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Co-Chairs

Paul A. Bunn, Jr., MD

James Dudley Chair in Cancer Research
Professor, Medical Oncology
University of Colorado Denver
Aurora, CO
Executive Director, International Association for the Study of Lung Cancer
(IASLC)

Roy S. Herbst, MD, PhD

Chief, Section of Thoracic Oncology
Professor of Medicine & Cancer Biology
Department of Thoracic / Head & Neck Medical Oncology
Co-Director, Phase I Clinical Trials Working Group
The University of Texas
M. D. Anderson Cancer Center
Houston, TX

Corey J. Langer, MD

CME CREDIT INFORMATION

Release Date: 1/7/11

Expiration Date: 1/7/12

Physicians: maximum of 8 AMA PRA Category 1 Credits™

Average time to complete each individual session: 20 minutes

CME-Accredited Webcasts, Presentation and Audio Downloads, and i-Tunes Podcast Downloads

19 case-based presentations from the live course

Third Annual Symposium on Personalized Therapies and Best Clinical Practices for Lung Cancer and Head and Neck Cancer

held in San Diego, California on August 28, 2010

You may participate in any or all of the sessions for CME credit or a Certificate of Attendance after you review the required ACCME (Accreditation Council on Continuing Medical Education) information on this page.

Overview and Faculty Disclosures

Sessions

Evaluation & Certificate

Overview of This CME-Accredited Educational Activity

Your Options for Methods of Participation are:

View any of the sessions online (PowerPoint Slides synced with the live activities audio)
Download the PowerPoint Presentations
Download session audio files as MP3s or podcasts
Sessions can be individually reviewed for credit. You can participate in as few or as many as you desire.

Overview

This activity will provide oncologists, hematologist/oncologists and other physicians and clinicians treating thoracic malignancies with the most current clinical and scientific data on this subject, including the added benefit of the "Best Data from ASCO" of June 2010. This CME activity will discuss how to utilize the most up-to-date clinical regimens for treating these malignancies, including the new "game-changing" data with initial, maintenance and relapsed therapies. You can earn up to 8 CME credits.

To make this symposium as interactive as possible it will be highly case study-based where you will select treatment strategies for each of the challenging patient cases. Clinical cases will be included in almost all presentations as well as in three, separate, dedicated case study sessions. And as in all our symposia there will be several lively "Point-CounterPoint Debates" addressing important controversial topics where you will vote your opinions before and after each debate.

Session #1: Personalizing Chemotherapy-Based Clinical Strategies, will be chaired by Dr. Paul Bunn, Jr. This session addresses the following clinical questions in practice: 1) Which chemotherapy strategies should be used based upon histology? 2) For what duration (# of cycles) should chemotherapy be given? 3) When and for whom should we use maintenance chemotherapy? 4) Is chemotherapy still the backbone of initial therapy? 5) What are the effective lab tests and biomarkers for personalizing chemotherapy that we can use in the clinic today? 6) How can we obtain tissue for using diagnostic tests - are their better methods than biopsy? 7) Should targeted therapies be combined with chemotherapy for maintenance therapy of Non-Small Cell Lung Cancer (NSCLC)? 8) Should targeted therapies be included with chemotherapy for treating Head and Neck Cancer (HNC)?

Session #2: Personalizing Anti-Angiogenesis-Based Clinical Strategies, will be chaired by Dr. Roy Herbst. This session addresses the following clinical questions in practice: 1) Are either monoclonal antibodies or small molecule tyrosine kinase inhibitors more effective than each other? 2) What are the issues related to treatment withdrawal from anti-angiogenic therapy such as toxicity with maintenance therapy? 3) Where are combinations of small molecules and chemotherapy useful? 4) What are the most important of these combinations to consider? 5) What are the optimal maintenance strategies? 6) What are the potential combinations of angiogenesis inhibition used with inhibition of other targets and pathways?

Session #3: Personalizing Anti-EGFR-Based Clinical Strategies, will be chaired by Dr. Paul Bunn, Jr. This session addresses the following clinical questions in practice: 1) Should all patients be tested for the EGFR mutation? 2) How do you manage EGFR resistance, both primary and secondary resistance? 3) How should long-term toxicity with EGFR inhibition be managed? 4) With what other targeted therapies should anti- EGFR agents be combined? 5) Are there any clinical trials in which we can enroll our patients with thoracic malignancies today that are particularly attractive?

Session #4: Investigational Targeted Therapies in Late-Stage Development, will be chaired by Dr. Corey Langer. This session is a review of the numerous investigational agents in late-stage clinical development for both NSCLC and SCLC that have not yet been adequately reviewed in any presentation of this symposium, thus far. The objective of this session is to ensure that the oncologists treating thoracic malignancies are aware of the many therapeutic options for enrolling their patients into clinical trials in addition to using the drugs that are currently available on the market. Several improvements have been made to this symposium that will help make it even better than last year's highly successful symposium.

Educational Statement of Need

LUNG CANCER
Until today, treatment decisions for lung cancer patients have been largely empirical. And with this empirical approach NSCLC patient outcomes have only marginally improved during the past several decades. Approximately 217,000 patients were diagnosed with lung cancer in 2009 and approximately 160,000 patients died that same year from this malignancy.

During the past year clinical data has emerged resulting in practice-changing paradigm shifts for the treatment of patients with NSCLC. This is especially relevant for initial and maintenance therapy of NSCLC with an increasing number of novel strategy options available, including both chemotherapy and targeted therapy-based approaches. The need exists to discuss when and where to best use each of these options for personalized and optimal patient care.

Chemotherapy has been an essential component for initial and maintenance therapy for thoracic malignancies. With the myriad of new data and options, standard therapy has undergone many major changes and several promising novel therapies are on the horizon. Advancements in molecular biomarker technology continue to evolve quite significantly and help lead to new clinical applications of these predictive and prognostic factors. These molecular biomarkers have helped researchers find more effective clinical roles for established and emerging chemotherapies and targeted therapies for treating NSCLC. Thus, a comprehensive understanding of both the science and of the practical aspects, or "how to use" the state-of-the-art molecular biomarker technology, is a major goal of the Third Annual Symposium on Personalized Therapies and Best Clinical Practices for Lung Cancer and Head & Neck Cancer.

HEAD & NECK CANCER
The treatment of Head and Neck Cancer (HNC) in patients with locally advanced, recurrent, or metastatic disease remains quite challenging. Long-term survival varies from 10% to 50%, depending upon the site, stage and resectability of the tumor. Surgical intervention is potentially curative in resectable patients.

Chemotherapy before definitive surgery and radiation therapy has been demonstrated to increase response in both localized disease and disease with lymph node metastasis. For many patients with unresectable, locally advanced HNC, induction chemotherapy with docetaxel, cisplatin and 5-FU is considered a standard of care. But how systemic therapy can be optimally applied in a personalized approach to the treatment of HNC is an important, current, clinical question-in-practice.

Improved results have been observed with the clinical applications of targeted therapies for HNC. Understanding the optimal roles of targeted therapies such as anti-EGFR strategies for the treatment of HNC are areas that are rapidly evolving and need to be reviewed.

Proteomics has helped provide further support for using anti-EGFR monotherapy with either erlotinib or cetuximab for squamous cell HNC. Much of the newest and key data for treating HNC involves an improved use of biomarkers. Data exists that suggests tumor HPV status is strongly associated with survival in patients with oropharyngeal cancer receiving standard of care chemo-radiation and that tumor HPV status should now be used as a stratification factor for all clinical trials in this malignancy. Also, data exists showing the prognostic significance of tumor HPV status in oropharyngeal cancer treated with chemo-radiation, but also that the biomarker p16 identifies a larger group of patients with improved prognosis. P16-positive tumors have a better prognosis than p16-negative tumors.

List of Sessions

Session 1: Personalizing chemotherapy-based clinical strategies Chair: Paul Bunn
1a.	Personalizing chemotherapy for NSCLC Which strategies are ready for prime time and which are emerging soon? George Simon
1b.	Personalizing systemic therapies for head & neck cancer. What is optimal therapy today? Maura Gillison
1c.	Maintenance chemotherapy-based personalized strategies for NSCLC. Ronald Natale
1d.	New clinical applications of chemotherapy-based strategies plus radiation for thoracic malignancies. How can this combined-modality approach be personalized? Walter Curran
1e.	Point-Counterpoint #1: Maintenance therapy should be a standard of care for the treatment of thoracic malignancies. Pro: Paul Bunn Con: Corey Langer
1f.	Session 1 Additional Case Study Edward Garon
Session 2: Personalizing anti-angiogenesis-based clinical strategies Chair: Roy Herbst
2a.	How reliable are genomic markers and other predictive factors for predicting efficacy with anti-angiogenesis agents? Are we there? John Heymach
2b.	Point-Counterpoint #2: Chemotherapy plus an angiogenesis inhibition strategy with a monoclonal antibody is a standard of care for patients eligible for this regimen. Pro: Karen Kelly Con: Alan Sandler
2c.	What are the optimal strategies using combinations of anti-angiogenesis monoclonal antibodies with other systemic therapies? Alan Sandler
2d.	How can we use anti-VEGF oral tyrosine kinase inhibition combined with other novel strategies for personalized therapy? Roy Herbst
2e.	Session #2 Additional Case Study Fairooz Kabbinavar
Session 3: Personalizing anti-EGFR-based clinical strategies Chair: Paul Bunn
3a.	Personalizing therapies for thoracic malignancies with anti-EGFR treatment strategies. A review of the practice changing and other key data. Paul Bunn
3b.	Developing personalized treatment strategies for managing primary and secondary resistance to anti-EGFR therapy for NSCLC. Lecia Sequist
3c.	How do we better involve our pathologists to help us do more effective EGFR and Kras testing? Ignacio Wistuba
3d.	How do we optimize anti-EGFR treatment strategies in the maintenance setting for patients with NSCLC? Mark Socinski
3e.	Point-Counterpoint #3: All patients receiving anti-EGFR therapy for thoracic malignancies should be screened for the EGFR mutation. Pro: Paul Bunn Con: Corey Langer
3f.	Session #3 Additional Case Study Barbara Gitlitz
Session 4: Investigational targeted therapies in late-stage development Chair: Corey Langer
4a.	Novel treatment strategies in late-stage development for NSCLC Roy Herbst
4b.	Novel treatment strategies in late-stage development for SCLC Karen Kelly

Educational Objectives

At the conclusion of all of these enduring materials, you should be able to:

Evaluate the roles of predictive and prognostic molecular biomarkers for the treatment of thoracic malignancies
Devise strategies to apply predictive and prognostic tests in the clinic in order to help develop personalized systemic therapy regimens for optimal treatment of patients with thoracic malignancies.
Evaluate the role of histology in the development of optimal treatment strategies for systemic therapy of thoracic malignancies.
Evaluate the role of gene mutations in the development of optimal treatment strategies for systemic therapy of thoracic malignancies.
Analyze the large amount of new clinical data revealed in 2009 and 2010 for personalization of treatments for patients with thoracic malignancies receiving first-line therapy and for those who are refractory to prior treatment, and, for NSCLC patients receiving maintenance therapy.
Determine the optimal roles of chemotherapy-based regimens for the personalized treatment of patients with thoracic malignancies.
Determine the newest applications of targeted therapies, including combinations of angiogenesis inhibition and combinations of EGFR inhibition in the first-line and maintenance settings for the treatment of patients with NSCLC.
Evaluate the strategies for treating EGFR-resistant NSCLC.
Devise strategies to optimize multi-modality approaches for the personalized treatment of HNC using molecular biomarkers for improved prognosis, and the use of blood-based testing to select HNC populations to receive anti-EGFR therapy.
Evaluate clinical data for personalizing the use of radiation therapy for locally advanced HNC and NSCLC.
Compare and contrast the clinical efficacy of the numerous investigational novel strategies in late-stage development for treating lung cancer.

Target Audience and CME Information

Target Audience
This CME activity is designed to meet the educational needs of medical oncologists, hematologist/oncologists, radiation oncologists, surgical oncologists, pathologists, Fellows, nurse practitioners/nurses, pharmacists, and other health care professionals who are involved in the treatment or management of patients with lung cancer or head and neck cancer. These thoracic malignancies are treated optimally by a multidisciplinary approach of clinicians and, thus, they are all targeted for invitation to these educational activities.

CME Accreditation & Credit Designation
The Oncology Learning Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Oncology Learning Center designates this educational activity for a maximum of 8 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Physician Assistants: AAPA accepts certificates of attendance for educational activities certified for Category 1 credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. Physician Assistants may receive a maximum of 8 hours of Category 1 credit for attending this symposium.

Nurse Practitioners, nurses, pharmacists and Fellows will receive a certificate of attendance that they can submit to their accrediting organizations for continuing education credit.

CME Certificate or Certificate of Participation
The relevant section(s) of the Evaluation Form pertaining to the session(s) of the enduring materials you have viewed or listened to, and the Request for Credit Form must be completed and submitted to the Oncology Learning Center following your participation in the enduring material educational activity to obtain CME credit. Physicians and other participants will be able to print their certificates after they complete these Forms.

Faculty & Disclosures

It is the policy of the Oncology Learning Center, Inc. (OLC) to ensure that all of its educational activities and materials are of the highest quality, and are balanced, objective, independent, free of commercial bias, and planned and developed with scientific rigor with strict adherence to all Accreditation Council for Continuing Medical Education (ACCME) rules and policies. The OLC evaluates all content, faculty and faculty disclosures for any potential conflicts of interest. Should any conflicts of interest be identified these conflicts are resolved in advance of the educational activity by independent peer reviewers who are experts in the subjects of the educational activity.

All faculty and OLC staff participating in the content, planning or implementation of an educational CME activity are required to disclose to the audience of the educational activity any relevant financial relationships or interests and to assist in the resolution of any conflict of interest that may arise from the relationship(s) or interest(s). It is also the policy of the OLC to require all faculty presenters to make a meaningful disclosure to the audience of their discussions of unlabeled or FDA unapproved drugs, products, tests or devices. This information will be available as part of the educational activity and related material.

The following faculty and OLC staff have reported real or potential relevant conflicts of interest and these conflicts have been resolved, prior to this educational activity through a peer-review process by two medical oncologists who have had no affiliation with this educational activity other than the peer review process.

Paul A. Bunn, Jr., MD (Co-Chair)

James Dudley Chair in Cancer Research
Professor, Medical Oncology
University of Colorado Denver
Aurora, CO
Executive Director, International Association for the
Study of Lung Cancer (IASLC)

Receipt of Intellectual Property Rights/Patent Holder: Co-investigator on CU patent for FISH testing for EGFR therapies.
Consultant: AstraZeneca,Eli Lilly, Amgen, Boehringer Ingelheim, Roche, Genentech, Bristol-Myers Squibb, OSI, Biodesix, Bayer, Daiichi, GlaxoSmithKline, Merck, Novartis, Poniard, Sanofi-Aventis
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Walter J. Curran, MD, FACR

Professor and Chair
Department of Radiation Oncology
Emory School of Medicine Chief Medical Officer
Winship Cancer Institute
Atlanta, GA
Chairman, Radiation Therapy Oncology Group (RTOG)

Consultant: Lilly Oncology, GlaxoSmithKline
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Edward B. Garon, MD

Associate Professor of Medicine
Department of Medicine, Hematology/Oncology
Jonsson Comprehensive Cancer Center
Thoracic Oncology Program Area
University of California at Los Angeles School of Medicine
Los Angeles, CA

Contracted Research: Genentech, Pfizer, Eli Lilly, AstraZeneca, Novartis, GlaxoSmithKline, Amgen
I have no real or apparent conflicts of interest to report.

Maura L. Gillison, MD, PhD

Jeg Coughlin Chair of Cancer Research
Professor of Internal Medicine & Epidemiology
Ohio State University Medical Center
Division of Hematology & Oncology
Columbus, OH

Consultant: GlaxoSmithKline
Research Funding: Merck

Barbara J. Gitlitz, MD

Associate Professor of Clinical Medicine
Department of Medicine
USC Norris Comprehensive Cancer Center
Los Angeles, CA

Consultant: Genentech, OSI
Speakers Bureau: Eli Lilly, Genentech, OSI

Roy S. Herbst, MD, PhD (Co-Chair)

Professor of Medicine
Chief, Section of Thoracic Medical Oncology
Department of Thoracic/Head and Neck Medical Oncology
Barnhart Family Distinguished Professor
in Targeted Therapies
The University of Texas M. D. Anderson Cancer Center
Houston, TX

Consultant: Abraxis, AstraZeneca, Eli Lilly, Roche, GlaxoSmithKline, Genentech

John V. Heymach, MD, PhD

Professor of Thoracic Head/Neck Medical Oncology
Professor of Cancer Biology
The University of Texas M. D. Anderson Cancer Center
Houston, TX

Consultant: Genentech, AstraZeneca, GlaxoSmithKline, Pfizer, Boehringer-Ingelheim
Contracted Research: AstraZeneca, GlaxoSmithKline, Pfizer

Fairooz Kabbinavar, MD

Professor of Medicine and Urologic Oncology
Henry Alvin and Carrie L. Meinhardt Chair,
Kidney Cancer Research
Medical Director, Thoracic Oncology and
Kidney Cancer Programs
Director Hematology-Oncology Fellowship Program
UCLA Institute of Urologic Oncology
Los Angeles, CA

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Eli Lilly, Genentech, Roche

Karen Kelly, MD

Professor of Medicine
Deputy Director
University of Kansas
Kansas Masonic Cancer Research Institute
Kansas City, MO

Consultant: Genentech
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Corey J. Langer, MD (Co-Chair)

Professor of Medicine
Director, Thoracic Oncology
Division of Hematology-Oncology
Abramson Cancer Center
University of Pennsylvania
Philadelphia, PA
Vice Chair, Radiation Therapy Oncology Group (RTOG)

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Bristol-Myers Squibb, ImClone, Sanofi-Aventis, Pfizer, Eli Lilly, Amgen, AstraZeneca, Novartis, Genentech, Bayer/Onyx, Abraxis, Abbott, Morphotek, Biodesix, Clarient, Caris DX
Contracted Research: Bristol-Myers Squibb, ImClone, Pfizer, Eli Lilly, Genentech, OSI
Speakers Bureau: Eli Lilly, Genentech, OSI, ImClone, Bristol-Myers Squibb
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Ronald B. Natale, MD

Medical Director
Clinical Lung Cancer Program
Medical Oncology
Cedars-Sinai Samuel Oschin Cancer Center
Los Angeles, CA

Consultant: Genentech, OSI
Contracted Research: Novartis, Amgen, MedImmune
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

Alan B. Sandler, MD

Professor of Medicine
Division Chief, Hematology & Medical Oncology
DeArmond Chair, Clinical Cancer Research
Oregon Health & Science University
Portland, OR
Co-Chair, Eastern Cooperative Oncology Group (ECOG)

Consultant: Abraxis, Boehringer-Ingelheim, Eli Lilly, Genentech (Roche), GlaxoSmithKline, Novartis, Pfizer, Prometheus, VeriStrat
Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: BMS, Chugai (Roche), Daiichi-Sankyo, Eli Lilly, Genentech (Roche), GlaxoSmithKline, Quintiles
Contracted Research: Genentech (Roche), Bristol-Myers Squibb, Eli Lilly, OSI, Pfizer

Lecia V. Sequist, MD, MPH

Assistant Professor, Department of Medicine
Harvard Medical School
Assistant Physician, Medicine,
Massachusetts General Hospital Cancer Center
Boston, MA

Consultant: GlaxoSmithKline
I intend to reference unlabeled/unapproved uses of drugs or products in my presentation.

George R. Simon, MD, FACP, FCCP

Director, Thoracic Oncology Program
Medical University of South Carolina
Charleston, SC

I have no real or apparent conflicts of interest to report.

Mark A. Socinski, MD

Professor of Medicine
Multidisciplinary Thoracic Oncology Program
Lineberger Comprehensive Cancer Center
University of North Carolina
Chapel Hill, NC

Fees for Non-CME Services Received Directly from Commercial Interest or their Agents: Genentech, Eli Lilly
Contracted Research: Genentech, Pfizer, Eli Lilly, Abraxis, Celgene, Synta

Ignacio I. Wistuba, MD

Professor
Departments of Pathology and
Thoracic/Head & Neck Medical Oncology
The University of Texas M. D. Anderson Cancer Center
Houston, TX

Consultant: Johnson & Johnson, Sanofi-Aventis

The Oncology Learning Center Staff

We have no real or apparent conflicts of interest to report.

This educational activity has been independently peer-reviewed.

Disclosure of Unlabeled Uses
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration (FDA). For additional information about approved uses, including approved indications, contraindications, and warnings, please refer to the prescribing information for each product or consult the Physicians' Desk Reference.

The Oncology Learning Center (OLC) does not recommend the use of any agent outside of the FDA labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the OLC. Please refer to the official FDA prescribing information for each product for discussion of approved indicated, contraindications, and warnings.

Educational Grants
Sincere appreciation is extended to the following companies for their generous support of this educational activity:

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