Health-related Quality of Life After Robotic-assisted vs Open Radical Cystectomy: Analysis of a Randomized Trial

Abstract

Purpose:We compare health-related quality of life using a broad range of validated measures in patients randomized to robotic-assisted radical cystectomy vs open radical cystectomy.Methods:We retrospectively analyzed patients that had enrolled in both a randomized controlled trial comparing robotic-assisted laparoscopic radical cystectomy vs open radical cystectomy and a separate prospective study of health-related quality of life. The prospective health-related quality of life study collected 14 patient-reported outcomes measures preoperatively and at 3, 6, 12, 18, and 24 months postoperatively. Linear mixed-effects models with an interaction term (study arm×time) were used to test for differences in mean domain scores and differing effects of approach over time, adjusting for baseline scores.Results:A total of 72 patients were analyzed (n=32 robotic-assisted radical cystectomy, n=40 open radical cystectomy). From 3-24 months post-radical cystectomy, no significant differences in mean scores were detected. Mean differences were small in the following European Organization for Research and Treatment of Cancer QLQ-C30 (Core Quality of Life Questionnaire) domains: Global Quality of Life (−1.1; 95% CI −8.4, 6.2), Physical Functioning (−0.4; 95% CI −5.8, 5.0), Role Functioning (0.7; 95% CI −8.6, 10.0). Mean differences were also small in bladder cancer–specific domains (European Organization for Research and Treatment of Cancer QLQ-BLM30 [Muscle Invasive Bladder Cancer Quality of Life Questionnaire]): Body Image (2.9; 95% CI −7.2, 13.1), Urinary Symptoms (8.0; 95% CI −3.0, 19.0). In Urostomy Symptoms, there was a significant interaction term (P < .001) due to lower open radical cystectomy scores at 3 and 24 months. Other domains evaluating urinary, bowel, sexual, and psychosocial health-related quality of life were similar.Conclusions:Over a broad range of health-related quality of life domains comparing robotic-assisted radical cystectomy and open radical cystectomy, there are unlikely to be clinically relevant differences in the medium to long term, and therefore health-related quality of life over this time period should not be a consideration in choosing between approaches.

Editorial Comment

“…3-5 With regard to sexual function, similar to data we have seen from robotic prostatectomy, nerve sparing appears more feasible with the robot. Studies including the current study by Clements et al 2 have shown no differences in HRQoL scores after 3-6 months, and most importantly, no oncologic differences between the 2 approaches. As the authors also included in their conclusion, at this point, we should focus more on surgeon experience and how we can deliver the best oncologic surgery to our bladder cancer patients, rather than focusing on robot vs open.…”

“…1 While most studies so far have focused on oncologic differences and complication rates between open radical cystectomy (ORC) and robotic-assisted radical cystectomy (RARC), there has not been much focus on the HRQoL differences between the 2 approaches. In this study, 2 authors from Memorial Sloan Kettering Cancer Center used a broad range of validated measures to analyze the HRQoL among patients who were previously enrolled in their landmark randomized controlled trial of RARC vs ORC. 3 Urostomy-related symptoms (eg, skin changes and leakage from the ostomy) were worse in the ORC cohort at 3 and then 24 months, but other than that, there were no other clinically significant long-term differences in HRQoL metrics between the 2 surgical approaches.…”

Will Patient-reported Outcomes Be the Key to Demonstrating the Value of Robotic Cystectomy? Data Are Accumulating but Clarity Is Not

“…Clements and colleagues lean into their findings, concluding that HRQOL should not be a driving factor in treatment decisions or recommendations for robotic-assisted cystectomy over an open approach. 9 That is a mostly true statement, though as with most things absolutes seldom come without exceptions.…”

“…In this issue of The Journal, Clements et al (page 901) add to growing evidence comparing robotic-assisted and open cystectomy through the lens of patient-reported and -centered outcomes, reporting small but insignificant differences in global quality of life, physical functioning, body image, and bladder cancer–specific domains, among others. 9 Among a subset of 72 patients who participated in a prior randomized trial comparing robotic-assisted cystectomy to open cystectomy 2 who also completed HRQOL surveys over a 2-year period after surgery, the authors did not observe significant differences in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (Core Quality of Life Questionnaire) scores or bladder cancer–specific domains measured using the EORTC QLQ-BLM30 (Bladder Cancer Quality of Life Questionnaire; Figures 2 and 3 in the article). These data are notable given the outcomes following both approaches were so similar.…”

Reply by Authors

“…As surgeons, our focus should remain on the long-term outcomes that define a good outcome after radical cystectomy: complete cancer control and an excellent functional recovery that allows patients to return to their preoperative lifestyle. 1 Whether these goals are achieved with robotic or open surgical techniques is much less important than following the established surgical/oncologic tenets of the procedure and a continued quest to provide successful and functional reconstructive options.…”