Monday, March 26, 2018, New Orleans, LA, 12:45 PM – 2:15 PM

Cases from the Community: Clinical Investigators Provide Their Perspectives on Emerging Research and Actual Patients with Ovarian Cancer

An Independent CME Satellite Symposium During the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer

Location:
Hyatt Regency New Orleans
601 Loyola Avenue
New Orleans, LA 70113
Phone: (504) 613-3933

Event Time (Central Time):
12:15 PM – 12:45 PM — Registration and Lunch Buffet
12:45 PM – 2:15 PM — Educational Meeting

Meeting Room:
Empire Ballroom A (Level 2)

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

Faculty:
Don S Dizon, MD
Director, Women's Cancers
Lifespan Cancer Institute
Director, Medical Oncology
Rhode Island Hospital
Associate Professor of Medicine
Alpert Medical School of Brown University
Providence, Rhode Island

Lainie P Martin, MD
Chief, Gynecologic Medical Oncology
Assistant Professor, Department of Hematology/Oncology
Fox Chase Cancer Center
Philadelphia, Pennsylvania


Bradley J Monk, MD
Professor
Division of Gynecologic Oncology
Arizona Oncology (US Oncology Network)
University of Arizona College of
Medicine - Phoenix
Creighton University School of Medicine at
St Joseph’s Hospital
Phoenix, Arizona

Angeles Alvarez Secord, MD, MHSc
Professor
Department of Obstetrics and Gynecology
Division of Gynecologic Oncology
Duke Cancer Institute
Durham, North Carolina

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



MODULE 1: Local and Systemic Therapeutic Considerations for Patients with Newly Diagnosed Advanced Ovarian Cancer (OC) — Dr Secord

Sample Community Oncologist Case Presentation

A 61-year-old woman presents with lower abdominal pain and a 20-lb weight loss over the past 4 months. On physical examination, the patient appears ill and is noted to have moderate ascites. Laboratory results reveal a CA-125 of 1,200 U/mL, and imaging studies identify a 12-cm mass in the left ovary with multiple peritoneal nodules (up to 2 cm) and significant para-aortic adenopathy. Cytology from paracentesis on the ascites demonstrates malignant cells consistent with serous adenocarcinoma.

Sample Case Discussion Questions
  • Given the patient’s condition and clinical presentation, would you recommend she consider neoadjuvant systemic therapy (NST) prior to surgery?
  • If you were going to use NST in this case, what regimen and administration method (intraperitoneal or intravenous) would you recommend?
  • What is known about the use of weekly versus every 3-week paclitaxel in this setting? What has been observed in clinical trials to date with the use of bevacizumab as a component of NST, and can you describe a situation in which you might consider this approach?
  • If this patient declined NST and underwent debulking surgery but had residual gross disease, what would you be thinking in terms of adjuvant therapy? How, if at all, would your decision-making change if she had microscopic disease?
  • Reimbursement and regulatory issues aside, are there situations in which you consider the use of bevacizumab as a component of up-front therapy for patients after primary debulking surgery? If so, what dose and schedule would you use, and how long would you administer it?
Faculty Presentation Topics
  • Phase III data comparing the safety and efficacy of NST versus up-front debulking surgery followed by adjuvant chemotherapy; patient selection for NST
  • Lingering controversies regarding the optimal dose, schedule and delivery of adjuvant chemotherapy in OC
  • Available research data with and current clinical role of bevacizumab as a component of up-front therapy for patients with newly diagnosed OC; impact of relapse risk on this decision

MODULE 2: Evolving Treatment Paradigms for Patients with Platinum-Sensitive Recurrent OC — Dr Monk

Sample Community Oncologist Case Presentation

A 66-year-old woman diagnosed with a Stage IIC ovarian adenocarcinoma undergoes debulking surgery followed by 6 cycles of IV carboplatin/paclitaxel. Genetic testing reveals wild-type BRCA and no other genomic alterations. Eighteen months later the patient experiences a significant rise in her CA-125 levels, and subsequent imaging reveals disease progression in the pelvis. The patient is started on carboplatin/gemcitabine/bevacizumab and achieves a complete response by CA-125 and imaging studies.

Sample Case Discussion Questions
  • Given that the patient relapsed 18 months after adjuvant carboplatin/paclitaxel, do you agree with the consulting physician’s use of carboplatin/gemcitabine, or would you have recommended some other cytotoxic backbone?
  • Do you agree that a patient such as this one should have bevacizumab included as a component of her therapy at first relapse?
  • What would you recommend in terms of maintenance therapy, if any, for this woman? How might your approach change based on her initial response to the carboplatin/gemcitabine/bevacizumab? Would you consider a PARP inhibitor as maintenance therapy for this woman? What if she had a germline BRCA mutation?
  • If you were going to offer this patient maintenance bevacizumab, based on your clinical experience, what is the likelihood she will have to stop it at some point because of toxicity?
  • If this patient maintains her platinum sensitivity, how might you approach treatment at second relapse? Would you consider maintenance therapy in this setting?
Faculty Presentation Topics
  • Research database supporting the FDA approval of bevacizumab in combination with chemotherapy followed by maintenance bevacizumab for patients with platinum-sensitive recurrent OC
  • Clinical and biologic factors affecting the choice of therapy at first relapse; influence of comorbidities, residual side effects and patient preferences
  • Effect of chemotherapy regimen, response to treatment and mutation status on the selection and use of maintenance therapy

MODULE 3: Patient- and Disease-Specific Considerations in the Management of Platinum-Resistant Recurrent OC — Dr Dizon

Sample Community Oncologist Case Presentation

A 56-year-old woman diagnosed with Stage IIIC ovarian adenocarcinoma undergoes debulking surgery followed by 6 cycles of IV carboplatin/paclitaxel. Genetic counseling reveals a germline mutation in BRCA1. Eighteen months later the patient’s CA-125 rises dramatically, and imaging reveals disease in the pelvis, which is biopsy proven to be recurrent adenocarcinoma. The patient is started on carboplatin/pegylated liposomal doxorubicin (PLD) and achieves a partial response. She is subsequently placed on niraparib maintenance but approximately 3 months into treatment presents with symptomatic ascites and pleural effusions. Paracentesis and thoracentesis reveal malignant cells consistent with her original diagnosis.

Sample Case Discussion Questions
  • When using PLD in OC, what dose and schedule do you generally employ? What is the maximum dose, if any, you would recommend?
  • What would you recommend for this patient at this point? Are there any data regarding the activity of bevacizumab in patients for whom prior PARP inhibitor therapy has failed, either in the maintenance or later-line setting?
  • What is the biologic rationale for why ascites and pleural effusion secondary to OC are responsive to bevacizumab?
  • If this patient had experienced recurrent disease 5 months after initial treatment with carboplatin/paclitaxel, would this have led you to believe that she was resistant to both carboplatin and paclitaxel? What data are available to help answer this question?
  • Do you believe there is something distinct about the biology of rapidly progressive disease, and how would you have proceeded had that been the case?
Faculty Presentation Topics
  • Mechanisms and determinants of platinum resistance
  • Available Phase III evidence with and practical use of bevacizumab alone or in combination with chemotherapy in the setting of platinum-resistant recurrent OC
  • Management of ascites and impact on quality of life in patients with abdominal symptoms treated with bevacizumab
  • Current nonprotocol role of other approved and commercially available anticancer therapies in the setting of platinum-resistant disease

MODULE 4: Novel Investigational Agents in Development for Patients with OC — Dr Martin

Sample Community Oncologist Case Presentation

A 61-year-old woman diagnosed with BRCA1/2 mutation-negative, Stage IIIC OC receives 6 cycles of adjuvant carboplatin/paclitaxel. One year later her CA-125 starts to rise, and imaging reveals recurrent peritoneal disease. She then receives carboplatin/gemcitabine/bevacizumab, achieves a partial response and is placed on maintenance bevacizumab. Five months into her maintenance bevacizumab her disease recurs with a rising CA-125 and mild abdominal pain. The patient wants to be as aggressive as possible with treatment and is interested in experimental approaches.

Sample Case Discussion Questions
  • What is the incidence of folate receptor alpha positivity in patients with OC, and how is it measured?
  • Have you seen objective responses in patients with refractory OC treated with mirvetuximab soravtansine? Do you believe this agent will eventually enter the OC treatment armamentarium?
  • How frequently are toxicities observed with mirvetuximab soravtansine, and how problematic are they for the patient and clinician to manage?
  • What is known about the efficacy and safety of immune checkpoint inhibitors in patients with OC?
  • What is the frequency of mismatch repair deficiency in patients with OC, and do you conduct microsatellite instability (MSI) testing for these individuals? Have responses to anti-PD-1/PD-L1 antibodies been observed in patients with and without MSI-high disease?
  • Do you believe anti-PD-1/PD-L1 antibodies may be more effective in combination with other systemic therapies? Which ones and why?
Faculty Presentation Topics
  • Mechanism of action of mirvetuximab soravtansine and biologic rationale for targeting the folate receptor in ovarian and other gynecologic cancers
  • Available safety and efficacy data with and active Phase III trials of mirvetuximab soravtansine for patients with OC
  • Biologic rationale for, available data with and ongoing evaluation of anti-PD-1/PD-L1 antibodies alone or in combination with other therapies for patients with OC
  • Other targeted agents (WEE1 kinase inhibitors, CDK4/6 inhibitors, et cetera) under investigation in OC

Target Audience:
This activity is intended for gynecologic oncologists, medical oncologists, gynecologists and other healthcare providers involved in the treatment of gynecologic cancers.

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

  • Review available efficacy and safety data with the use of neoadjuvant chemotherapy followed by surgical cytoreduction for patients with Stage IIIC or IV ovarian cancer (OC), and identify patients who may be suitable for this approach.
  • Summarize existing research data and ongoing clinical trials documenting the risks and benefits of angiogenesis inhibition in the management of newly diagnosed advanced OC, and identify individuals who may benefit from this treatment strategy.
  • Develop a treatment algorithm for the management of progressive epithelial OC, considering the response to prior therapy, genomic profile, goals of treatment and the relative efficacy and safety of evidence-based therapeutic strategies.
  • Recognize the toxicities associated with therapeutic agents and regimens commonly used in the care of patients with OC, and offer supportive management strategies to minimize and/or ameliorate these side effects.
  • Develop an understanding of the mechanisms of action, available data and potential clinical roles of compounds under investigation for patients with advanced OC in preparation for their potential introduction into clinical practice.

CME Credit Form:
A credit form will be given to each participant at the conclusion of this 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 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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 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 activity is supported by educational grants from Genentech BioOncology, ImmunoGen Inc and Merck.

Hyatt Regency New Orleans
601 Loyola Avenue
New Orleans, LA 70113
Phone: (504) 613-3933

Meeting Room:
Empire Ballroom A (Level 2)

Directions:
The Hyatt Regency New Orleans hotel is the main venue for the SGO Annual Meeting on Women's Cancer.

 
Thank you for your interest in our educational program. At this time online registration is closed. However, seats are still available for the meeting.

If you are interested in attending, please visit our onsite registration desk located outside the Empire Ballroom A (Level 2) of the Hyatt Regency New Orleans (601 Loyola Avenue). Our onsite registration desk will be open starting at 11:00 AM on Monday, March 26, 2018.

We will accept new registrations on a first come, first served basis. Please note, onsite registration does not guarantee participation in the session or meal service, and seating will be prioritized for clinicians in practice.

If you have any questions, please feel free to contact us via email at Meetings@ResearchToPractice.com or call (800) 233-6153.

NOTICE:
Registration for this event is independent of registration for the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer.