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 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Acknowledgment of Commercial Support

This activity is supported by educational grants from Merck & Co, Inc; Novartis Pharmaceuticals Corporation; and Prometheus Laboratories Inc.

Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse


Release Date: June 30, 2019
Expiration Date: June 30, 2020
Media: Internet - based

Activity Overview

In this program, physicians Omid Hamid, MD, and Geoffrey T. Gibney, MD, presented best practices in the management of melanoma with nurses Grace Cherry, RN, MSN, NP, and Krista M. Rubin, MS. Participants shared clinical data underlying treatment decisions that are commonly made in advanced melanoma, including the choice of adjuvant therapy and treatment using BRAF/MEK inhibitors and checkpoint inhibitors in selected patients. Participants also discussed the importance of interprofessional collaboration in educating patients on potential adverse events (AEs) and managing AEs across melanoma. Treatment strategies in development, including combination BRAF/MEK inhibition and checkpoint inhibition, are also discussed in this program, as well as early data from combination clinical trials.

Benefits of Participating

  • Learn best practices in the multidisciplinary management of melanoma
  • Recognize clinical data from the latest pivotal trials both in treatment of melanoma and in the adjuvant setting
  • Develop strategies for counseling patients on the potential AEs associated with therapies across melanoma and learn how to implement best practices for monitoring and management
  • Realize strategies for implementation of best practices in interprofessional collaboration for the benefit of patients

CME Activity Table of Contents

  • Module 1: Pretest
  • Module 2: Best Practices in the Management of Melanoma: Utilizing Actionable Mutations in the Adjuvant Setting
  • Module 3: Therapeutic Considerations With BRAF/MEK Inhibitors and PD-1 Inhibitors
  • Module 4: Managing Treatment-Related Toxicities in Melanoma
  • Module 5: Posttest

Acknowledgement of Commercial Support

This activity is supported by educational grants from Merck & Co, Inc; Novartis Pharmaceuticals Corporation; and Prometheus Laboratories Inc.

Instructions for This Activity and Receiving Credit

  • You will need to log in 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 audio files/content until you finish the presentation.
  • At the end of the activity, educational content/audio files will be available for your reference.
  • In order to receive a CME/CE certificate, you 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.” You may immediately download a CME/CE certificate upon completion of these steps.


Target Audience

This educational program is directed toward oncology nurses and other oncology healthcare professionals who participate in the multidisciplinary treatment and management of patients with melanoma.

Learning Objectives

Upon successful completion of this educational program, you should be better prepared to:

  • Outline the mechanistic rationale and recent evidence on evolving BRAF/MEK inhibition and immunotherapeutic strategies for melanoma management.
  • Consider the clinical significance of practice-changing datasets concerning BRAF/MEK inhibition and immunotherapeutic strategies, and their application in the treatment of patients with melanoma.
  • Apply best practices to proactively identify and mitigate the impact of treatment-related toxicities in settings in which patients with melanoma are managed.
  • Evaluate nursing opportunities to optimize counseling in the setting of melanoma to manage treatment-related toxicities.

Faculty, Staff, and Planners’ Disclosures

Faculty

Omid Hamid
Omid Hamid, MD
Chief, Translational Research and Immuno-Oncology
Director, Cutaneous Malignancies
The Angeles Clinic and Research Institute
Director, Experimental Therapeutics
Cedars-Sinai Medical Care Foundation
Los Angeles, CA

Disclosures: Grant Research Support: AstraZeneca, BMS, Celldex, Genentech/Roche, Immunocore, Incyte, Merck, Merck Serono, MedImmune, Novartis, Pfizer, Rinat; Consultant: Amgen, BMS, Genentech/Roche, Merck, Novartis; Other: Amgen, Array BioPharma, BMS, Genentech/Roche, Novartis..

Grace Cherry
Grace Cherry, RN, MSN, NP
Oncology Nurse Practitioner
UCLA Melanoma Program
Los Angeles, CA

Disclosures: Grace Cherry has no relevant financial relationships with commercial interests to disclose.

Geoffrey T. Gibney
S.Geoffrey T. Gibney, MD
Co-Leader, Melanoma Disease Group
Member, Developmental Therapeutics (Phase I) Program
Georgetown Lombardi Comprehensive Cancer Center
MedStar Georgetown University Hospital
Washington, DC

Disclosures: Consultant: Novartis, BMS, Array BioPharma, Jounce, NewLink Genetics.

Krista M. Rubin
Krista M. Rubin, MS
Nurse Practitioner, Center for Melanoma
Massachusetts General Hospital Cancer Center
Boston, MA

Disclosures: Consultant: Merck, BMS, Novartis.

The staff of Physicians' Education Resource®, LLC (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 create a conflict of interest (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 or nurse 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 program.

PER Pulse Recaps

1 of 3
Insight from Omid Hamid, MD–PER Pulse™ Recap:
Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse

Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse is a continuing medical education–certified program. For this program, chair Omid Hamid, MD, was joined by expert faculty Geoffrey T. Gibney, MD; Krista M. Rubin, MS; and Grace Cherry, RN, MSN, NP, to discuss the latest data in melanoma regarding the use of BRAF/MEK inhibitors and checkpoint inhibitors.

This first of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making with regard to appropriate use of targeted and immunotherapeutic treatments in patients with advanced melanoma. Below are some highlights from the activity featuring Dr Hamid:

  • In melanoma, across stage IIIA, stage IIIB, and stage IIIC patients, the risk of recurrence is high, ranging from 48% to 85%.1 There is also an appreciable risk in patients with BRAF-mutant stage IIIB and stage IIIC disease, with the risk of relapse estimated at 77% in patients with BRAF mutations versus 55% in BRAF wild-type patients.2
  • The COMBI-AD study, presented by Georgina Long et al, showed an improvement in relapse-free survival (RFS) with the combination of dabrafenib and trametinib versus placebo (HR, 0.49; 95% CI, 0.40-0.59; P <.001), with a benefit observed at 5 years of follow-up.3,4
  • In the CheckMate 067 study, in the BRAF-mutant population of patients with advanced melanoma, the overall survival (OS) rate with the combination of nivolumab and ipilimumab was 67%, while ipilimumab alone showed an OS rate at the same time point of 37%.5
  • In the adjuvant setting, checkpoint inhibitors have been evaluated both in the adjuvant therapy of resected stage III melanoma (KEYNOTE-054) and resected stage III and IV melanoma (CheckMate 238).6,7
  • In KEYNOTE-054, pembrolizumab prolonged RFS, progression-free survival, and OS. After 15 months of follow-up, RFS favored pembrolizumab (1-year rate of RFS, 75.4% vs 61.0%; HR, 0.57; P <.001), regardless of PD-L1 status or BRAF V600E mutational status.6
  • Also in the adjuvant setting, nivolumab outperformed ipilimumab in CheckMate 238. After a minimum follow-up of 18 months, 12-month RFS favored nivolumab recipients (70.5% vs 60.8%; HR, 0.65; P <.001).7

“The increasing complexity of therapy in melanoma also offers multiple therapeutic options for use in clinical trials to improve outcomes for our patients in the adjuvant setting.”

— Omid Hamid, MD

References

  1. Romano E, Scordo M, Dusza SW, et al. Site and timing of first relapse in stage III melanoma patients: implications for follow-up guidelines. J Clin Oncol. 2010;28(18):3042-3047. doi: 10.1200/JCO.2009.26.2063.
  2. Barbour AP, Tang YH, Armour N, et al. BRAF mutation status is an independent prognostic factor for resected stage IIIB and IIIC melanoma: implications for melanoma staging and adjuvant therapy. Eur J Cancer. 2014;50(15):2668-2676. doi: 10.1016/j.ejca.2014.06.009.
  3. Hauschild A, Dummer R, Schadendorf D, et al. Longer follow-up confirms relapse-free survival benefit with adjuvant dabrafenib plus trametinib in patients with resected BRAF V600-mutant stage III melanoma. J Clin Oncol. 2018;36(35):3441-3449. doi: 10.1200/JCO.18.01219.
  4. Long GV, Hauschild A, Santinami M, et al. Updated relapse-free survival (RFS) and biomarker analysis in the COMBI-AD trial of adjuvant dabrafenib + trametinib (D + T) in patients with resected BRAF V600 mutant stage III melanoma. Presented at: 2018 European Society for Medical Oncology Congress; Munich, Germany; October 22, 2018. oncologypro.esmo.org/Meeting-Resources/ESMO-2018-Congress/Updated-relapse-free-survival-RFS-and-biomarker-analysis-in-the-COMBI-AD-trial-of-adjuvant-dabrafenib-trametinib-D-T-in-patients-pts-with-resected-BRAF-V600-mutant-stage-III-melanoma. Accessed June 1, 2019.
  5. Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377(14):1345-1356. doi: 10.1056/NEJMoa1709684.
  6. Eggermont AMM, Blank CU, Mandala M, et al. Adjuvant pembrolizumab versus placebo in resected stage III melanoma. N Engl J Med. 2018;378(19):1789-1801. doi: 10.1056/NEJMoa1802357.
  7. Weber J, Mandala M, Del Vecchio M, et al; CheckMate 238 Collaborators. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017;377(19):1824-1835. doi: 10.1056/NEJMoa1709030.

2 of 3
Insight from Geoffrey T. Gibney, MD–PER Pulse™ Recap:
Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse

Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse is a continuing medical education–certified program. For this program, Geoffrey T. Gibney, MD, was joined by chair Omid Hamid, MD; Krista M. Rubin, MS; and Grace Cherry, RN, MSN, NP, to discuss the latest data in melanoma regarding the use of BRAF/MEK inhibitors and checkpoint inhibitors.

This second of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making with regard to appropriate use of targeted and immunotherapeutic treatments in patients with advanced melanoma. Below are some highlights from the activity featuring Dr Gibney:

  • The objective response rate with BRAF/MEK inhibitor therapy is approximately 60% to 70% with adjuvant treatment, with similar outcomes in terms of median progression-free survival across studies of approximately 11 to 15 months, even across studies of varying design.1-4
  • Nurses must be aware of differences in safety characteristics and use characteristics. For example, dabrafenib/trametinib is associated with higher rates of pyrexia than other agents, whereas the vemurafenib/cobimetinib combination is associated with higher rates of photosensitivity.1-4
  • At 3 years of follow-up in the CheckMate 067 study, in the BRAF-mutant population, the overall survival (OS) rate with the combination of nivolumab and ipilimumab was 67%, while ipilimumab alone showed an OS rate at the same time point of 37%.5 This compares with a 44% survival rate in patients receiving dabrafenib/trametinib at the 36-month mark in the COMBI-D study.2
  • Although overall response rates in patients with melanoma with brain metastases receiving BRAF/MEK inhibitor therapy versus immunotherapy were similar, estimated at 58% versus 55%, respectively, the median duration of response was longer in patients receiving immunotherapy (6.5 months versus not reached).6,7
  • In medical oncology, because of the duration of response data with checkpoint inhibitors, immunotherapy is generally preferred over BRAF/MEK inhibitor therapy.

“The anti–PD-L1 and BRAF/MEK inhibitors are options for patients with advanced melanoma with BRAF V600 mutations, and based on durability of response, BRAF/MEK inhibitors may have the greatest benefit in patients with low-volume disease.”

— Geoffrey T. Gibney, MD

References

  1. Schachter J, Ribas A, Long GV, et al. Pembrolizumab versus ipilimumab for advanced melanoma: final overall survival results of a multicentre, randomised, open-label phase 3 study (KEYNOTE-006). Lancet. 2017;390(10105):1853-1862. doi: 10.1016/S0140-6736(17)31601-X.
  2. Long GV, Flaherty KT, Stroyakovskiy D, et al. Dabrafenib plus trametinib versus dabrafenib monotherapy in patients with metastatic BRAF V600E/K-mutant melanoma: long-term survival and safety analysis of a phase 3 study. Ann Oncol. 2017;28(7):1631-1639. doi: 10.1093/annonc/mdx176.
  3. Dummer R, Ascierto PA, Gogas HJ, et al. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial [published correction appears in Lancet Oncol. 2018;19(10):e509]. Lancet Oncol. 2018;19(10):1315-1327. doi: 10.1016/S1470-2045(18)30497-2.
  4. Ascierto PA, McArthur GA, Dréno B, et al. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016;17(9):1248-1260. doi: 10.1016/S1470-2045(16)30122-X.
  5. Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377(14):1345-1356. doi: 10.1056/NEJMoa1709684.
  6. Davies MA, Saiag P, Robert C, et al. Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017;18(7):863-873. doi: 10.1016/S1470-2045(17)30429-1.
  7. Tawbi HA, Forsyth PA, Algazi A, et al. Combined nivolumab and ipilimumab in melanoma metastatic to the brain. N Engl J Med. 2018;379(8):722-730. doi: 10.1056/NEJMoa1805453.

3 of 3
Insight from Grace Cherry, RN, MSN, NP–PER Pulse™ Recap:
Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse

Community Practice Connections™: Optimizing Outcomes in Melanoma with BRAF/MEK Inhibitor and Immunotherapeutic Strategies: Essentials for the Onco-Nurse is a continuing medical education–certified program. For this program, Grace Cherry, RN, MSN, NP, was joined by chair Omid Hamid, MD; Krista M. Rubin, MS; and Geoffrey T. Gibney, MD, to discuss the latest data in melanoma regarding the use of BRAF/MEK inhibitors and checkpoint inhibitors.

This third of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision making with regard to appropriate use of targeted and immunotherapeutic treatments in patients with advanced melanoma. Below are some highlights from the activity featuring Ms Cherry:

  • Tremendous progress has occurred in the treatment of melanoma, as shown by a meta-analysis conducted by Korn et al. In this meta-analysis of 42 studies across more than 2000 patients treated between 1975 and 2004, it was found that median overall survival in those years was just 6.2 months, median progression-free survival was 1.7 months, and 1-year survival rates averaged 25.5%.1,2
  • With the BRAF/MEK inhibitors, it is possible to prevent certain toxicities. For example, nurses may counsel patients to use sunblock to protect them from photosensitivity. Patients should also be aware of the potential for gastrointestinal toxicities and for cutaneous adverse events, including whole body rash.3
  • In addition to being able to explain BRAF/MEK inhibitors to patients, it is important for nurses to be able to explain the mechanism of checkpoint inhibition. Checkpoint inhibitors work by inhibiting the PD-1 receptors on T cells that prevent T cells from interacting with the PD-L1 on melanoma cells.4
  • In patients receiving 4 or more weeks of treatment with immunosuppressive steroid therapy at prednisone levels of 20 mg daily or greater, patients may also receive prophylaxis for Pneumocystis jirovecii infection using trimethoprim/sulfamethoxazole, atovaquone, or pentamidine. Antifungal prophylaxis, vitamin D, and calcium may also be added to the patient’s regimen.5,6
  • Through counseling by nurses and multidisciplinary professionals, immune-related adverse events may be identified earlier and managed more effectively. In addition, when these adverse events are managed, they should be managed appropriately with the correct dose of steroid therapy administered with prophylactic treatment over the course of at least 6 weeks.5,6

“We have come a long way. In the early 1990s we had only 1 treatment option, and now we have an expanding group of treatments that offer hope for our patients.”

—Grace Cherry, RN, MSN, NP

References

  1. Korn EL, Liu PY, Lee SJ, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008;26(4):527-534. doi: 10.1200/JCO.2007.12.7837.
  2. NCCN Clinical Practice Guidelines in Oncology. Cutaneous Melanoma, version 2.2019. National Comprehensive Cancer Network website. nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Published March 12, 2019. Accessed June 6, 2019.
  3. Welsh SJ, Corrie PG. Management of BRAF and MEK inhibitor toxicities in patients with metastatic melanoma. Ther Adv Med Oncol. 2015;7(2):122-136. doi: 10.1177/1758834014566428.
  4. Michot JM, Bigenwald C, Champiat S, et al. Immune-related adverse events with immune checkpoint blockade: a comprehensive review. Eur J Cancer. 2016;54:139-148. doi: 10.1016/j.ejca.2015.11.016.
  5. Horvat TZ, Adel NG, Dang TO, et al. Immune-related adverse events, need for systemic immunosuppression, and effects on survival and time to treatment failure in patients with melanoma treated with ipilimumab at Memorial Sloan Kettering Cancer Center. J Clin Oncol. 2015;33(28):3193-3198. doi: 10.1200/JCO.2015.60.8448.
  6. Merrill SP, Reynolds P, Kalra A, et al. Early administration of infliximab for severe ipilimumab-related diarrhea in a critically ill patient. Ann Pharmacother. 2014;48(6):806-810. doi: 10.1177/1060028014528152.

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