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      Metastatic Pancreatic Cancer: ASCO Guideline Update

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          Abstract

          PURPOSE

          The aim of this work was to provide an update to the ASCO guideline on metastatic pancreatic cancer pertaining to recommendations for therapy options after first-line treatment.

          METHODS

          ASCO convened an Expert Panel and conducted a systematic review to update guideline recommendations for second-line therapy for metastatic pancreatic cancer.

          RESULTS

          One randomized controlled trial of olaparib versus placebo, one report on phase I and II studies of larotrectinib, and one report on phase I and II studies of entrectinib met the inclusion criteria and inform the guideline update.

          RECOMMENDATIONS

          New or updated recommendations for germline and somatic testing for microsatellite instability high/mismatch repair deficiency, BRCA mutations, and TRK alterations are provided for all treatment-eligible patients to select patients for recommended therapies, including pembrolizumab, olaparib, larotrectinib, or entrectinib, or potential clinical trials. The Expert Panel continues to endorse the remaining recommendations for second-line chemotherapy, as well as other recommendations related to treatment, follow-up, and palliative care from the 2018 version of this guideline. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .

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          How quickly do systematic reviews go out of date? A survival analysis.

          Kaveh Shojania, Margaret Sampson, Mohammed T Ansari … (2007)
          Systematic reviews are often advocated as the best source of evidence to guide clinical decisions and health care policy, yet we know little about the extent to which they require updating. To estimate the average time to changes in evidence that are sufficiently important to warrant updating systematic reviews. Survival analysis of 100 quantitative systematic reviews. Systematic reviews published from 1995 to 2005 and indexed in ACP Journal Club. Eligible reviews evaluated a specific drug or class of drug, device, or procedure and included only randomized or quasi-randomized, controlled trials. Quantitative signals for updating were changes in statistical significance or relative changes in effect magnitude of at least 50% involving 1 of the primary outcomes of the original systematic review or any mortality outcome. Qualitative signals included substantial differences in characterizations of effectiveness, new information about harm, and caveats about the previously reported findings that would affect clinical decision making. The cohort of 100 systematic reviews included a median of 13 studies and 2663 participants per review. A qualitative or quantitative signal for updating occurred for 57% of reviews (95% CI, 47% to 67%). Median duration of survival free of a signal for updating was 5.5 years (CI, 4.6 to 7.6 years). However, a signal occurred within 2 years for 23% of reviews and within 1 year for 15%. In 7%, a signal had already occurred at the time of publication. Only 4% of reviews had a signal within 1 year of the end of the reported search period; 11% had a signal within 2 years of the search. Shorter survival was associated with cardiovascular topics (hazard ratio, 2.70 [CI, 1.36 to 5.34]) and heterogeneity in the original review (hazard ratio, 2.15 [CI, 1.12 to 4.11]). Judgments of the need for updating were made without involving content experts. In a cohort of high-quality systematic reviews directly relevant to clinical practice, signals for updating occurred frequently and within a relatively short time.
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            NTRK fusion detection across multiple assays and 33,997 cases: diagnostic implications and pitfalls

            James P. Solomon, Irina Linkov, Andrea Rosado … (2019)
            With the FDA approval of larotrectinib, NTRK fusion assessment has recently become a standard part of management for patients with locally advanced or metastatic cancers. Unlike somatic mutation assessment, the detection of NTRK fusions is not straightforward, and various assays exist at the DNA, RNA, and protein level. Here, we investigate the performance of immunohistochemistry and DNA-based next-generation sequencing to indirectly or directly detect NTRK fusions relative to an RNA-based next-generation sequencing approach in the largest cohort of NTRK fusion positive solid tumors to date. A retrospective analysis of 38,095 samples from 33,997 patients sequenced by a targeted DNA-based next-generation sequencing panel (MSK-IMPACT), 2189 of which were also examined by an RNA-based sequencing assay (MSK-Fusion), identified 87 patients with oncogenic NTRK1-3 fusions. All available institutional NTRK fusion positive cases were assessed by pan-Trk immunohistochemistry along with a cohort of control cases negative for NTRK fusions by next-generation sequencing. DNA-based sequencing showed an overall sensitivity and specificity of 81.1% and 99.9%, respectively, for the detection of NTRK fusions when compared to RNA-based sequencing. False negatives occurred when fusions involved breakpoints not covered by the assay. Immunohistochemistry showed overall sensitivity of 87.9% and specificity of 81.1%, with high sensitivity for NTRK1 (96%) and NTRK2 (100%) fusions and lower sensitivity for NTRK3 fusions (79%). Specificity was 100% for carcinomas of the colon, lung, thyroid, pancreas, and biliary tract. Decreased specificity was seen in breast and salivary gland carcinomas (82% and 52%, respectively), and positive staining was often seen in tumors with neural differentiation. Both sensitivity and specificity were poor in sarcomas. Selection of the appropriate assay for NTRK fusion detection therefore depends on tumor type and genes involved, as well as consideration of other factors such as available material, accessibility of various clinical assays, and whether comprehensive genomic testing is needed concurrently.
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              Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

              Edward Balaban, Pamela B Mangu, Alok A. Khorana … (2016)
              To provide evidence-based recommendations to oncologists and others for treatment of patients with locally advanced, unresectable pancreatic cancer.
              Article 0 comments Cited 138 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Title: Journal of Clinical Oncology
                Abbreviated Title: JCO
                Publisher: American Society of Clinical Oncology (ASCO)
                ISSN (Print): 0732-183X
                ISSN (Electronic): 1527-7755
                Publication date (Electronic): August 05 2020
                Page: JCO.20.01364
                Affiliations
                [1 ]University of Cincinnati, Cincinnati, OH
                [2 ]American Society of Clinical Oncology, Alexandria, VA
                [3 ]University of California, San Francisco, San Francisco, CA
                [4 ]Université de Lorraine and Institut de Cancérologie de Lorraine, Lorraine, France
                [5 ]Morrison Cancer Center, Hastings, NE
                [6 ]Memorial Sloan Kettering Cancer Center, New York, NY
                [7 ]Huntsman Cancer Institute, University of Utah School of Medicine, Salt Lake City, UT
                [8 ]Phoenix VA Medical Center, Phoenix, AZ
                [9 ]Stanford University, Palo Alto, CA
                [10 ]Cleveland Clinic, Cleveland, OH
                [11 ]Pancreatic Cancer Action Network, Manhattan Beach, CA
                [12 ]Barbara Ann Karmanos Cancer Institute, Farmington Hills, MI
                [13 ]MD Anderson Cancer Center, Houston, TX
                [14 ]New York Presbyterian/Weill Cornell Medical Center, New York, NY
                [15 ]University of Michigan, Ann Arbor, MI
                [16 ]Duke University, Durham, NC
                [17 ]Johns Hopkins Medicine, Baltimore, MD
                [18 ]Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
                Article
                DOI: 10.1200/JCO.20.01364
                PubMed ID: 33197225
                SO-VID: e831fb94-fc42-442e-bbc7-dcb7f7fe65d5
                Copyright © © 2020
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