Accreditation/Credit Designation

Physicians’ Education Resource®, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians’ Education Resource®, LLC, designates this enduring material 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.

Acknowledgment of Commercial Support

This activity is supported by educational grants from AstraZeneca and Tesaro, Inc.

Oncology Consultations® in Ovarian Cancer: Differentiating Among Clinical Trial Designs to Match PARP to Patient


Release Date: October 31, 2018
Expiration Date: October 31, 2019
Media: Internet - based

 

Activity Overview

This activity, Oncology Consultations® in Ovarian Cancer: Differentiating Among Clinical Trial Designs to Match PARP to Patient, developed in the Physicians’ Education Resource, LLC, (PER®) established Oncology Consultations® legacy format, focuses on the landscape of clinical trial design and key data guiding the use of PARP inhibitors in ovarian cancer. This presentation features Dr. Susana Campos and Dr. Shannon Westin reviewing the study designs that led to current and emerging indications for the use of PARP inhibitors and discussing ongoing clinical trials in this field. Throughout this activity, they provide their expert viewpoints on the role of PARP inhibitors in ovarian cancer, including placing cutting-edge data into the context of case-based discussion to guide the use of PARP inhibitors for treatment of your patients.

Acknowledgement of Commercial Support

This activity is supported by educational grants from AstraZeneca Pharmaceuticals and Tesaro, Inc.

Instructions for This Activity and Receiving Credit

  • You will need to log in to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “Educational Content/Video Files” will be available for your reference.
  • To receive a CME/CE certificate, participants must complete the activity.
  • Complete the Posttest and pass with a score of 70% or higher, complete the Evaluation, and then click on “Request for Credit.” Participants may immediately download a CME/CE certificate upon completion of these steps.


Target Audience

This activity is directed toward medical oncologists, gynecologic oncologists, radiation oncologists, surgical oncologists, and other health care professionals who manage and treat patients with ovarian cancer.

Educational Objectives

At the conclusion of this activity, you should be better prepared to:

  1. Differentiate among recent clinical trials of PARP inhibitors with respect to trial design and clinical outcomes
  2. Develop strategies to recognize and manage adverse events of PARP inhibitor therapies among patients with ovarian cancer
  3. Utilize knowledge of clinical trial designs, results, and patient-specific characteristics to personalize a treatment plan in the care of patients with ovarian cancer

Faculty, Staff, and Planners' Disclosures

Faculty

Susana Campos
Susana Campos, MD
Assistant Professor of Medicine
Harvard Medical School
Dana Farber Cancer Institute
Boston, MA

Disclosure: Consultant: Clovis

Shannon N. Westin
Shannon N. Westin, MD, MPH, FACOG
Associate Professor
Department of Gynecologic Oncology and Reproductive Medicine
Director, Early Drug Development
The University of Texas MD Anderson Cancer Center
Houston, TX

Disclosure: Grant/Research Support: AstraZeneca, Genentech, Clovis, Tesaro, Bayer, Novartis, Cotinga Pharmaceuticals; Consultant: AstraZeneca, Roche/Genentech, Clovis, Tesaro, Merck, Ovation, Medivation, OncLive, Medscape

The staff of PER® have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest (COI)

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME/CE activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME/CE activity to disclose all relevant financial relationships with commercial interests. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a COI.

Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME/CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME/CE activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician or nurse relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.

PER Pulse™ Recaps

1 of 3

The online continuing education program Oncology Consultations® in Ovarian Cancer: Differentiating Among Clinical Trial Designs to Match PARP to Patient features an engaging discussion on the current and emerging roles of PARP inhibitor therapy in the treatment of ovarian cancer. Susana M. Campos, MD, MPH, and Shannon N. Westin, MD, MPH, FACOG, reviewed the landscape of treatment options and covered key emerging data regarding the use of PARP inhibitors for ovarian cancer, exchanged perspectives on the challenges in treatment, and reviewed clinical decision making in the context of patient cases.

This first of 3 PER Pulse™ Recaps from this Oncology Consultations® program focuses on expert perspectives on integrating PARP inhibitor therapy into the plan of care. Below are some key points of discussion from the program.

  • Ovarian cancer is the most deadly gynecological malignancy, and unlike screening options for many other malignancies, an effective method to screen patients for ovarian cancer has yet to be identified; 59% of patients receive a diagnosis of advanced-stage disease.
  • Although many patients may have a complete response to initial lines of therapy, the majority of them are likely to relapse.
  • Patients should be screened for germline mutations up front, and testing for somatic mutations is important to guide clinical decision making and patient counseling regarding the options available to them.
  • Brain metastases can and do occur in ovarian cancer and may be seen more frequently with patients living longer.
  • Dr Campos and Dr Westin agreed that gastrointestinal disorders and fatigue are among the most difficult adverse events to manage and for patients to tolerate when using PARP inhibitors.
  • PARP inhibitors are an important addition to the available treatment options for patients with ovarian cancer, and benefits were seen in the maintenance setting for patients with or without BRCA mutations.

2 of 3

The online continuing medical education program Oncology Consultations® in Ovarian Cancer: Differentiating Among Clinical Trial Designs to Match PARP to Patient features an engaging discussion on the current and emerging roles of PARP inhibitor therapy in the treatment of ovarian cancer. Susana M. Campos, MD, MPH, and Shannon N. Westin, MD, MPH, FACOG, reviewed the landscape of treatment options and covered key emerging data regarding the use of PARP inhibitors for ovarian cancer, exchanged perspectives on the challenges in treatment, and reviewed clinical decision making in the context of patient cases.

This second of 3 PER Pulse™ Recaps from this Oncology Consultations® program focuses on the landmark clinical trials that have supported the role of PARP inhibitors in treating ovarian cancer, as well as on future directions and ongoing clinical trials.

Dr Westin said that although opinions differ on when to incorporate PARP inhibitors into therapy, she will consider it for maintenance therapy in patients regardless of germline or somatic mutation status. The landmark trials for the currently available PARP inhibitors for the treatment of ovarian cancer included similar patient populations, those who had relapsed ovarian cancer that was in response to the most recent line of platinum-based chemotherapy.

In the ENGOT-OV16/NOVA trial, niraparib was compared with placebo. Patients were enrolled with (n = 201) or without (n = 345) germline BRCA mutations, and treatment was given in 28-day cycles until progression or intolerable toxicity. At a median duration of follow-up of 16.9 months, niraparib significantly extended median progression free survival (mPFS) to 21.0 months compared with 5.5 months with placebo in the patients with BRCA mutations. The mPFS was also extended in the group without BRCA mutations to 9.3 months with niraparib compared with 3.9 months with placebo.1

Olaparib was compared with placebo in the SOLO-2 and Study 19 trials. SOLO-2 enrolled only patients with a known BRCA mutation or suspected deleterious mutations, and olaparib improved the mPFS to 19.1 months compared with 5.5 months with placebo. In the Study 19 trial, which enrolled patients with or without BRCA mutations, olaparib improved mPFS in the overall population to 8.4 months compared with 4.8 months with placebo.2,3

The ARIEL3 trial included patients with or without BRCA mutations and compared rucaparib with placebo. Rucaparib improved mPFS in both the intention-to-treat population (10.8 months) and the group with BRCA mutations (16.6 months) compared with placebo (5.5 months in both groups).4

Many ongoing major trials are examining additional roles for PARP inhibitor therapy in ovarian cancer treatment, including combination therapy in multiple settings and the role of PARP inhibitors in earlier lines of therapy. Additionally, Dr Westin said an exciting area of upcoming research will be efforts to overcome PARP inhibitor resistance, which is seen in both maintenance therapy and in earlier lines of treatment.

References

  1. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. doi: 10.1056/NEJMoa1611310.
  2. Pujade-Lauraine E, Ledermann JA, Selle F, et al; SOLO2/ENGOT-Ov21 Investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial [erratum in Lancet Oncol. 2017;18(9):e510. doi: 10.1016/S1470-2045(17)30639-3]. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2.
  3. Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012;366(15):1382-1392. doi: 10.1056/NEJMoa1105535.
  4. Coleman RL, Oza AM, Lorusso D, et al; ARIEL3 Investigators. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial [erratum in Lancet. 2017;390(10106):1948. doi: 10.1016/S0140-6736(17)32702-2]. Lancet. 2017;390(10106):1949-1961. doi: 10.1016/S0140-6736(17)32440-6.

3 of 3

The online continuing medical education program Oncology Consultations® in Ovarian Cancer: Differentiating Among Clinical Trial Designs to Match PARP to Patient features an engaging discussion on the current and emerging roles of PARP inhibitor therapy in the treatment of ovarian cancer. Susana M. Campos, MD, MPH, and Shannon N. Westin, MD, MPH, FACOG, reviewed the landscape of treatment options and covered key emerging data regarding the use of PARP inhibitors for ovarian cancer, exchanged perspectives on the challenges in treatment, and reviewed clinical decision making in the context of patient cases.

This third of 3 PER Pulse™ Recaps from this Oncology Consultations® program focuses on clinical decision making, taking into account individual patient factors and the adverse event (AE) profiles of PARP inhibitors to identify an appropriate treatment option.

Anemia, neutropenia, fatigue, and thrombocytopenia were among the most common AEs in trials of olaparib, niraparib, and rucaparib. Dr Campos and Dr Westin pointed out that it is important to optimize supportive care for AEs during treatment with PARP inhibitors to avoid stopping treatment when possible, such as the use of transfusions for anemia. The goal is to keep patients on treatment long enough to have the opportunity to assess efficacy.

Thrombocytopenia is of particular importance and occurred commonly in clinical trials with niraparib but was less frequent with olaparib and rucaparib. However, creatinine increases occurred commonly with olaparib and rucaparib but not with niraparib. Finally, the differing metabolic processing of these PARP inhibitors is another key consideration; olaparib and rucaparib are both processed by several cytochrome enzymes for which metabolism of other drugs could have consequences on efficacy and safety, whereas niraparib did not have significant interactions with these enzymes.1-4

References

  1. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. doi: 10.1056/NEJMoa1611310.
  2. Pujade-Lauraine E, Ledermann JA, Selle F, et al; SOLO2/ENGOT-Ov21 Investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial [erratum in Lancet Oncol. 2017;18(9):e510. doi: 10.1016/S1470-2045(17)30639-3]. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2.
  3. Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012;366(15):1382-1392. doi: 10.1056/NEJMoa1105535.
  4. Coleman RL, Oza AM, Lorusso D, et al; ARIEL3 Investigators. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial [erratum in Lancet. 2017;390(10106):1948. doi: 10.1016/S0140-6736(17)32702-2]. Lancet. 2017;390(10106):1949-1961. doi: 10.1016/S0140-6736(17)32440-6.

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