BOSTON – Colon cancer patients who undergo a minimally invasive surgical procedure to remove their tumors experience only slightly better quality-of-life outcomes than those who have the standard surgery, according to the findings of a national clinical trial that is comparing the two procedures. The results will be published in the Jan. 16 issue of the Journal of the American Medical Society.
Researchers from Dana-Farber Cancer Institute and the Mayo Clinic and their colleagues found that compared with patients who had the standard operation, those who had a laparoscopic-assisted colectomy were able to leave the hospital about a day earlier, on average, and required less pain medication while hospitalized. However, their levels of pain and quality of life immediately following surgery and two months thereafter were the same as those who had the standard operation.
“These results were certainly a surprise, as it was generally assumed that quality of life after laparoscopic surgery would be substantially better,” says Jane C. Weeks, MD, MSc, the study’s lead author and director of Dana-Farber’s Center for Outcomes and Policy Research.
“Although we did see modest advantages for laparoscopic surgery, these findings need to be considered in context,” explains Weeks. “The goal of colon cancer surgery is to cure the cancer. Until the longer term results of this study are available in a few years, and we know whether laparoscopic surgery is as effective as the standard operation in controlling the cancer, we believe that it should be viewed as experimental and offered only as part of a clinical trial.”
With a standard, or open, colectomy, the surgeon makes an incision on the patient’s abdomen large enough to allow the tumor and surrounding tissues to be fully exposed, and removes the tumor directly, working inside the patient’s abdomen.
In a laparoscopic-assisted colectomy, the surgeon accesses the colon through small slits in the patient’s abdomen. A small video-tipped probe and surgical tools inserted through the slits enable the surgeon to locate and manipulate the affected section of the colon. This section is pulled outside the body through an incision only a few inches long, and the tumor is removed with the same techniques used in a standard colectomy.
The controlled, multicenter study followed 428 colon cancer patients who were randomly assigned to undergo either a standard colectomy or a laparoscopic-assisted colectomy. Surgeons were allowed to perform an open colectomy on those patients who were initially assigned to the laparoscopic-assisted colectomy group if they deemed it medically necessary.
The patients’ quality of life outcome scores were derived from data from surveys they completed prior to surgery and 2 days, 2 weeks and 2 months postoperatively. The surveys focused on the patients’ frequency of symptoms, such as nausea and fatigue. They also measured levels and frequency of pain and assessed how the surgery impacted five specific areas of their lives.
“These findings are not critical of minimally invasive procedures in general,” says Heidi Nelson, MD, a colorectal cancer surgeon at the Mayo Clinic in Rochester, Minn., principal investigator of the trial and co-lead author of the paper. But she said that compared to patients with benign conditions, the stakes are higher for cancer patients.
“In evaluating laparoscopic surgery for colon cancer, we have to weigh the quality-of-life benefits against the long-term control of the cancer,” says Nelson. “The fact that we found only modest benefits makes it all the more important to answer the question of whether laparoscopic-assisted colectomy is as safe as the standard procedure.”
The trial is part of the National Cancer Institute’s Clinical Outcomes of Surgical Therapy (COST) study, which is being conducted to measure the disease-free survival and overall survival rates of colon cancer patients who underwent laparoscopic-assisted colectomies and to compare these data to those who had open colectomies.
Weeks and Nelson wrote the paper with Shari Gelber, MS, of Dana-Farber, and Daniel Sargent, PhD, and Georgene Schroeder, MS, of the Mayo Clinic, on behalf of the COST Study Group.
Dana-Farber Cancer Institute (http://www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), a designated comprehensive cancer center by the National Cancer Institute.
Journal
JAMA