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Program Description
RCC has been one of the more drug-resistant malignancies. An interest in the identification of specific targets for therapy has been underway for the last century and has recently received enormous attention with the knowledge expansion of molecular targets. Molecular complexities of both the disease (renal cell cancer) and the treatment (targeted therapy) are resulting in a rapidly evolving environment in the treatment of kidney cancer.

Healthcare providers will now have access to information that tracks the progress of clinical research and evolving treatment strategies for patients with RCC. The Renal Cell Carcinoma Slide Compendium and CME-Certified Enduring Presentation Series, is an online resource of slide modules (not certified for CE credit) and CME-Certified presentations available as web-based, self-study enduring activities available from the Kidney Cancer Association (www.kidneycancer.org).

Visit www.RCCTrends.com often to access the latest information and progress of clinical research and evolving treatment strategies for patients with RCC as new slide modules and CME-Certified enduring activities are released in April, July, and October 2008.


Program Description
This CME slide compendium will provide an overview of the recent developments in the treatment of renal cell carcinoma (RCC), including a synthesis of important clinical trials and clinical practice approaches. RCC has been one of the more drug-resistant malignancies. An interest in the identification of specific targets for therapy has been underway for the last century and has recently received enormous attention with the knowledge expansion of molecular targets. Molecular complexities of both the disease (renal cell cancer) and the treatment (targeted therapy) are resulting in a rapidly evolving environment in the treatment of kidney cancer.

A number of new first-line and second-line targeted therapies (bevacizumab, sunitinib, sorafenib, axitinib, and temsirolimus) have demonstrated, through their interaction with the vascular endothelial growth factor (VGEF) pathway, the ability to block angiogenesis and induce tumor shrinkage and/or tumor necrosis, leading to a delay in tumor growth. The role of these drugs in the algorithm for treatment of patients with renal cell carcinoma has drawn much attention and questions remain regarding timing of use, patient selection according to risk group, and the evolving standard of care.

Based on current and rapidly evolving management strategies in advanced RCC and the educational needs of community- and hospital-based healthcare providers, the Renal Cell Carcinoma Slide Compendium and CME-Certified Enduring Presentation Series, has been developed as an online resource available from the Kidney Cancer Association to healthcare providers with an interest to access information that tracks the progress of clinical research and evolving treatment strategies for patients with RCC.

The Renal Cell Carcinoma Slide Compendium and CME-Certified Presentation Series is a compilation of 11 slide modules (available as a resource for download either as a PDF or PowerPoint presentation and not certified for continuing education credit) and 10 CME-Certified presentations available as individual web-based, self-study enduring activities. The certified presentations and slide modules will be released in April, July, and October 2008. An overview of slide modules and certified presentations to be released in 2008 by the Kidney Cancer Association appear below.

Slide Library
Module I (Release date: April 2008)
Understanding Renal Cell Carcinoma
RCC: Basic Characteristics and Diagnostic Issues
Objectives and Outcomes of Surgical Treatment
Objectives and Outcomes of Cytokine Therapy

Module II (Release date: July 2008)
Clinically Available Targeted Therapy: Sunitinib and Sorafenib
Clinically Available Targeted Therapy: Bevacizumab
Clinically Available Targeted Therapy: Temsirolimus
Nursing Considerations With the Use of Targeted Therapy

Module III (Release date: October 2008)
Clinical Challenges Associated With Advanced RCC
Individualizing Therapy for Patients With Advanced RCC
Palliative Care Considerations in RCC Management

CME-Certified Presentations
Module I (Release date: April 2008)
Understanding the Pathophysiology of RCC: Implications for Novel Therapeutic Approaches
Altering the Natural History of RCC
Surgical Considerations for Localized RCC
Do Cytokines Still Have a Place in the Management of Advanced RCC?

Module II (Release date: July 2008)
Transcending Conventional Treatment of RCC: The Role of Targeted Therapies
Insight Into How to Combine and/or Sequence Systemic Therapies
Nursing Considerations With the Use of Targeted Therapy

Module III (Release date: October 2008)
Preventing Relapse: A Critical Quest in RCC Management
Individualizing Therapy for Patients With Advanced RCC
Pain Management, Supportive Care, and Palliative Care in RCC

Target Audience
This activity has been designed for community-and hospital-based medical oncologists, hematologists, urologists, nephrologists, and allied healthcare providers who provide medical care and support to patients with renal cell carcinoma.

Learning Objectives
At the conclusion of this activity, participants should be able to
  Define current and evolving standards of care for the treatment of early and advanced RCC
  Assess emerging clinical data evaluating the use of systemic therapies for metastatic RCC, either sequentially and/or in combination, and in the first-line and second-line settings
  Identify strategies to individualize therapy for patients and hence optimize their therapeutic outcomes
  Recognize and identify patient quality-of-life considerations associated with RCC

Activity Director
Robert A. Figlin, MD
Arthur and Rosalie Kaplan Chair in Oncology
Professor and Chair, Medical Oncology and Therapeutics Research
City of Hope National Medical Center and Beckman Research Institute
Associate Director for Clinical Research
City of Hope Comprehensive Cancer Center
Duarte, California

Faculty
Michael B. Atkins, MD
Deputy Chief, Division of Hematology/Oncology
Director of Biologic Therapy and Cutaneous Oncology Programs
Director, Cancer Clinical Trials Office
Associate Director for Clinical Research
Beth Israel Deaconess Medical Center
Leader, Kidney Cancer Program
Dana-Farber/Harvard Cancer Center
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Ronald M. Bukowski, MD
Director, Experimental Therapeutics
Taussig Cancer Center
Professor of Medicine
Cleveland Clinic Foundation Lerner College of Medicine of Case Western Reserve University
Cleveland, Ohio

Nancy P. Moldawer, RN, MSN
Clinical Research Operations Manager
Division of Medical Oncology and Experimental Therapeutics
City of Hope National Medical Center
Duarte, California

Robert J. Motzer, MD
Associate Professor of Medicine
Cornell University Medical College
Professor of Medicine
Weill Medical College of Cornell University
Member, Memorial Sloan-Kettering Cancer Center
New York, New York

Christopher G. Wood, MD, FACS
Associate Professor of Urology
Department of Urology
The University of Texas M.D. Anderson Cancer Center
Houston, Texas

CME Accreditation & Disclosures

Accreditation

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the City of Hope and Alliance Medical Communications. The City of Hope is accredited by the ACCME to provide continuing medical education for physicians.

Designation of Credit
This activity is designated for 5 AMA Physicians’ Recognition Award™ credits. To receive your CME credits you are requested to review the material in full and take the post-test and evaluation. Your evaluation of the activity and comments will remain confidential.

Disclosure
City of Hope takes responsibility for the content, quality and scientific integrity of this continuing medical education (CME) activity. Prior to their participation in this City of Hope CME activity, all faculty/presenters have disclosed any real or apparent vested commercial interest(s) in both those companies whose products may be discussed during the course of the activity and in those companies acting as commercial supporters of the activity. City of Hope further requires that prior to the activity, faculty/presenters have disclosed their intention to discuss any off-label and/or investigational (not yet approved for any purpose) use of pharmaceuticals or medical devices. Written disclosure of faculty/presenters’ specific commercial relationships and/or intent to discuss off-label and/or investigational is provided below.

Robert A. Figlin, MD (Activity Director)
Commercial Interest Relationship
Amgen, GlaxoSmithKline plc; Keryx
Biopharmaceuticals, Inc.; Pfizer Inc; Wyeth
Grant/Research Support
Keryx Biopharmaceuticals, Inc; Pfizer Inc;
Wyeth
Consultant

Michael B. Atkins, MD
Commercial Interest Relationship
Novartis AG Grant/Research Support
Antigenics Inc.; Aveo Pharmaceuticals, Inc.;
Bayer Healthcare AG; Genentech, Inc.;
Novartis AG; Onyx Pharmaceuticals, Inc.;
Pfizer Inc; Wyeth
Consultant

Ronald N. Bukowski, MD
Commercial Interest Relationship
Bayer Healthcare AG; Pfizer Inc; Wyeth Consultant
Bayer Healthcare AG; Genetech, Inc.; Pfizer Inc; Wyeth Speakers’ Bureau

Nancy P. Moldawer RN, MSN
Commercial Interest Relationship
Wyeth Consultant

Robert J. Motzer, MD
Commercial Interest Relationship
Genentech, Inc.; Novartis AG; Pfizer Inc;
Wyeth
Grant, Research Support
Bayer Healthcare AG; Onyx Pharmaceuticals, Inc. Speakers’ Bureau

Christopher G. Wood, MD
Commercial Interest Relationship
Antigenics Inc.; Bristol-Myers Squibb
Company; Ethicon, Inc.; Pfizer Inc; Pharmion
Corporation
Consultant
Bayer Healthcare AG; Pfizer Inc Speakers’ Bureau
Antigenics Inc.; Bayer Healthcare AG; Bristol-Myers Squibb Company; Ethicon, Inc.; Pharmion Corporation Honorarium

The following faculty reported specific mention of off-label and/or investigational use of products within their presentations.

Michael B. Atkins, MD
Product Investigational and/or Off-Label Use
Bevacizumab Renal cell carcinoma
IL-2 Renal cell carcinoma
IFN-α & IFN-α-2a Renal cell carcinoma
MPA (medroxyprogesterone acetate) Renal cell carcinoma
Sorafenib Renal cell carcinoma

Ronald N. Bukowski, MD
Product Investigational and/or Off-Label Use
AP2-3573 Renal cell carcinoma
Bevacizumab Renal cell carcinoma
CI-1040 Renal cell carcinoma
Cetuximab Renal cell carcinoma
Erlotinib Renal cell carcinoma
Everolimus Renal cell carcinoma
Gefitinib Renal cell carcinoma
IL-2 Renal cell carcinoma
IFN-α Renal cell carcinoma
ISIS-5132 Renal cell carcinoma
Panitumumab Renal cell carcinoma
PTK/ZK Renal cell carcinoma
Rapamycin Renal cell carcinoma
Sorafenib Renal cell carcinoma
Sunitinib Renal cell carcinoma

Christopher G. Wood, MD
Product Investigational and/or Off-Label Use
IL-2 Renal cell carcinoma
IFN-α Renal cell carcinoma

Acknowledgements
This educational program is made possible through an unrestricted educational grant from


Core Competencies
The American Board of Medical Specialties and the Accreditation Council of Graduate Medical Education have embarked on a joint initiative to quantify and evaluate a set of six physician core competencies by which the individual physician will be measured for Residency Certification, Board Certification and more recently, Maintenance of Certification. Individual hospitals and other health care delivery organizations will now also be evaluated by the Joint Commission of Healthcare Organizations on their practice and demonstration of the six core competencies.

In brief, “core competencies” refers to those six abilities (competencies) that are central (core) to the practice of medicine, specifically: 1) Patient Care, 2) Medical Knowledge, 3) Practice-based Learning, 4) Interpersonal and Communication Skills, 5) Professionalism and 6) Systems-based Practice. More details about each competency are included below.

All educational content presented will have been reviewed by the program directors. To assist participants in demonstrating their completion of continuing medical education in the 6 core competencies, we asked each presenter to indicate for which of the core competencies will the educational content of their presentation provide information or insight. Presentations may address more than one. Responses are listed in the table immediately following this section.

1) Patient Care that is compassionate, appropriate, and effective for the treatment of health problems and the promotion of health

2) Medical Knowledge about established and evolving biomedical, clinical, and cognate (e.g. epidemiological and social-behavioral) sciences and the application of this knowledge to patient care

3) Practice-Based Learning and Improvement that involves investigation and evaluation of their own patient care, appraisal and assimilation of scientific evidence, and improvements in patient care

4) Interpersonal and Communication Skills that result in effective information exchange and teaming with patients, their families, and other health professionals

5) Professionalism, as manifested through a commitment to carrying out professional responsibilities, adherence to ethical principles, and sensitivity to a diverse patient population

6) Systems-Based Practice, as manifested by actions that demonstrate an awareness of and responsiveness to the larger context and system of health care and the ability to effectively call on system resources to provide care that is of optimal value

Faculty Core Competency addressed by presentation
Michael B. Atkins, MD 1 – 2
Ronald N. Bukowski, MD 1 – 6
Robert A. Figlin, MD 1 – 6
Nancy P. Moldawer, RN, MSN 1 – 6
Robert J. Motzer, MD 1 – 6
Christopher G. Wood, MD 1, 2, 3, & 6

Cultural Diversity
The California legislature has passed AB 1195 which states that as of July 1, 2006 all Category 1 CME activities that relate to patient care must include a cultural diversity/linguistics component.

DEFINITIONS: Cultural competency means a set of integrated attitudes, knowledge, and skills that enables a health care professional or organization to care effectively for patients from diverse cultures, groups, and communities. Linguistic competency means the ability of a physician and surgeon to provide patients who do not speak English or who have limited ability to speak English, direct communication in the patient's primary language.

If there is relevant cultural diversity information relating to age, gender, race, socio-economics, sexual orientation, religion, language, ethnicity, etc. that impacts the care of the patient, faculty are required to include it in his/her presentation. All members of the faculty reported there is no cultural diversity and patient care data within his/her presentation.