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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 1.0 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 an educational grant from Pfizer Inc.

Community Practice Connections™: Transforming Treatment Paradigms in Renal Cell Carcinoma: Understanding the Role of Risk Stratification and Emerging Data in the Adjuvant Setting


Release Date: August 30, 2018
Expiration Date: August 30, 2019
Media: Internet - based
 

Activity Overview

Community Practice Connections: Transforming Treatment Paradigms in Renal Cell Carcinoma: Understanding the Role of Risk Stratification and Emerging Data in the Adjuvant Setting consists of a series of interactive clinical vignettes, short video interviews with leading experts in renal cell carcinoma (RCC), and short summaries of clinical data related to these issues. The video interviews address decision points in the clinical vignettes, as well as questions commonly faced in the community oncology practice setting.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from Pfizer Inc.

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 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 certificate upon completion of these steps.


Target Audience

This educational program is directed toward urologists, medical oncologists, surgical oncologists, and radiation oncologists interested in the treatment of RCC. Nurse practitioners, physician assistants, nurses, and other healthcare professionals involved in the treatment and management of patients with RCC are also invited to participate.

Learning Objectives

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

  • Substantiate treatment decisions in the management of RCC at key decision points along the disease continuum, based on the most pertinent clinical trial evidence for targeted therapy
  • Integrate knowledge of patient selection and single-agent and combination strategies in the context of mechanisms of action, kinetics of response, best practices in monitoring, and key information that informs adjuvant treatment in the care of patients with RCC
  • Manage treatment-related toxicities as a component of therapeutic decision making in adjuvant treatment settings for patients with RCC
  • Evaluate recent clinical trial data, key ongoing trials, and how emerging adjuvant strategies may further impact the RCC treatment landscape

Faculty

Robert A. Figlin, MD, FACP
Steven Spielberg Family Chair in Hematology Oncology
Professor of Medicine and Biomedical Sciences
Director, Division of Hematology/Oncology
Deputy Director, Integrated Oncology Service Line
Deputy Director, Samuel Oschin Comprehensive Cancer Institute
Cedars-Sinai Medical Center
Los Angeles, CA

Disclosure: Grant/Research Support: Peloton, Bristol-Myers Squibb, Argos, Exelixis, Calithera, Merck; Consultant: Johnson & Johnson, CBT, Pfizer, Acceleron, Bristol-Myers Squibb

Allan J. Pantuck, MD, MS, FACS
Professor of Urology
Executive Chair, Medical Institutional Review Board
Vice Chair, Academic Affairs
Director, Urologic Oncology Fellowship
UCLA Institute of Urologic Oncology
Department of Urology
David Geffen School of Medicine at UCLA
Los Angeles, CA

Disclosure: Consultant:  Pfizer

Alain Ravaud, MD, PhD
Professor of Medical Oncology
Head, Department of Medical Oncology
Bordeaux University Hospital
Bordeaux, France
 

Disclosure: Consultant/Advisory Board: Pfizer, Novartis, Bristol-Myers Squibb, Roche, Ipsen; Other:  Transportation and housing for meetings or conferences: Pfizer, Bristol-Myers Squibb, AstraZeneca

Cora N. Sternberg, MD, FACP
Chief, Department of Medical Oncology
San Camillo and Forlanini Hospitals
Rome, Italy
 
 

Disclosure: Consultant: Bristol-Myers Squibb, Pfizer, Ipsen

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

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 activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. 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 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®.

PER Pulse Recap™

PER Pulse Recap (1 of 3)

In this continuing medical education (CME)-certified activity, Community Practice Connections™: Transforming Treatment Paradigms in Renal Cell Carcinoma: Understanding the Role of Risk Stratification and Emerging Data in the Adjuvant Setting, program chair, Robert A. Figlin, MD, and expert faculty, Allan J. Pantuck, MD, MS, Alain Ravaud, MD, PhD, and Cora N. Sternberg, MD, discuss recent clinical data and treatment decisions based on clinical vignettes in the adjuvant treatment of renal cell carcinoma (RCC).
 
This first of 3 PER Pulse™ Recaps summarizing the online program focuses on practice-based approaches for stratifying risk and selecting patients for adjuvant treatment of RCC. Below are some highlights from the activity featuring Drs. Figlin and Pantuck: 
  • Overview of the differences in the definition of “high-risk RCC” across the 3 published, prospective, phase III studies that evaluated the efficacy and safety of adjuvant TKI therapy: S-TRAC, ASSURE, and PROTECT
  • Staging systems and other options for improving selection of patients at high risk for RCC recurrence after nephrectomy
  • The clinical impact of the S-TRAC trial data and subsequent FDA approval of sunitinib for the adjuvant treatment of high-risk patients with RCC
  • Faculty perspectives on the most pertinent pathology report information for defining patient risk, including histology, size and grade of tumor, lymph node involvement, and presence of sarcomatoid features
  • Discussion of emerging gene signatures and genetic alterations, such as loss of chromosome 9p and 14, to guide decision-making in the adjuvant RCC setting


“The ability to define a patient as high risk in the past was primarily an academic issue. But with the approval of sunitinib last year for adjuvant treatment of high-risk patients, it becomes an important clinical question.”
 
 — Allan J. Pantuck, MD, MS, FACS

References
  1. Cheville JC, Lohse CM, Zincke H, et al. Sarcomatoid renal cell carcinoma: an examination of underlying histologic subtype and an analysis of associations with patient outcome. Am J Surg Pathol. 2004;28(4):435-441.
  2. Frank I, Blute ML, Cheville JC, et al. An outcome prediction model for patients with clear cell renal cell carcinoma treated with radical nephrectomy based on tumor stage, size, grade and necrosis: the SSIGN score. J Urol. 2002;168(6):2395-2400. https://doi.org/10.1016/S0022-5347(05)64153-5.
  3. Karakiewicz PI, Briganti A, Chun FK, et al. Multi-institutional validation of a new renal cancer-specific survival nomogram. J Clin Oncol. 2007;25(11):1316-1322. https://doi.org/10.1200/JCO.2006.06.1218.
  4. Leibovich BC, Blute ML, Cheville JC, et al. Prediction of progression after radical nephrectomy for patients with clear cell renal cell carcinoma: a stratification tool for prospective clinical trials. Cancer. 2003;97(7):1663-1671. https://doi.org/10.1002/cncr.11234.
  5. Motzer RJ, Mazumdar M, Bacik J, et al. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17(8):2530-2540. https://doi.org/10.1200/JCO.1999.17.8.2530.
  6. Sengupta S, Lohse CM, Leibovich BC, et al. Histologic coagulative tumor necrosis as a prognostic indicator of renal cell carcinoma aggressiveness. Cancer. 2005;104(3):511-520. https://doi.org/10.1002/cncr.21206.
  7. Thompson RH, Leibovich BC, Lohse CM, et al. Dynamic outcome prediction in patients with clear cell renal cell carcinoma treated with radical nephrectomy: the D-SSIGN score. J Urol. 2007;177(2):477-480. https://doi.org/10.1016/j.juro.2006.09.057.
  8. Zisman A, Pantuck AJ, Dorey F, et al. Improved prognostication of renal cell carcinoma using an integrated staging system. J Clin Oncol. 2001;19(6):1649-1657. https://doi.org/10.1200/JCO.2001.19.6.1649.
  9. Zisman A, Pantuck AJ, Wieder J, et al. Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol. 2002;20(23):4559-4566. https://doi.org/10.1200/JCO.2002.05.111.

PER Pulse Recap (2 of 3)

This second of 3 PER Pulse™ Recaps summarizing the online program focuses on data and controversies stemming from reported negative trials of adjuvant targeted therapy for renal cell carcinoma (RCC), including the potential contributions of disease and patient characteristics, agents, or dosing and exposure to drugs on the negative outcomes. Below are some highlights from the activity featuring Drs. Figlin, Ravaud, and Sternberg:
  • An update on results from the phase III, placebo-controlled ATLAS trial, which evaluated pazopanib as adjuvant therapy for patients with high-risk RCC, and was terminated after failing to meet the primary endpoint of disease-free survival (DFS) at interim analysis
  • A discussion of the involvement of toxicity-related dose modifications:
    • In the PROTECT study of adjuvant pazopanib in patients with RCC, DFS was improved among patients who received the 800-mg starting dosage (hazard ratio [HR], 0.663 [95% CI, 0.491-0.895]; P =.0077) versus patients who received the 600-mg starting dosage, and there was no difference in toxicity-related treatment discontinuation.
    • In the ASSURE trial of sunitinib versus sorafenib in patients with high-risk RCC, no significant differences in DFS were observed based on dose exposure, duration of therapy, or starting dosage.
  • The importance of discussing with appropriate patients the positive S-TRAC trial results, which showed longer DFS in patients with locoregional clear-cell RCC at high risk of recurrence after resection treated with adjuvant sunitinib versus placebo (median DFS: 6.8 years vs 5.6 years, respectively [HR, 0.76 (95% CI, 0.59 to 0.98); P =.03]) without necessitating dose modifications.


“[In terms of future ATLAS study results], we need to see 1) the population of patients who were treated, 2) the outcomes for subgroups, and 3) whether it sheds any additional light on dose intensity and outcome in the populations at highest risk for recurrence.”
 — Robert A. Figlin, MD, FACP

References
  1. Haas NB, Manola J, Uzzo RG, et al. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2016;387(10032):2008-2016. https://doi.org/10.1016/S0140-6736(16)00559-6.
  2. Motzer RJ, Haas NB, Donskov F, et al. Randomized phase III trial of adjuvant pazopanib versus placebo after nephrectomy in patients with locally advanced renal cell carcinoma (RCC) (PROTECT). J Clin Oncol. 2017;35(35):2916-2923. https://doi.org/10.1200/JCO.2017.73.5324.
  3. Ravaud A, Motzer RJ, Pandha HS, et al. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med. 2016;375(23):2246-2254. https://doi.org/10.1056/NEJMoa1611406.

PER Pulse Recap (3 of 3)

This third of 3 PER Pulse™ Recaps summarizing the online program focuses on the positive results of the S-TRAC trial in patients with renal cell carcinoma (RCC) at high risk of recurrence after nephrectomy and their clinicial implications. Below are some highlights from the activity featuring Drs. Robert A. Figlin, MD, and Alain Ravaud, MD, PhD:
  • An overview of the S-TRAC trial1 evaluated 1 year of sunitinib versus placebo as adjuvant therapy in 615 patients with RCC at high risk of recurrence post-resection, and demonstrated and met its disease-free survival (DFS) primary endpoint (HR, 0.76 [95% CI, 0.59-0.98]; P  =.03), including updated data showing DFS benefit of sunitinib across all subgroups.
  • Faculty interpretation of results from all 4 recent trials in adjuvant RCC therapy and their perspectives on and personal approaches to adjuvant therapy in RCC, such as dosing choices, enrolling patients in clinical trials, and understanding the spectrum of toxicity and its impact on patients in the early-disease setting
  • The importance of collaborative, multidisciplinary care of patients with high-risk RCC, including balanced discussions about therapy options, risks and benefits, and the gaps in communication and coordination of care among the healthcare team in the setting of RCC


“With sunitinib, you need to have fair discussions with your patients [about DFS and side effects]. Some patients would like to have the most chance of gain and not to have recurrence and will want to receive sunitinib…And there could be some patients who say, ‘I don’t want anything more than surgery. I don’t want side effects.’”
 
 — Alain Ravaud, MD, PhD

Reference
  1. Ravaud A, Motzer RJ, Pandha HS, et al. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med. 2016;375(23):2246-2254. https://doi.org/10.1056/NEJMoa1611406.
  2. Motzer RJ, Ravaud A, Patard JJ, et al. Adjuvant sunitinib for high-risk renal cell carcinoma after nephrectomy: subgroup analyses and updated overall survival results. Eur Urol. 2018;73:62-68. http://dx.doi.org/10.1016/j.eururo.2017.09.008.
For additional commentary about these topics and others, visit www.gotoper.com to access more resources from the archived Community Practice Connections™: Transforming Treatment Paradigms in Renal Cell Carcinoma: Understanding the Role of Risk Stratification and Emerging Data in the Adjuvant Setting.






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