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Table 2 Summary of the 2021 SICG-SIFIPAC-SICE-WSES multidisciplinary consensus on the management of rectal cancer in the elderly. Statements and recommendations

From: Multidisciplinary management of elderly patients with rectal cancer: recommendations from the SICG (Italian Society of Geriatric Surgery), SIFIPAC (Italian Society of Surgical Pathophysiology), SICE (Italian Society of Endoscopic Surgery and new technologies), and the WSES (World Society of Emergency Surgery) International Consensus Project

Consensus Topic: A. Epidemiology

Key Question: 1. Socioeconomic burden. In elderly patients with rectal cancer, how does pre-existing frailty affect the incidence of adverse events and healthcare costs?

Statement: Frailty should not be considered a contraindication to surgery in elderly patients with rectal cancer. It is instead a condition that requires a correct choice of the proper surgical technique and a careful peri-operative care to reduce complication rate and consequently healthcare costs.

1.1.1.1.1.1.1.1.25. No Recommendation

Agreement: 94.1%

 

Consensus Topic: A. Epidemiology

Key Question: 2. Screening strategies. In elderly patients with rectal cancer, how do the current screening strategies compared with no screening affect prognosis?

Statement: The potential benefits of screening for rectal cancer in elderly patients may vary broadly with age, life expectancy, and screening modalities. Life expectancy and comorbidity should be carefully considered in this context. Subject testing negative for screening, especially after negative colonoscopy, could consider discontinuing screening tests at the age of 75 years.

1.1.1.1.1.1.1.1.26. Recommendation: The experts’ panel recommends against screening in patients older than 85 years. We suggest a careful selection on an individual basis for patients between the ages of 76 and 85 years, according to their health status (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 88.2%

 

Consensus Topic: B. Pre-intervention strategies

Key Question: 3. Improvement strategies for patient involvement in healthcare decision-making. In elderly patients with rectal cancer, how do the strategies for patient involvement in healthcare decision-making compared with the standard decision-making pathways affect compliance to planned treatments?

Statement: In elderly patients with rectal cancer, the will of the patient to be involved in the decision-making process should be investigated to improve patients’ adherence to planned treatments.

1.1.1.1.1.1.1.1.27. Recommendation: The experts’ panel recommends the adoption of strategies for patient involvement in healthcare decision-making, the evaluation of the social background, and a discussion with the patient about therapeutic modalities for rectal cancer (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 94.1%

 

Consensus Topic: B. Pre-intervention strategies

Key Question: 4. Frailty assessment and multidisciplinary evaluation. In elderly patients with rectal cancer, how does the frailty assessment compared with standard assessment strategies influence the outcomes of neoadjuvant treatment, surgical care, recovery, and oncological outcomes?

Statement: No study directly compared the outcomes of rectal cancer treatment after frailty vs. standard assessment in patients aged above 70 years; however, despite its limitations, the

literature shows that frailty, but not age, is an independent risk factor for mortality, morbidity, and re-admissions after rectal cancer surgery, radiotherapy, and palliative chemotherapy for metastatic disease.

1.1.1.1.1.1.1.1.28. Recommendation: The expert’s panel suggests the use of a frailty score in the preoperative evaluation of rectal cancer patients above 70 years of age (Weak recommendation, Low quality of evidence—2C).

Agreement: 97.1%

 

Consensus Topic: B. Pre-intervention strategies

Key Question: 5. Definition and prioritization of patient-centered outcomes. In elderly patients with rectal cancer, how does the prioritization of patient-centered outcomes compared to standard reported outcomes influence the treatment strategies?

Statement: When deciding the best therapy for elderly patients with rectal cancer, many factors should be considered, such as preoperative frailty and functional status, operative curability, tumor stage, co-morbidities, life expectancy, and patient desire.

1.1.1.1.1.1.1.1.29. Recommendation: The experts’ panel recommends involving elderly patients with rectal cancer in a shared decision-making process for the therapeutic pathway with a “two-way communication” between healthcare-professionals and patients/caregivers (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 97.1%

 

Consensus Topic: C. Diagnosis and staging

Key Question: 6. In elderly patients with rectal cancer, how does pelvic Magnetic Resonance Imaging (MRI) perform, compared to Endoscopic Ultrasonography (EUS), in the staging and re-staging following neoadjuvant therapy?

Statement: Both EUS and MRI provide reasonable diagnostic accuracy in the staging of rectal cancer. However, EUS outperforms MRI in overall T, overall N, T1 and T3 staging. Morphological re-assessment of T- or N-stage by MRI or EUS after neoadjuvant therapy is currently not accurate or consistent enough for clinical application. EUS is slightly superior to MRI in re-staging the T category after neoadjuvant therapy, whereas the re-assessment by MRI before surgery appears to have a clinical role in excluding circumferential resection margin involvement. The multidisciplinary team should be aware of advantages and disadvantages of both modalities and choose the appropriate method while considering diagnostic accuracy of each test in each specific condition.

Recommendation: The experts’s panel recommends that either EUS or MRI should be used based on local availability and expertise. MRI has relatively high diagnostic accuracy for preoperative circumferential resection margin assessment and should be used for accurate preoperative staging when muscularis propria invasion and adjacent organ invasion is suspected. Given the operating characteristics of EUS and MRI and lack of consensus in guidelines, clinical decision may ultimately be determined by access to resources, local expertise, and institutional policy (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 85.3%

 

Consensus Topic: D. Neoadjuvant therapy

Key Question: 7. Indication, timing, compliance, and outcomes of neoadjuvant therapy. In elderly patients with locally advanced stage II-III resectable rectal cancer, how does short-course radiotherapy compared to standard neoadjuvant chemo-radiotherapy affect the oncological outcome?

Statement: Preoperative short-course radiotherapy (PSCRT) and preoperative long-course chemo-radiotherapy (PLCCRT) are both effective as neoadjuvant treatments for locally advanced stage II-III resectable rectal cancer. The primary advantage of PSCRT is its lower toxicity compared with PLCCRT. This advantage could be particularly relevant in frail elderly patients with rectal cancer. PSCRT with delayed (more than 4 weeks) surgery may be an effective strategy for elderly and frail patients with locally advanced stage II-III resectable rectal cancer who have a poor performance status or significant comorbidities.

1.1.1.1.1.1.1.1.30. Recommendation: The experts’ panel suggests short-course radiotherapy with delayed surgery for more than 4 weeks in elderly frail patients with locally advanced stage II-III resectable rectal cancer (Weak recommendation, Moderate quality of evidence—2B).

Agreement: 87.9%

 

Consensus Topic: E. Surgery

Key Question: 8. Prehabilitation, Enhanced Recovery After Surgery (ERAS). In elderly patients with rectal cancer, how do ERAS pathways compared to standard practice affect early surgical outcomes and recovery?

Statement: As the ERAS protocol is conceived to improve postoperative outcomes independently from age, it is intuitive to conclude that older patients could benefit from the correct application of ERAS protocols. The importance of assessing frailty in surgical patients appears to be of crucial importance to assure the correct implementation and adherence to the protocols.

1.1.1.1.1.1.1.1.31. Recommendation: The experts’ panel suggests that ERAS protocols should be always implemented for elderly patients undergoing rectal surgery, regardless of age. A correct evaluation of frailty should be performed before surgery in order to obtain the maximum benefit from the application of the protocol in elderly population (Weak recommendation, Moderate quality of evidence—2B).

Agreement: 97.1%

 

Consensus Topic: E. Surgery

Key Question: 9. Oral antibiotic prophylaxis. In elderly patients with rectal cancer, how does oral plus intravenous antibiotic prophylaxis affect the rate of surgical site infection (SSI) compared to intravenous antibiotic prophylaxis only?

Statement: Current evidence suggests a potentially significant role for oral antibiotic prophylaxis, either in combination with mechanical bowel preparation or alone, in the prevention of postoperative complications in elective colorectal surgery. In elderly patients, oral plus intravenous antibiotic prophylaxis may improve the rate of surgical site infection.

1.1.1.1.1.1.1.1.32. Recommendation: The experts’ panel recommends that in elderly patients with rectal cancer, oral plus intravenous antibiotic prophylaxis should be preferred over intravenous antibiotic prophylaxis alone in order to reduce postoperative SSIs (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 94.1%

 

Consensus Topic: E. Surgery

Key Question: 10. Local excision. In elderly patients with T1 low rectal cancer, how does local excision with curative intent affect functional and oncological outcomes compared to rectal resection?

Statement: In elderly patients with T1 low rectal cancer, local excision with curative intent does not affect long-term functional outcomes. Patients aged > 70 do not show consistent variations of anorectal function after the excision of T1 low rectal cancer without neoadjuvant radiotherapy. Full thickness local excision of T1 rectal cancer can be applied safely in elderly patients with oncological results that are comparable to radical surgery if the pre-operative selection is accurate. If high risk features are present, the choice of local excision has to be made on a case by case basis and balanced with the operative risk. The possibility to administer adjuvant therapy in this case should be considered.

1.1.1.1.1.1.1.1.33. Recommendation: The experts’ panel suggests to consider local excision as a valid alternative to Total Mesorectal Excision (TME) among the therapeutic options for T1 rectal cancer in elderly frail patients, due to promising functional and oncological outcomes (Weak recommendation, Moderate quality of evidence—2B).

Agreement: 97.1%

 

Consensus Topic: E. Surgery

Key Question: 11. In elderly patients with a low invasive rectal cancer, how does local excision with palliative intent, if feasible, affect functional and oncological outcomes compared to rectal resection with TME?

Statement: Local excision is used in combination with neoadjuvant chemo-radiotherapy as an alternative tool to major resection in more advanced rectal cancer. Even if a study specifically addressing the elderly population does not currently exist, the mean age of patients undergoing such a management is higher than those receiving TME. In this case, anorectal function after excision may be affected by the radiation therapy but still seems to be better than in TME patients. Regarding oncological outcomes, there seems to be no difference between radical TME and local excision with palliative purposes.

1.1.1.1.1.1.1.1.34. Recommendation: The experts’ panel suggests to consider local excision as a palliative approach in elderly patients when they are judged unfit for major surgery, in combination with neoadjuvant therapy, when feasible (Weak recommendation, Low quality of evidence—2C).

Agreement: 91.2%

 

Consensus Topic: E. Surgery

Key Question: 12. Local Excision. In elderly patients with a cT2/T3 N0 low rectal cancer, how does radiotherapy followed by local excision compared to rectal resection with TME affect functional and oncological outcomes?

Statement: In elderly patients with a small cT2/T3 N0 low rectal cancer, radiotherapy followed by local excision in clinically good responders may offer no long term difference in oncological outcomes compared to TME. In elderly patients with a cT2/T3 N0 low rectal cancer, radiotherapy followed by local excision may offer impaired functional outcomes, but in any case better than after TME.

1.1.1.1.1.1.1.1.35. Recommendation: The panel recommends to consider elderly patients with small cT2/T3 N0 low rectal cancers suitable for neoadjuvant therapy and organ sparing transanal local excision following chemo-radiotherapy (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 91.2%

 

Consensus Topic: E. Surgery

Key Question: 13. Local Excision. In elderly patients who underwent local excision of a sessile polyp of the low rectum, with an unexpected result of a pT2/T3 Nx cancer on the resultant histopathology, how does postoperative radiotherapy compare to rectal resection with TME in terms of functional and oncological outcomes?

Statement: In elderly fit patients who underwent local excision for a low rectal sessile polyp with final pathology of pT2/T3 rectal cancer, radical surgery with TME is the treatment of choice. However, in case of contraindication to major surgery due to comorbidities, other treatments should be considered including adjuvant radiotherapy. The accurate definition of the surgical risk is a key point to guide towards the most appropriate decision.

1.1.1.1.1.1.1.1.36. Recommendation: The experts’ panel recommends radical surgery with TME as treatment of choice in elderly patients fit for surgery after the local excision of a sessile polyp of the low rectum subsequently confirmed as a pT2/T3 Nx cancer on the histopathology result (Strong recommendation, Moderate quality of evidence—1B).

Agreement: 96.8%

 

Consensus Topic: E. Surgery

Key Question: 14. Minimally invasive surgery (laparoscopic/robotic TME, TaTME). In elderly patients with rectal cancer, how does minimally invasive surgery (laparoscopic/robotic-assisted) compared to open surgery affect recovery, functional and oncological outcomes?

Statement: In elderly fit patients with rectal cancer, a consistent amount of evidence suggests that laparoscopic TME is safe and feasible and is associated with short-term benefits compared to open surgery. There is insufficient evidence to support potential benefits of robotic and transanal approaches for rectal cancer resection in elderly patients compared to laparoscopy or open surgery.

1.1.1.1.1.1.1.1.37. Recommendation: The experts’ panel suggests laparoscopic TME in elderly fit patients with rectal cancer after a careful evaluation of patient’s medical history, performance status, and tumor characteristics (Weak recommendation, Moderate quality of evidence—2B). Minimally invasive surgery approaches other than laparoscopy and open surgery may be considered for TME in elderly patients with rectal cancer after a careful evaluation of patient’s medical history, performance status, and tumor characteristics. Open surgery may be appropriate in selected cases, including locally advanced tumors, multiple previous abdominal operations, or previous pelvic surgery. (Neutral recommendation due to very limited and low-quality evidence).

Agreement: 96.8%

 

Consensus Topic: E. Surgery

Key Question: 15. Early versus delayed ileostomy closure. In elderly patients with low rectal cancer who underwent low anterior resection with diverting loop ileostomy, how does early ileostomy closure compared to delayed ileostomy closure affect complications and quality of life?

Statement: In elderly patients with low rectal cancer who underwent low anterior resection with diverting loop ileostomy, early ileostomy closure is safe and feasible. Early closure is related with lower incidence of postoperative small bowel obstruction, stoma-related complications and better functional outcomes, despite a relatively higher surgical site infection rate compared with late closure.

1.1.1.1.1.1.1.1.38. Recommendation: The experts’ panel suggests that in selected elderly fit patients, early (within 2 weeks) closure of ileostomy after rectal resection should be performed. (Weak recommendation, Moderate quality of evidence—2B).

Agreement: 87.9%

 

Consensus Topic: F. Watch and wait

Key Question: 16. Watch and wait, indications and outcomes. In elderly patients with rectal cancer, how does the watch and wait strategy in case of absence of clinically detectable residual tumor after neoadjuvant therapy affect functional and oncological outcomes compared to rectal resection?

Statement: In elderly patients with rectal cancer, in case of complete clinical response after neoadjuvant therapy, watch and wait may be considered a safe strategy, especially in selected patients, such as frail patients and patients with low-rectal tumors, with comparable oncological outcomes and better functional results in comparison to surgery.

1.1.1.1.1.1.1.1.39. Recommendation: The experts’ panel suggests a watch and wait strategy in selected frail elderly patients with low-rectal tumors in case of complete clinical response after neoadjuvant therapy. A stringent surveillance protocol, at least in the first 3 years, and a candid discussion with the patient about the potential risks of this strategy are recommended (Weak recommendation, Low quality of evidence—2C).

Agreement: 97.0%

 

Consensus Topic: G. Adjuvant chemotherapy

Key Question: 17. Adjuvant chemotherapy. In elderly patients with rectal cancer who underwent radical surgery with curative intent, does fluoropyrimidine-based adjuvant chemotherapy improve the oncological outcome compared with clinical and radiological follow-up?

Statement: There is little evidence to support benefit of adjuvant chemotherapy for elderly patients with rectal cancer who have undergone radical surgery with curative intent compared with clinical and radiological follow-up.

Recommendation: The experts’ panel suggests that for selected stage III and stage II high-risk elderly patients with rectal cancer who underwent radical surgery with curative intent, a fluoropyrimidine-based adjuvant chemotherapy should be preferred to clinical and radiological follow-up. Decision to perform adjuvant chemotherapy (alone or associated with radiotherapy) has to be taken after a multidimensional and geriatric assessment and must be shared within the multidisciplinary board, taking into account individual cancer risk of recurrence, DYPD evaluation, previous treatment (surgery alone or preoperative chemo-radiotherapy), patient’s performance status and comorbidities (Weak recommendation, Low quality of evidence—2C).

Agreement: 93.8%

 

Consensus Topic: H. Liver disease

Key Question: 18. Treatment of synchronous liver metastases: In elderly patients with rectal cancer, how do sequential resections (liver then rectum, or vice-versa) compared to simultaneous resection affect postoperative morbidity, mortality, and oncological outcomes?

Statement: Liver resections in elderly patients aged > 75 years with colorectal liver metastases show equivalent disease-free survival compared with younger patients, although in these patients perioperative mortality is almost doubled and overall morbidity rate seems to be higher. Simultaneous and staged colorectal and hepatic resections for synchronous liver metastases have comparable postoperative morbidity and mortality, recurrence rate, and 5-year overall survival. However, the simultaneous approach seems to be safe only in selected elderly patients with less severe liver disease. Patients with a high burden of liver disease may be more likely to benefit from early liver-first approach after down-staging therapy.

1.1.1.1.1.1.1.1.40. Recommendation: The experts’ panel suggests staged or simultaneous liver resection for colorectal liver metastases in elderly patients depending on the burden of liver disease and patient’s frailty status. Caution should be taken in performing major hepatectomies in patients aged > 75 years, given the increase in postoperative morbidity and mortality (Weak recommendation, Moderate quality of evidence—2B).

Agreement: 97.1%

 

Consensus Topic: I. Emergency presentations

Key Question: 19. Obstructing rectal cancer. In elderly patients with obstructing upper rectal cancer, how does bridge-to-surgery rectal stent placement compared to emergency surgery affect oncological outcomes and the rate of minimal access surgery?

Statement: In elderly patients with obstructing upper rectal cancer, bridge-to-surgery rectal stent placement (when possible) compared to emergency surgery could improve short-term results, even potentially increasing the rate of minimal access surgery, with similar disease-free and overall survival rates.

1.1.1.1.1.1.1.1.41. Recommendation: The experts’ panel suggests that in elderly patients with obstructing upper rectal cancer, bridge-to-surgery rectal stent placement (when possible) should be preferred over emergency surgery (Weak recommendation, Moderate quality of evidence—2B).

Agreement: 82.4%