Treatment of Patients with Early-Stage Colorectal Cancer
Publication Date: February 25, 2019
Last Updated: December 15, 2022
Treatment
Table 2. Non-metastatic, non-obstructing colon cancer
Colon Cancer Stage I: T1-2N0M0, Colon Cancer Stage IIA: T3N0 (no high-risk features), Colon Cancer Stage IIA: T3N0 (with high risk features)
Patients with non-obstructing, resectable, localized colon cancer
General surgeons should perform open resection following standard oncologic principles. (H, S)
Basic and Limited
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Patients with non-obstructing, resectable, localized colon cancer
If suitable, surgical oncologists and/or colorectal surgeons with adequate training in laparoscopic or minimally invasive techniques should perform laparoscopic or minimally invasive resection following standard oncologic principles and, if Maximal, using the most appropriate techniques and instruments. (H, S)
Enhanced and Maximal
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Patients with non-obstructing, resectable, localized colon cancer
If laparoscopy is contraindicated, surgical oncologists and/or colorectal surgeons should use an open surgical approach. (H, S)
Enhanced and Maximal
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Table 3. Colon Cancer Stages IIB-IIC: T4N0 (Non-obstructing)
Patients with non-obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer
Basic
General surgeons should perform an open en bloc resection (including adjacent invaded organ) following standard oncologic principles. (H, S)
General surgeons should perform an open en bloc resection (including adjacent invaded organ) following standard oncologic principles. (H, S)
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Patients with non-obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer with contraindications and/or en bloc resection not possible
Basic and Limited
If contraindications and/or en bloc resection not possible, efforts should be made to transfer a patient to a higher-level facility. (IC-H, S)
If contraindications and/or en bloc resection not possible, efforts should be made to transfer a patient to a higher-level facility. (IC-H, S)
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Patients with non-obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer with emergent symptoms
Basic
In an emergency, surgery performed by general surgeons should be limited to life-saving procedures (ie. segmental resection of bleeding or perforated tumors). (IC-H, S)
In an emergency, surgery performed by general surgeons should be limited to life-saving procedures (ie. segmental resection of bleeding or perforated tumors). (IC-H, S)
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Patients with non-obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer
Limited
General surgeons should perform an open en bloc resection following standard oncologic principles. (H, S)
General surgeons should perform an open en bloc resection following standard oncologic principles. (H, S)
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Patients with non-obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer
Enhanced
Colorectal surgeons and/or surgical oncologists should perform a laparoscopic en bloc resection following standard oncologic principles. (H, S)
Colorectal surgeons and/or surgical oncologists should perform a laparoscopic en bloc resection following standard oncologic principles. (H, S)
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Patients with non-obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer
Enhanced and Maximal
If a laparoscopic en bloc resection is not possible, surgical oncologists and/or colorectal surgeons should perform an open approach. (H, S)
If a laparoscopic en bloc resection is not possible, surgical oncologists and/or colorectal surgeons should perform an open approach. (H, S)
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Patients with non-obstructing, resectable, locally advanced (ie., with invasion of adjacent structures) colon cancer
Maximal
If there are no contraindications, surgical oncologists and/or colorectal surgeons should perform an en bloc resection following standard oncologic principles using the most advanced techniques. (H, S)
If there are no contraindications, surgical oncologists and/or colorectal surgeons should perform an en bloc resection following standard oncologic principles using the most advanced techniques. (H, S)
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Table 4. Colon Cancer Stages IIB-IIC: T3N0 Obstructing or T4N0 (Obstructing)
Patients with obstructing, locally advanced (ie., with invasion of adjacent structures) resectable colon cancer
Basic
General surgeons should perform emergency resection and/or diversion (if resection is not possible) if feasible following standard oncologic principles. (H, S)
General surgeons should perform emergency resection and/or diversion (if resection is not possible) if feasible following standard oncologic principles. (H, S)
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Patients with obstructing, locally advanced (ie., with invasion of adjacent structures) resectable colon cancer
Limited
General surgeons should perform emergency surgical resection and/or diversion following standard oncologic principles. (H, S)
General surgeons should perform emergency surgical resection and/or diversion following standard oncologic principles. (H, S)
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Patients with obstructing, locally advanced (ie., with invasion of adjacent structures) resectable colon cancer
Enhanced
Surgical oncologists and/or colorectal surgeons should perform emergency surgical resection and/or diversion following standard oncologic principles. (H, S)
Surgical oncologists and/or colorectal surgeons should perform emergency surgical resection and/or diversion following standard oncologic principles. (H, S)
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Patients with obstructing, locally advanced (ie., with invasion of adjacent structures) resectable colon cancer
Enhanced and Maximal
For left-sided obstructing colon cancers, surgical oncologists and/or colorectal surgeons with specialist skills/training may place a colonic stent. (H, S)
For left-sided obstructing colon cancers, surgical oncologists and/or colorectal surgeons with specialist skills/training may place a colonic stent. (H, S)
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Patients with obstructing, locally advanced (ie., with invasion of adjacent structures) resectable colon cancer
Maximal
Surgical oncologists and/or colorectal surgeons should perform emergency surgical resection and/or diversion following standard oncologic principles using the most advanced techniques. (H, S)
Surgical oncologists and/or colorectal surgeons should perform emergency surgical resection and/or diversion following standard oncologic principles using the most advanced techniques. (H, S)
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Table 5. High-Risk Obstructing Colon Cancer and Colon Cancer Diagnoses Eligible for Adjuvant Treatment
Patients with obstructing, locally advanced (ie., with invasion of adjacent structures) colon cancer T4N0/T3N0 high-risk features (high risk-obstructing)
Enhanced and Maximal
Medical oncologists should offer adjuvant chemotherapy after surgery and fully discussing the risks and benefits with the patient. (H, S)
Medical oncologists should offer adjuvant chemotherapy after surgery and fully discussing the risks and benefits with the patient. (H, S)
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Patients with high-risk, obstructing stage II colon cancer
Enhanced and Maximal
Medical oncologists may offer adjuvant chemotherapy after surgery and fully discussing the risks and benefits with the patient. (H, S)
Medical oncologists may offer adjuvant chemotherapy after surgery and fully discussing the risks and benefits with the patient. (H, S)
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Patients with high risk, obstructing stage III colon cancer
Maximal
Medical oncologists should offer adjuvant chemotherapy after surgery and fully discussing the risks and benefits with the patient. (H, S)
Medical oncologists should offer adjuvant chemotherapy after surgery and fully discussing the risks and benefits with the patient. (H, S)
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Table 6. Rectal Cancer Stage I– clinical stage T1 N0
Patients with nonmetastatic cT1N0 rectal cancer
Basic and Limited
General surgeons should perform surgery following total mesorectal excision (TME) principles. (H, S)
General surgeons should perform surgery following total mesorectal excision (TME) principles. (H, S)
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Patients with nonmetastatic cT1N0 rectal cancer
Enhanced and Maximal
Surgical oncologists/and or colorectal surgeons should perform TME following standard oncologic principles and, in Maximal settings, using the most advanced techniques. (H, S)
Surgical oncologists/and or colorectal surgeons should perform TME following standard oncologic principles and, in Maximal settings, using the most advanced techniques. (H, S)
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Patients with select low risk (cT1N0 without adverse features like G3, V1, L1) T1N0 rectal cancers
Maximal
Surgical oncologists and/or colorectal surgeons may perform local excisional procedures such as TEM. (I, M)
Surgical oncologists and/or colorectal surgeons may perform local excisional procedures such as TEM. (I, M)
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Table 7. Rectal Cancer Stage I– clinical stage T2 N0
Patients with nonmetastatic cT2N0 rectal cancer
Basic and Limited
General surgeons should perform surgery following TME principles. (H, S)
General surgeons should perform surgery following TME principles. (H, S)
Basic and Limited
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Patients with nonmetastatic cT2N0 rectal cancer
Enhanced
Surgical oncologists and/or colorectal surgeons should perform TME following standard oncologic principles. (H, S)
Surgical oncologists and/or colorectal surgeons should perform TME following standard oncologic principles. (H, S)
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Patients with nonmetastatic cT2N0 rectal cancer
Maximal
Surgical oncologists and/or colorectal surgeons should perform TME following standard oncologic principles, using the most advanced techniques. (H, S)
Surgical oncologists and/or colorectal surgeons should perform TME following standard oncologic principles, using the most advanced techniques. (H, S)
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Table 8. Rectal Cancer Stage IIA– clinical stage T3 N0
Patients with clinically resectable cT3N0 rectal cancer
Basic and Limited
If TME is feasible, general surgeons should perform surgery following TME principles. (I, M)
If TME is feasible, general surgeons should perform surgery following TME principles. (I, M)
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Patients with clinically resectable cT3N0 rectal cancer
Basic and Limited
If surgery following TME principles is not feasible, then clinicians should transfer patients to a higher capacity facility. (IC-I, M)
If surgery following TME principles is not feasible, then clinicians should transfer patients to a higher capacity facility. (IC-I, M)
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Patients with clinically resectable cT3N0 rectal cancer at high risk who did not receive neoadjuvant treatment
Basic
Surgeons or oncologists may offer basic adjuvant therapy; limited chemotherapy may be offered. (I, M)
Surgeons or oncologists may offer basic adjuvant therapy; limited chemotherapy may be offered. (I, M)
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Patients with clinically resectable cT3N0 rectal cancer at high risk who did not receive neoadjuvant treatment
Limited
Surgeons or oncologists may offer basic adjuvant chemotherapy; radiation therapy may be offered in addition to chemotherapy, if available. (I, M)
Surgeons or oncologists may offer basic adjuvant chemotherapy; radiation therapy may be offered in addition to chemotherapy, if available. (I, M)
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Patients with clinically resectable cT3N0 rectal cancer where there is no indication on MRI that surgery is likely to be associated with either an R2 or an R1 resection
Enhanced and Maximal
Surgical oncologists and/or colorectal surgeons should perform TME following standard oncologic principles and, in Maximal settings, using the most advanced techniques. (H, S)
Surgical oncologists and/or colorectal surgeons should perform TME following standard oncologic principles and, in Maximal settings, using the most advanced techniques. (H, S)
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Patients with clinically resectable cT3N0 rectal cancer
Enhanced and Maximal
Multidisciplinary teams should base decisions regarding neoadjuvant therapy (CRT or SCPRT) on preoperative, MRI-predicted CRM (1mm), EMVI and more advanced T3 substages (T3c/T3d), which define the risk of both local recurrence and/or synchronous and subsequent metastatic disease. (H, S)
Multidisciplinary teams should base decisions regarding neoadjuvant therapy (CRT or SCPRT) on preoperative, MRI-predicted CRM (1mm), EMVI and more advanced T3 substages (T3c/T3d), which define the risk of both local recurrence and/or synchronous and subsequent metastatic disease. (H, S)
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Patients with clinically resectable pT3N0 rectal cancer at high risk who had surgery and did not receive neoadjuvant treatment
Enhanced
Medical oncologists may offer chemoradiation. (H, S)
Medical oncologists may offer chemoradiation. (H, S)
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Patients with clinically resectable cT3N0 rectal cancer
Maximal
Treatment decisions regarding neoadjuvant therapy (CRT or SCPRT) should be based on preoperative, MRI-predicted CRM (1mm), EMVI and more advanced T3 substages (T3c/T3d), which define the risk of both local recurrence and/or synchronous and subsequent metastatic disease. (H, S)
Treatment decisions regarding neoadjuvant therapy (CRT or SCPRT) should be based on preoperative, MRI-predicted CRM (1mm), EMVI and more advanced T3 substages (T3c/T3d), which define the risk of both local recurrence and/or synchronous and subsequent metastatic disease. (H, S)
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Patients with clinically resectable cT3N0 rectal cancer, high-risk stage II rectal cancer, and all patients with stage III rectal cancer
Maximal
Medical oncologists should assess pathologic stage after surgery and should offer adjuvant chemotherapy to reduce the risk of local and systemic recurrence. (H, S)
Medical oncologists should assess pathologic stage after surgery and should offer adjuvant chemotherapy to reduce the risk of local and systemic recurrence. (H, S)
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Table 9. Early-Stage Colon Cancer Post-Treatment Surveillance
Treated patients with Stage II CRC
Basic
Medical history, physical exam every 6 months for minimum 3 years. CEA every 6 months for minimum 3 years if available. Chest x-ray and abdominal ultrasound twice in the first 3 years. Colonoscopy once in the first 1–2 years after surgery (if colonoscopy available in local or referral setting). If colonoscopy is unavailable, may perform a double contrast barium enema and/or for left-sided tumors a sigmoidoscopy. (L, W)
Medical history, physical exam every 6 months for minimum 3 years. CEA every 6 months for minimum 3 years if available. Chest x-ray and abdominal ultrasound twice in the first 3 years. Colonoscopy once in the first 1–2 years after surgery (if colonoscopy available in local or referral setting). If colonoscopy is unavailable, may perform a double contrast barium enema and/or for left-sided tumors a sigmoidoscopy. (L, W)
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Treated patients with Stage II CRC
Limited
Medical history, physical exam and CEA every 6 months for 3–5 years. Abdominal and chest CT scan twice in the first 3 years. Colonoscopy once in the first 1–2 years after surgery (if colonoscopy available in local or referral setting). In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1–2 year time point. (I, M)
Medical history, physical exam and CEA every 6 months for 3–5 years. Abdominal and chest CT scan twice in the first 3 years. Colonoscopy once in the first 1–2 years after surgery (if colonoscopy available in local or referral setting). In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1–2 year time point. (I, M)
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Treated patients with Stage II CRC at standard risk
Enhanced
Medical history, physical exam and CEA every 6 months for 3–5 years. Abdominal and chest CT scan annually for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
Medical history, physical exam and CEA every 6 months for 3–5 years. Abdominal and chest CT scan annually for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
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Treated patients with Stage II CRC at high risk
Enhanced
Medical history, physical exam and CEA every 3–6 months for 5 years. Abdominal and chest CT scan every 6–12 months for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
Medical history, physical exam and CEA every 3–6 months for 5 years. Abdominal and chest CT scan every 6–12 months for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
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Treated patients with Stage II CRC at standard and high risk
Maximal
Medical history, physical exam and CEA every 6 months for 3–5 years (high risk for 6 years). Abdominal and chest CT scan annually (high risk every 6–12 months) for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
Medical history, physical exam and CEA every 6 months for 3–5 years (high risk for 6 years). Abdominal and chest CT scan annually (high risk every 6–12 months) for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
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Table 10. Early-Stage Rectal Cancer Post-Treatment Surveillance
Treated patients with rectal cancer
Basic
Medical history, physical exam every 6 months for minimum 3 years. CEA every 6 months for minimum of 3 years if available. Chest x-ray and abdominal and pelvic ultrasound twice in the first 3 years. Rectosigmoidoscopy or colonoscopy, (if colonoscopy available in local or referral setting), once in the first 1–2 years after surgery (I, M)
Medical history, physical exam every 6 months for minimum 3 years. CEA every 6 months for minimum of 3 years if available. Chest x-ray and abdominal and pelvic ultrasound twice in the first 3 years. Rectosigmoidoscopy or colonoscopy, (if colonoscopy available in local or referral setting), once in the first 1–2 years after surgery (I, M)
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Treated patients with rectal cancer at standard risk
Limited, Enhanced, and Maximal
Medical history, physical exam and CEA every 6 months for 3–5 years. CTa scan of the chest, abdomen and pelvis twice in the first 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age (if colonoscopy available in local or referral setting). (For Enhanced, for those patients who have not received pelvic radiation) (I, M)
Medical history, physical exam and CEA every 6 months for 3–5 years. CTa scan of the chest, abdomen and pelvis twice in the first 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age (if colonoscopy available in local or referral setting). (For Enhanced, for those patients who have not received pelvic radiation) (I, M)
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Treated patients with rectal cancer at high risk
Enhanced and Maximal
Medical history, physical exam and CEA every 3–6 months for 5 years. CTa scan of the chest, abdomen and pelvis 6–12 months for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. (I, M)
Medical history, physical exam and CEA every 3–6 months for 5 years. CTa scan of the chest, abdomen and pelvis 6–12 months for 3 years. Colonoscopy 1 year after surgery then every 5 years or earlier as clinically indicated up to 75 years of age. (I, M)
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Treated patients with rectal cancer who have not received pelvic radiation or who underwent surgery without TME or who have had a positive circumferential resection margin
Basic
Digital rectal exam or rectosigmoidoscopy may be performed every 6 months for 3 years based on availability. (L, W)
Digital rectal exam or rectosigmoidoscopy may be performed every 6 months for 3 years based on availability. (L, W)
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Treated patients with rectal cancer at standard risk who have not received pelvic radiation or who underwent surgery without TME or who have had a positive circumferential resection margin
Limited
Digital rectal exam or rectosigmoidoscopy should be performed every 6 months for 3 years based on availability.a (I, M)
Digital rectal exam or rectosigmoidoscopy should be performed every 6 months for 3 years based on availability.a (I, M)
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Treated patients with rectal cancer at standard risk who have not received pelvic radiation
Enhanced and Maximal
A rectosigmoidoscopy should be performed every 6 months for 2–5 years.a (I, M)
A rectosigmoidoscopy should be performed every 6 months for 2–5 years.a (I, M)
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Treated patients with rectal cancer at high risk who have not received pelvic radiation or who underwent surgery without TME or underwent endoscopic mucosal dissection, or who have had a positive circumferential resection margin
Enhanced and Maximal
A rectosigmoidoscopy and/or endoscopic rectal ultrasound should be performed every 6 months for 2–5 years.a (I, M)
A rectosigmoidoscopy and/or endoscopic rectal ultrasound should be performed every 6 months for 2–5 years.a (I, M)
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Treated patients with rectal cancer, where a complete colonoscopy was not done at the time of diagnostic workup
Basic
A colonoscopy, (if colonoscopy available in local or referral setting), or barium enema, should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
A colonoscopy, (if colonoscopy available in local or referral setting), or barium enema, should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point. (I, M)
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Treated patients with rectal cancer at high risk who have not received a complete colonoscopy at the time of diagnosis
Limited, Enhanced, and Maximal
A colonoscopy, (if colonoscopy available in local or referral setting) should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point.a (I, M)
A colonoscopy, (if colonoscopy available in local or referral setting) should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point.a (I, M)
a In cases where a complete colonoscopy was not done at the time of diagnostic workup, a colonoscopy should be done as soon as reasonable after completion of adjuvant therapy and not necessarily at the 1-year time point.
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Recommendation Grading
Overview
Title
Treatment of Patients with Early-Stage Colorectal Cancer
Authoring Organization
American Society of Clinical Oncology
Publication Month/Year
February 25, 2019
Last Updated Month/Year
October 2, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Document Objectives
To provide resource-stratified, evidence-based recommendations on the treatment and follow-up of patients with early-stage colorectal cancer.
Target Patient Population
People with early-stage colorectal cancer (colon cancer stages I-IIIC and rectal cancer stages I-III)
Target Provider Population
Clinicians, public health leaders, and policymakers in all resource settings
PICO Questions
What is the optimal treatment of patients with colon cancer clinical stages I-IIIC in high-incidence and resource-constrained settings?
What is the optimal treatment of patients with rectal cancer stages I-III?
What are the optimal strategies for post-treatment surveillance for patients treated for early colorectal cancer?
Inclusion Criteria
Male, Female, Adult, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient, Radiology services, Operating and recovery room
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Treatment, Management
Keywords
colon cancer, colorectal cancer, Early-Stage Colorectal Cancer
Source Citation
DOI: 10.1200/JGO.18.00214 Journal of Global Oncology , no. 5 (December 01, 2019) 1-19.
Supplemental Methodology Resources
Methodology
Number of Source Documents
40
Literature Search Start Date
January 1, 2007
Literature Search End Date
December 31, 2017
Description of External Review Process
ASCO has a rigorous review process for guidelines. After the draft has been approved by the Expert Panel, the guideline is independently reviewed and approved by the Clinical Practice Guideline Oversight Committee (CPGC). Select members of the CPGC are asked to critically review the guideline prior to the next scheduled CPGC meeting. The CPGC members then present the results of their reviews to the full committee, discuss the review with the full committee, and the CPGC votes on whether to approve the guideline (with recusals from members who have relationships with affected companies). Approved ASCO Guidelines are then submitted to the Society’s journal for consideration of publication.
Description of Public Comment Process
ASCO Guidelines are available for open comment for a 2 to 3‐week period. Guideline recommendations available for open comment are posted on asco.org/open‐comment‐guidelines. Prospective reviewers must contact ASCO to request to review the draft guideline recommendations and are required to sign a non‐disclosure and confidentiality agreement before receiving the draft guideline recommendations. Reviewers must identify themselves by name and affiliation; anonymous comments will not be accepted. Guidelines staff review and summarize comments and bring relevant comments to the Expert Panel Co‐ chairs, and to the entire panel if necessary. Any changes made from the open comment process will be reviewed by the entire panel prior to CPGC approval. Comments are advisory only and ASCO is not bound to make any changes based on feedback from open comment. ASCO does not respond to reviewers or post responses to comments; however, major edits to the draft will be reflected in the open comment discussion.
Specialties Involved
Colon And Rectal Surgery, Gastroenterology, Internal Medicine General, Oncology, Surgery General, Medical Oncology, Surgical Oncology, Radiation Oncology, Oncology, Oncology, Oncology
Description of Systematic Review
The Protocol specifies the purpose of the guideline product, target patient population, clinical outcomes of interest, key features of the systematic literature review, and a proposed timeline for completion. ASCO staff, the Expert Panel Co‐Chairs, and possibly other panel members selected by the Co‐Chairs (the Expert Panel Steering Committee), will typically draft the protocol for full panel review. A standard protocol worksheet is used for consistency.
Once the Co‐Chairs have approved a first draft of the Protocol, the Protocol will be shared with the full Expert Panel. At the discretion of the Guidelines Director, the CPGC leadership and/or the CPGC Methodology Subcommittee may review the Protocol to make suggestions for revision intended to clarify aspects of the plan for developing the guideline. These suggestions are sent to the Expert Panel Co‐Chairs. Work on the systematic literature review can proceed upon the sign‐off of the Protocol by the Expert Panel.
List of Questions
See Full Text.
Description of Study Criteria
See Supplement.
Description of Search Strategy
Upon approval of the Protocol, a systematic review of the medical literature is conducted. ASCO staff use the information entered into the Protocol, including the clinical questions, inclusion/exclusion criteria for qualified studies, search terms/phrases, and range of study dates, to perform the systematic review. Literature searches of selected databases, including The Cochrane Library and Medline (via PubMed) are performed. Working with the Expert Panel, ASCO staff complete screening of the abstracts and full text articles to determine
eligibility for inclusion in the systematic review of the evidence.
Unpublished data from meeting abstracts are not generally used as part of normal ASCO guideline development (“Meeting Data”). However, abstract data from reputable scientific meetings and congresses may be included on a case‐by‐case basis after review by the CPGC leadership. Expert Panels should present a rationale to support integration of abstract data into a guideline. The CPGC leadership will consider the following inclusion criteria for the unpublished scientific meeting data: 1) whether the data were independently peer reviewed in connection with a reputable scientific meeting or congress; 2) the potential clinical impact of the unpublished data; 3) the methodological quality and validity of the associated study; 3) the potential harms of not including the data; and 4) the availability of other published data to inform the guideline recommendations.
Description of Study Selection
Literature search results were reviewed and deemed appropriate for full text review by two ASCO staff reviewers in consultation with the Expert Panel Co-Chairs. Data were extracted by two staff reviewers and subsequently checked for accuracy through an audit of the data by another ASCO staff member. Disagreements were resolved through discussion and consultation with the Co-Chairs if necessary. Evidence tables are provided in the manuscript and/or in Data Supplement.
Description of Evidence Analysis Methods
ASCO guideline recommendations are crafted, in part, using the GuideLines Into DEcision Support (GLIDES) methodology. ASCO adopted a five‐step approach to carry out quality appraisal, strength of evidence ratings and strength of recommendations ratings. The ASCO approach was primarily adapted from those developed by the AHRQ,, USPSTF, and GRADE, however with the validation of the GRADE methodology, the sole use of GRADE is being evaluated by the Clinical Practice Guidelines Committee.
Description of Evidence Grading
High: High confidence that the available evidence reflects the true magnitude and direction of the net effect (i.e., balance of benefits v harms) and that further research is very unlikely to change either the magnitude or direction of this net effect.
Intermediate: Moderate confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.
Low: Low confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction this net effect.
Insufficient: Evidence is insufficient to discern the true magnitude and direction of the net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.
Description of Recommendation Grading
ASCO uses a formal consensus methodology based on the modified Delphi technique in clinically important areas where there is limited evidence or a lack of high‐quality evidence to inform clinical guidance recommendations.
Evidence Based: There was sufficient evidence from published studies to inform a recommendation to guide clinical practice.
Formal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. Therefore, the Expert Panel used a formal consensus process to reach this recommendation, which is considered the best current guidance for practice. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). The results of the formal consensus process are summarized in the guideline and reported in the Data Supplement (see the Supporting Documents" field).
Informal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. The recommendation is considered the best current guidance for practice, based on informal consensus of the Expert Panel. The Panel agreed that a formal consensus process was not necessary for reasons described in the literature review and discussion. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak").
No recommendation: There is insufficient evidence, confidence, or agreement to provide a recommendation to guide clinical practice at this time. The Panel deemed the available evidence as insufficient and concluded it was unlikely that a formal consensus process would achieve the level of agreement needed for a recommendation.
Description of Funding Source
ASCO provides funding for Guideline Development.
Company/Author Disclosures
ASCO Conflict of Interest Policy complies with the CMSS Code for Interactions with Companies. ASCO requires disclosure by individuals involved in drafting, reviewing, and approving guideline recommendations.
Percentage of Authors Reporting COI
100