Surgical resection of solid tumors remains the cornerstone of multidisciplinary care for patients with early-stage and advanced malignancies. Although organizations such as the National Cancer Institute and National Comprehensive Cancer Network publish guidelines and treatment algorithms for the care of cancer patients, none of these protocols addresses the fundamental question of what constitutes the critical elements of an operative procedure for cancer resection. Overall, standards for oncologic resections are surprisingly lacking. Quality control in clinical trials involving surgery has been inconsistent and makes comparison across studies inaccurate or impossible.
To address the technical aspects of standardizing surgical care, the American College of Surgeons Clinical Research Program, a program of the Alliance for Clinical Trials in Oncology and the College, formed the Cancer Care Standards Development Committee. For the last three years, the committee, led by Kelly K. Hunt, MD, FACS (co-author of this article), worked to develop a manual that details the critical elements of cancer surgery as first envisioned by Heidi Nelson, MD, FACS (co-author of this article). The resulting textbook, Operative Standards for Cancer Surgery, is now complete and will be available for purchase in July at the Wolters Kluwer website.
Development of the manual
The manual was conceived in response to the need for a standardized description of “minimum standards” for various cancer operations to serve as a reference for clinical trials that include surgical interventions. More specifically, the idea was to create a standards manual that could serve as a reference in the development of clinical trials that include operations such as breast-conserving surgery, pancreaticoduodenectomy, or lobectomy, rather than require investigators to establish or re-establish the basic principles of these operations with the development of each new trial. The goal was to minimize variability across study sites and improve adherence to minimum standards for patients treated both on and off a clinical trial. As the project matured, it became clear that this manual could serve many purposes, ranging from surgical education to providing a basis for operative report templates and quality improvement databases.
The committee chose to focus on four specific disease sites for the first edition of the manual—breast, colon, lung, and pancreas. For each disease site, several common operative procedures that the committee agreed were important to describe were chosen. The manual is not a surgical atlas; rather, the emphasis is on oncologic fundamentals and the critical elements in the conduct of an operation and intraoperative decision making.
In addition, the committee participants who developed the manual identified areas of controversy and posed several key questions that were then analyzed using a systematic review of current literature. These may serve as the basis for a new clinical trial within each disease site.
A leadership committee was assigned to address each disease group. This leadership group included a section editor, a methodologist, and an art/illustrations editor. Surgeons with expertise in each disease site were recruited from all of the national societies and cooperative groups for the broadest possible representation. International experts also were invited to participate in each section. Much of the initial work was done on conference calls, followed by collaborative writing over the next year and a half. This work culminated in the completed textbook, which will also be available as an online resource.
The final product
The manual provides concrete recommendations on the proper conduct of operations and detailed information on the oncologic principles, avoidable pitfalls, and quality of the evidence on which these recommendations are based. The manual is focused on the decisions that are made from skin incision to skin closure, and the recommendations are based on the strongest available evidence. Because randomized trials have not addressed all of the components of operations within each disease site, it was important to draw on the experience and consensus of the experts writing the individual chapters. Identifying the lack of evidence on certain topics has been an unintended consequence of writing this manual and has galvanized the authors into establishing standards where none currently exist. With the participation of more than 120 surgeons in this first edition, it is perhaps the best resource currently available on the proper conduct of an operation for cancer of the breast, colon, lung, and pancreas.
In anticipation of continued evolution in surgical oncology, these initial four disease site sections will be updated every two to three years. Planning is already under way for the second edition of the manual and will include procedures in melanoma, gastric cancer, esophageal cancer, rectal cancer, and thyroid cancer.
Frank Detterbeck, MD, FACS, FCCP, professor of surgery (section of thoracic surgery); chief, thoracic surgery; surgical director, thoracic oncology; and associate director, clinical affairs, Yale Cancer Center, New Haven, CT, described the role of the manual best in the introduction to the chapter on lung cancer:*
The purpose of this section is to describe a minimal standard for the actions that should be taken in the surgical care of [lung] cancer patients, with the ultimate goal of improving the quality of care these patients receive. In this way, the aim…is to “raise the floor” rather than define the absolute ceiling of what can be achieved; further improvement is always possible. This standard should serve as a guide for surgeons who are focused on delivering high-quality care to achieve the best outcomes for their patients.
*American College of Surgeons Clinical Research Program, Alliance for Clinical Trials in Oncology. Operative Standards for Cancer Surgery: Volume I: Breast, Lung, Pancreas, Colon. Philadelphia, PA: Lippincott, Williams, and Wilkins; 2015.