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


Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

 

 Authors

Davendra P.S. Sohal, Pamela B. Mangu, Alok A. Khorana, Manish A. Shah, Philip A. Philip, Eileen M. O’Reilly, Hope E. Uronis, Ramesh K. Ramanathan, Christopher H. Crane, Anitra Engebretson, Joseph T. Ruggiero, Mehmet S. Copur, Michelle Lau, Susan Urba, and Daniel Laheru

THE BOTTOM LINE

Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

Guideline Question

What is the treatment of patients with metastatic pancreatic cancer?

Target Population

Patients with metastatic pancreatic cancer.

Target Audience

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

Methods

An Expert Panel developed clinical practice guideline recommendations that are based on a systematic review of the medical literature.

Key Recommendations

Recommendation 1.1: 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).

Recommendation 1.2: The baseline PS, symptom burden, and comorbidity profile of a patient with metastatic pancreatic cancer should be evaluated carefully (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 1.3: The goals of care (to include a discussion of an advance directive), patient preferences, as well as support systems should be discussed with every patient with metastatic pancreatic cancer 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 metastatic pancreatic cancer should be the standard of care (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 1.5: Every patient with pancreatic cancer should be offered information about clinical trials, which include 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: FOLFIRINOX is recommended for patients who meet all of the following criteria: ECOG PS 0 to 1, favorable comorbidity profile, patient preference and support system for aggressive medical therapy, and access to chemotherapy port and infusion pump management services (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 2.2: Gemcitabine plus NAB-paclitaxel is recommended for patients who meet all of the following criteria: ECOG PS 0 to 1, relatively favorable comorbidity profile, and patient preference and support system for relatively aggressive medical therapy (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 2.3: Gemcitabine alone is recommended for patients who have either an ECOG PS 2 or a comorbidity profile that precludes more-aggressive regimens and who wish to pursue cancer-directed therapy. The addition of either capecitabine or erlotinib to gemcitabine may be offered in this setting (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: moderate).

Recommendation 2.4: Patients with an ECOG PS $ 3 or with poorly controlled comorbid conditions despite ongoing active medical care should be offered cancer-directed therapy only on a case-by-case basis. The major emphasis should be on optimizing supportive care measures (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: moderate).

Recommendation 3.1: Gemcitabine plus NAB-paclitaxel can be offered as second-line therapy for patients who meet all of the following criteria: first-line treatment with FOLFIRINOX, ECOG PS 0 to 1, relatively favorable comorbidity profile, and patient preference and support system for aggressive medical therapy (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: moderate).

Recommendation 3.2: Fluorouracil plus oxaliplatin, irinotecan, or nanoliposomal irinotecan can be offered as second-line therapy for patients who meet all of the following criteria: first-line treatment with gemcitabine plus NAB-paclitaxel, ECOG PS 0 to 1, relatively favorable comorbidity profile, patient preference and support system for aggressive medical therapy, and chemotherapy port and infusion pump management (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: moderate).

Recommendation 3.3: Gemcitabine or fluorouracil can be considered as second-line therapy for patients who have either an ECOG PS 2 or a comorbidity profile that precludes more-aggressive regimens and who wish to pursue cancer-directed therapy (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: moderate).

Recommendation 3.4: No data are available to recommend third-line (or greater) therapy with a cytotoxic agent. Clinical trial participation is encouraged (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: moderate).

Recommendation 4.1: Patients with metastatic 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 assessment 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 5.1: Patients with metastatic pancreatic cancer should be offered aggressive treatment of the pain and symptoms of the cancer and/or the cancer-directed therapy (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 6.1: For patients on active cancer-directed therapy outside a clinical trial, imaging to assess first response should be offered at 2 to 3 months from the initiation of therapy. CT scans with contrast are the preferred modality. Thereafter, clinical assessment, conducted frequently during visits for cancer-directed therapy, should supplant imaging assessment. The routine use of positron emission tomography scans for the management of patients with pancreatic cancer is not recommended. CA19-9 is not considered an optimal substitute for imaging for the assessment of treatment response (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Recommendation 6.2: No data exist on the duration of cancer-directed therapy. An ongoing discussion of goals of care and assessment of treatment response and tolerability should guide decisions to continue or hold/terminate cancer-directed therapy (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Additional Resources

More information that includes 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/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 any therapy for metastatic pancreatic cancer?A multiphase computed tomography (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 metastatic pancreatic cancer should be evaluated carefully.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

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 metastatic 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 metastatic 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, which include 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 first-line treatment for patients with metastatic pancreatic cancer?

FOLFIRINOX is recommended for patients who meet all of the following criteria:

  • ECOG PS 0-1
  • Favorable comorbidity profile
  • Patient preference and support system for aggressive medical therapy
  • Access to chemotherapy port and infusion pump management services.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

Gemcitabine plus nab-paclitaxel is recommended for patients who meet all of the following criteria:

  • ECOG PS 0-1
  • Relatively favorable comorbidity profile
  • Patient preference
  • Support system for relatively aggressive medical therapy.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

Gemcitabine alone is recommended for patients who either have an ECOG PS 2 or have a co-morbidity profile precluding more aggressive regimens, and the wish to pursue cancerdirected therapy. The addition of either capecitabine or erlotinib to gemcitabine may be offered in this setting.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

Patients with an ECOG PS ≥ 3 or with poorly controlled comorbid conditions despite ongoing active medical care should be offered cancer-directed therapy only on a case by case basis. The major emphasis should be on optimizing supportive care measures.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

What is the appropriate therapy for patients with metastatic pancreatic cancer who experience either disease progression or intolerable toxicity on prior regimens for metastatic pancreatic cancer?

Gemcitabine plus nab-paclitaxel can be offered as second-line therapy for patients who meet all of the following criteria:

  • First-line treatment with FOLFIRINOX
  • ECOG PS 0-1
  • Relatively favorable comorbidity profile
  • Patient preference
  • A support system for aggressive medical therapy

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: moderate

Fluorouracil plus oxaliplatin, irinotecan, or nanoliposomal irinotecan can be offered as second-line therapy for patients who meet all of the following criteria:

  • First-line treatment with gemcitabine plus nab-paclitaxel
  • ECOG PS 0-1
  • Relatively favorable comorbidity profile
  • Patient preference and a support system for aggressive medical therapy
  • Chemotherapy port and infusion pump management

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: moderate

Gemcitabine or fluorouracil can be considered as second-line therapy for patients who either have an ECOG PS of 2 or have a co-morbidity profile precluding more aggressive regimens, and wish to pursue cancer-directed therapy.

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: moderate

There are no available data to recommend third (or greater)- line therapy with a cytotoxic agent. Clinical trial participation is encouraged.

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: moderate

When should the concept of palliative care be introduced?People with metastatic 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 palliatve care consult and services.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

For people with metastatic pancreatic cancer, what are the recommended strategies for relief of pain and symptoms?People with metastatic pancreatic cancer should be offered aggressive treatment for the pain and symptoms of the cancer and/or the cancer-directed therapy.

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

What is the recommended frequency of follow-up care/surveillance for people with metastatic pancreatic cancer?For patients on active cancer-directed therapy outside of a clinical trial, imaging to assess first response should be offered at 2 to 3 months from the initiation of therapy. CT scans with contrast are the preferred modality. Thereafter, clinical assessment, conducted frequently during visits for cancer-directed therapy, should supplant imaging assessment. The routine use of positron emission tomography (PET) scans for management of patients with pancreatic cancer is not recommended. CA19-9 is not considered an optimal substitute for imaging for assessing treatment response.

Type: Informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: strong

No data exist on the duration of cancer-directed therapy. An ongoing discussion of goals of care, and assessment of treatment response and tolerability, should guide decisions to continue or hold/terminate cancer-directed therapy.

Type: Informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: strong


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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