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 This is an original JCO publication from 2016. Please visit the JCO website to access the full article.


Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

 

 Authors

Edward P. Balaban, Pamela B. Mangu, Alok A. Khorana, Manish A. Shah, Somnath Mukherjee, Christopher H. Crane, Milind M. Javle, Jennifer R. Eads, Peter Allen, Andrew H. Ko, Anitra Engebretson, Joseph M. Herman, John H. Strickler, Al B. Benson III, Susan Urba, and Nelson S. Yee

THE BOTTOM LINE

Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

Guideline Question

What is the treatment of patients with locally advanced, unresectable pancreatic cancer (LAPC)?

Target Population

Patients diagnosed with LAPC.

Target Audience

Medical oncologists, radiation oncologists, surgeons, gastroenterologists, and other caregivers

Methods

An Expert Panel was convened to develop clinical practice guideline recommendations on the basis of a systematic review of the medical literature.

Key Recommendations

Recommendation 1.1: A multiphase computed tomography scan of the chest, abdomen, and pelvis should be performed to assess extent of disease. Other staging studies should be performed only as dictated by symptoms (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 1.2: The baseline performance status, symptom burden, and comorbidity profile of a patient diagnosed with LAPC should be carefully evaluated (Type: evidence based, benefits outweigh harms; Evidence quality: high; Strength of recommendation: strong).

Recommendation 1.3: The goals of care (including a discussion of an advance directive), patient preferences, and support systems should be discussed with every person diagnosed with LAPC and his or her caregivers (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 1.4: Multidisciplinary collaboration to formulate treatment and care plans and disease management for patients with LAPC should be the standard of care (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 1.5: Every person with pancreatic cancer should be offered information about clinical trials—therapeutic trials in all lines of treatment, as well as palliative care, biorepository/biomarker, and observational studies (Type: informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 2.1: Initial systemic therapy with combination regimens is recommended for most patients who meet the following criteria: Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1, a favorable comorbidity profile, and patient preference and a support system for aggressive medical therapy. There is no clear evidence to support one regimen over another, and physicians may offer therapy on the basis of extrapolation from data derived from studies in the metastatic setting. For some patients, chemoradiotherapy (CRT) or stereotactic body radiation therapy (SBRT) may be offered up front, on the basis of patient and physician preference (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 3.1: If there is local disease progression after induction chemotherapy, but without evidence of systemic spread, then CRT or SBRTmay be offered to patients who meet the following criteria: First-line chemotherapy treatment is completed or terminated because of progression or toxicity; ECOG PS # 2; a comorbidity profile that is adequate, including adequate hepatic and renal function and hematologic status; and patient preference (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 3.2: CRT or SBRT may be offered to patients who have responded to an initial 6 months of chemotherapy or have stable disease but have developed unacceptable chemotherapy-related toxicities or show a decline in performance status, as a consequence of chemotherapy toxicity (Type: evidence-based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 3.3: If there is response or stable disease after 6 months of induction chemotherapy, CRT or SBRT may be offered as an alternative to continuing chemotherapy alone for any patient with LAPC (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 4.1: Clinicians may offer SBRT for treatment of patients with LAPC, although additional prospective and/or randomized trials are required to compare results of SBRT with chemotherapy alone and SBRT (Type: informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: moderate).

Recommendation 5.1: All people who have not benefited from first-line treatment and have disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline (www.asco.org/guidelines/MetPC; summary table of recommendations in Data Supplement 7.) (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: moderate).

Recommendation 5.2: Refer people with LAPC who have not benefited from treatment and have disease progression for a clinical trial (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 6.1: People with LAPC should have a full assessment of symptom burden, psychological status, and social supports, as early as possible—preferably at the first visit. In most cases, this will indicate a need for a formal palliative care consult and services (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 7.1: People with LAPC should be offered aggressive treatment of pain and other symptoms of cancer and/or cancer-directed therapy (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 7.2: A short course of palliative radiotherapy (five to 10 treatments) may be offered to for patients with LAPC who meet the following criteria: prominent local symptoms, such as abdominal pain and/or worsening jaundice and/or GI bleeding as a result of tumor invasion; local infiltration into the GI tract causing impending gastric outlet or duodenal obstruction; and patient preference (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: moderate).

Recommendation 8.1: In the absence of randomized controlled trial evidence, the Panel recommends that people who have completed treatment and have stable disease or no disease progression schedule follow-up visits every 3 to 4 months that include a physical examination and liver and renal function laboratory testing for a 2-year duration. The intervals can then be increased to every 6 months (Type: Informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Recommendation 8.2: Data are not definitive, but the Panel recommends testing markers (cancer antigen 19-9) and imaging (computed tomography) should be performed at least every 3 to 4 months during the first 2 years. Imaging intervals can be increased to every 6 months once stability is comfortably established. The routine use of positron emission tomography imaging for the management of LAPC is not recommended. Tumor markers such as cancer antigen 19-9 should not replace imaging as an assessment (Type: Informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Additional Resources

More information, including a Data Supplement with additional evidence tables, a Methodology Supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources, is available at www.asco.org/guidelines/LAPC, www.asco.org/guidelines/MetPC, and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net

ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care and that all patients should have the opportunity to participate.

SUMMARY OF RECOMMENDATIONS

Clinical QuestionRecommendationEvidence Rating
After a histopathologic confirmation of pancreatic adenocarcinoma diagnosis, what initial assessment is recommended before initiating therapy for locally advanced, unresectable pancreatic cancer?A multiphase CT scan of the chest, abdomen and pelvis should be performed to assess extent of disease. Other staging studies should be performed only as dictated by symptoms.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

The baseline performance status, symptom burden, and comorbidity profile of a patient diagnosed with locally advanced, unresectable pancreatic cancer should be carefully evaluated.

Type: evidence based, benefits outweigh harms

Evidence quality: high

Strength of recommendation: strong

The goals of care (including a discussion of an advance directive), patient preferences, as well as support systems should be discussed with every person diagnosed with locally advanced, unresectable pancreatic cancer and his/her caregivers.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

Multidisciplinary collaboration to formulate treatment and care plans and disease management for patients with locally advanced, unresectable pancreatic cancer should be the standard of care.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

Every person with pancreatic cancer should be offered information about clinical trials - therapeutic trials in all lines of treatment, as well as palliative care, biorepository/biomarker, and observational studies.

Type: informal consensus, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

What is the appropriate initial treatment approach for people diagnosed with LAPC?Initial systemic therapy with combination regimens is recommended for most patients who meet the following criteria:

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

ECOG PS 0-1

A favorable comorbidity profile

Patient preference

A support system for aggressive medical therapy
There is no clear evidence to support one regimen over another and physicians may offer therapy based on extrapolation from data derived from studies in the metastatic setting. For some patients, CRT or SBRT may be offered upfront, based on patient and physician preference.
Which patients with locally advanced, unresectable pancreatic cancer may be offered radiation therapy (CRT/SBRT)?If there is local disease progression following induction chemotherapy, but without evidence of systemic spread, then chemoradiotherapy may be offered to patients who meet the following criteria:

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

First line chemotherapy treatment is completed or terminated
Performance status of ECOG ≤ 2
A comorbidity profile that is adequate, including adequate hepatic and renal function and hematological status
Patient preference
Chemoradiotherapy may be offered to patients who have responded to an initial 6 months of chemotherapy or have stable disease, or have developed unacceptable chemotherapy-related toxicities or show a decline in performance status, as a consequence of chemotherapy toxicity.

Type: evidence-based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

If there is response or stable disease after 6 months of induction chemotherapy, chemoradiotherapy may be offered as an alternative to continuing chemotherapy alone for any patient with locally advanced, unresectable pancreatic cancer.

Type: evidence-based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

Which people with locally advanced, unresectable pancreatic cancer may be initially offered SBRT?Clinicians may offer SBRT for treatment of patients with LAPC, although the evidence quality is intermediate so additional prospective and/or randomized trials are required to definitively compare results of SBRT with chemotherapy alone and SBRT.

Type: informal consensus, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

Which people with locally advanced, unresectable pancreatic cancer whose disease has progressed (abdominal pain, worsening jaundice, increase in size of tumor and/or new metastatic lesions on imaging study; persistently rising serum CA 19-9) should be offered additional treatment per the ASCO Metastatic Pancreatic Cancer Guideline?All people who have not benefited from first line treatment and have disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline (www.asco.org/guidelines/MetPC).

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

Refer people with locally advanced, unresectable pancreatic cancer who have not benefited from treatment and have disease progression for a clinical trial.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

When should the concept of palliative care be introduced? When should a palliative care consult be intitiated?People with locally advanced, unresectable 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 most cases, this will indicate a need for a formal palliative care consult and services.

Type: evidence based, benefits outweigh harms

Evidence quality: moderate

Strength of recommendation: strong

For people with locally advanced, unresectable pancreatic cancer, what are the recommended strategies for relief of pain and symptom burden?People with LAPC should be offered aggressive treatment for the pain and other symptoms of the cancer and/or cancerdirected therapy.

Type: evidence based, benefits outweigh harms

Evidence quality: moderate

Strength of recommendation: strong

A short course of palliative radiotherapy (conventional RT or SBRT) may be offered to for patient with locally advanced, unresectable pancreatic cancer who meet the following critieria:

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

Prominent local symptoms such as abdominal pain, and/or worsening jaundice, and/or gastrointestinal bleeding
Local infiltration into the gastro-intestinal tract causing impending gastric outlet or duodenal obstruction
Patient preference
What is the recommended frequency of follow up care/surveillance for people with locally advanced, unresectable pancreatic cancer?In the absence of RCT evidence, the Panel consensus is that patients with LAPC who have completed treatment and have stable disease or no disease progression, schedule follow-up visits every 2-3 months that include a physical exam and liver and renal function laboratory testing for a two year duration. The intervals can then be increased to every 6 months.

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: strong

Data are not definitive, but the Panel recommends testing markers (CA 19-9) and imaging (CT) should be performed at least every 3 months during the first two years. Imaging intervals can be increased to every 6 months once stability is comfortably established. The routine use of PET/CT imaging for the management of LAPC is not recommended. Tumor markers such as CA 19-9 should not replace imaging as an assessment.


ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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