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Disclaimer: CME certification for these activities has expired. All information is pertinent to the timeframe in which it was released.


Maintaining Breast Cancer Remission While Preventing Toxicities: The Triumph Of Adjuvant Therapy


GOAL
To provide oncologists and primary care physicians who treat breast cancer with up-to-date clinical information about various therapeutic options for early stage breast cancer.

TARGET AUDIENCE
This activity is designed for oncologists and primary care physicians who treat breast cancer. No prerequisites required.

LEARNING OBJECTIVES
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. At the conclusion of this activity, the participant should be able to:

  • Discuss new strategies for the sequencing of hormonal agents.
  • Evaluate clinical evidence of using aromatase inhibitors as adjuvant therapy for early breast cancer.
  • Define new directions in treatment protocols for postmenopausal women with hormone-receptorÐpositive breast cancer.
  • Analyze clinical trial data and discuss the evolving roles of bisphosphonates in the management of bone loss in postmenopausal women undergoing treatment for breast cancer.

ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education
for physicians.

CREDIT DESIGNATION STATEMENT
The Johns Hopkins University School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

The estimated time to complete this educational activity: 2 hours.

Release date: November 15, 2006. Expiration date: November 15, 2008.

DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of The Johns Hopkins University School of Medicine name implies review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.

This program is supported by an educational grant from Novartis Oncology.

Full Disclosure Policy Affecting CME Activities:
As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. The Program Director and Participating Faculty reported the following:

PROGRAM DIRECTOR

Vered Stearns, MD
Associate Professor of Oncology
Breast Cancer Program
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins School of Medicine
Baltimore, Maryland
Dr Stearns reports receiving grants/research support from GlaxoSmithKline, Novartis, and Pfizer, Inc; and serving as a consultant for Wyeth.

PARTICIPATING FACULTY

Aman U. Buzdar, MD
Professor
Department of Breast Medical Oncology
The University of Texas M.D. Anderson  Cancer Center
Houston, Texas
Dr Buzdar reports receiving grants/research support from AstraZeneca, Genentech, Pfizer, Inc, Roche, and Taiho Pharmaceutical Co., Ltd.; and receiving honoraria from AstraZeneca and Pfizer, Inc.

Catherine Van Poznak, MD
Assistant Professor
Department of Internal Medicine
Hematology/Oncology
University of Michigan
Ann Arbor, Michigan
Dr Van Poznak reports serving as a consultant for Amgen, Novartis, and Roche; and receiving honoraria from Amgen, Novartis, and Roche.

Notice: The audience is advised that articles in this CME activity contain reference(s) to unlabeled or unapproved uses of drugs or devices.

Unlabeled/unapproved uses of drugs:
Dr Buzdar—zoledronic acid, in clinical trials for treating low bone bass.
Dr Van Poznak—denosumab, in clinical trials exploring bone mineral density and bone metastases; zoledronic acid, in clinical trials for treating low bone mass; clodronate, treating low bone mass and in clinical trials for the prevention of breast cancer recurrence; ibandronate, treating low bone mass and in clinical trials for prevention of breast cancer recurrence.

All other faculty have indicated that they have not referenced unlabeled/unapproved uses of drugs or devices.

Johns Hopkins Advanced Studies in Medicine provides disclosure information from contributing authors, lead presenters, and participating faculty. Johns Hopkins Advanced Studies in Medicine does not provide disclosure information from authors of abstracts and poster presentations. The reader shall be advised that these contributors may or may not maintain financial relationships with pharmaceutical companies.

MAINTAINING BREAST CANCER REMISSION WHILE PREVENTING TOXICITIES: THE TRIUMPH OF ADJUVANT THERAPY
Vered Stearns, MD*

Adjuvant hormonal therapy results in substantial survival improvement in women with hormone-receptor-positive early breast cancer (BC). For many years, tamoxifen was the standard adjuvant hormonal therapy for premenopausal and postmenopausal patients. However, results from multiple large, randomized trials have prompted the American Society of Clinical Oncology (ASCO) to recommend that adjuvant therapy for postmenopausal patients include an aromatase inhibitor (AI) to lower the risk of BC recurrence.1 The increasing use of AIs has been accompanied by heightened awareness that their long-term use is associated with clinically significant bone loss. As a result, ASCO has concluded that oncologists must take a greater role in the regular assessment and management of the bone health of postmenopausal patients with BC.2

This issue of Johns Hopkins Advanced Studies in Medicine discusses the latest findings from the 42nd ASCO Annual Meeting in June 2006 on the use of AIs and the management of bone health in patients with BC. In this issue's first article, 'Adjuvant Endocrine Therapy for Postmenopausal Women with Early Breast Cancer,' Aman U. Buzdar, MD, comprehensively analyzes the results of many studies that prompted ASCO to recommend AI therapy for postmenopausal women with hormone-receptor-positive early BC. Dr Buzdar begins by looking back at the history of clinical trials of adjuvant therapy for BC.

After a brief review of endocrine therapy options, Dr Buzdar details the findings of the 2 trials that directly compared AIs and tamoxifen: the Arimidex, Tamoxifen, Alone or in Combination trial and the Breast International Group 1-98 letrozole trial. Both trials support the initial use of an AI instead of tamoxifen as adjuvant therapy. Dr Buzdar then covers studies that established that switching to AI therapy after 2 to 3 years of tamoxifen improves survival time compared with 5 years of tamoxifen therapy. These trials include the Italian Tamoxifen Anastrozole trial, the Austrian Breast and Colorectal Cancer Study Group (ABCSG) anastrozole trial 8, the Arimidex-Nolvadex 95 trial, and the Intergroup Exemestane Study. Dr Buzdar also reviews the findings of the MA.17 letrozole trial and the ABCSG 6a anastrozole trial, both of which clearly showed the benefits of adding AI therapy after 5 years of tamoxifen therapy.

Dr Buzdar then explains the safety of AIs compared with tamoxifen, particularly with regard to less common but more serious adverse side effects. Compared with tamoxifen, AIs are less likely to cause thromboembolic events and endometrial cancer. Moreover, although an association between AI therapy and increased risk of fracture has been established, Dr Buzdar notes that a definitive conclusion regarding the cardiovascular risk of AIs cannot yet be made because so few events have been reported thus far. Dr Buzdar continues by assessing the results of modeling studies regarding which adjuvant therapies are likely to result in the greatest reduction in years of life lost to BC recurrence in the postmenopausal population in general and in specific BC patient subgroups by hormone-receptor status. Dr Buzdar concludes with a discussion of the results of studies on the use of bisphosphonates in managing the adverse effects of AIs on bone.

A more in-depth review of the adverse effects of BC and its treatment on bone health and methods of counteracting those adverse effects, titled 'Toward New Horizons in Breast Cancer Treatment-Induced Bone Loss,' is provided by Catherine Van Poznak, MD. Dr Van Poznak begins with a brief discussion of the magnitude of the problem of osteoporosis and related fractures, in addition to the devastating combined adverse effects of osteoporosis and BC on quality of life. She then reviews the studies that have established the adverse effects of breast cancer treatments with emphasis on the effects of hormone deprivation on the bone health of patients with BC. Dr Van Poznak also explains bone health management measures, such as whom to screen for low bone mass and when, which nutritional interventions and lifestyle measures to recommend, and which osteoporosis therapies are appropriate for use in patients with BC. Continuing with an in-depth discussion of the use of bisphosphonates to treat osteoporosis in patients with BC, Dr Van Poznak then concludes by evaluating studies of the investigational use of bisphosphonates in preventing bone metastases.

This monograph also features abstracts of selected posters presented at the 42nd ASCO Annual Meeting, including summaries of key studies on the survival benefits of AIs, their adverse effects on bone health, and the use of the investigational agent denosumab in treating bone disease in patients with BC.

By discussing the use of AIs as adjuvant hormonal therapy in postmenopausal patients with BC and the management of the adverse effects of BC therapy, including AIs on bone health, this monograph aims to provide oncologists with the information necessary to increase survival time and enhance the quality of life for long-term survivors of BC. It is expected that oncologists and primary care physicians will have an increasing role in managing long-term treatments and the toxicities in BC survivors.

Additionally, this monograph emphasizes the need for continued research to determine: 1) the optimal use of available agents for preventing BC recurrence or for preventing or treating bone loss in postmenopausal patients with BC; 2) the role of promising new drugs; and 3) whether the use of bisphosphonates can prevent bone metastases from developing in postmenopausal patients with early BC.

The content in this monograph was developed with the assistance of a staff medical writer. Each author had final approval of his/her article and all its contents.

REFERENCES

1. Winer EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer: status report 2004. J Clin Oncol. 2005;23:619-629.
2. Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol. 2003;21:4042-4057.

*Associate Professor of Oncology, Breast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland.
Address correspondence to: Vered Stearns, MD, Associate Professor of Oncology, Breast Cancer Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, CRB 1M53, 1650 Orleans Street, Baltimore, MD 21231.
E-mail: Vstearn1@jhmi.edu.





Johns Hopkins Advanced Studies in Medicine (ISSN-1558-0334), is published by Galen Publishing, LLC, d/b/a ASiM, PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2012 by Galen Publishing. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. ASiM is a registered trademark of The Healthcare Media Group, LLC.