Release Date: June 30, 2018
Expiration Date: June 30, 2019
Media: Internet - based
Gastrointestinal (GI) cancers are some of the most complex solid tumors to treat owing to their heterogeneity. Optimized patient care requires a high level of interdisciplinary cooperation. In this online activity, focused on expert interviews, you will engage with renowned surgical and medical experts, John Marshall, MD, Michael A. Choti, MD, Michael J. Pishvaian, MD, PhD, and Robin Sommers, DNP, ANP, AOCNP; gain insight into recommended treatment options; and consider the neoadjuvant, adjuvant, and surgical decision making necessary to manage patients with GI malignancies. The content and interviews are based on presentations delivered in April 2018 at the 3rd Annual School of Gastrointestinal Oncology™ (SOGO®).
For busy oncologists focused on the daily management of complex patients with GI malignancies, this activity provides you with a unique opportunity to gain a multidisciplinary perspective to apply to the patient-care setting.
Below are some clinical pearls and highlights from the activity:
Despite treatment advances, pancreatic cancer is associated with a relatively poor outcome for most patients. Research findings, such as those from the ESPAC-4 trial showing benefit of adjuvant treatment with gemcitabine plus capecitabine, are changing the standard of care for patients.
Genomic testing and tumor prognostic markers in GI malignancies are providing oncologists with comprehensive and detailed information, but applying the findings to the context of the individual patient and determining which mutations are actionable requires enhanced clinical education and skill.
Treatment with immune checkpoint inhibitors provides survival benefits, but toxicities associated with treatment need to be carefully managed. Employing strategies to mitigate the risks may encourage adherence to treatment for some patients.
Acknowledgment of Commercial Support
This activity is supported by educational grants from Boston Biomedical, Inc., Exelixis, Inc., Lilly, Merck Sharp & Dohme Corp., and Taiho Oncology.
For further information concerning Lilly grant funding, visit www.lillygrantoffice.com
Instructions for This Activity and Receiving Credit
You will need to login to participate in the activity.
Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
At the end of the activity, “educational content/video files” will be available for your reference.
In order to receive a CME/CE certificate, participants must complete the activity.
Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a CME/CE certificate upon completion of these steps.
This educational program is directed toward oncologists and gastroenterologists whose primary practice focus is GI cancers, and who intend to reinforce their knowledge base and expand their expertise in GI diagnosis, risk stratification, personalization of care, and best practices for multidisciplinary communication. Participants will be primarily oncologists, gastroenterologists, or fellows in training whose practice requires mastery and a critical understanding of the fundamental principles, pivotal published studies, and emerging information on the pathogenesis and management of GI cancers.
Upon completion of this activity, you should be able to:
Describe the patient- and tumor-related prognostic markers important to the stratification of risk and clinical decision making in managing patients with GI malignancies
Use pivotal trial evidence to inform multidisciplinary clinical decision making in the personalized management of advanced forms of GI cancers
Assess strategies to proactively plan for, prevent, and mitigate predictable toxicities associated with therapies used to treat GI tumors
Apply emerging clinical trial data to manage cases in the context of evolving treatment paradigms for GI cancers
Faculty, Staff, and Planners' Disclosures
Robert L. Coleman, MD, FACOG, FACS
Chief, Division of Hematology/Oncology
University of Texas, MD Anderson Cancer Center
Director, Ruesch Center for the Cure of GI Cancers
Disclosures: Grant/Research Support: Amgen, Bayer, Caris, Celgene, Genentech, Taiho; Consultant: Amgen, Bayer, Caris, Celgene, Genentech, Indivumed; Speakers Bureau: Amgen, Bayer, Celgene, Genentech, Taiho
Michael A. Choti, MD
Chief of Surgery
Banner MD Anderson Cancer Center
Disclosure: Dr. Choti has no relevant financial relationships with commercial interests to disclose.
Michael J. Pishvaian, MD, PhD
Phase I Medical Oncologist
Medical Director, CRMO
Co-Director, Reusch Center Pancreatic Cancer Program
Georgetown Lombardi Comprehensive Cancer Center
Disclosure: Grant/Research Support: PanCAN; Consultant: Caris, Celgene, Perthera, Sirtex; Speakers Bureau: Caris, Celgene, Sirtex; Shareholder: Perthera
Robin Sommers, DNP, ANP, AOCNP
Center for Gastrointestinal Oncology
Department of Medical Oncology
Dana-Farber Cancer Institute
Disclosure: Ms. Sommers has no relevant financial relationships with commercial interests to disclose.
The staff of Physicians' Education Resource®, LLC, have no relevant financial relationships with commercial interests to disclose.
Disclosure Policy and Resolution of Conflicts of Interest (COI)
As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.
Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.
Off-Label Disclosure and Disclaimer
This CME/CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME/CE activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER or any of the companies that provided commercial support for this activity.
PER Pulse Recap™
PER Pulse Recap (1 of 3)
The live continuing medical education (CME) activity, 3rd Annual School of Gastrointestinal Oncology™ (SOGO®)
, was held April 28, 2018, in New York City. Co-Chairs Dr. John Marshall and Dr. Michael A. Choti were joined by faculty experts in medical oncology, surgical oncology, and radiation oncology to discuss gastrointestinal (GI) cancers in a multi-track conference format incorporating didactic presentations, Medical Crossfire®
panel discussions, and case-based presentations. Meeting highlights include the latest data on prognostic and predictive markers and how these data impact clinical decision making in evolving treatment strategies.
This first of 3 PER Pulse™ Recaps will focus on molecular testing including mismatch repair (MMR) and microsatellite instability (MSI) to inform treatment decisions for patients with colorectal cancer (CRC). Below are some highlights from the meeting featuring Dr. Marshall:
“I think the knowledge base for most general oncologists on how to measure MSI is a little low, and so we all need to make sure we know what we’re doing when we measure MSI.”
-- John Marshall, MD
Mismatch repair‒deficient (dMMR) tumors can carry hundreds of mutations, with increased mutations correlating to greater immunogenicity. Testing for MMR and/or MSI comprises part of standard-of-care molecular testing for patients with CRC.
In May 2017, the US Food and Drug Administration (FDA) granted the first tissue/site-agnostic approval to pembrolizumab for adult and pediatric patients with metastatic or unresectable, MSI-high (MSI-H) or dMMR solid tumors that had progressed following previous treatment, and who had no acceptable alternative treatment options, or in those with MSI-H or dMMR CRC that had progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.1
In cohort B of the KEYNOTE-164 trial,2
the activity of pembrolizumab was assessed in 63 patients with metastatic CRC, with MSI-H status confirmed locally by immunohistochemistry or polymerase chain reaction and ≥1 prior lines of therapy (fluoropyrimidine, oxaliplatin, irinotecan, or anti-VEGF/EGFR). The primary endpoint was objective response rate (ORR). The median (range) duration of follow-up was 12.6 months (range, 0.1-15.4 months).
ORR was 32% (95% CI, 21-45), with 2 complete responses and 18 partial responses
Median duration of response (DoR) was not reached (NR); 95% of responses were continuing, with DoR ≥6 months in 75% of responders
Median progression-free survival (PFS) was 4.1 months (95% CI, 2.1-NR), with a 12-month PFS rate of 41%
Median overall survival (OS) was NR, with a 12-month OS rate of 76%
PER Pulse Recap (2 of 3)
US Food and Drug Administration website. FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560040.htm. Accessed June 11, 2018.
Le DT, Kavan P, Kim TW, et al. KEYNOTE-164: pembrolizumab for patients with advanced microsatellite instability high (MSI-H) colorectal cancer. J Clin Oncol. 2018;36(suppl; abstr 3514).
As a follow-up to the live continuing medical education (CME) activity, 3rd Annual School of Gastrointestinal Oncology™ (SOGO®)
, held April 28, 2018, in New York City, this second of 3 PER Pulse™ Recaps will focus on neoadjuvant and adjuvant treatment options for pancreatic cancer. Below are some highlights from the meeting featuring Dr. Choti:
For patients with resectable pancreatic cancer, chemotherapy may be offered in the neoadjuvant setting.
“In patients undergoing neoadjuvant chemotherapy for pancreatic cancer, we typically offer either FOLFIRINOX or gemcitabine plus nab-paclitaxel. We don’t have clear data on the effectiveness of those regimens in the neoadjuvant setting, but they are highly effective regimens in patients with first-line advanced disease, so more and more, I think there is an enthusiasm for recommending one of those regimens, even in the neoadjuvant setting.”
-- Michael A. Choti, MD
Despite treatment advances, pancreatic cancer is associated with a relatively poor outcome for most patients. Research findings, such as those from the ESPAC-4 trial showing benefit of adjuvant treatment with gemcitabine plus capecitabine, are changing the standard of care (SOC) for patients.
In the multicenter, open-label, phase III ESPAC-4 trial,1
732 patients with resected pancreatic cancer were randomized to receive either adjuvant gemcitabine monotherapy or adjuvant combination therapy with gemcitabine plus capecitabine. Adjuvant gemcitabine plus capecitabine significantly improved median overall survival (Table 1
Based on the findings from the ESPAC-4 trial, adjuvant treatment with gemcitabine plus capecitabine is becoming the new SOC.
In the advanced setting, the National Comprehensive Cancer Network (NCCN) guidelines for first-line treatment for patients with metastatic pancreatic cancer and good performance status include treatment with either FOLFIRINOX or gemcitabine plus nab
-paclitaxel as preferred options (both category 1 recommendations). Other category 1 treatment options include monotherapy with gemcitabine or combination therapy with gemcitabine plus erlotinib.2
PER Pulse Recap (3 of 3)
Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017;389:1011-1024. doi: 10.1016/S0140-6736(16)32409-6.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Pancreatic Adenocarcinoma. Version 1.2018. www.nccn.org.
As a follow-up to the live continuing medical education (CME) activity, 3rd Annual School of Gastrointestinal Oncology™ (SOGO®)
, held April 28, 2018, in New York City, this third of 3 PER Pulse™ Recaps will focus on the role of precision medicine in gastrointestinal (GI) cancers. Below are some highlights from the meeting featuring Dr. Pishvaian:
The use of noninvasive prognostic molecular biomarkers, or “liquid biopsies,” such as those found in circulating tumor cells or circulating tumor DNA (ctDNA) is a strategy generating significant clinical interest. Liquid biopsies in patients with colorectal cancer (CRC) may be useful to assess risk of recurrence and to identify those at risk of developing resistance to anti-EGFR therapy. The joint guidelines from the American Society for Clinical Pathology, College of American Pathologists (CAP), Association for Molecular Pathology, and American Society of Clinical Oncology (ASCO) for molecular biomarkers for the evaluation of CRC suggest that molecular biomarkers tested with liquid biopsy hold promise for clinical practice; however, additional validation studies are needed.1
“I think we need to educate ourselves on what kind of tests to get and how to utilize these tests. A lot of physicians are trying to use blood-based tests, and they may have their place in testing for specific genes, but as a broad-based molecular profiling service, it’s probably not the best way to go. Using tumor tissue is going to be the most valuable resource.”
-- Michael J. Pishvaian, MD, PhD
A recent joint review by ASCO and CAP of ctDNA analysis in patients with cancer suggests that some ctDNA assays have shown clinical validity and utility in certain advanced cancers. Overall, however, there is a lack of evidence supporting the use of the majority of ctDNA assays in advanced cancer. Discordance has been shown between ctDNA results and assay results from tumor tissue samples; therefore, additional testing of negative ctDNA findings with genotyping tumor specimens is recommended.2
Genomic testing and tumor prognostic markers in GI malignancies are providing oncologists with comprehensive and detailed information; however, applying the findings to the context of the individual patient and determining which mutations are actionable requires enhanced clinical education and skill. The evidence base to date identifies certain mutations as highly actionable in GI cancers (Figure
Evidence supporting the use of PARP inhibitor therapy for BRCA
-mutated pancreatic cancer is emerging. A phase I trial of 17 patients evaluated cisplatin, gemcitabine, and veliparib in 2 patient cohorts: those with germline BRCA
mutations and those with wild‐type BRCA
pancreatic ductal adenocarcinoma. In the 9 BRCA
+ patients, considerable antitumor activity was noted, with an objective response rate of 77.8% (7/9). Improvements in median overall survival (mOS) were also noted, with mOS in BRCA
+ patients of 23.3 months (95% CI, 3.8‐30.2) versus 11 months (95% CI, 1.5‐12.1) in BRCA
Sepulveda AR, Hamilton SR, Allegra CJ, et al. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology. J Clin Oncol. 2017;35:1453-1486. doi: 10.1200/JCO.2016.71.9807.
Merker JD, Oxnard GR, Compton C, et al. Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review. J Clin Oncol. 2018;36:1631-1641. doi: 10.1200/JCO.2017.76.8671.
Pishvaian MJ. Unpublished data. April 2018.
O'Reilly EM, Lee JW, Lowery MA, et al. Phase 1 trial evaluating cisplatin, gemcitabine, and veliparib in 2 patient cohorts: germline BRCA mutation carriers and wild-type BRCA pancreatic ductal adenocarcinoma. Cancer. 2018;124:1374-1382. doi: 10.1002/cncr.31218.
For additional commentary about these topics and others, visit www.gotoper.com
to access more resources from the archived 3rd Annual School of Gastrointestinal Oncology™ (SOGO®).