Laparoscopic and open surgery for colorectal cancer: reaching equipoise?

(CLASICC) trial 1 and a discussion of evaluations of new technologies. Studies of laparoscopic compared with open surgical techniques are paradigms for the numerous situations we as oncologists (medical, surgical, and radiation) must analyze. The subtleties are often lost in the panorama and panache of study results. Furthermore, the biases of the particular interest groups are expressed with the support of the data, with the same data used to spin results in opposite directions. In preparing this editorial, I challenged myself, on behalf of the readership, to analyze the results of this and other similar trials on open compared with laparoscopic-assisted large bowel cancer surgery as the devil’s advocate and his/her adversary. The 3-year results of a randomized trial designed to compare laparoscopic-assisted with open resections for large bowel cancer are reported in this issue. This multi-institution, UK MRC–supported trial report adds to the oncologic, technical, and quality of life (QoL) outcome data on this subject. Two recent meta-analyses collect information from the Barcelona, 2 Clinical Outcomes of Surgical Therapy (COST), 3 and Colon Cancer Laparoscopic or Open Resection (COLOR) trials, 4 and the first reporting of the CLASICC trial, 5 and provide the reader not familiar with the topic an excellent synopsis of the structure and comparability and an overall perspective on the questions at hand. 6,7 The initial shortterm reporting of the CLASICC trial was an intent-to-treat report that documented an equal number of patients with Duke’s C2 (stages IIIB and IIIC) and final pathologic diagnoses. The hospital mortality was 5%. Of note, patients requiring conversion from laparoscopic assisted to open had more complications, and those with laparoscopic low anterior resections for rectal cancer had an increased number of involved resection margins. The current report expands on the early results of the 794 patients from the CLASICC trial, with an extended follow-up on survival, diseasefree survival, surgical morbidity, and QoL end points. This was a study performed with care and clarity, structured with precision, and reported within the confines of the data. Despite equivalent survival and local control, two findings are worrisome: an increase in port site/incision local recurrence that was nine times greater in the laparoscopic group (nine in the laparoscopic and one in the open), and a positive margin rate for laparoscopic rectal resections that was twice that for open. These findings may be a result of technical issues that are the burden of the laparoscopic approach. Whether they can be overcome with greater care in specimen delivery and rectal resection remains an important element in the consideration of the nonequivalence of the procedures. It is of considerable interest that the patient-reported QoL scores were nearly equal in both groups. The long-term variation that was seen in the laparoscopic group was a prolonged or persistent negative impact on financial status, physical functioning, and social functioning. This may focus us on improving the immediate variables for the open resection patient and recognizing that leaving the hospital sooner and requiring fewer pain medications while in the hospital may have their own opportunities for improvement. Many readers may skip the details and quickly read the conclusion that laparoscopic-assisted bowel surgery is equivalent to open surgery for the cancer patient. However, a more detailed reading will expose some of the confounding factors that will be important in deciding whether the results are unique to this study, or can be generalized. Let us examine the following on the reported outcomes: patient selection, site selection, surgeon selection, market forces, and investigator bias and the effect of a nonblinded trial.