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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 2.0 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 2.0 Contact Hours.

Acknowledgment of Commercial Support

This activity is supported by educational grants from AstraZeneca Pharmaceuticals, Genomic Health, Inc., and Helsinn Therapeutics (U.S.), Inc.

Provider and Caregiver Connection™: Addressing Patient Concerns in the Management of Premenopausal Breast Cancer


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

Activity Overview

Treatment of premenopausal breast cancer has evolved in recent years with the advent of molecular diagnostics, the incorporation of ovarian suppression in endocrine therapy, and the addition of targeted therapeutic agents. Premenopausal women with breast cancer face unique medical and psychosocial challenges that impact treatment decisions and their adherence to therapy.

This educational activity has the dual objectives of updating healthcare providers on the latest developments in the treatment of premenopausal breast cancer, as well as bringing greater attention to the patient perspective along the continuum of care. This will be accomplished through a combination of didactic presentation (featuring audio clips of experts providing their perspectives on the state of the art in premenopausal breast cancer management) and an informative panel discussion hosted by expert clinicians featuring a patient and her caregiver-husband sharing their personal experiences, along with advice and valuable disease information.
By participating in this exciting program, you will learn about:

  • Recent clinical studies that inform clinical decision-making and evolving treatment strategies for the premenopausal patient with breast cancer
  • Optimizing care for the premenopausal patient with breast cancer by mitigating adverse events and addressing fertility preservation and quality-of-life concerns
  • Effective communication with patients, their caregivers, and the multidisciplinary team

Acknowledgement of Commercial Support

This activity is supported by educational grants from AstraZeneca Pharmaceuticals,
Genomic Health, Inc., and Helsinn Therapeutics (U.S.), Inc.
 

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 activity is directed toward medical oncologists, hematologists, surgical oncologists, nurse practitioners (NPs), nurses, physician assistants, (PAs) and psychiatrists involved in the treatment and management of premenopausal patients with advanced breast cancer.  Pharmacists, researchers, fellows, and other healthcare professionals interested in the treatment of breast cancer may also participate.

Learning Objectives

Upon completion of this activity, you should be better prepared to:

  • Differentiate considerations for the premenopausal patient and how these differ from postmenopausal treatment settings in the care of patients with breast cancer
  • Determine how biomarker and genetic characterization informs clinical decision-making and evolving treatment strategies for the premenopausal patient with breast cancer
  • Apply practical strategies to address inherent issues critical to optimize the care of younger women with breast cancer, including mitigation of treatment-related toxicities, quality-of-life concerns, and fertility preservation
  • Incorporate skills that promote effective communication and coordination of care between the provider and the patient/caregiver in the management of premenopausal patients with breast cancer

Faculty, Staff, and Planners' Disclosures

Chair

Don S. Dizon, MD, FACP, FASCO
Director, Women's Cancers
Lifespan Cancer Institute
Director, Medical Oncology
Rhode Island Hospital
Associate Professor of Medicine
The Warren Alpert Medical School of Brown University
Providence, RI

Disclosure: Dr. Dizon has no relevant financial relationships with commercial interests to disclose.

Faculty

Debu Tripathy, MD
Professor and Chair, Department of Breast Medical Oncology
The University of Texas MD Anderson Cancer Center
Houston, TX
 
 

Disclosure: Grant/Research Support: Novartis; Consultant: Novartis, Pfizer

Denalee O’Malley, PhD, LSW
Instructor
Rutgers State University of New Jersey
Rutgers Robert Wood Johnson Medical School
Department of Family Medicine and Community Health
New Brunswick, NJ

Disclosure: Dr. O’Malley has no relevant financial relationships with commercial interests to disclose.

Dr. Anya Silver (Patient Interviewee)
Dr. Andrew Silver (Caregiver Interviewee)
Disclosures: Drs. Anya Silver and Andrew Silver have no relevant financial relationships with commercial interests to disclose.

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 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)

Insight from Debu Tripathy, MD, and Don S. Dizon, MD – PER Pulse™ Recap: Patient and Caregiver Communication™: Addressing Patient Concerns in the Management of Premenopausal Breast Cancer
 
This first of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Patient and Caregiver Communication™: Addressing Patient Concerns in the Management of Premenopausal Breast Cancer, focuses on the prognostic value of molecular assays in premenopausal women with estrogen receptor‒positive (ER+) breast cancer, including perspectives on the clinical evidence supporting their use.
 
In premenopausal patients with breast cancer, the decision to pursue endocrine therapy, chemotherapy, or the combination of endocrine therapy and chemotherapy is influenced by tumor risk factors (eg, hormone receptor status, nodal positivity, tumor size, histology), patient factors (eg, age, comorbidity), and the results of genetic assays and algorithms to predict the risk of recurrence.3 Commercial genomic assays (eg, Oncotype DX®, MammaPrint®, Endopredict®, PAM50, Breast Cancer Index) can add prognostic information for patients with ER+ tumors to distinguish between those at low and high risk of recurrence, and have been adopted in the recently implemented American Joint Commission on Cancer, 8th Edition, Cancer Staging System and in clinical practice guidelines.1-3

“The advent of molecular testing has greatly helped us in terms of triaging risk. It used to be that just about all patients were recommended chemotherapy for early-stage breast cancer, including those with hormone receptor‒positive breast cancer.”  
 
“In the early-stage setting we want to make sure that we have a good understanding of what a patient's risk is, and this would involve not only anatomic staging but also molecular staging with gene expression profiling to make the best decision. And then in these patients that we feel need ovarian suppression or chemotherapy, we have to make sure that we estimate the benefit of these therapies, and that we discuss both the short- and long-term risks with them.”
 
‒ Debu Tripathy, MD

The large, randomized MINDACT study demonstrated the prognostic value of MammaPrint for patients with high clinical risk but low genetic risk (as assessed by MammaPrint) but was not designed to assess whether there was a benefit of chemotherapy in these patients.4 An analysis of younger patients from the MINDACT study found a comparable prognostic value of Mammaprint across age groups.5

A recent analysis of 6711 women with mid-range Oncotype DX scores (11-25) in the TAILORx study found that the addition of chemotherapy provided no benefit over endocrine therapy alone. However, further analysis found that chemotherapy provided some benefit in women age ≤50 years with mid-range scores (n = 2216). In these patients, chemotherapy was associated with a lower rate of distant recurrence in women with a recurrence score ≥16, but no significant improvement in overall survival was observed.6

It is unclear whether this benefit could be related to chemotherapy-induced premature menopause, or if similar benefits might be achieved with ovarian suppression with an aromatase inhibitor.

“The estimate is that now 70% of patients with newly diagnosed breast cancer will not require chemotherapy. However, there did seem to be some chemotherapy benefit for patients (age ≤50 years) with an intermediate recurrence score of 16-25.”
 
“Uncertainty remains as to whether or not these younger patients with intermediate recurrence scores will do just as well if we do ovarian suppression plus an aromatase inhibitor.”
 
Don S. Dizon, MD


“It's possible that what we're looking at is the fact that patients were getting an ovarian suppression effect from the chemo, and that may have made the chemo look better.”
 
‒  Debu Tripathy, MD


References
 
1. National Comprehensive Cancer Network. Breast Cancer [Version 1.2018]. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed May 7, 2018.
2. Amin MB, Edge SB, Greene FL, Byrd DR, eds.  AJCC Cancer Staging Manual. 8th ed. New York: Springer; 2017. 
3. Krop I, Ismaila N, Andre F, et al. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology clinical practice guideline focused update. J Clin Oncol. 2017;35:2838-2847.
4. Cardoso F, van’t Veer LJ, Bogaerts J, et al. 70-Gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375:717-729.
5. Aalders K, Genbrugge E, Poncet C, et al. Young age and the risk of disease recurrence as assessed by the 70-gene signature — an analysis from the EORTC 10041/BIG 03-04 MINDACT trial. Presented at the 40th Annual San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX. Abstract P1-07-08. https://www.sabcs.org/Portals/SABCS2016/Documents/SABCS-2017-Abstracts.pdf
6. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer [published online June 3, 2018]. N Engl J Med. 2018.  doi: 10.1056/NEJMoa1804710. 

PER Pulse Recap (2 of 3)

This second of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Patient and Caregiver Communication™: Addressing Patient Concerns in the Management of Premenopausal Breast Cancer, focuses on recent clinical trials supporting the use of cyclin-dependent kinase (CDK) 4/6 inhibitors in premenopausal patients with ER+ advanced breast cancer.
 
The addition of CDK4/6 inhibitors to endocrine therapy has significantly improved progression-free survival as compared with endocrine therapy alone in first-line and endocrine-resistant treatment of HR-positive, HER2-negative, advanced breast cancer in postmenopausal women, and recent studies suggest a similar benefit when combining CDK4/6 inhibitors with endocrine therapy in premenopausal women.9-16

“We think that the pathway that involves these cyclin-dependent kinases is important in the development of estrogen-independent tumor growth.”
 
The earlier clinical data really showed benefit with CDK4/6 inhibition with aromatase inhibitors in the postmenopausal patient, but we have seen now emerging data suggesting they absolutely play a role in the premenopausal patient with metastatic breast cancer."
 
Don S. Dizon, MD
  • The PALOMA-3 trial of fulvestrant plus palbociclib/placebo in women with HR+ advanced breast cancer and prior progression included 108 premenopausal patients who also received goserelin ovarian suppression. In these premenopausal patients, treatment with fulvestrant plus palbociclib significantly improved median progression-free survival (PFS) versus fulvestrant plus placebo (9.5 months vs 5.6 months, respectively), which is comparable to results observed in the overall PALOMA-3 population.6,7
  • Pre-/perimenopausal women receiving a GnRH analog with fulvestrant plus abemaciclib in the MONARCH-2 study achieved a similar improvement in median PFS and objective response rate versus fulvestrant plus placebo as was observed in the overall population of women with HR+ advanced breast cancer and prior progression.8
  • In MONALEESA-7, the first randomized phase III trial investigating the use of CDK4/6 inhibitors frontline in premenopausal women with advanced HR+ breast cancer, the addition of ribociclib to goserelin plus tamoxifen/nonsteroidal AI significantly improved median PFS as compared with placebo (23.8 months vs 13.0 months, respectively; hazard ratio [HR], 0.55 [95% CI, 0.4–0.69]; P <.0001).5 Based on this study, the US Food and Drug Administration recently expanded the indication for ribociclib to include the combination of ribociclib with an aromatase inhibitor as an initial endocrine therapy for pre-/perimenopausal women with HR+, HER2-negative, advanced/metastatic breast cancer.9
“MONALEESA-7 convincingly showed that the benefits that we have seen previously with CDK4/6 inhibitors, roughly a doubling of the progression-free survival, was also seen in this pre- and perimenopausal population, and moreover, it was also seen with tamoxifen as with the group treated with aromatase inhibitors.”
 
Debu Tripathy, MD

Ongoing clinical trials will help to address many unanswered questions about the use of CDK4/6 inhibitors in premenopausal patients with breast cancer, including studies of response-predictive biomarkers, new combination strategies, and the potential of CDK4/6 inhibitors in early-stage and HER2+ disease.

References
 
1. Finn RS, Martin M, Rugo HS, Jones S, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
2. Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+, HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884.
3. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646.
4. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-1547.
5. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with HR-positive, advanced breast cancer: results from the randomised phase 3 MONALEESA-7 trial. Lancet Oncol. 2018;19(7):904-915.
6. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016;17(4):425-439.
7. Loibl S, Turner, NC, Ro J, et al. Palbociclib combined with fulvestrant in premenopausal women with advanced breast cancer and prior progression on endocrine therapy: PALOMA-3 results. Oncologist. 2017;22:1-11.
8. Neven P, Rugo HS, Tolaney SM, et al. Abemaciclib for pre/perimenopausal women with HR+, HER2- advanced breast cancer. J Clin Oncol. 2018;36(suppl; abstr 1002).
9. FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer [press release]. 2018. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm613803.htm.  Accessed July 26, 2018.
 

PER Pulse Recap (3 of 3)

This third of 3 PER Pulse™ Recaps from the continuing medical education (CME) activity, Patient and Caregiver Communication™: Addressing Patient Concerns in the Management of Premenopausal Breast Cancer, focuses on addressing the fertility and quality-of-life challenges of women facing a breast cancer diagnosis at a young age.
 
A breast cancer diagnosis poses significant challenges for all women. However, premenopausal women have unique medical and psychosocial concerns, including the impact of treatment on their career, fertility, ability to raise children, sexuality, as well as a variety of psychological and emotional challenges related to facing a life-threatening disease in the prime of their personal, professional, and reproductive life.
 
Communication between the practitioner and patient is critical for selecting the most appropriate therapy, managing treatment side effects, understanding and discussing the long-term outlook, and addressing the impact of the disease and its treatment on overall quality of life.

“Fertility needs to be addressed at the initial diagnosis of breast cancer, and particularly before women start treatment. We are aware of great data that suggest even having that discussion can improve quality of life, if you compare that to women who do not recall ever having been given the option of fertility preservation.”  
 
“I also discuss genitourinary symptoms of menopause, which can be far more profound in women who are menstruating at diagnosis, and then experience treatment-related amenorrhea and are dealing with an acute onset of menopausal symptoms from ovarian suppression or chemotherapy-related ovarian failure.”
 
Don S. Dizon, MD

This activity features an extensive patient and caregiver interview, facilitated by Drs. Dizon and O'Malley, which explores many features of the management of premenopausal breast cancer, and emphasizes the perspective of the patient when facing a breast cancer diagnosis at a young age and the associated challenges of managing the disease.

“Especially for young women, this may be their first serious illness, so the healthy self is grieved. And hair loss is a very tangible loss that marks a woman socially.”
 
‒ Denalee O'Malley, PhD, MSW


“I would really encourage doctors to ask questions that maybe are not specifically clinical but that do take into account that person's whole experience.”
 
‒ Anya Silver, PhD
Premenopausal Breast Cancer Patient

For additional commentary about these topics and others, visit www.gotoper.com to access more resources from this and other meetings.







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