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Accreditation/Credit Designation

Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians' Education Resource®, LLC designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669, for 1.5 Contact Hours.

Acknowledgement of Commercial Support

This activity is supported by educational grants from AstraZeneca, Genomic Health, Inc. and Novartis Pharmaceuticals Corporation.

Community Practice Connections™: 2nd Annual International Congress on Oncology Pathology™


Release Date: August 31, 2018
Expiration Date: August 31, 2019
Media: Internet - based

Activity Overview

Recent advancements in the understanding of the role of distinct phenotypic and genotypic tumor characteristics have created the potential for oncologists and pathologists to hone management plans and improve patient outcomes. Information on appropriate testing methodology and strategies to best use the results of those tests can help to optimize your clinical decision making. As the volume and pace of emerging clinical trial findings pertaining to actionable treatment targets for your patients continues to increase, this educational activity has been designed to provide the latest information on key topics in pathology that can readily be applied to clinical practice in a variety of settings. This activity is intended to facilitate awareness of recent advancements in the field of cancer pathology and enhance multidisciplinary collaboration. Video commentary from leading clinical experts in oncology and pathology will provide you with their perspectives on critical topics in pathology assessment of malignancies commonly encountered in clinical practice, and the clinical implications of those assessments.

Acknowledgement of Commercial Support

This activity is supported by educational grants from AstraZeneca, Genomic Health, Inc. and Novartis Pharmaceuticals Corporation.

 

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.


Target Audience

This educational activity is directed toward pathologists and oncologists interested in the management of patients with cancer. Fellows, residents, nurse practitioners, nurses, physician assistants, researchers, and other health care professionals interested in the treatment of patients with cancer are also invited to participate.

Learning Objectives

Upon completion of this activity, you should be better prepared to:

  • Identify recent advancements to understand current and emerging biomarkers among commonly encountered malignancies
  • Analyze pathology-associated disparities and variances in care for patients with cancer
  • Apply current clinical evidence and evolving guidelines in cancer pathology to the tailoring of patient testing and treatment protocols
  • Formulate multidisciplinary strategies to optimize cancer diagnosis and management
  • Outline the roles of genomic and targeted assays in management of patients with cancer

Faculty, Staff, and Planners' Disclosures

Faculty

Alain Borczuk, MD
Professor of Pathology and Laboratory Medicine
Vice Chairman for Anatomic Pathology
Department of Pathology and Laboratory Medicine
Weill Cornell Medicine
New York, NY

Disclosure: No relevant financial relationships with commercial interests to disclose.

Balazs Halmos, MD
Professor of Clinical Medicine
Director, Thoracic/Head & Neck Oncology
Director, Clinical Cancer Genomics
Albert Einstein College of Medicine/Montefiore Medical Center
Bronx, NY

Disclosure: Grant Research Support: Mirati Therapeutics, Eli Lilly, AstraZeneca, Merck, Bristol-Myers Squibb, Boehringer Ingelheim, Novartis, Takeda, Pfizer; Consultant: Foundation One, Guardant Health, AstraZeneca, Pfizer, Boehringer Ingelheim, Eli Lilly, Genentech, Novartis, Takeda, Bristol-Myers Squibb, Novartis

Daniel P. Petrylak, MD
Professor of Medicine (Medical Oncology) and Urology
Director, Prostate and GU Medical Oncology
Director, Prostate Cancer Translational Research Group
Yale Cancer Center
New Haven, CT

Disclosure: Grant Research Support: Agensys, AstraZeneca, Bayer, Clovis Oncology, Dendreon, Eli Lilly, Endocyte, Genentech, Innocrin, Johnson & Johnson, Lilly, MedImmune, Medivation, Merck, Millennium, Novartis, Pfizer, Progenics Pharmaceuticals, Roche Laboratories, Sanofi Aventis, Sotio; Consultant: Astellas, AstraZeneca, Bayer, Bellicum Pharmaceuticals, Dendreon, Exelixis, Ferring Pharmaceuticals, Johnson & Johnson, Lilly, Medivation, Millennium, Pfizer, Roche Laboratories, Sanofi Aventis.

The staff of PER® 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®.

PER Pulse Recap™

PER Pulse Recap (1 of 3)

Advances in the Management of Breast Cancer

Several genomic assays have been developed to guide treatment options for patients with early-stage hormone receptor–positive (HR+) breast cancer. Among these is a 21-gene expression assay that predicts benefit with chemotherapy for patients with a high recurrence score and a low risk of recurrence in the absence of chemotherapy for those who have a low score. Historically, uncertainty regarding the degree of benefit with chemotherapy has been associated with those who have an intermediate score. In a prospective trial that registered 10,273 women with HR+, HER2-negative (HER2), axillary node–negative breast cancer, 6711 patients with intermediate scores were randomized to receive either chemoendocrine therapy or endocrine therapy alone.1 This study demonstrated that endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive-free survival (HR, 1.08; 95% CI, 0.94-1.24; P = .26).1 At 9 years, both groups had comparable rates of freedom from disease recurrence at a distant site, invasive disease-free survival (IDFS), and overall survival (OS). Of note, IDFS chemotherapy benefit was shown to vary with the combination of age and recurrence score (P = .004), with some degree of benefit with respect to IDFS seen for patients who were ≤50 years of age.1

Another recent study addressed a different clinical question, focusing on treatment selection for patients with a high clinical risk of recurrence of breast cancer but low genomic risk, using a 70-gene signature test. This phase III study enrolled 6693 women with the goal of assessing whether among those patients with high clinical risk and low genetic risk profiles who did not receive chemotherapy, the lower boundary of the 95% CI for the 5-year survival rate without distant metastasis would be the noninferiority value or greater.2 For women who had early-stage disease and were at high clinical risk and low genomic risk of recurrence, the avoidance of chemotherapy based on the 70-gene assay yielded a 5-year survival rate that was 1.5% lower than that seen with chemotherapy.2

  • Ongoing research is being conducted in patients with early-stage HR+/HER2- breast cancer to optimize treatment selection.
  • For further exploration of intriguing developments in cancer pathology assessment and emerging personalized approaches to its management, please go to: gotoper.com/online-cme-activities/cpc/community-practice-connections-2nd-annual-international-congress-on-oncology-pathology.

References

  1. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379(12):111-121. doi: 10.1056/NEJMoa1804710.
  2. Cardoso F, van’t Veer LJ, Bogaerts J, et al; MINDACT Investigators. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717-729. doi: 10.1056/NEJMoa1602253.

PER Pulse Recap (2 of 3)

Optimizing the Utilization of Clinical Biopsies in Lung Cancer

Several molecular targets have been identified as a means of guiding treatment decisions for patients with non–small cell lung cancer (NSCLC). Among those encompassed by National Comprehensive Cancer Network (NCCN) guidelines are EGFR abnormalities, ALK translocations, programmed death-ligand 1 (PD-L1) testing, ROS1 translocation, and BRAF abnormalities.1 EGFR and BRAF testing are often assessed through hot-spot gene-panel testing, with mutational analysis preferred for EGFR assessment over IHC.1 PD-L1 may be assessed through immunohistochemistry (IHC), whereas ALK and ROS1 translocations may be assessed through fluorescence in situ hybridization assays or immunohistochemistry (IHC).1

Timely and appropriate execution of molecular testing in anatomic pathology is crucial to optimizing treatment plans for patients with cancer. In a recent study, testing on lung carcinomas had a higher rate of NCCN guideline adherence than other cancer types (74% for lung, 44% for colon, 61% for melanoma [P <.001]).2 In this study, although most laboratories did not have a formal turnaround time policy for molecular testing, 78% reported that they were routinely able to meet the recommended 10-day turnaround time for EGFR and ALK testing.2 In another study, conducted by Gutierrez and colleagues, 41% of patients with nonsquamous NSCLC were untested for both EGFR and ALK. Reasons for not testing were not reported in 78% of these cases, with 13% of cases reporting insufficient tissue sampling.3 Recent findings have indicated that the threshold for detection of tumor variants using Sanger sequencing is approximately 10% tumor prevalence, whereas other studies involving more refined PCR strategies may require as little as 0.1% prevalence.4

Tumor mutational burden (TMB) as a potential biomarker for patient selection for particular treatment options has also garnered clinical interest. In a recent study evaluating patients with NSCLC with a high TMB (≥10 mutations/Mb), PFS was significantly greater for patients receiving first-line ipilimumab plus nivolumab compared with chemotherapy, regardless of PD-L1 expression.5 In another study that assessed patients with advanced NSCLC who were treated with anti–programmed cell death protein 1 (PD-1) or anti–PD-L1 therapy, TMB was greater in patients who had durable clinical benefit compared with those who had no durable benefit.6 Targeted next-generation sequencing accurately estimated TMB, with elevated TMB improving the likelihood of treatment benefit with immune checkpoint inhibitor therapy. Both TMB and PD-L1 expression were noted to have comparable predictive capacity, and the authors concluded that using both of these variables in predictive models could enhance their predictive power.6

  • Several molecular targets have been identified as a means of guiding treatment decisions for patients with NSCLC.
  • Liquid biopsy may be an alternative to standard approaches when tissue biopsies are inadequate or unfeasible.
  • For further exploration of intriguing developments in cancer pathology assessment and emerging personalized approaches to its management, please go to: gotoper.com/online-cme-activities/cpc/community-practice-connections-2nd-annual-international-congress-on-oncology-pathology.

References

  1. NCCN Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer. Version 5.2018. Accessed August 8, 2018.
  2. Volmar KE, Idowu MO, Souers RJ, Nakhleh RE. Molecular testing in anatomic pathology and adherence to guidelines: a College of American Pathologists Q-Probes study of 2230 testing events reported by 26 institutions. Arch Pathol Lab Med. 2015;139(9):1115-1124. doi: 10.5858/arpa.2014-0513-CP.
  3. Gutierrez ME, Choi K, Lanman RB, et al. Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunities. Clin Lung Cancer. 2017;18(6):651-659. doi: 10.1016/j.cllc.2017.04.004.
  4. Morris S, Subramanian J, Gel E, et al. Performance of next-generation sequencing on small tumor specimens and/or low tumor content samples using a commercially available platform. PLoS One. 2018;13(4):e0196556. doi: 10.1371/journal.pone.0196556.
  5. Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med. 2018;378(22):2093-2104. doi: 10.1056/NEJMoa1801946.
  6. Rizvi H, Sanchez-Vega F, La K, et al. Molecular determinants of response to anti-programmed cell death (PD)-1 and anti-programmed death-ligand 1 (PD-L1) blockade in patients with non-small-cell lung cancer profiled with targeted next-generation sequencing. J Clin Oncol. 2018;36(7):633-641. doi: 10.1200/JCO.2017.75.3384.

PER Pulse Recap (3 of 3)

Personalized Treatment Approaches to Lung and Genitourinary Malignancies

Genitourinary Cancers

Several factors are considered when sequencing agents for the treatment of prostate cancer, including whether the patient is symptomatic or asymptomatic. The presence and types of metastases are also relevant factors, as is whether or not the patient has received docetaxel therapy. Histologic assessment is also relevant, because different treatments may be employed for a patient with adenocarcinoma than for a patient with small cell prostate cancer. Biological markers such as androgen receptor evaluation may also be employed in the future.1

In bladder cancer, the treatment paradigm for patients with platinum-refractory disease has changed because of multiple checkpoint inhibitors: atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab. Two of these treatments, atezolizumab and pembrolizumab, have been approved as first-line therapy for patients with metastatic urothelial cancer who are cisplatin ineligible.2 Not only does programmed death-ligand 1 (PD-L1) staining appear to be associated with a higher response rate to immunotherapy in bladder cancer, but a recent FDA alert also reported that in the ongoing KEYNOTE-361 and IMVIGOR-130 studies, the data monitoring committees found that in the monotherapy arms of both trials, patients with PD-L1 low status had decreased survival compared with those who received cisplatin or carboplatin-based therapy.3 Both trials have stopped enrolling patients whose tumors have PD-L1 low status to their respective immunotherapy monotherapy arms.3 PD-L1 expression should be assessed in patients who are undergoing frontline checkpoint inhibition therapy for metastatic urothelial cancer.2

Lung Cancer

The KEYNOTE-042 study recently addressed the issue of treatment response for patients with non–small cell lung cancer (NSCLC) based on PD-L1 tumor proportion scores.4 In this study, patients with treatment-naïve locally advanced or metastatic NSCLC who had a PD-L1 tumor proportion score (TPS) ≥1% were randomized to treatment with pembrolizumab or chemotherapy. Patients who were treated with pembrolizumab had a significantly greater overall survival than those treated with chemotherapy (16.7 months vs 12.1 months; P = .0018). When this was evaluated further in an exploratory analysis, patients who had a TPS score of ≥50% had a greater degree of benefit when treated with pembrolizumab than those with a TPS of 1% to 49%.4

With respect to immunogenetics, the mutational landscape has also been shown to affect the efficacy of immunotherapy. In the CheckMate 026 study, patients with a high tumor mutational burden (TMB) who were treated with nivolumab had a greater median progression-free survival (PFS) than those treated with chemotherapy, whereas those who had a low/medium TMB had a greater median PFS with chemotherapy than with immunotherapy.5 In this same study, when a combination of PD-L1 and TMB was analyzed, patients with a high TMB and high PD-L1 responded most favorably to the use of immunotherapy. TMB is also being developed as a blood-based biomarker.5

  • Immunotherapy options are changing the treatment landscape for patients with bladder cancer and lung cancer.
  • For further exploration of intriguing developments in cancer pathology assessment and emerging personalized approaches to its management, please go to: gotoper.com/online-cme-activities/cpc/community-practice-connections-2nd-annual-international-congress-on-oncology-pathology.

References

  1. Beltran H, Antonarakis ES, Morris MJ, Attard G. Emerging molecular biomarkers in advanced prostate cancer: translation to the clinic. Am Soc Clin Oncol Educ Book. 2016;35-131-141. doi: 10.14694/EDBK_159248.
  2. NCCN Clinical Practice Guidelines in Oncology. Bladder Cancer, version 5.2018. National Comprehensive Cancer Network website. nccn.org/professionals/physician_gls/pdf/bladder.pdf. Published July 3, 2018. Accessed August 12, 2018.
  3. Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA alerts health care professionals and investigators: FDA statement - decreased survival in some patients in clinical trials associated with monotherapy. FDA website. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608253.htm. Published May 18, 2018. Accessed August 11, 2018.
  4. Lopes G, Wu Y-L, Kudaba I, et al. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: open-label, phase 3 KEYNOTE-042 study. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago IL. Abstract LBA4. http://ascopubs.org/doi/10.1200/JCO.2018.36.18_suppl.LBA4.
  5. Peters S, Creelan B, Hellmann MD, et al. Impact of tumor mutation burden on the efficacy of first-line nivolumab in stage iv or recurrent non-small cell lung cancer: an exploratory analysis of CheckMate 026 [Abstract CT082]. Cancer Res. 2017;77(suppl 13):CT082-CT082. cancerres.aacrjournals.org/content/77/13_Supplement/CT082.






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