ASCO Releases Clinical Practice Guideline on Treatment of Potentially Curable Pancreatic Cancer

By Matthew Stenger
Posted: 6/14/2016 10:12:32 AM
Last Updated: 6/14/2016 10:12:32 AM

ASCO has released a clinical practice guideline on the treatment of potentially curable pancreatic cancer, as reported by Alok A. Khorana, MD, of Cleveland Clinic, and colleagues, in the Journal of Clinical Oncology. The recommendations are based on expert panel systematic review of the literature from 2002 to 2015. A total of nine randomized controlled trials met criteria for the review. The ASCO panel was co-chaired by Dr. Khorana and Matthew H. G. Katz, MD, of The University of Texas MD Anderson Cancer Center. Key recommendations are provided here, followed by notation of the type, quality, and strength of evidence.

Initial Assessment

• 1.1: 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 to assess the anatomic relationships of the primary tumor and the presence of intra-abdominal metastases. Endoscopic ultrasonography and/or diagnostic laparoscopy may be used as supplemental studies 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 (evidence-based, benefits outweigh harms; quality = high; strength = strong).
• 1.2: Baseline performance status, symptom burden, and comorbidity profile should be carefully evaluated (evidence-based, benefits outweigh harms; quality = high; strength = strong).
• 1.3: The goals of care (including discussion of advance directives), patient preferences, and support systems should be discussed with every patient 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, including 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).

Potentially Curative Primary Tumor Resection

• 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 of metastatic disease, performance status and comorbidity profile appropriate for a major abdominal operation, no radiographic interface between the primary tumor and the mesenteric vasculature on high-definition cross-sectional imaging, and a CA 19-9 level (in the absence of jaundice) suggestive of potentially curable disease (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).

Preoperative Therapy and Planned Primary Tumor Resection

• 3.1: Preoperative therapy is recommended for patients who meet any of the following criteria: radiographic findings suspicious but not diagnostic for extrapancreatic disease, performance status or comorbidity profile not currently appropriate (but potentially reversible) for a major abdominal operation, a radiographic interface between the primary tumor and the mesenteric vasculature on cross-sectional imaging that does not meet appropriate criteria for primary resection, or a CA 19-9 level (in the absence of jaundice) suggestive of disseminated disease (evidence-based, benefits outweigh harms; quality = low; strength =  strong).
• 3.2: Preoperative therapy should be offered as an alternative treatment strategy for any patient who meets all criteria in recommendation 3.1 (evidence-based, benefits outweigh harms; quality = low; strength = strong).
• 3.3: If preoperative therapy is administered, a complete restaging evaluation is recommended after completion of treatment and before final surgical planning (informal consensus, benefits outweigh harms; quality = intermediate; strength = strong).

Adjuvant Therapy After R0 or R1 Resection

• 4.1: All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy with either gemcitabine or fluorouracil plus folinic acid in the absence of medical or surgical contraindications. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery. There are currently no data to support combination chemotherapy regimens in the adjuvant setting, and the panel recommends against such use unless used as part of a clinical trial (evidence-based, benefits outweigh harms; quality = high; strength = strong).
• 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 the results of an ongoing international randomized controlled trial (informal consensus, benefits outweigh harms; quality = intermediate; strength = moderate).
• 4.3: For patients who received preoperative therapy, there are no randomized controlled trial data to guide the administration of postoperative therapy. The panel recommends a total of 6 months of adjuvant therapy (including a preoperative regimen) be offered based on extrapolation from adjuvant therapy trials (informal consensus, benefits outweigh harms; quality = low; strength = strong).

Palliative Care Services

• 5.1: Patients 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 (informal consensus, benefits outweigh harms; quality = intermediate; strength = strong).
• 5.2: Patients who have undergone pancreatectomy should receive ongoing supportive care for symptom burden that may result from the operation and (preoperative and/or adjuvant) chemotherapy (informal consensus, benefits outweigh harms; quality = intermediate; strength = strong).

Frequency of Follow-up

• 6.1: In the absence of randomized controlled trial 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 (informal consensus, benefits outweigh harms; quality = low; strength = moderate).

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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