=3,169) who underwent radical cystectomy at 24 Swedish hospitals from January 2011 to December 2018. Of these, 889 underwent robot-assisted laparoscopic surgery and 2,280 underwent open surgery.
No significant differences in baseline characteristics remained after propensity scoring. For the matched groups, three-fourths were men, median age was 71, and patients' median BMI was 26. A majority of patients had an American Society of Anesthesiologists score of II (50-56%) or III (32-37%). Most of the tumors were T2 (56-57%), followed by CIS/Ta/T1 (28%) and T3 (10-11%). About a third of the patients received neoadjuvant chemotherapy prior to surgery, and 18% had undergone prior surgery or radiation therapy.
The researchers performed two sensitivity analyses for the overall survival analysis (one based on year of surgery and another that excluded low-volume hospitals -- those that performed fewer than 25 radical cystectomies per year), both of which confirmed the apparent mortality benefit with the robotic approach.
Estimated cancer-specific mortality rates were not significantly different: 27.6% in the robotic group versus 30.2% in the open surgery group at 5 years, and 30.3% versus 32.3%, respectively, at 7 years (P=0.16). Other-cause mortality at 5 years was 11% in the robotic group and 12.1% in the open surgery group, and 11.4% versus 16.5% at 7 years (P=0.03).
For complications of any grade, the robotic group saw higher rates of infections (34.4% vs 29.2%), as noted, but fewer events in the cardiovascular and respiratory systems (4.4% vs 6.4%), in the abdominal wall or stoma (4.4% vs 12%), and fewer lymphoceles (1.4% vs 4.2%).
Disclosures
Mortezavi reported grant support from Krebsliga Schweiz Research. Co-authors had no disclosures.
Primary Source
JAMA Network Open
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