Tuesday, December 5, 2017, San Antonio, Texas, 8:00 PM – 9:45 PM (Central Time)

Data + Perspectives: Clinical Investigators Explore the Emerging Role of PARP Inhibition in the Management of Breast Cancer

Location:
San Antonio Marriott Rivercenter
101 Bowie Street
San Antonio, TX 78205
Hotel Phone: (210) 223-1000

Time:
8:00 PM – 9:45 PM (Central Time) — Educational Dinner Meeting

Meeting Room:
Grand Ballroom (3rd Floor)

There is no registration fee for this event. However, preregistration is advised, as seating is limited.

Faculty:
Susan M Domchek, MD
Director, MacDonald Women’s Cancer
Risk Evaluation Center
Executive Director, Basser Center for BRCA
Basser Professor in Oncology
Perelman School of Medicine
University of Pennsylvania
Philadelphia, Pennsylvania

Karen A Gelmon, MD
Professor, Medicine
Head, Division of Medical Oncology
University of British Columbia
Medical Oncologist, BC Cancer Agency
Vancouver Cancer Centre
Vancouver, Canada

Mark Robson, MD
Clinic Director, Clinical Genetics Service
Associate Attending Physician
Clinical Genetics and Breast Cancer Medicine
Associate Member
Memorial Sloan Kettering Cancer Center
Associate Professor of Medicine
Weill Medical College of Cornell University
New York, New York

Hope S Rugo, MD
Professor of Medicine
Director
Breast Oncology and Clinical Trials Education
University of California, San Francisco
Helen Diller Family
Comprehensive Cancer Center
San Francisco, California

Moderator:
Neil Love, MD
Research To Practice
Miami, Florida



MODULE 1: Biologic Rationale for PARP Inhibition; Indications for BRCA and Multigene Panel Testing in Patients with Breast Cancer — Dr Domchek

Faculty Presentation Topics

  • BRCA pathway deficiencies and implications for cancer pathogenesis
  • Incidence of BRCA1/2 alterations and other relevant genetic abnormalities in patients with and without a family history of breast cancer
  • Available guidelines and/or consensus statements regarding the current indications for BRCA analysis in breast cancer
  • Similarities, differences and optimal use of available BRCA testing platforms
  • Identification of other genomic signatures (eg, homologous recombination deficiency) that may predict benefit from PARP inhibition 

Discussion Questions

  • Given the recent announcement of the positive OlympiAD trial, how might guideline recommendations regarding genetic assessment change in the future if olaparib were to become accessible to individuals with germline BRCA-mutant metastatic breast cancer?
  • What is known about the frequency of somatic BRCA mutations in patients with metastatic breast cancer? Are individuals found to harbor these abnormalities more or less sensitive to PARP inhibition?
  • What do we know about the activity of PARP inhibitors among patients without BRCA germline mutations? 

MODULE 2: Available Research with and Potential Clinical Role of Olaparib in Metastatic Breast Cancer — Dr Robson

Faculty Presentation Topics

  • Design, entry criteria and patient enrollment in the Phase III OlympiAD trial
  • Progression-free survival advantage associated with olaparib versus chemotherapy in OlympiAD; results of other secondary endpoints (eg, overall survival, objective response rates)
  • Impact, if any, of hormone receptor status, prior platinum exposure and number of lines of prior chemotherapy on the activity of olaparib
  • Dose and schedule of olaparib in breast cancer compared to ovarian cancer
  • Ongoing evaluation of adjuvant olaparib in patients with high-risk HER2-negative breast cancer and a germline BRCA1/2 mutation

Discussion Questions

  • Given the progression-free survival benefit observed with the use of olaparib versus chemotherapy in OlympiAD, do you believe this agent warrants FDA approval? If so, at what point in time would you like to be able to access it (first line, second line, et cetera) for your patients with germline BRCA-mutant disease?
  • How frequently are BRCA mutations observed in patients with ER-positive breast cancer? Did olaparib behave differently in these types of patients versus those with triple-negative disease in OlympiAD? Would you consider using a PARP inhibitor in a patient with HER2-positive disease?
  • If olaparib were approved, how should it be sequenced relative to platinum-based chemotherapy? What about relative to endocrine therapy in those with ER-positive disease? 

MODULE 3: Clinical Database with and Ongoing Evaluation of Other PARP Inhibitors in Breast Cancer — Dr Rugo

Faculty Presentation Topics

  • Efficacy and tolerability data with other PARP inhibitors under investigation in breast cancer: talazoparib, veliparib, niraparib, rucaparib, et cetera
  • Recent results from the Phase II ABRAZO trial evaluating talazoparib in patients with advanced breast cancer and a germline BRCA1/2 mutation
  • I-SPY 2: Contribution of veliparib to standard neoadjuvant chemotherapy for triple-negative breast cancer; impact of DNA repair deficiency signatures on response rates
  • Design, eligibility criteria and estimated completion dates of ongoing and planned Phase III trials evaluating PARP inhibitors in BRCA-deficient metastatic breast cancer
  • Available data with and ongoing evaluation of novel combination strategies with PARP inhibitors and other systemic approaches (eg, chemotherapy, immune checkpoint inhibitors) 
  • Emerging early data from the TOPACIO trial evaluating niraparib in combination with pembrolizumab in patients with triple-negative breast cancer or ovarian cancer

Discussion Questions

  • Do you believe there are any biologic differences among the various PARP inhibitors under investigation?
  • What early activity and safety data have been published evaluating other commercially available (niraparib, rucaparib) and investigational (eg, talazoparib, veliparib) PARP inhibitors in patients with metastatic breast cancer with and without BRCA mutations? Did any of the findings from these evaluations stand out from an activity or tolerability standpoint?
  • Given that the FDA approvals of niraparib and olaparib for ovarian cancer extend to patients with and without BRCA mutations, is this approach being evaluated in breast cancer? Is there any reason to believe PARP inhibitors would or would not work in patients with BRCA wild-type breast cancer?
  • From a biologic standpoint, are there specific classes of therapy (eg, chemotherapy, anti-VEGF therapy, immunotherapy) that may exhibit greater synergy with PARP inhibition than others?

MODULE 4: Prevention, Recognition and Management of Toxicities Associated with PARP Inhibitors in Breast Cancer — Dr Gelmon

Faculty Presentation Topics

  • Comparative incidence of side effects (eg, anemia, gastrointestinal [GI] toxicities, pneumonitis) and adverse events associated with the use of olaparib in breast versus ovarian cancer
  • Available adverse event data from published studies of PARP inhibitors in breast cancer, including the OlympiAD trial
  • Recognition and optimal management of PARP inhibitor-related side effects in ovarian cancer; dose reduction and discontinuation strategies and potential application to breast cancer clinical practice
  • Incidence of myelodysplastic syndromes/acute myeloid leukemia in patients receiving PARP inhibitors for ovarian versus breast cancer

Discussion Questions

  • What strategies are available to prevent and/or ameliorate the GI toxicities (eg, nausea, dyspepsia, diarrhea) associated with olaparib? How do you typically employ dose reductions and/or delays in patients experiencing significant GI toxicity?
  • What is the incidence of anemia in patients receiving olaparib? How should patients receiving the drug be monitored for this side effect? What interventions can be offered to patients to mitigate this toxicity? What about pneumonitis?
  • How do the side effects documented with olaparib in ovarian and breast cancer trials compare to those that have been seen in clinical trials of other PARP inhibitors?

Target Audience:
This activity is intended for medical oncologists, breast cancer surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

Learning Objectives:
Upon conclusion of this activity, participants should be able to:

  • Recall available guideline recommendations regarding the indications for BRCA mutation testing for patients diagnosed with breast cancer (BC), and use the results of this analysis to inform protocol and nonprotocol treatment decision-making.
  • Understand the biologic rationale for the investigation of PARP inhibition as monotherapy or in combination with other systemic approaches for patients with BC, and use this insight to prioritize clinical trial opportunities for appropriate individuals eligible for participation.
  • Recall emerging Phase III efficacy data with the use of PARP inhibition in patients with metastatic BC harboring a BRCA1/2 mutation, and consider the potential diagnostic and therapeutic implications of these findings on future clinical care.
  • Educate patients regarding the side effects associated with the use of PARP inhibitors, and develop preventive and emergent strategies to reduce or ameliorate these toxicities.
  • Describe mechanisms of acquired tumor resistance to PARP inhibitors, and identify investigational therapeutic opportunities to circumvent this process.

CME Credit Form:
A CME credit form will be given to each participant at the conclusion of the activity.

Accreditation Statement:
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement:
Research To Practice designates this live activity for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC):
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.75 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

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Disclosure Policy:
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME/CNE activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Financial disclosures will be provided in meeting course materials.

Supporters:
This live activity is supported by educational grants from AbbVie Inc, AstraZeneca Pharmaceuticals LP, Myriad Genetic Laboratories Inc, Pfizer Inc and Tesaro Inc.

San Antonio Marriott Rivercenter
101 Bowie Street
San Antonio, TX 78205
Hotel Phone: (210) 223-1000

Meeting Room:
Grand Ballroom (3rd Floor)

Directions:
The Marriott Rivercenter hotel is conveniently located within walking distance (1.5 blocks) of the Henry B Gonzalez Convention Center.

 

This activity is intended for medical oncologists, breast cancer surgeons, radiation oncologists and other healthcare professionals involved in the diagnosis and treatment of breast cancer.

There is no registration fee for this event. However, preregistration is advised, as seating is limited.

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I am a practicing physician, fellow or other healthcare provider involved in the treatment of cancer.

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