Potentially Curable Pancreatic Adenocarcinoma
Publication Date: June 10, 2019
Last Updated: December 15, 2022
Treatment
A multiphase computed tomography (CT) scan of the abdomen and pelvis using a pancreatic protocol or magnetic resonance imaging (MRI) should be performed for all patients with pancreatic cancer to assess the anatomic relationships of the primary tumor and to assess for the presence of intra-abdominal metastases. Endoscopic ultrasonography and/or diagnostic laparoscopy may be used as supplemental studies, and to facilitate acquisition of a biopsy specimen. A chest X-ray may be performed to stage the thorax. Other staging studies should be performed only as dictated by symptom burden. A serum level of CA 19-9 and baseline standard laboratory studies should be assayed. ( EB , H , B , S )
3336
The baseline performance status, symptom burden, and comorbidity profile of a person diagnosed with potentially curable pancreatic cancer should be carefully evaluated. ( EB , H , B , S )
3336
The goals of care (including a discussion of advance directives), patient preferences, and support systems should be discussed with every person diagnosed with potentially curable pancreatic cancer and his or her caregivers. ( EB , I , B , S )
3336
Multidisciplinary collaboration to formulate treatment and care plans and disease management for patients with potentially curable pancreatic cancer should be the standard of care. ( EB , I , B , S )
3336
Every person with pancreatic cancer should be offered information about clinical trials, including therapeutic trials in all lines of treatment, as well as palliative care, biorepository/biomarker, and observational studies.
( IC , I , B , S )3336
Primary surgical resection of the primary tumor and regional lymph nodes is recommended for patients with potentially curable pancreatic cancer who meet all of the following criteria: no clinical evidence for metastatic disease, a performance status and comorbidity profile appropriate for a major abdominal operation, no radiographic interface between primary tumor and mesenteric vasculature on high-definition cross-sectional imaging, and a CA 19-9 level (in absence of jaundice) suggestive of potentially curable disease. ( EB , I , B , S )
3336
Preoperative therapy is recommended for patients with pancreatic cancer who meet any of the following criteria: radiographic findings suspicious but not diagnostic for extrapancreatic disease, a performance status or comorbidity profile not currently appropriate (but potentially reversible) for a major abdominal operation, a radiographic interface between primary tumor and mesenteric vasculature on cross-sectional imaging that does not meet appropriate criteria for primary resection, or a CA 19-9 level (in absence of jaundice) suggestive of disseminated disease. ( EB , L , B , S )
3336
Preoperative therapy should be offered as an alternative treatment strategy for any patient who meets all criteria in 2.1.
( EB , L , B , S )3336
If preoperative therapy is administered, a complete restaging evaluation is recommended after completion of treatment and before final surgical planning. ( IC , I , B , S )
3336
UPDATED. All patients with resected pancreatic adenocarcinoma who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The modified combination regimen of 5FU, oxaliplatin and irinotecan as used in the latter part of the PRODIGE 24/CCTG PA.6 trial (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 D1, and 5-FU 2.4 g/m2 over 46 h every 14 days for 12 cycles) is preferred in the absence of concerns for toxicity or tolerance. Alternatively, doublet therapy with gemcitabine and capecitabine or monotherapy with gemcitabine alone or fluorouracil plus folinic acid alone can be offered. ( EB , H , B , S )
3336
Adjuvant chemoradiation may be offered to patients who did not receive preoperative therapy and present post-resection with microscopically positive margins (R1) and/or node-positive disease after completion of 4 to 6 months of systemic adjuvant chemotherapy as outlined in 4.1. There is clinical equipoise regarding the benefit of adjuvant radiation therapy in this setting pending results of an ongoing international RCT.
( IC , I , B , M )3336
For patients with pancreatic cancer who received preoperative therapy, there are no RCT data to guide the administration of postoperative therapy. The Panel recommends that a total of 6 months of adjuvant therapy (including preoperative regimen) be offered based on extrapolation from adjuvant therapy trials. ( IC , L , B , S )
3336
People with potentially curable pancreatic cancer should have a full assessment of symptom burden, psychological status, and social supports as early as possible, preferably at the first visit. In some cases, this may indicate a need for a formal palliative care consult and services. (IC, B, S, I)
3336
People who have undergone pancreatectomy for potentially curable pancreatic cancer should receive ongoing supportive care for symptom burden that may result from the surgery and (preoperative and/or adjuvant) chemotherapy.
( IC , I , B , S )3336
In the absence of RCT evidence, the Panel recommends that people who have completed treatment for potentially curable pancreatic cancer and have no evidence of disease be monitored for recovery of treatment-related toxicities and recurrence. Visits may be offered at 3- to 6- month intervals; the role of serial cross-sectional imaging, the extent to which surveillance intervals should be prolonged over time, and the duration of recommended surveillance are all undefined. ( IC , L , B , M )
3336
Recommendation Grading
Overview
Title
Potentially Curable Pancreatic Adenocarcinoma
Authoring Organization
American Society of Clinical Oncology
Publication Month/Year
June 10, 2019
Last Updated Month/Year
October 2, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Document Objectives
The purpose of this guideline update is to incorporate recently reported practice-changing evidence into ASCO’s recommendations on potentially curable pancreatic adenocarcinoma.
Target Patient Population
People diagnosed with potentially curable pancreatic cancer
Target Provider Population
Medical oncologists, radiation oncologists, surgeons, gastroenterologists, and other caregivers
PICO Questions
What is the appropriate adjuvant regimen for patients with pancreatic adenocarcinoma who have undergone an R0 or R1 resection of their primary tumor?
Inclusion Criteria
Male, Female, Adult, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient, Radiology services
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Treatment
Diseases/Conditions (MeSH)
D000230 - Adenocarcinoma
Keywords
pancreatic cancer, Pancreatic Adenocarcinoma, curable
Source Citation
DOI: 10.1200/JCO.19.00946 Journal of Clinical Oncology 37, no. 23 (August 10, 2019) 2082-2088.
Supplemental Methodology Resources
Methodology
Number of Source Documents
15
Literature Search Start Date
June 1, 2015
Literature Search End Date
January 8, 2019
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
Gastroenterology, Internal Medicine General, Oncology, 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