May 1, 2022
The lines have crossed. Survival rates for rectal cancer now surpass those for patients with colon cancer.1 This improvement in rectal cancer survival is the culmination of 30−40 years of advances in imaging to determine clinical stage, refinements in neoadjuvant therapy, and attention to surgical principles and pathologic techniques, including establishing margin status, lymph node involvement, and grading of surgical specimens. The successful management of rectal cancer requires a multidisciplinary approach with technology and specialists typically clustered in metropolitan areas, which are less accessible to patients in small towns and rural areas across the US and Canada.
The American College of Surgeons (ACS) National Accreditation Program for Rectal Cancer (NAPRC) certifies centers that meet rigorous criteria to provide all aspects of multidisciplinary care for rectal cancer patients. A compendium of established standards across the many required specialty services recently was collated into the Fundamentals of Rectal Cancer Surgery (FRCS) posted on the American Society of Colon and Rectal Surgeons (ASCRS) website (fascrs.org). Although all of these components may be in place, access to care remains an issue for many Canadian and US patients because of obstacles related to time and distance to specialty centers and specialists. This challenge has been debated previously without resolution.2
Most rural or small-town patients lack the resources or support to travel long distances, and these individuals usually prefer to stay close to home and be treated by local nonspecialist surgeons. Anecdotal reports show that the practice of specialist surgeons managing the rural patient have proven successful but unsustainable.3
A potential solution involves local general surgeons managing these distant patient populations using the standards and principles of multidisciplinary care established in the FRCS. The following description of how rectal cancer care evolved in British Columbia (BC) and Alberta (AB) highlights this approach. This topic was discussed during a panel session at Clinical Congress 2021, Treatment of Rectal Cancer in the Community.
A high local recurrence rate for rectal cancer was identified in a 1996 audit of patients treated for rectal cancer in BC. General surgeons in the province initiated the review in response to a high rate of postoperative local recurrence of cancer. Pelvic recurrence at 4 years occurred in 16% of rectal cancer patients for all stages and in 27% of stage III patients.4
Factors contributing to a higher rate of local recurrence after surgical resection of rectal cancer than after resection of colon cancer include difficulty defining and dissecting surgical anatomy in the deep pelvis compared with the open abdomen, nonstandardized resection of the rectum, and poor adherence to international standards for the provision of neoadjuvant radiotherapy. Approximately 10% of operative reports included statements that the rectal cancer was resected with clear gross radial margins and that all mesorectal lymph nodes were removed. Only 50% of pathology reports assessed whether radial margins were histologically cancer-free. The mean number of lymph nodes identified at pathology evaluation was six instead of 12. Adjuvant radiotherapy was provided to 50% of eligible rectal cancer patients with stage II or III rectal cancer.
Recognizing the significance of high local recurrence rates for rectal cancer patients in BC, the Colorectal Surgical Tumour Group of the Surgical Oncology Network (SON) of BC Cancer designed a management plan aimed at standardizing care across the province with the goal of reducing local recurrence. The plan included:
Total mesorectal excision (TME) was the recommended surgical technique for excision of the rectal cancer and all mesorectal lymph nodes in an intact mesorectal fascia envelope. Local recurrence rates at 10 years for curative resections using TME reported by Heald and colleagues were as low as 4%.5 A new protocol for preoperative short-course radiotherapy recommended by Pahlman and colleagues in Sweden reduced local recurrence from 27% to 11% after follow-up at a minimum of 5 years.6 The combination of short-course preoperative radiotherapy and TME resulted in a 2-year local recurrence of 2.4% in a Dutch national trial.7
After review of published outcomes in England, Sweden, and the Netherlands, the clinical guidelines for rectal cancer management in BC were modified to include preoperative clinical staging using computed tomography (CT), magnetic resonance imaging (MRI), and endorectal ultrasound to serve as the basis for recommending short-course preoperative radiation for stages II and III rectal cancer followed by TME.8 Guidelines for pathology reporting include assessment of the radial resection margin and examination of at least 12 lymph nodes.9,10 Clinically fixed tumors and lesions having predicted close or threatened resection margins prompted a recommendation for long-course neoadjuvant (preoperative) chemoradiotherapy.
To implement the new treatment strategies, an education program was designed for surgeons, pathologists, and radiation oncologists involved in the care of these rectal cancer patients. Education sessions offered in 2002–2003 consisted of lectures, live surgery with a video link to the audience, and hands-on dissection of the pelvis in cadaver labs.11 Session topics included imaging, radiotherapy, and chemotherapy in the preoperative phase, specimen processing, gross and microscopic findings, and standardized pathology reporting. World experts from Sweden, the Netherlands, the UK, and the US were invited instructors. Course participants responded favorably to the educational value of the sessions and knowledge retention tests suggested good knowledge transfer.12
The next step was to implement the treatment plan and to inform family physicians in BC of the new rectal cancer management strategy. This information was transmitted via the BC Medical Journal in a July−September 2003 two-part theme issue.
The Colorectal Surgical Tumour Group of the SON collected and analyzed data on patient outcomes. Patients treated with curative-intent major resection of rectum cancer in the year after the education courses were audited. This group of patients was compared with patients treated in the initial study. The main finding was a decrease in 2-year pelvic recurrence from 18.2% to 9.2% for stage III rectal cancer and from 9.6% to 6.9% overall.13 Use of adjuvant radiotherapy increased to 65%, mostly given in the preoperative (neoadjuvant) setting. Negative radial margins were achieved in 87% of patients. Pathology reporting revealed an increased assessment of the radial margin to 97% of cases and an average of 12 lymph nodes harvested per case.
The final step of the quality improvement (QI) process involved providing feedback to participants. Ongoing reports were provided to BC surgeons at the annual spring meeting of the BC Surgical Society and to oncologists at the annual fall meeting of BC Cancer, as well as through the SON newsletter. A rectal cancer education course update took place in 2008 to report the final outcomes. Feedback to family physicians in BC continues to be provided in the BC Medical Journal.
As with many QI projects, important aspects of care requiring further attention include the community of family physicians, surgeons, oncologists, and pathologists who are integral to the care of rectal cancer patients. Technical problems with surgical resection of rectal cancer persist in BC. Positive radial margins for rectal cancer location in proximity to the anal sphincter were recorded in 35% of specimens with cancers in the distal third of the rectum (less than 5 cm from the anus).14 The high rate of positive radial resection margin in the distal third of the rectum was anticipated. Nagtegaal and colleagues for the Dutch collaborative reported a 30% positive margin rate for distal third rectal cancer patients associated with a high perforation rate of 13.7% and a survival rate of 38.5%.15
Defining anatomy and precise dissection in the deep pelvis can be difficult. Additional training is needed to consistently achieve clear radial excision margins along TME planes in the narrow fixed bony pelvis, crowded with surrounding genital and urinary organs. Radical resection of distal-third rectal cancer may require TME plus wide levator excision, resulting in a large pelvic floor defect, which may require vascularized flap reconstruction using a transposed abdominal rectus musculocutaneous flap. If the rectal cancer does not invade the anal sphincter, a sphincter-sparing resection and stapled or hand-sewn colo-anal anastomosis may be performed. Also in BC, the rate of permanent colostomy for distal-third rectal cancer did not decrease after the education courses, in contrast to the 10% permanent colostomy rate in specialized units, according to the authors’ personal observations.
Thus, it seems reasonable to recommend that surgeons who operate for rectal cancer less frequently could refer difficult distal-third rectal cancers to specialist surgeons in high-volume centers.16
Rectal cancer management is best decided in a multidisciplinary conference (MDC) that includes diagnostic radiology, surgery, pathology, and medical and radiation oncology. Input from geriatrics, nursing, and patient support groups may be included in discussions.
MDC discussion of individualized rectal cancer case management options that could enable organ preservation or optimization of radiotherapy and chemotherapy is recommended. Organ preservation options include endorectal techniques and trans-anal endoscopic surgery for early cancers, along with potential nonoperative management for patients who have complete clinical response after neoadjuvant or total neoadjuvant therapy.
MDC discussion will invoke evidence-based treatment options from clinical trials: MRI in Rectal Cancer European Equivalence (MERCURY) Study and Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and TME (PROSPECT) Trial. These studies provide evidence-based case selection for safe avoidance of preoperative radiation.17,18 The Rectal cancer And Preoperative Induction therapy followed by Dedicated Operation (RAPIDO) Trial, Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (PRODIGE) Trial, and Organ Preservation of Rectal Adenocarcinoma (OPRA)
Trial provide evidence-based optimized treatment sequencing, radiotherapy duration, and chemotherapy regimen.19-21 In BC, the referral of patients with cancer in the distal third of the rectum to high-volume specialist centers continues to evolve (see Figure 1).
Multidisciplinary discussions and collaboration provide optimal strategies for neoadjuvant treatment and surgical intervention. QI in rectal cancer treatment in BC ideally will continue in cycles of assessment, strategy, and execution with help from the SON.
Within this multidisciplinary framework of care, limitations in resources and geographic expanse pose challenges to QI in this large province. Referrals of patients with distal third of the rectum cancer to high-volume specialist centers continue to evolve. Patient awareness, education, and advocacy will continue driving the quest to improve outcomes of rectal cancer care in BC.
Alberta comprises approximately 4.4 million people spread over 661,800 km2, an area slightly smaller than Texas. Provincial healthcare is delivered through Alberta Health Services (AHS), the largest fully integrated health system in Canada, with 125,000 employees and five comprehensive cancer centers. An estimated 500 to 525 rectal cancers are diagnosed annually, with approximately 50 surgeons performing operations in 85% of patients at 16 hospitals.
In 2013, an internal review of rectal cancer outcomes in the province by surgeon investigators identified several quality-of-care issues. Variability in both practice and reporting was associated with variable outcomes. While variable practice at the individual and system level directly affects outcomes, variable reporting has an indirect effect because of the multidisciplinary nature of rectal cancer care and limitations resulting from incomplete communication.
A Partnership for Research and Innovation in the Health System grant from AHS and Alberta Innovates was obtained to develop and implement a provincial evidence-based care pathway to standardize rectal cancer care and improve outcomes in 2014–2018. Although the initial project was focused on improving surgical care, it became apparent that QI would require a multidisciplinary approach because of the interdisciplinary nature of rectal cancer care. QI focused on four areas:
Baseline provincial data for rectal cancer care in 2010−2013 were collected from the Alberta Cancer Registry, Alberta Cancer Surgery database, and chart review. The data were gathered from five disciplines: surgery, radiology, pathology, radiation oncology, and medical oncology. At the time, fewer than 50% of patients underwent a preoperative MRI, and synoptic reporting was limited. In some regions, fewer than 50% of appropriate patients were evaluated for neoadjuvant treatment, and surgical quality was variable, with incomplete pathologic reporting of important variables such as CRM and grading of TME specimens.
Opinion leaders representing the five disciplines at the five provincial cancer centers were engaged to review the baseline data and determine best practices, adopt standards of care, identify appropriate quality measures, and determine/adopt best reporting practices (synoptic, if possible). These elements were incorporated into a comprehensive rectal cancer care pathway.
Five change management strategies were adopted to influence both process and practitioner behavior, including:25
Focused discipline-specific education days in surgery, radiology, and pathology with invited international opinion leaders were scheduled in the two major centers with video links. CME continued throughout the study period, with regular outreach using tailored traveling talks about local and provincial outcomes with clinicians at the five provincial cancer centers. An audit/feedback system was created to collect individual quality and process measures for radiologists, surgeons, and pathologists with discipline-specific report cards for individual practitioners distributed through a secure web portal. Synoptic MRI, surgical, and pathology reports were adopted with embedded computer prompts.
Improvements were realized in all four QI areas on a provincial basis. By the end of the study period, staging pelvic MRIs were obtained in 83% of patients, more than 80% of which were reported synoptically.
As of 2018, more than 90% of T3 cancers were evaluated by an oncologist, with 86% of those patients receiving neoadjuvant treatment. MDC is now established in all five cancer centers.
From a surgical perspective, the CRM positivity rate stabilized with a mean rate of 6% in 2016−2018. As of 2018, quality of pathologic specimens had improved with complete (grade 3) mesorectal excision in 73% of cases and near complete (grade 2) in another 18%. Some consolidation of surgery occurred, with high-volume surgeons performing 75% of all operations.
Change management strategies that were most successful included CME with opinion leaders and meetings with local clinicians discussing results and comparing them with provincial standards. MDCs improved communication and referrals between disciplines and helped drive synoptic reporting as colleagues recognized the importance of complete reports for optimal decision-making. Individual audit and feedback for practitioners reinforced individual performance.
Initially, the effort was greeted with some resistance to change because of traditional views of physician autonomy and perceived loss of control. Follow-up discussion centered on the benefits of participating within a larger surgical QI collaborative and the gains for patients with respect to appropriateness, safety, and quality. Early investigators fielded questions about the validity of the data. These concerns were countered through transparent discussion of the methodology of data acquisition and discussion of the results by center, with individual data relegated to report cards available only to each surgeon.
In addition, some clinicians perceived the change to synoptic reports as added work. Discussions at MDC demonstrated the importance of specific data points for decision-making by other disciplines; synoptic reports ensured all essential data were present and accessible.
Open communication to articulate key goals and striving for inclusiveness ensured that everyone’s viewpoint was represented and established a connection with the decision process. Although the logical piece is important to stimulate interest in change, the emotional piece is essential to change behavior.
There is no endpoint to QI. Our ongoing challenges in the care of rectal cancer patients include:
Although most surgical care is provided by colorectal surgeons and surgical oncologists, at present, 18% of surgical care is delivered by generalists. Smaller cancer centers have identified generalists with special interest and training in rectal cancer surgery. Cases are preferentially sent to these individuals, several of whom have become high volume surgeons with excellent outcomes. This model has worked well as our population density in many parts of the province is low. More complex cases are triaged to subspecialists as required.
Fortunately, there appear to be several methods of enhancing rectal cancer outcomes than long distance travel.26 General surgeons in BC recognized the problem of local recurrence of rectal cancer, initiated the response and followed through on the delivery and integration of multidisciplinary care. In Alberta, a multifaceted approach to improve multidisciplinary care was enacted to improve obvious deficiencies in the care provided. Accordingly, rectal cancer cases scattered among general surgeons were funneled to select surgeons within various groups who were committed and educated in TME, so that low volume rectal cancer surgeons could become high volume rectal cancer surgeons by virtue of increased case numbers and enhanced surgical expertise.27
In Kentucky, the Markey Cancer Center Affiliate Network was established to link small rural hospitals to academic centers to initiate guideline-based therapy closer to home and provide complex surgical care at the high-volume academic center. Furthermore, these established networks may facilitate communication between surgeons when emergent intervention in a rural hospital becomes necessary. For instance, the location and type of diverting stoma in the acutely obstructed rectal cancer patient in a rural setting can be optimized by a preoperative discussion between the attending rural surgeon and the specialist surgeon at the network academic center.28
Raising local standards and practices of rectal cancer care (decentralization) is in opposition to the European solution of centralized rectal cancer care. Centralization of rectal cancer care to high-volume academic centers has been documented to increase distance traveled, to decrease access to care, and is associated with higher mortality.28 Furthermore, Xu and colleagues state that “consideration needs to be given to the risk of cutting off access to care for vulnerable socioeconomic groups.”29 These authors also suggest “targeting standardizing quality of care through widespread adoption of NAPRC standards, as opposed to centralization alone, could help mitigate volume differences and improve outcomes and survival in patients with rectal cancer.”29
The Canadian experience offers varied approaches to improving rectal cancer outcomes, with the common thread of striving to provide established standards of rectal cancer care among all disciplines involved in managing these patients.