Download (CCO) Practice Guideline on Adjuvant Ovarian Ablation (OA)

American Society of Clinical Oncology
Endorsement of the
Cancer Care Ontario (CCO)
Practice Guideline on Adjuvant Ovarian
Ablation (OA) in the Treatment of
Premenopausal Women with Early Stage
Invasive Breast Cancer
Introduction
• Cancer Care of Ontario (CCO) published a
guideline, “Adjuvant Ovarian Ablation in the
Treatment of Premenopausal Women with Early
Stage Invasive Breast Cancer,” in July 2010
• Ovarian ablation or suppression includes all
methods: surgical oophorectomy, medical
suppression, and ovarian irradiation.
• Guideline considered for endorsement, requiring
both methodologic and content review
Guideline Clinical Questions
Question 1: How does adjuvant ovarian ablation
(OA) as systemic therapy improve clinically
meaningful outcomes (disease-free survival, overall
survival, quality of life and toxicity) when compared
with and/or added to other systemic therapies,
specifically chemotherapy and tamoxifen?
Question 2: What is the best way to ablate or
suppress ovarian function: surgical oophorectomy,
ovarian irradiation or medical suppression
CCO Guideline Development
• Guideline developed by the CCO Program in
Evidence-Based Care (PEBC)
• Guideline staff included members of the PEBC
Breast Cancer Disease Site Group and systematic
review/guideline methodologists
• Target population includes premenopausal
women with hormone receptor-positive earlystage invasive breast cancer
CCO Guideline Development
Databases searched:
• MEDLINE searched from 1966 – September 2009
• Cochrane Library search through September 2009
Online conference proceedings, all searched
through September 2009:
•
•
•
•
ASCO Annual Meeting
San Antonio Breast Cancer Symposium
Canadian Medical Association Infobase
National Guideline Clearing House
ASCO Methods Review
• Appraisal of Guidelines for Research and
Evaluation (AGREE) II - tool used by guideline
developers, evaluators
• Three ASCO senior guideline staff members
completed “Rigour of Development” subscale of
the AGREE II
• Seven-item subscale assesses both:
– quality of approach to gather and synthesize data, and
– methods to create the guideline recommendations
• Literature search updated since CCO guideline
published
– No trials met inclusion/exclusion criteria
ASCO Content Review
• Ad Hoc Panel of subject matter experts, primarily
breast oncologists
• Panel members completed 8-item Guideline
Endorsement Content Review Form
– Assesses clarity, clinical utility of recommendations
– Evaluates consistency of recommendations with available
data
• Form adapted by ASCO from the CCO PEBC
Practitioner Feedback instrument
Recommendations
• Clinical Question 1: What is the clinical efficacy
of OA versus other systemic therapy +/- OA?
– OA should not be routinely added to systemic therapy
with chemotherapy, tamoxifen, or the combination of
tamoxifen and chemotherapy.
– OA alone is not recommended as an alternative to any
other form of systemic therapy except in the specific
case of patients who are candidates for other forms of
systemic therapy but who for some reason will not
receive any other systemic therapy (e.g., patients who
cannot tolerate other forms of systemic therapy or
patients who choose no other form of systemic
therapy).
Recommendations
• Clinical Question 2. If indicated, What is
best method of OA?
– When chemical suppression using LHRH agonists
is the chosen method of OA, in the opinion of the
Breast Cancer DSG monthly injection is the
recommended mode of administration. The mode
of administration in nearly all of the available trials
has been monthly administration.
Qualifying Statements
CCO Guideline includes qualifying statements;
these were also endorsed.
• OA was not compared with current systemic
regimens; difficult to contextualize available data.
• EBCTCG meta-analysis is foundation for
recommendation to use OA in patients who
refuse systemic therapy. Patients might not be
representative.
Qualifying Statements
• OA may be non-inferior to CMF chemotherapy;
thus, OA may be reasonable alternative to CMF.
However, trials were not designed to assess noninferiority/equivalency
• No evidence available to suggest optimal method
to achieve ovarian ablation
ASCO Ad Hoc Panel Updates
ASCO panel members made the following
points, in addition to endorsing CCO guideline:
1) In patients who do embark upon ovarian
suppression using LHRH agonists, ovarian
suppression is not always successfully achieved.
Ovarian suppression cannot be confirmed by
cessation of menses alone, and estradiol assays
are not always reliable indicators of ovarian
function.
ASCO Ad Hoc Panel Updates
2) Many of the studies that address the role of
OA in premenopausal women with breast cancer
included women with hormone receptornegative disease or unknown hormone receptor
status. There is no evidence of benefit of OA in
these patients.
ASCO Ad Hoc Guideline
Content Review Panel
Panel Member
Institution
Jennifer J. Griggs, M.D., M.P.H, Chair
University of Michigan
Holly Anderson, R.N., B.S.N.
Breast Cancer Coalition of Rochester
Nancy E. Davidson, M.D.
University of Pittsburgh
N. Lynn Henry, M.D., Ph.D.
University of Michigan
Clifford A. Hudis, M.D.
Memorial Sloan-Kettering Cancer Center
James L. Khatcheressian, M.D.
Virginia Commonwealth University
Ann H. Partridge, M.D., M.P.H.
Dana Farber Cancer Institute
ASCO Guidelines
This resource is a practice tool for physicians based on an
ASCO® practice guideline. The practice guideline and this
presentation are not intended to substitute for the
independent professional judgment of the treating physician.
Practice guidelines do not account for individual variation
among patients and may not reflect the most recent
evidence. This presentation does not recommend any
particular product or course of medical treatment. Use of the
practice guideline and this resource is voluntary. The full
practice guideline and additional information are available at
http://www.asco.org/endorsements/OA. Copyright © 2011 by
American Society of Clinical Oncology®. All rights reserved.