The American College of Surgeons (ACS) and the Alliance for Clinical Trials in Oncology announced that they have begun work on the second volume of a comprehensive, evidence-based examination of cancer surgery techniques and recommendations.
The first volume of Operative Standards for Cancer Surgery, published by Wolters Kluwer and released in June, focuses on four specific disease sites—breast, lung, pancreas, and colon. This first-of-its-kind standards manual was developed to serve as a reference in the development of clinical trials that include operations like breast-conserving surgery for breast cancer or lobectomy for lung cancer.
Kelly Hunt, MD, FACS, Program Director for the ACS Clinical Research Program and former chair of the Cancer Care Standards Development Committee, which sponsored the project, said this publication was not meant to be an instructional manual. It was envisioned by Heidi Nelson, MD, FACS, former director of the ACS Clinical Research Program, to examine the critical elements that need to occur in the operating room from skin incision to skin closure that assure the best oncological outcomes.
“What we wanted to try to do was to define what we call the critical elements of an operation,” Hunt said. “We went through and prioritized what the critical elements were that have a direct relationship with the final oncologic outcomes,” she explained. Critical elements were defined by expert surgeons in each field who ranked them. The first volume of the manual also gives recommendations for each procedure, lists the data used to study that recommendation, and tells the reader how weak or strong their recommendation is for that critical element.
There were areas of controversy where doctors could not clearly say that a component of an operation was critical to the oncologic outcome, Hunt said. For those areas, which they called key controversies, the researchers performed a systematic review of available data, with the aim of eventually designing clinical trials that can answer outstanding questions.
The Alliance is now working with the ACS Commission on Cancer (CoC) to incorporate the critical elements as standards and quality metrics for cancer centers in the future, Hunt said. The second volume of the manual will focus on melanoma, as well as gastric, esophagus, thyroid, and rectal cancers.
Hunt noted that it’s important to study outcomes so physicians can be sure that certain procedures are justified. Surgeons are often trained to do things a certain way, she said, adding that some procedures may not lead to enhanced oncologic outcomes because they cause morbidity or other difficulties for patients.
“If we perform an operation and it’s difficult to recover from and patients don’t get adjuvant therapy, we may not have done the optimal thing, so we have to constantly reevaluate our approach,” Hunt said.