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Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education 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.

Physicians' Education Resource®, LLC, is approved by the California Board of Registered Nursing, Provider #16669, for 1.5 Contact Hours.

Acknowledgement of Commercial Support

This activity is supported by an educational grant from AstraZeneca.

Community Practice Connections: Nursing Opportunities to Improve Outcomes with the Advent of PARP Inhibitors in the Care of Women's Cancers


Release Date: June 29, 2018
Expiration Date: June 29, 2019
Media: Internet - based
 

Activity Overview

The advent of PARP inhibitor therapy is transforming the treatment landscape for your patients with breast and ovarian cancers. Because of the frequent and unique opportunities that you have to improve clinical outcomes for your patients, we have developed an engaging multimedia educational activity to enhance your understanding of the effectiveness of these new strategies, methods to mitigate and manage predictable and distinct adverse events, and the importance of counseling your patients concerning the use of these novel approaches, which are very different from traditional oncology agents in several aspects, including the way that they work and the efficacy and safety profiles that they carry.

This activity, featuring video commentary from a multidisciplinary panel of clinical experts, will present best practices that you can utilize in the treatment, management, and overall care of patients with breast and ovarian cancers who may be candidates for PARP inhibitor therapy. The latest clinical evidence will be discussed, as well as practical considerations to help you optimize patient management.

Acknowledgment of Commercial Support

This activity is supported by an educational grant from AstraZeneca.


Instructions for This Activity and Receiving Credit

  • You will need to login 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.
  • In order 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 educational program is directed toward all attendees of the ONS 43rd Annual Congress, including nurses and other healthcare professionals with an interest in the treatment of patients with breast and ovarian cancers.

Learning Objectives

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

  1. Outline the underlying mechanisms by which PARP inhibitors exert their activity in the treatment of cancer
  2. Delineate key concepts and findings from pivotal trials that have evaluated PARP inhibitors for the treatment of ovarian and breast cancers
  3. Practically apply knowledge of PARP inhibitor strategies to real-world clinical scenarios in which nurses counsel patients with ovarian and breast cancers
  4. Develop processes to proactively mitigate the impact of adverse events in the treatment of ovarian and breast cancers

Co-Chairs

Lorraine Lopez, RN, BSN
Nurse Manager
Arizona Oncology – Biltmore Cancer Center
Division of Gynecology Oncology
Phoenix, AZ
 

Disclosures: No relevant financial relationships with commercial interests to disclose.

Bradley J. Monk, MD, FACS, FACOG
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, AZ

Disclosure: Consultant: Abbvie, Advaxis, Amgen, AstraZeneca, Biodesix, Clovis, Genmab, Gradalis, ImmunoGen, Incyte, Insys, Mateon, Merck, Myriad, Perthera, Pfizer, Precision Oncology, Roche/Genentech, Tesaro Inc, VBL Therapeutics; Speakers Bureau: AstraZeneca, Clovis, Janssen/ Johnson & Johnson, Roche/Genentech, Tesaro Inc.

Faculty

Jennifer K. Litton, MD
Associate Professor
Department of Breast Medical Oncology
The University of Texas MD Anderson Cancer Center
Houston, TX
 

Disclosure: Grant Research Support: AstraZeneca, Pfizer, EMD Serono, GlaxoSmithKline, Genentech; Consultant: AstraZeneca, Pfizer

Jill Schwartz-Gomez, RN, CCRP
Senior Research Nurse
Department of Breast Medical Oncology
The University of Texas MD Anderson Cancer Center
Houston, TX

Disclosures: No relevant financial relationships with commercial interests to disclose.

The staff of Physicians' Education Resource®, LLC 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 Recap™

PER Pulse Recap (1 of 3)

Optimizing PARP Inhibitor Efficacy in Ovarian and Breast Cancer—Updates for Nurses

PARP inhibitors are a new class of therapy that provides additional options for the treatment of recurrent ovarian cancer, as well as maintenance therapy for patients who achieve a complete (CR) or partial response (PR) after platinum-based chemotherapy. Olaparib has been approved as treatment for patients with germline BRCA-mutated metastatic ovarian cancer who have received ≥3 prior chemotherapy regimens, as well as maintenance therapy for patients with ovarian cancer who have achieved a CR or PR after platinum-based chemotherapy.1 Rucaparib has been approved as treatment for patients with germline or somatic BRCA-mutated metastatic ovarian cancer who have received ≥2 prior chemotherapy regimens, as well as maintenance therapy for patients who have responded to platinum-based chemotherapy.2 Niraparib is approved for maintenance treatment for patients with recurrent ovarian cancer who have had a CR or PR to platinum-based chemotherapy.3

Combination approaches involving the use of PARP inhibitors for the treatment of patients with ovarian cancer are also being investigated. Several different options combining PARP inhibitors with immunotherapy are actively being studied, as are combinations with bevacizumab.

Several PARP inhibitors have been assessed in phase III studies for the treatment of patients with breast cancer. The OlympiAD study4 compared the safety and efficacy of olaparib 300 mg twice daily with a chemotherapy treatment of physician’s choice (capecitabine, eribulin, or vinorelbine) in the treatment of patients with HER2-negative, germline BRCA-mutated, metastatic breast cancer (MBC). The primary endpoint of this study was progression-free survival (PFS), with secondary endpoints including time to second progression or death, overall survival, objective response rate, safety and tolerability, and patient quality of life. The study met its primary endpoint of PFS, leading to the approval of olaparib for patients with HER2-negative, germline BRCA-mutated MBC who have received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.5

The phase III EMBRACA study6 employed a similar trial design for the PARP inhibitor talazoparib, comparing the safety and efficacy of this option with those of physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in the treatment of patients with locally advanced or metastatic, HER2-negative breast cancer and a germline BRCA1 or BRCA2 mutation. This study also met its primary endpoint of PFS, and talazoparib is currently being assessed by the FDA for potential approval. PARP inhibitors have demonstrated efficacy in the treatment of patients with HER2-negative, germline BRCA-mutated MBC, and several ongoing studies are attempting to answer clinical questions regarding the role of PARP inhibitors in other patient populations with breast cancer.
  • The era of targeted therapy for patients with ovarian cancer and breast cancer has arrived, with the approval of PARP inhibitors.
  • For further exploration of intriguing developments in PARP inhibitor therapy for women’s cancers and expert clinical faculty commentary, please go to gotoper.com/online-cme-activities/cpc/community-practice-connections-nursing-opportunities-to-improve-outcomes-with-the-advent-of-parp-inhibitors-in-the-care-of-womens-cancers.
References

1. Olaparib [prescribing information]. Wilmington, DE: AstraZeneca; 2018. azpicentral.com/lynparza_tb/pi_lynparza_tb.pdf. Accessed June 6, 2018.
2. Rucaparib [prescribing information]. Boulder, CO: Clovis Oncology, Inc.; 2018. clovisoncology.com/files/rubraca-prescribing-info.pdf. Accessed June 6, 2018.
3. Niraparib [prescribing information]. Waltham, MA: TESARO, Inc.; 2018. zejula.com/application/files/1715/2156/1557/prescribing_information.pdf. Accessed June 6, 2018.
4. Robson M, Im SA, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533. doi: 10.1056/NEJMoa1706450.
5. FDA approves olaparib for germline BRCA-mutated metastatic breast cancer. US Food and Drug Administration website. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm592357.htm. Updated January 12, 2018. Accessed June 1, 2018.
6. Litton JK, Rugo HS, Ettl J, et al. A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced breast cancer and a germline BRCA-mutation. Presented at: 2017 San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX. Abstract GS6-07.


PER Pulse Recap (2 of 3)

Opportunities for Nursing to Improve Outcomes in Breast and Ovarian Cancers

With the advent of PARP inhibitors, there are opportunities to improve outcomes for patients with breast cancer and ovarian cancer. Regarding the treatment of breast cancer, data from phase III studies have shown that the use of PARP inhibition contributes to a statistically significant delay in the time to deterioration of patient quality of life (QoL). In the OlympiAD study,1 the median time to global health-related QoL (HRQoL) was 15.3 months for patients treated with treatment of physician’s choice, and this value was not reached in patients treated with olaparib. Furthermore, HRQoL was better maintained with olaparib compared with treatment of physician’s choice, as the mean change from baseline in global HRQoL score across all visits was 3.9 versus –3.6, a difference of 7.5 (95% CI, 2.48-12.44; P = .0035). Similar results were shown with the EMBRACA study2; the median time to clinically meaningful deterioration in EORTC QLQ-C30 QoL scores for patients treated with treatment of physician’s choice was 6.3 months compared with 24.3 months for patients treated with talazoparib. The mean change from baseline in global health status/QoL for patients treated with talazoparib was 3.0 compared with –5.4 for patients who received treatment of physician’s choice (P <.0001). 

Multidisciplinary teams can be very effective in alleviating the distress associated with both disease- and treatment-related symptoms.3 A variety of self-report screening instruments can be used to help identify elements of distress in patients with cancer.3 Multidisciplinary teams may also help to address barriers to enrollment in clinical trials involving PARP inhibitors, such as insufficient educational resources, language, complexity of informed consent, limited advocacy/navigation support, and a bias against enrollment in clinical trials for ovarian cancer that has been recently diagnosed.3 Even when patients with advanced epithelial ovarian cancer are presenting for first-line chemotherapy, the potential for significant improvement with clinical trials exists. A recent retrospective review of patients with a diagnosis of stage II to stage IV epithelial ovarian cancer and presenting for first-line chemotherapy was conducted to identify barriers to enrollment in clinical trials.4 While two-thirds of patients were enrolled in a clinical trial, 33% were not. Patients enrolled in clinical trials were significantly younger than patients who did not enroll (median, 61 vs 68 years; P = .002). Performance status, clinical stage, and race were similar between enrolled and nonenrolled groups.4
  • Clinical studies of patients with breast cancer have demonstrated the potential for treatment with PARP inhibition to improve patient quality of life relative to chemotherapy.
  • Multidisciplinary teams can help to alleviate distress associated with breast and ovarian cancers, as well as overcome barriers to enrollment in clinical trials.
  • For further exploration of intriguing developments in PARP inhibitor therapy for women’s cancers and expert clinical faculty commentary, please go to gotoper.com/online-cme-activities/cpc/community-practice-connections-nursing-opportunities-to-improve-outcomes-with-the-advent-of-parp-inhibitors-in-the-care-of-womens-cancers.
References

1. Robson M, Ruddy KJ, Im SA, et al. OlympiAD: health-related quality of life (HRQoL) in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice. Ann Oncol. 2017;28(suppl 5). doi: 10.1093/annonc/mdx365.053.
2. Litton JK, Rugo HS, Ettl J, et al. A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced breast cancer and a germline BRCA-mutation. Presented at: 2017 San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX. Abstract GS6-07.
3. Bookman MA, Gilks CB, Kohn EC, et al. Better therapeutic trials in ovarian cancer. J Natl Cancer Inst. 2014;106(4):dju029. doi: 10.1093/jnci/dju029.
4. Greenwade MM, Moore KN, Gillen JM, et al. Factors influencing clinical trial enrollment among ovarian cancer patients. Gynecol Oncol. 2017;146(3):465-469. doi: 10.1016/j.ygyno.2017.06.035.


PER Pulse Recap (3 of 3)

Management of Adverse Events Associated With PARP Inhibitor Therapy

A range of adverse events (AEs) have been associated with the use of PARP inhibition in patients with ovarian cancer. Cardiovascular, hematologic, and gastrointestinal (GI) AEs have been reported, as well as problems with fatigue.1 Gastrointestinal toxicities are generally mild in nature, with the incidence of grades 3/4 nausea being approximately 3% to 4%, grades 3/4 emesis being approximately 2% to 4%, and grades 3/4 diarrhea being 0% to 1%. The National Comprehensive Cancer Network guidelines describe management strategies for nausea and vomiting; antiemetic therapy may be tapered and ultimately discontinued if nausea is absent or diminishes within the first few cycles.2

In ARIEL3, 34% of patients experienced elevations in alanine aminotransferase or aspartate aminotransferase concentrations, but these increases were not associated with elevated serum bilirubin levels or other signs of hepatic toxicity.3 Elevations in creatinine have been associated with the use of olaparib and rucaparib; other potential sources of impaired kidney function should be ruled out. For patients with ovarian cancer who receive olaparib or rucaparib, blood counts should be monitored monthly for the first year of therapy and subsequently assessed intermittently.4,5 Milder degrees of myelosuppression may be addressed with dose interruption. If toxicities require frequent interruption, then dose reduction may be necessary. It may be permissible to provide transfusion for treatment-associated anemia and still maintain therapy.1 For more severe degrees of hematologic toxicities (grades 3/4), dosing with PARP inhibitors should be interrupted until values have returned to grade ≤1, and the PARP inhibitor should be resumed at the next-lowest dose. If counts do not normalize within 4 weeks, referral to a hematologist may be necessary.6

Patients receiving niraparib should be monitored regularly for problems with hypertension, as well as other cardiovascular toxicities such as tachycardia and palpitations.6 Anemia, leukopenia, neutropenia, and thrombocytopenia have all been reported with niraparib, and patients with a baseline platelet count of ≤150,000/μL and/or weight ≤77 kg may need to begin dosing at 200 mg rather than 300 mg, to minimize the risk for problems with thrombocytopenia and other hematologic toxicities.7 Blood counts should be monitored weekly when beginning niraparib and more frequently if platelet counts are decreasing.6 Laboratory assessment should occur every week for patients who require dose adjustment; again, prescription labels should be consulted for patients taking PARP inhibitors.4-6

Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are rare events that have been associated with PARP inhibitor use in clinical studies. Results from large phase III studies have shown that the risk for development of AML and MDS is approximately 1% to 2% in patients with ovarian cancer treated with maintenance PARP inhibition.3,8,9

Finally, fatigue is commonly experienced by patients who receive PARP inhibitor therapy. This AE may have a significant impact on patient quality of life and should be screened for regularly.10 As with GI symptoms, fatigue may come from a variety of different sources. It may be disease related or treatment related or come from any of several other potential sources. Fatigue may be addressed with both pharmacologic and nonpharmacologic approaches.10
  • Several adverse events have been associated with the use of PARP inhibitor therapy, including fatigue, anemia, and gastrointestinal difficulties, among others. Management strategies for these adverse events are becoming established as data from clinical studies accumulate.
  • For further exploration of intriguing developments in PARP inhibitor therapy for women’s cancers and expert clinical faculty commentary, please go to gotoper.com/online-cme-activities/cpc/community-practice-connections-nursing-opportunities-to-improve-outcomes-with-the-advent-of-parp-inhibitors-in-the-care-of-womens-cancers.
References

1. Gunderson CC, Matulonis U, Moore KN. Management of the toxicities of common targeted therapeutics for gynecologic cancers. Gynecol Oncol. 2018;148(3):591-600. doi: 10.1016/j.ygyno.2018.01.010.
2. NCCN guidelines. Antiemesis. Version 2.2018. NCCN website. nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed June 6, 2018.
3. 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. Lancet. 2017;390(10106):1949-1961. doi: 10.1016/S0140-6736(17)32440-6.
4. Rucaparib [prescribing information]. Boulder, CO: Clovis Oncology, Inc.; 2018. clovisoncology.com/files/rubraca-prescribing-info.pdf. Accessed June 6, 2018.
5. Olaparib [prescribing information]. Wilmington, DE: AstraZeneca; 2018. azpicentral.com/lynparza_tb/pi_lynparza_tb.pdf. Accessed June 6, 2018.
6. Niraparib [prescribing information]. Waltham, MA: TESARO, Inc.; 2018. zejula.com/application/files/1715/2156/1557/prescribing_information.pdf. Accessed June 6, 2018.
7. Moore KN, Mirza MR, Matulonis UA. The poly (ADP ribose) polymerase inhibitor niraparib: management of toxicities. Gynecol Oncol. 2018;149(1):214-220. doi: 10.1016/j.ygyno.2018.01.011.
8. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164. doi: 10.1056/NEJMoa1611310.
9. Pujade-Lauraine E, Ledermann JA, Selle F, et al. 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. Lancet Oncol. 2017;18(9):1274-1284. doi: 10.1016/S1470-2045(17)30469-2.
10. Moore KN, Monk BJ. Patient counseling and management of symptoms during olaparib therapy for recurrent ovarian cancer. Oncologist. 2016;21(8):954-963. doi: 10.1634/theoncologist2015-0268.







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