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AGENDA Agendas are subject to change because we are always striving to improve the quality of your educational experience. MD Anderson may substitute faculty with comparable expertise on rare occasions necessitated by illness, scheduling conflicts, and so forth. 11:00 – 11:10 AM Introduction and Pre-Assessment 11:10 – 11:25 AM Pathology and Molecular Markers for Nonsmall Cell Lung Cancer (NSCLC) William D. Travis, MD 11:25 – 11:45 AM First-Line and Targeted Therapy for NSCLC Jyoti D. Patel, MD 11:45 AM – 12:00 PM Maintenance and Duration of Therapy for NSCLC Silvia Novello, MD, PhD 12:00 – 12:10 PM Questions and Answers 12:10 – 12:40 PM Tumor Board Discussion David S. Ettinger, MD 12:40 – 12:55 PM Questions and Answers 12:55 – 1:00 PM Final Remarks and Post-Assessment Case Study Selections Case 1: A 50-year-old, never smoker, Asian female presents with dyspnea on exertion. Cytology was positive for adenocarcinoma (TTF1 positive , CK 7 positive, CK 20 negative). Case 2: A 69-year-old Caucasian male with a 50-pack-per-year smoking history presented with a 4- month productive cough, dyspnea on exertion, and no hemoptysis. A transbronchial biopsy of an N2 lymph node revealed squamous cell carcinoma. HISTOLOGY MATTERS: Personalized Therapy for Patients with NSCLC

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AGENDAAgendas are subject to change because we are always striving to improve the quality of your educational experience. MD Anderson may substitute faculty with comparable expertise on rare occasions necessitated by illness, scheduling conflicts, and so forth.

11:00 – 11:10 AM Introduction and Pre-Assessment

11:10 – 11:25 AM Pathology and Molecular Markers for Nonsmall Cell Lung Cancer (NSCLC)William D. Travis, MD

11:25 – 11:45 AM First-Line and Targeted Therapy for NSCLC Jyoti D. Patel, MD

11:45 AM – 12:00 PM Maintenance and Duration of Therapy for NSCLC Silvia Novello, MD, PhD

12:00 – 12:10 PM Questions and Answers

12:10 – 12:40 PM Tumor Board Discussion David S. Ettinger, MD

12:40 – 12:55 PM Questions and Answers

12:55 – 1:00 PM Final Remarks and Post-Assessment

Case Study Selections

Case 1: A 50-year-old, never smoker, Asian female presents with dyspnea on exertion. Cytology waspositive for adenocarcinoma (TTF1 positive , CK 7 positive, CK 20 negative).

Case 2: A 69-year-old Caucasian male with a 50-pack-per-year smoking history presented with a 4-month productive cough, dyspnea on exertion, and no hemoptysis. A transbronchial biopsyof an N2 lymph node revealed squamous cell carcinoma.

HISTOLOGY MATTERS: Personalized Therapy for Patients with NSCLC

Recent advances in the recognition of histologic subtypes as prognostic and predictive factors in nons-mall cell lung cancer (NSCLC) have created a new era of personalized therapy for patients with this dis-ease. According to the latest data, the histologic subtype of NSCLC may influence a patient’s treatmentregimen and, in turn, survival outcome. As a result, the National Comprehensive Cancer Network rec-ommends the use of histology and biomarkers as predictive factors when selecting therapy for certainpatients. Another recent development in the treatment of patients with advanced NSCLC is the discoverythat maintenance chemotherapy is effective for some following first-line chemotherapy. In treating thesepatients, the variety and range of complicating factors can perplex even the best-educated physicians.Given the clinical impact of recent developments in NSCLC, clinicians require education to increase theirknowledge, competence, and performance in using therapies to manage patients with NSCLC and topromote closer relationships within the multidisciplinary teams to optimize patient outcomes.

After attending this activity, the participant will demonstrate the ability to:

• DESCRIBE the prognostic and predictive role of histologic features and immunohistochemical markers in NSCLC therapy and how gene expression profiling and mutation analysis may help to customize therapy for patients with NSCLC. [MK, PC]

• ASSESS current and emerging therapeutic strategies based on tumor biology that incorporate targeted agents with chemotherapy for patients with advanced NSCLC. [MK, PC]

• APPLY techniques that improve interprofessional communication to maintain continuity of care andrelay treatment expectations to patients with NSCLC. [MK, PC, IC]

American Board of Medical Specialties/Accreditation Council for Graduate Medical Education GeneralCompetency Assignments: IC = interpersonal and communication skills; MK= medical knowledge; PC = patient care.

The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scien-tific integrity of this CME activity.

OVERVIEW

LEARNING OBJECTIVES

This symposium will focus on personalized therapy for patients with advanced NSCLC based on histol-ogy and gene expression profiling.

GOAL

HISTOLOGY MATTERS: Personalized Therapy for Patients with NSCLC

PARTICIPATING FACULTY

DAVID S. ETTINGER, MD (Chair)The Alex Grass Professor of Oncology

Johns Hopkins University School of MedicineBaltimore, Maryland

SILVIA NOVELLO, MD, PhD Assistant Professor

Thoracic Oncology Unit University of Turin San Luigi Hospital

Turin, Italy

JYOTI D. PATEL, MDAssociate Professor

Department of MedicineHematology Oncology Division

Northwestern University Feinberg School of Medicine

Chicago, Illinois

WILLIAM D. TRAVIS, MDAttending Thoracic Pathologist

Department of Pathology Memorial Sloan Kettering Cancer Center

New York, New York

HISTOLOGY MATTERS: Personalized Therapy for Patients with NSCLC

CME INFORMATIONACCREDITATION STATEMENT – The Johns Hopkins University School of Medicine is accredited by the Accreditation Councilfor Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT – The Johns Hopkins University School of Medicine designates this live activity for amaximum of 2.0 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of theirparticipation in the activity.

FORMAT – This educational activity is a live meeting consisting of approximately 2.0 hours of interactive clinical presentations.This activity is designed to engage the audience and encourage dialogue with the presenters. Thus, audience participation is crit-ical to enhancing the open exchange of opinions and ideas that facilitate the flow of knowledge.

To receive a CME certificate, participants will complete an evaluation and self-report form documenting the amount of time theyspent in the activity and return it to a member of the staff upon departure. A certificate will be mailed to you.

FULL DISCLOSURE POLICY AFFECTING CME ACTIVITIES – As a provider approved by the Accreditation Council forContinuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office of ContinuingMedical Education (OCME) to require signed disclosure of the existence of financial relationships with industry from any individ-ual in a position to control the content of a CME activity sponsored by OCME. Members of the Planning Committee are requiredto disclose all relationships regardless of their relevance to the content of the activity. Faculty are required to disclose only thoserelationships that are relevant to their specific presentation. The following relationships have been reported for this activity:

SPEAKERS

David S. Ettinger, MD Reports serving as a consultant for Biodesix, Boehringer Ingelheim, Daiichi Sankyo Company,Ltd, Eli Lilly and Company, Genentech, Inc, Merck & Co, Inc, Novartis Pharmaceuticals Corporation, Poniard Pharmaceuticals, Prometheus, Inc, Shin Nippon Biomedical Laboratories,Ltd, and Telik, Inc.

Jyoti D. Patel, MD Reports serving as an advisor for Genentech, Inc.

No other speakers have indicated that they have any financial interests or relationships with a commercial entity whose productsor services are relevant to the content of their presentation(s).

PLANNERS

David S. Ettinger, MD Reports serving as a consultant for Biodesix, Boehringer Ingelheim, Daiichi Sankyo Company,Ltd, Eli Lilly and Company, Genentech, Inc, Merck & Co, Inc, Novartis Pharmaceuticals Corporation, Poniard Pharmaceuticals, Prometheus, Inc, and, Shin Nippon Biomedical Laboratories, Ltd, and Telik, Inc.

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution that receives thegrant, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s)are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their efforton the project(s).

OFF-LABEL PRODUCT DISCUSSION – No speaker has indicated that he/she will reference unlabeled/unapproveduses of drugs or products.

DISCLAIMER – The opinions and recommendations expressed by faculty and other experts whose input is included in this pro-gram are their own. This handout is produced for educational purposes only. Use of Johns Hopkins University School of Medicinename implies review of educational format, design, and approach. Please review the complete prescribing information of specif-ic drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects before administeringpharmacologic therapy to patients.

COPYRIGHT INFORMATION – All rights reserved. No part of this syllabus may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embodied in articles or reviews.

CONFIDENTIALITY DISCLAIMER FOR CME CONFERENCE ATTENDEES

I certify that I am participating in this Johns Hopkins University School of Medicine activityfor CME-accredited training and/or educational purposes.

I understand that while I am participating in this capacity, I may be exposed to "protectedhealth information," as that term is defined and used in Johns Hopkins policies and in thefederal HIPAA privacy regulations (the "Privacy Regulations"). Protected health informationis information about a person's health or treatment that identifies the person. I also under-stand that while I am participating in this capacity I will be treated as a temporary memberof Johns Hopkins for purposes of the Privacy Regulations only.

I pledge and agree to use and disclose any of this protected health information only for thetraining and/or educational purposes of my visit and to keep the information confidential.

I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have aboutmy obligations under this Confidentiality Pledge or under any of the Hopkins policies and pro-cedures and applicable laws and regulations related to confidentiality. The contact informa-tion is: Johns Hopkins Privacy Officer, telephone: 410-502-7983, e-mail: [email protected].

“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine,as sponsor of this activity, has relayed information with the CME attendees/participants and certifythat the visitor is here for training, education and/or observation purposes only.”

HISTOLOGY MATTERS: Personalized Therapy for Patients with NSCLC

JULY 3, 2011

Johns Hopkins University School of MedicineOffice of Continuing Medical Education720 Rutland Avenue/Turner 20 Reviewed & Approved by: Baltimore, Maryland 21205-2195 General Counsel, Johns HopkinsMedicine (4/1/03)

Faculty

Jyoti D. Patel, MDAssociate Professor

Department of MedicineHematology Oncology Division

Northwestern UniversityFeinberg School of Medicine

Chicago, Illinois

William D. Travis, MDAttending Thoracic Pathologist

Department of PathologyMemorial Sloan Kettering

Cancer CenterNew York, New York

David S. Ettinger, MD (Chair)The Alex Grass Professor

of OncologyJohns Hopkins University

School of MedicineBaltimore, Maryland

Silvia Novello, MD, PhDAssistant Professor

Thoracic Oncology UnitUniversity of TurinSan Luigi Hospital

Turin, Italy

DisclosuresFULL DISCLOSURE POLICY AFFECTING CME ACTIVITIES – As a provider approved by the Accreditation Council forContinuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office ofContinuing Medical Education (OCME) to require signed disclosure of the existence of financial relationships withindustry from any individual in a position to control the content of a CME activity sponsored by OCME. Members ofthe Planning Committee are required to disclose all relationships regardless of their relevance to the content of theactivity. Faculty are required to disclose only those relationships that are relevant to their specific presentation. Thefollowing relationships have been reported for this activity:

SpeakersDavid S. Ettinger, MD, reports serving as a consultant for Biodesix, Boehringer Ingelheim, Daiichi SankyoCompany, Ltd, Eli Lilly and Company, Genentech, Inc, Merck & Co, Inc, Novartis Pharmaceuticals Corporation,Poniard Pharmaceuticals, Prometheus, Inc, Shin Nippon Biomedical Laboratories, Ltd, and Telik, Inc.Jyoti D. Patel, MD, reports serving as an advisor for Genentech, Inc.

No other speakers have indicated that they have any financial interests or relationships with a commercial entitywhose products or services are relevant to the content of their presentation(s).

PlannerDavid S. Ettinger, MD, reports serving as a consultant for Biodesix, Boehringer Ingelheim, Daiichi SankyoCompany, Ltd, Eli Lilly and Company, Genentech, Inc, Merck & Co, Inc, Novartis Pharmaceuticals Corporation,Poniard Pharmaceuticals, Prometheus, Inc, and, Shin Nippon Biomedical Laboratories, Ltd, and Telik, Inc.

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution thatreceives the grant, typically through the Office of Research Administration. Individual investigators who participate inthe sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support fromthe institution to support their effort on the project(s).

OFF-LABEL PRODUCT DISCUSSION – No faculty member has indicated that their presentation will includeinformation on off-label products.

Agenda11:00 – 11:10 AM Introduction and Pre-Assessment

11:10 – 11:25 AM Pathology and Molecular Markers for NonsmallCell Lung Cancer (NSCLC)William D. Travis, MD

11:25 – 11:45 AM First-Line and Targeted Therapy for NSCLCJyoti D. Patel, MD

11:45 AM – 12:00 PM Maintenance and Duration of Therapy for NSCLCSilvia Novello, MD, PhD

12:00 – 12:10 PM Questions and Answers

12:10 – 12:40 PM Tumor Board DiscussionDavid S. Ettinger, MD

12:40 – 12:55 PM Questions and Answers

12:55 – 13:00 PM Final Remarks and Post-Assessment

Learning ObjectivesAfter attending this activity, the participant will demonstrate the ability to:

• DESCRIBE the prognostic and predictive role of histologic featuresand immunohistochemical markers in NSCLC therapy and how geneexpression profiling and mutation analysis may help to customizetherapy for patients with NSCLC. [MK, PC]

• ASSESS current and emerging therapeutic strategies based on tumorbiology that incorporate targeted agents with chemotherapy forpatients with advanced NSCLC. [MK, PC]

• APPLY techniques that improve interprofessional communication tomaintain continuity of care and relay treatment expectations topatients with NSCLC. [MK, PC, IC]

The Johns Hopkins University School of Medicine takes responsibility forthe content, quality, and scientific integrity of this CME activity.

American Board of Medical Specialties/Accreditation Council for GraduateMedical Education General Competency Assignments: IC = interpersonaland communication skills; MK= medical knowledge; PC = patient care.

Accreditation & CreditDesignation Statements

ACCREDITATION STATEMENT – The JohnsHopkins University School of Medicine isaccredited by the Accreditation Council forContinuing Medical Education to providecontinuing medical education for physicians.

CREDIT DESIGNATION STATEMENT – The JohnsHopkins University School of Medicine designatesthis live activity for a maximum of 2.0 AMA PRACategory 1 Credit(s)TM. Physicians should claimonly the credit commensurate with the extent oftheir participation in the activity.

Educational Grant

The Johns Hopkins University School of Medicine

would liketo acknowledge an

educational grant fromLilly USA, LLC.

To follow along with today’spresentation on your iPhone or iPad,

please download the presentationthrough our activity website,

www.jhasim.com/wclc.

Presentation Download

If you did not receive an evaluation formand would like to receive CME credit foryour participation in today’s meeting,please visit http://www.jhasim.com/wclc/to download and complete an evaluationform. Please remit the completed form byfax to 908-253-9002 or e-mail as a .pdfattachment to [email protected].

Evaluation Form