Robotic nipple-sparing mastectomy performed with the da Vinci SP system made by Intuitive is safe and effective compared with open surgery in women with early-stage breast cancer, according to results of a randomized investigational device exemption (IDE) trial presented at the annual meeting of the American Society of Breast Surgeons.
Though robotic-assisted surgery resulted in longer procedures, there was less blood loss and similar surgical results, effects on quality of life, and early postoperative outcomes. No robotic cases required conversion to open surgery.
“These findings support the safe adoption of robotic nipple-sparing mastectomy in carefully selected patients following structured training and in experienced centers,” Katherine Kopkash, MD, clinical professor of surgery at the University of Chicago Pritzker School of Medicine in Illinois, said during a media briefing. “Ongoing follow-up to better define long-term oncologic outcomes will continue.”
The trial, conducted at 14 sites with 23 surgeons specially trained to perform robotic nipple-sparing mastectomy, was stopped early after the robotic system received 510(k) clearance from the FDA for this purpose.
Following a roll-in phase to allow surgeons to become comfortable with the system, investigators enrolled 81 women with early-stage breast cancer who were scheduled to undergo nipple-sparing mastectomy with implant-based reconstruction and had a BMI below 30 kg/m2, a breast cup size of C or smaller, and breast ptosis with a grade ≤2.
Robotic surgery was associated with increased overall procedure time (mean 141.6 vs 83.9 min; P<0.001) and reconstruction time (mean 79.7 vs 62.6 min; P=0.008). The robotic system held the advantage, however, in estimated blood loss (mean 60.3 vs 89.4 mL; P=0.033).
Other outcomes, including nipple-areola complex preservation, unplanned reoperation, and positive surgical margins did not differ between groups. There were no cancer recurrences through 6 months.
The researchers measured quality-of-life changes between baseline and 6 months using a validated questionnaire for patients with breast cancer called BREAST-Q. Though there appeared to be more favorable changes across several domains—including satisfaction with breasts and psychosocial, physical, and sexual well-being—with robotic surgery, none of the changes were significantly different between the two groups.
Through 42 days, serious adverse events, which included hematoma requiring reoperation, seroma, wound dehiscence, pneumothorax, and infections leading to implant loss, occurred at statistically similar rates irrespective of surgical method (P=0.19).
Of note, Dr. Kopkash said, “none of the robotic nipple-sparing mastectomy serious adverse events were deemed to be device-related by the data safety monitor.”
She indicated that the findings have broad applicability.
“The technique we used in our protocol was reproducible amongst many surgeons and many different institutions in the country,” she said. “While serious adverse events and patient-reported outcomes were more favorable in the robotic group, these differences were not statistically significant. Operative times were longer in the robotic nipple-sparing mastectomy [group], likely reflecting early experience with the technique, and are expected to improve over time.”
A subanalysis indicated that surgeons grew speedier when using the robotic system over just a few cases. “We analyzed the change from first to third robotic nipple-sparing mastectomy, and that showed a statistically significant improvement, with the time dropping by nearly an hour,” Dr. Kopkash said.
Additional data is forthcoming on surgeon satisfaction with robotic surgery.
Image by J_art / Getty Images
