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 This is an original JCO publication from 2017. Please visit the JCO website to access the full article.


Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

 

 Authors

Alok A. Khorana, Pamela B. Mangu, Jordan Berlin, Anitra Engebretson, Theodore S. Hong, Anirban Maitra, Supriya G. Mohile, Matthew Mumber, Richard Schulick, Marc Shapiro, Susan Urba, Herbert J. Zeh, and Matthew H.G. Katz

THE BOTTOM LINE

Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

Guideline Question

What is the treatment of patients with potentially curable pancreatic cancer?

Target Population

Patients diagnosed with potentially curable pancreatic cancer.

Target Audience

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

Methods

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

Updated Recommendation

Recommendation 4.1: All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery (Type: evidence based, benefits outweigh harms; Evidence quality: high; Strength of recommendation: strong).

2016 Recommendations

Recommendation 1.1: A multiphase computed tomography scan of the abdomen and pelvis using a pancreatic protocol or magnetic resonance imaging should be performed for all patients 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 (Type: evidence based, benefits outweigh harms; Evidence quality: high; Strength of recommendation: strong).

Recommendation 1.2: The baseline performance status, symptom burden, and comorbidity profile of a patient diagnosed with potentially curable pancreatic cancer 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 advance directives), patient preferences, and support systems should be discussed with every patient diagnosed with potentially curable 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 potentially curable 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 person 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 (Type: informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 2.1: Primary surgical resection of the primary tumor and regional lymph nodes is recommended for patients who meet all of the following criteria: no clinical evidence for metastatic disease, 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 (Type: evidence based, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 3.1: 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 (Type: evidence based, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Recommendation 3.2: Preoperative therapy should be offered as an alternative treatment strategy for any patient who meets all criteria in Recommendation 2.1 (Type: evidence based, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Recommendation 3.3: If preoperative therapy is administered, a complete restaging evaluation (see Clinical Question 1) is recommended after completion of treatment and before final surgical planning (Type: informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Updated Recommendation 4.1: All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The doublet regimen of gemcitabine and capecitabine is a new option; alternatively, monotherapy with gemcitabine alone or fluorouracil plus folinic acid can be offered if there are concerns about toxicity or tolerance. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery (Type: evidence based, benefits outweigh harms; Evidence quality: high; Strength of recommendation: strong).

Recommendation 4.2: Adjuvant chemoradiation may be offered to patients who did not receive preoperative therapy and present after 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 Recommendation 4.1. There is clinical equipoise regarding the benefit of adjuvant radiation therapy in this setting pending results of an ongoing international randomized controlled trial (RCT) (Type: Informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: moderate).

Recommendation 4.3: 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 (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: strong).

Recommendation 5.1: Patients 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 instances, this may indicate a need for a formal palliative care consult and services (Type: informal consensus, benefits outweigh harms; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 5.2: Patients who have undergone pancreatectomy for potentially curable pancreatic cancer should receive ongoing supportive care for symptom burden that may result from the operation and (preoperative and/or adjuvant) chemotherapy (Type: informal consensus, benefits outweigh harm; Evidence quality: intermediate; Strength of recommendation: strong).

Recommendation 6.1: In the absence of RCT evidence, the panel recommends that patients who have completed treatment of 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 (Type: informal consensus, benefits outweigh harms; Evidence quality: low; Strength of recommendation: moderate).

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/ gastrointestinal-cancer-guidelines 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 potentially curable pancreatic cancer?A multi-phase 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 intraabdominal metastases. Endoscopic ultrasonography and/or diagnostic laparoscopy may be used as supplemental studies, and to facilitate acquisition of a biopsy specimen. A chest Xray 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.

Type: evidence based, benefits outweigh harms

Evidence quality: high

Strength of recommendation: strong

The baseline performance status, symptom burden, and comorbidity profile of a person diagnosed with potentially curable pancreatic cancer should be evaluated carefully.

Type: evidence based, benefits outweigh harms

Evidence quality: high

Strength of recommendation: strong

The goals of care (including a discussion of advance directives), patient preferences, as well as support systems should be discussed with every person diagnosed with potentially curable 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 potentially curable 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

Which patients with potentially curable pancreatic cancer should be offered a potentially curative strategy with primary tumor resection?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:

Type: evidence based, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

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

An acceptable CA 19-9 level (in absence of jaundice) suggestive of localized disease

Which patients with potentially curable pancreatic cancer should be offered a potentially curative strategy with preoperative therapy, followed by a planned primary tumor resection?Preoperative therapy is recommended for patients with pancreatic cancer who meet any of the following criteria:

Type: evidence based, benefits outweigh harms

Evidence quality: low

Strength of recommendation: strong

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 the criteria in Clinical Question 2

A CA 19-9 level (in absence of jaundice) suggestive of disseminated disease

Preoperative therapy should be offered as an alternative treatment strategy for any patient who meets all criteria in Recommendation 2.1 (above).

Type: evidence based, benefits outweigh harms

Evidence quality: low

Strength of recommendation: strong

If preoperative therapy is administered, a complete restaging evaluation (see Clinical Question 1) is recommended after completion of treatment and before final surgical planning.

Type: informal consensus benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor?All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The doublet regimen of gemcitabine and capecitabine is a new option; alternatively, monotherapy with gemcitabine alone or fluorouracil plus folinic acid can be offered if there are concerns about toxicity or tolerance. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery.

Type: evidence based, benefits outweigh harms

Evidence quality: high

Strength of recommendation: strong

Adjuvant chemoradiation may be offered to patients who did not receive preoperative therapy and present post-resection with microscopically positive margins (R1) and/or nodepositive disease after completion of 4 to 6 months of systemic adjuvant chemotherapy as outlined in recommendation 3.1. There is clinical equipoise regarding the benefit of adjuvant radiation therapy in this setting pending results of an ongoing international RCT.

Type: Informal consensus, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: moderate

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.

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: strong

When should palliative care services be initiated for people with pancreatic cancer that is potentially curable by surgery?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 palliatve care consult and services.

Type: informal consensus, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

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.

Type: informal consensus, benefits outweigh harms

Evidence quality: intermediate

Strength of recommendation: strong

What is the recommended frequency of follow up care/surveillance for people with potentially curable pancreatic cancer after the administration of potentially curative multimodality therapy that includes resection?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:

Type: informal consensus, benefits outweigh harms

Evidence quality: low

Strength of recommendation: moderate

Recovery of treatment-related toxicities

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.


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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