Every patient 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.— Davendra P.S. Sohal, MD, MPH
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As reported in the Journal of Clinical Oncology by Davendra P.S. Sohal, MD, MPH, of Cleveland Clinic, and colleagues, ASCO has released a clinical practice guideline on the treatment of patients with metastatic pancreatic cancer.1 Recommendations are based on an expert panel systematic review of the literature from April 2014 to June 2015. A total of 24 randomized controlled trials met the criteria for the review. The panel was co-chaired by Dr. Sohal and Daniel Laheru, MD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. Key recommendations are provided here, with notation of the type, quality, and strength of evidence.
Initial Assessment
1.1: A multiphase computed tomography 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 should be evaluated carefully (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
Daniel Laheru, MD
1.3: The goals of care (including discussion of an advance directive), patient preferences, as well as 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: Every patient 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 (informal consensus, benefits outweigh harms; quality = intermediate; strength = strong).
First-Line Treatment
2.1: FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) is recommended for patients who meet all of the following criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 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 (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
2.2: Gemcitabine plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) is recommended for patients who meet all of the following criteria: ECOG performance status of 0 to 1, relatively favorable comorbidity profile, and patient preference and support system for relatively aggressive medical therapy (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
2.3: Gemcitabine alone is recommended for patients who have either an ECOG performance status of 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 (evidence-based, benefits outweigh harms; quality = intermediate; strength = moderate).
2.4: Patients with an ECOG performance status of at least 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 (evidence-based, benefits outweigh harms; quality = intermediate; strength = moderate).
Subsequent Treatment
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, an ECOG performance status of 0 to 1, relatively favorable comorbidity profile, and patient preference and support system for aggressive medical therapy (informal consensus, benefits outweigh harms; quality = low; strength = moderate).
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, an ECOG performance status of 0 to 1, relatively favorable comorbidity profile, patient preference and support system for aggressive medical therapy, and chemotherapy port and infusion pump management (informal consensus, benefits outweigh harms; quality = low; strength = moderate).
3.3: Gemcitabine or fluorouracil can be considered as second-line therapy for patients who have either an ECOG performance status of 2 or a comorbidity profile that precludes more-aggressive regimens and who wish to pursue cancer-directed therapy (informal consensus, benefits outweigh harms; quality = low; strength = moderate).
3.4: No data are available to recommend third-line (or beyond) therapy with a cytotoxic agent. Clinical trial participation is encouraged (informal consensus, benefits outweigh harms; quality = low; strength = moderate).
Palliative Care
4.1: Patients should have a full assessment of symptom burden, psychological status, and social supports as early as possible, preferably at the first visit. In most cases, this assessment will indicate a need for a formal palliative care consult and services (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
Pain and Symptom Relief
5.1: Patients should be offered aggressive treatment of pain and symptoms of cancer and/or the cancer-directed therapy (evidence-based, benefits outweigh harms; quality = intermediate; strength = strong).
Frequency of Follow-up
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. Computed tomography 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. CA 19-9 is not considered an optimal substitute for imaging for the assessment of treatment response (informal consensus, benefits outweigh harms; quality = low; strength = strong).
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 (informal consensus, benefits outweigh harms; quality = low; strength = strong). ■
Disclosure: For full disclosures of the study authors, visit www.jco.ascopubs.org.
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