NEW YORK (Reuters Health) – The risk of cancer recurrence is increased slightly after laparoscopic rather than open surgical management of uterine cancer, according to study findings reported in the Journal of Clinical Oncology online January 30.
“These results, combined with previous findings from this study of improved QOL and decreased complications associated with laparoscopy, are reassuring to patients and allow surgeons to reasonably suggest this method as a means to surgically treat and stage patients with presumed early-stage uterine cancers,” the authors conclude.
Dr. Joan L. Walker, at the University of Oklahoma, Oklahoma City, and colleagues conducted a randomized trial comparing perioperative and short-term outcomes of surgical management of uterine cancer performed via laparoscopy or laparotomy. In 2009 they reported that results favored laparoscopy. However, there was concern that recurrence rates might be higher with laparoscopy because the lack of tactile sense could lead to metastatic tumor being missed.
The current study focuses on recurrence rates and overall survival in the study population of 2181 women after a median follow-up of 59 months. The team specified that laparoscopy would be considered inferior to laparotomy if the hazard ratio for recurrence were 1.4 or more. Based on expected rates, this would be equivalent to an absolute difference in recurrence rates of 5.3% at 3 years.
The actual hazard ratio was 1.14 but the upper confidence limit was 1.46, “falling short of the protocol-specified definition of noninferiority,” the authors found.
However, actual recurrence rates at 3 years were lower than expected (11.39% with laparoscopy and 10.24% with laparotomy), so the absolute difference of 1.14% was less than the specified noninferiority margin, they note.
Overall 5-year survival was “excellent” and identical in the two arms at 89.8%, Dr. Walker and colleagues report.
“These results do not demonstrate a survival decrement from laparoscopy, which allows patients and surgeons comfort in choosing the less morbid procedure,” they conclude.
The authors of an accompanying editorial write, “One can reasonably conclude that there is not a substantial increase in recurrence rates with laparoscopic surgery. However, because the study did not achieve noninferiority, it is important to not dismiss the possibility that a small difference may actually exist.”
They hope that other ongoing trials of minimally invasive surgery will be reassuring.
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