Laparoscopic Colectomy for Cancer Offers Minimal Short-Term Benefit Over Open Colectomy
Abstract & Commentary
Synopsis: Most of the available literature evaluating laparoscopic-assisted colectomy (LAC) for colon cancer indicates that it offers some benefit in terms of decreased postoperative pain. However, this approach has never been the subject of a randomized trial that uses validated quality of life (QOL) instruments rather than simply measuring analgesic intake. The Clinical Outcomes of Surgical Therapy (COST) study, a Phase III NCI-sponsored high priority intergroup trial, has just released its first analysis of short-term QOL results, and reported that LAC offers minimal benefits over open colectomy (OC), and, therefore, should continue to be limited to clinical trials.
Source: Weeks JC, et al. JAMA. 2002;287:321-328.
Beginning in 1994, the north central can-cer Treatment Group spearheaded an intergroup trial that was meant to test the hypotheses that disease-free survival and overall survival following LAC and OC are equivalent, and that LAC is associated with superior QOL outcomes. This study was conducted to assess the safety and efficacy of LAC for colon cancer. Participants included ECOG, CALGB, SWOG, RTOG, NCI Canada, and the NSABP. Thirty-seven centers in the United States participated in the short-term QOL portion of the study. Patient accrual into that component of the trial ceased in February 1999, and those results were just reported by Weeks and colleagues. The trial itself remains in progress, and the survival results will not be available for several years.
In order to participate in the study, patients had to have a nonobstructing, nonperforated adenocarcinoma of the ascending or descending colon that was laparoscopically resectable. There were 576 patients randomized, including 289 in the LAC arm and 287 in the OC arm. There were 215 evaluable patients in the LAC arm and 213 evaluable patients in the OC arm. The 2 groups were demographically similar, including stage of disease. The mean age was 68.2 years in the LAC arm and 69.4 years in the OC arm. Gender was evenly split in each group. There were stringent guidelines for the surgeons in the study, as well. Each surgeon had to have done at least 20 laparoscopic colon procedures to qualify for the study, and they had to submit a video demonstrating proper oncologic technique. The first 500 cases performed in the trial were videotaped, and random audits were conducted.
QOL issues were measured using self-administered scales and telephone assessments. A 13-item symptoms distress scale (SDS) recorded self-reported findings relating to nausea, appetite, insomnia, pain, fatigue, bowel, concentration, appearance, breathing, outlook, and cough. The Quality of Life Index (QLI), a 5-item instrument, looked at activity, daily living, health, support, and outlook. The Global rating QOL scale scored a patient’s state of health on a 0-100 range looking back over the preceding 2 weeks. Inpatient analgesic use and length of inpatient stay were also recorded.
The analysis of results was conducted on an intention-to-treat basis. Fifty-four patients were converted from LAC to OC for a variety of reasons, most commonly for adhesions, advanced disease, and poor visibility. The only statistically significant difference between the 2 treatment arms for the QOL instruments was in the Global QOL at 2 weeks into the postoperative period. The median score for the LAC group was 80 vs. 75 for the OC group (P = .009). In addition, the LAC patients required a median of 1 day of parenteral analgesics vs. 2 days for the OC group (P = .03), and a median of 3 days of oral analgesics vs. 4 days for the OC group (P < .001). No differences were found based on surgeon’s experience or venue, from private practice to tertiary care center.
Weeks et al concluded that, based on directly measured benefits rather than proxies like analgesic requirements and length of stay, LAC conferred minimal benefit over standard open colectomy. Since the efficacy of LAC is still unproven, in accordance with the 1994 policy statement of the American Society of Colon and Rectal Surgeons, LAC should not be offered for treatment of colon cancer outside of a clinical trial.
Comment by Edward J. Kaplan, MD
Some of the potential advantages of laparoscopic colectomy for cancer are: use of a minimally invasive approach; decreased postoperative pain; decreased length of stay; and earlier return to work. The potential disadvantages are: inadequate resection; port site recurrences; and unusual pattern of metastatic spread. Weeks et al concluded that use of an LAC approach did not translate into a statistically significant improvement in postoperative symptoms or QOL either in the immediate postoperative period or up to 2 months out. Modest, but statistically significant, benefits were seen in postoperative analgesic use and length of stay. Weeks et al state that the magnitude of the differences observed between the 2 treatment arms was lower than what has been commonly reported in the literature. They postulate that the reason for this difference is their use of direct rather than indirect measures of QOL. Weeks et al are confident that their results are widely applicable since they were consistent across the heterogeneous group of participating surgeons and institutions in the study.
It remains to be seen whether LAC is as oncologically successful as OC. For example, trocar port site recurrences have been reported with LAC and could be an inherent danger associated with the procedure. On the other hand, these types of recurrences may become less common as a particular surgeon progresses along the learning curve.1
As more and more details of the study emerge, we will get an idea about whether LAC is feasible for colon cancer. The trial closed to accrual in August 2001. According to a recent update, there have been no differences in the extent of resection or the number of lymph nodes resected between treatment arms.2
If QOL issues are comparable and efficacy is comparable, then the last factor that might determine whether LAC is finally adopted is cost. If it turns out to be less expensive than OC, then LAC may supplant OC in laparoscopically resectable cases. Until then, LAC for colon cancer must be reserved for patients enrolled in clinical trials.
References
1. Zmora O et al. Surg Oncol Clin N Am. 2001;10: 625-638.
2. Nelson H. Swiss Surg. 2001;7:248-251.
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