Prevalence and Safety of Off-Label Use of Chemotherapeutic Agents in Older Patients With Breast Cancer: Estimates From SEER-Medicare Data

Background: Prescribing drugs outside of the label indication is legal and may reflect standard practice; however, some off-label use may be inappropriate. This study measured the prevalence and safety of off-label use both in accordance with practice guidelines and inconsistent with practice guidelines in older patients with breast cancer. Patients and Methods: The SEER-Medicare data set was used to identify women diagnosed with breast cancer. Intravenous chemotherapy was identified using Medicare claims and classified as either on-label, off-label but included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer (“off-label/supported”), or off-label and not included in the NCCN Guidelines (“off-label/unsupported”). Hospitalization/emergency department (ED) admission rates were compared. Results: A total of 13,347 women were treated with 16,127 regimens (12% of women switched regimen); 64% of regimens were offlabel/supported, 25% were on-label, and 11% were off-label/unsupported, and hospitalization/ED admission occurred in 27%, 25%, and 32% of regimens, respectively (P<.0001). Drugs never included in the NCCN Guidelines for Breast Cancer accounted for 19% of off-label/unsupported use (1% of total use). Conclusions: Off-label use without scientific support was not common, whereas 64% of use was off-label/supported, reflecting the fact that widely accepted indications are often not tested in registration trials. Off-label/supported use will likely increase as more drugs are expected to have activity across cancer sites, and therefore understanding the implications of such use is critical.

Target Audience

This activity has been designed to meet the educational needs of physicians and nurses involved in the management of patients with cancer.

Learning Objectives

Upon completion of this activity, participants will be able to:

  • Outline the “off-label” use of drugs in oncology
  • Summarize the importance of adherence to clinical guidelines and/or FDA-approved label for prescribing drugs and providing optimal care
Additional information

No commercial support was received for this article.

Course summary
Available credit: 
  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 ANCC contact hours
  • 1.00 Participation
Course opens: 
Course expires: 

Michelle L. McDonald, MD
Department of Urology
UC San Diego Health System
La Jolla, California

J. Kellogg Parsons, MD, MHS
Department of Urology
UC San Diego Health System
La Jolla, California


Disclosure of Relevant Financial Relationships
All faculty and activity planners participating in NCCN continuing education activities are expected to disclose any relevant financial relationships with a commercial interest as defined by the ACCME’s, ANCC’s, and ACPE’s Standards for Commercial Support. All faculty presentations have been reviewed for adherence to the ACCME’s Criterion 7: The provider develops activities/educational interventions independent of commercial interests (SCS 1, 2, and 6) by experts on the topics. Full disclosure of faculty relationships will be made prior to the activity.

Ms. Eaton and Dr. Panageas have disclosed that they have no financial interests, arrangements, affiliations, or commercial interests with the manufacturers of any products discussed in this article or their competitors. Dr. Sima has disclosed that she is employed by Genentech, Inc.

This work was partially supported by the Goldstein Fund and Core Grant (P30CA008748) awards. This work was previously presented as a poster at the 2012 San Antonio Breast Cancer Symposium.

Kerrin M. Green, MA, Assistant Managing Editor, JNCCN—Journal of the National Comprehensive Cancer Network
Ms. Green has disclosed that she has no relevant financial relationships.

Deborah J. Moonan, RN, BSN, Director, Continuing Education, hasdisclosed that she has no relevant financial relationships.

Ann Gianola, MA, Manager, Continuing Education Accreditation & Program Operations, has disclosed that she has no relevant financial relationships.

Kristina M. Gregory, RN, MSN, OCN, Vice President, Clinical Information Operations, has disclosed that she has no relevant financial relationships.

Rashmi Kumar, PhD, Senior Manager, Clinical Content, has disclosed that she has no relevant financial relationships.

The ACCME/ANCC/ACPE defines “conflict of interest” as when an individual has an opportunity to affect CE content about products or services of a commercial interest with which he/she has a financial relationship.

ACCME, ACPE, and ANCC focuses on financial relationships with commercial interests in the 12-month period preceding the time that the individual is being asked to assume a role controlling content of the CE activity. ACCME, ACPE, and ANCC have not set a minimal dollar amount for relationships to be significant. Inherent in any amount is the incentive to maintain or increase the value of the relationship. The ACCME, ACPE, and ANCC defines “’relevant’ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

All faculty for this continuing education activity are competent in the subject matter and qualified by experience, training, and/or preparation to the tasks and methods of delivery.

The National Comprehensive Cancer Network (NCCN) is accredited by the ACCME to provide continuing medical education for physicians.

NCCN designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

NCCN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center`s Commission on Accreditation.

NCCN designates the education activity for a maximum of 1.0 contact hour. Accreditation as a provider refers to recognition of educational activities only; accredited status does not imply endorsement by NCCN or ANCC of any commercial products discussed/displayed in conjunction with the educational activity. Kristina M. Gregory, RN, MSN, OCN, is our nurse planner for this educational activity.

All clinicians completing this activity will be issued a certificate of participation.

Release date: January 1, 2016
Expiration date: January 1, 2017

Available Credit

  • 1.00 AMA PRA Category 1 Credit™
  • 1.00 ANCC contact hours
  • 1.00 Participation


Please login or register to take this course.

Required Hardware/software

To access this activity, users will need:

  • A device with an Internet connection
  • Adobe Reader or other PDF reader software for article and certificate viewing/printing