ASCO Releases Clinical Practice Guideline on Treatment of Locally Advanced, Unresectable Pancreatic Cancer

As reported by Edward P. Balaban, DO, of Penn State Hershey Cancer Institute, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on the treatment of locally advanced, unresectable pancreatic cancer. The recommendations are based on expert panel systematic review of literature from January 2002 to June 2015; 26 randomized controlled trials met the review criteria. The panel was co-chaired by Dr. Balaban and Nelson S. Yee, MD, PhD, of Penn State Hershey Cancer Institute. Key recommendations are provided here. Following each is notation of the type, quality, and strength of the recommendation.

Initial Assessment

  • 1.1: A multiphase computed tomography (CT) scan of the chest, abdomen, and pelvis should be performed to assess the extent of disease. Other staging studies should be performed only as dictated by symptoms (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 1.2: Baseline performance status, symptom burden, and comorbidity profile of a patient diagnosed with locally advanced pancreatic cancer should be carefully evaluated (evidence-based, benefits outweigh harms; quality = high; strength = strong).
  • 1.3: The goals of care (including discussion of an advance directive), patient preferences, and support systems should be discussed with every person diagnosed with locally advanced pancreatic cancer and his or her caregivers (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 1.4: Multidisciplinary collaboration to formulate treatment and care plans and disease management should be the standard of care (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 1.5: All patients should be offered information about clinical trials—therapeutic trials in all lines of treatment, as well as palliative care, biorepository/biomarker, and observational studies (informal consensus, benefits outweigh harms; quality = intermediate; strength = strong).

Initial Treatment

  • 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 or stereotactic body radiation therapy may be offered upfront, on the basis of patient and physician preference (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).

Radiation Therapy

  • 3.1: If there is local disease progression after induction chemotherapy, but without evidence of systemic spread, then chemoradiotherapy or stereotactic body radiation therapy may be offered to patients who meet the following criteria: first-line chemotherapy is completed or terminated because of progression or toxicity; ECOG PS ≤ 2; a comorbidity profile that is adequate, including hepatic and renal function and hematologic status; and patient preference (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 3.2: Chemoradiotherapy or stereotactic body radiation therapy 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 (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 3.3: If there is response or stable disease after 6 months of induction chemotherapy, chemoradiotherapy or stereotactic body radiation therapy may be offered as an alternative to continuing chemotherapy alone for any patient (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 4.1: Clinicians may offer stereotactic body radiation therapy, although additional prospective and/or randomized trials are required to compare the results of stereotactic body radiation therapy with chemotherapy alone and stereotactic body radiation therapy (informal consensus, benefits outweigh harms; quality = intermediate; strength = moderate).

Additional Treatment

  • 5.1: All patients 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; evidence-based, benefits outweigh harms; quality = intermediate; strength = moderate).
  • 5.2: Refer patients who have not benefited from treatment and have disease progression for a clinical trial (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).

Palliative Care

  • 6.1: Patients should have 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 (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).

Pain and Symptom Burden

  • 7.1: Patients should be offered aggressive treatment of pain and other symptoms of cancer and/or cancer-directed therapy (evidence based, benefits outweigh harms; quality = intermediate; strength = strong).
  • 7.2: A short course of palliative radiotherapy (5–10 treatments) may be offered to patients who meet the following criteria: prominent local symptoms, such as abdominal pain and/or worsening jaundice and/or gastrointestinal bleeding as a result of tumor invasion; local infiltration into the gastrointestinal tract causing impending gastric outlet or duodenal obstruction; and patient preference (evidence-based, benefits outweigh harms; quality = intermediate; strength = moderate).

Frequency of Follow-up

  • 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 (informal consensus, benefits outweigh harms; quality = low; strength = strong).
  • 8.2: Data are not definitive, but the panel recommends testing markers (CA 19-9) and imaging (computed tomography) 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 locally advanced pancreatic cancer is not recommended. Tumor markers such as CA 19-9 should not replace imaging as an assessment (informal consensus, benefits outweigh harms; quality = low; strength = strong).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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