TITLE: Systemic Therapy for Patients with Advanced HER2-Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Table of Contents
Data Supplement 1: Expanded Discussion: Brain Metastases and HER2-Positive Metastatic Breast Cancer
Data Supplement 2: Search Strategy string Data Supplement 3: QUOROM Diagram Data Supplement 4: Clinical Questions
Data Supplement 5: Multiple Chronic Conditions Table
Data Supplement 6: Expanded Discussion: Patient and Clinician Communication
Data Supplement 7: Consensus Rating Panel members with Disclosures Data Supplement 8: Glossary of Terms
DATA SUPPLEMENT 1. Expanded Discussion: Brain Metastases and HER2-Positive Metastatic Breast Cancer
Note:
For brain metastases clinical questions, upon review of the available evidence, the ASCO Systemic Therapy for Patients with Advanced HER2-Positive Breast Cancer Expert Panel concluded that the majority of the evidence was insufficient to inform evidence-based
recommendations for a traditional ASCO clinical practice guideline. Therefore, ASCO used the formalconsensus-based process described in the Methodology Supplement. The data cited for this section were not systematically collected, nor considered sufficiently specific to patients with HER2-positive metastatic breast cancer to inform evidence-based
recommendations; but rather were used to help members form opinions. References are available in the guideline <link>.
Brain Metastases and HER2-Positive Metastatic Breast Cancer (expanded discussion) This section provides background on the recommendations on the management of patients with brain metastases. Brain metastases are common in patients with advanced HER2-positive breast cancer, with up to half of patients (40-50%) experiencing a brain relapse prior to death. As of the production of this guideline, there were no other published guidelines on the treatment of patients with HER2-positive breast cancer and brain metastases. General guidelines for treatment may be divided by prognosis of patients and extent of brain metastatic disease. Patients with favorable prognoses are those with good performance status and effective systemic therapy options. The criteria may include Karnofsky Performance Status (KPS) ≥70, age, controlled extracranial disease, and/or if good salvage systemic therapy options for extracranial disease are available. Sperduto et al. found that the worst survival in patients with breast cancer brain metastasis were those with KPS <50, age > 60 years, and triple-negative histology, whereas the best survival occurred in patients with HER2-positive breast cancer and good performance status. In some studies, although HER2-positive status was associated with relatively good survival, there was a shorter interval from diagnosis of primary breast cancer to the development of brain metastases, in both patients with HER2-positive and triple-negative breast cancer.
The majority of the available high-level data on the management of patients with brain metastases are not specific to patients with breast cancer. Studies often pool patients with breast cancer of all subtypes together with patients with other tumor types, e.g. lung cancer. Data specific to patients with breast cancer are often from single-arm or observational studies. In addition, several of these studies were conducted in the pre-HER2-targeted based-therapy era. Approximately 5% of patients with advanced, HER2-positive breast cancer and brain metastases have leptomeningeal metastases, but this guideline did not comprehensively review treatment of patients with leptomeningeal metastases.
Because the ASCO guideline a priori criteria to include evidence in this guideline were not met, the recommendations on patients with HER2-positive breast cancer with brain
metastases were formulated by expert consensus. Due to the above-mentioned criteria, none of the recommendations were rated as having an aggregate evidence quality rating of high. The ASCO Expert Panel on Patients with HER2-Positive Metastatic Breast Cancer used a modified-Delphi method to achieve formal consensus. As part of the development of various types of ASCO recommendations (e.g., formal consensus and evidence-based), Expert Panels rate the overall quality of the evidence and the strength of each recommendation. Using these ratings, the Panel assigned a Recommendation Strength of Weak for most
recommendations (except where specifically noted). This connotes that “there is some confidence that the recommendation offers the best current guidance for practice.” (See the Methodology Supplement)
Local Therapy
The principal local therapies for brain metastatic disease are surgery, whole brain radiotherapy (WBRT), and stereotactic radiosurgery (SRS). Existing brain metastasis treatment guidelines, such as those developed by the NCCN, are non-disease specific. A particularly important consideration for the patients with HER2-positive breast cancer and brain metastasis is the role of WBRT in management of limited brain metastatic disease.
Whole Brain Radiotherapy (WBRT)
WBRT has played an important role in the palliative radiotherapy of patient with brain metastases for greater than five decades, with an early case series demonstrating an improvement in survival with WBRT versus historical estimates with supportive care alone. While WBRT is effective in palliating symptomatic brain metastases; it can be associated with short- and long-term complications. These may be divided into acute (during and within weeks of treatment), sub-acute (within three months of treatment), and late/chronic (beginning >three-six months following treatment) complications, based on their time of presentation. WBRT is also associated with significant acute fatigue which may persist for three-six months following WBRT and is thought to reflect white matter demyelination injury. Of particular concern are the neurocognitive sequelae of WBRT. Late effects of WBRT occurring months to years following treatment may include leukoencephalopathy and vascular injury resulting in increased risk of stroke.
WBRT plus Stereotactic Radiosurgery (SRS)
The addition of WBRT to surgery for a solitary brain metastasis in a randomized trial that compared outcomes to surgery alone showed improved local and distant brain control, but no improvement in survival (only 10% of patients in this study had breast cancer). The addition of WBRT to SRS for one to four brain metastases in a randomized study (7% of patients in this study had breast cancer) was associated with improved local control and decreased distant brain failure, but no survival benefit versus SRS alone. In that trial, although central nervous system (CNS) control was the most important determinant in neurocognitive function (as assessed by the Mini-Mental State Examination [MMSE]), there was a suggestion that WBRT was associated with worse cognitive function in long-term survivors, as evidenced by
differences in the 36-month actuarial free rate of a 3-point decline in MMSE relative to SRS alone.
In another randomized trial of SRS versus WBRT plus SRS for one to three brain metastases (13% of patients in this study had breast cancer), the addition of WBRT was associated with improved local and distant brain control, but also with increased treatment-related fatigue and neurocognitive decline versus SRS alone. While the omission of WBRT for limited (less than or equal to four metastases) brain metastatic disease is associated with an increased risk of distant brain failure, it has not been shown to diminish survival or duration of functional independence.
months).
Systemic Therapies
There are currently no systemic therapies that have been approved for use in the treatment of patients with breast cancer and brain metastases. Data are primarily available from single-arm prospective trials, and in some cases, from case series and/or retrospective studies. The recent, single-arm, Phase II LANDSCAPE trial demonstrated significant brain activity for the combination of lapatinib and capecitabine for patients with HER2-positive brain metastasis. The CNS objective response rate was 65.9%, (95% CI 50.1–79.5) (defined as 50% or greater volumetric reduction of CNS lesions in the absence of increased steroid dosing). However, this treatment was associated with a 49% Grade 3/4 toxicity rate, above that seen in the short-term with radiation therapy approaches such as WBRT or SRS. The majority (78%) of first
treatment failures were in the CNS, with a median failure time of 5.5 months. Radiation therapy, WBRT, or SRS were given to most patients. The overall survival of 17 months suggests that the delay of radiation therapy was not harmful. The overall impact on QOL of this approach remains to be determined. However, further study is required before this approach can be considered a standard approach in patients with HER2-positive brain metastases. If patients have asymptomatic, low volume brain metastases and have not received radiation therapy, upfront therapy with lapatinib and capecitabine is an option, although radiation therapy in this setting is still the standard option.
Treatment of intracranial progression after initial therapy
There are no high level, randomized data to guide the choice of treatment in patients whose disease has progressed in the brain after initial therapy, and the impact on overall survival is unclear. Not surprisingly, disease burden, tumor subtype, and performance status influence survival after treatment for intracranial progression. In non-randomized case series, a subset of patients does appear to derive benefit, at least as measured by reductions in tumor burden or symptoms, or in terms of favorable survival.
Because this guideline is intended to specifically cover patients with HER2-positive advanced breast cancer, the authors chose key areas that may be specific to these patients and do not intend these recommendations to comprehensively provide guidance for managing patients with all types of breast cancer and brain metastases. For example, although patients with HER2-positive disease (a small proportion) and other types of metastatic breast cancer have leptomeningeal disease, these recommendations only briefly address this. This is because there is not high-quality evidence specific to patients with HER2-positive metastatic breast cancer and leptomeningeal disease (and only a small proportion of patients with HER+ disease have leptomeningeal disease). Other issues that not addressed here further are radionecrosis and supportive care for patients with brain metastases. Other groups’ guidelines address some of the issues more in-depth for patients with brain metastases, not specifically with HER2-positive disease, including leptomeningeal metastases, and/or supportive care for patients with brain metastases. Although ASCO has not formally endorsed these guidelines, nor is this a complete list, citations are provided for the readers’ reference in the guideline (link).
Assumptions underlying these recommendations include the fact that existing high-level evidence is not specific to patients with brain metastases who have HER2-positive metastatic breast cancer and therefore, it is not possible to rate the aggregate evidence as high (see Methodology Supplement). In addition, the authors favor a team approach to the management of the patients described in this guideline. A team ideally includes radiation oncologists, neurosurgeons, and medical oncologists.
This guideline provides the first formal expert consensus-based recommendations of the management of patients with HER2-positive breast cancer and brain metastases. The Expert Panel suggests that future research in this patient population will further inform this area.
DATA SUPPLEMENT 2. Literature Search Strategy
((((“Breast neoplasms”[MH] OR “carcinoma, ductal, breast”[MH] OR (“breast” [MeSH] AND "neoplasms"[MeSH])) AND ((“Central Nervous System Neoplasms”[MH] OR “Brain neoplasms”[MH]) OR ((“Central Nervous System”[MH] or “Brain”[MH] ) AND ("neoplasms"[MeSH] OR “Neoplasm metastasis”[MH])))) AND Female[MH] AND (“Cranial Irradiation”[MH] OR “Radiosurgery”[MH] OR “Radiotherapy”[MH] OR “Antineoplastic Protocols”[MH] OR “Antineoplastic Combined Chemotherapy Protocols”[mh])) AND ((“randomized controlled trial”[pt] OR “controlled clinical trial”[pt] OR “clinical trial”[pt] OR "clinical trial"[TIAB] OR "clinical trials"[TIAB] OR “clinical trials as topic”[MeSH] OR “controlled clinical trials as topic”[MeSH] OR “randomized controlled trials as topic”[MeSH] OR “clinical trials, phase III as topic”[MeSH] OR “clinical trials, phase IV as topic”[MeSH] OR “clinical trial, phase III”[pt] OR “clinical trial, phase IV”[pt] OR “random allocation”[MeSH] OR ((control[TIAB] OR randomized[TIAB] OR placebo[TIAB) AND (study[TIAB] OR studies[TIAB] OR trial[TIAB] OR trials[TIAB] OR evaluation[TIAB] OR evaluate[TIAB] OR design[TIAB]))) OR ((meta-analysis[pt] OR meta-analysis as topic[MeSH] OR “meta-analysis”[TIAB] OR “meta analysis”[TIAB] OR analyses”[TIAB] OR “meta analyses”[TIAB] OR “meta-analyzed”[TIAB] OR “meta-analysed”[TIAB] OR “meta “meta-analyzed”[TIAB] OR “meta analysed”[TIAB] OR (meta[TIAB] AND analysis[TIAB]) OR (meta-[TIAB] AND analysis[TIAB])) OR ((critical[TIAB] OR critically[TIAB] OR systematic[TIAB] OR systematically[TIAB] OR evidence-based[TIAB] OR “evidence based”[TIAB]) AND (review[pt] OR review[TIAB] OR reviews[TIAB] OR reviewed[TIAB] OR appraise[TIAB] OR appraises[TIAB] OR appraised[TIAB] OR appraisal[TIAB] OR assess[TIAB] OR assesses[TIAB] OR assessed[TIAB] OR assessment[TIAB] OR evaluate[TIAB] OR evaluates[TIAB] OR evaluated[TIAB] OR evaluation[TIAB] OR critique[TIAB] OR critiques[TIAB] OR analysis[TIAB] OR analyses[TIAB] OR analyzed[TIAB] OR analysed[TIAB])) OR ((evidence-based[TIAB] OR “evidence based”[TIAB]) AND (guideline[TIAB] OR guidelines[TIAB] OR recommendation[TIAB] OR recommendations[TIAB] OR consensus[MeSH] OR consensus[TIAB] OR consensuses[TIAB])) OR (review literature as topic[MeSH] OR consensus development conference[pt] OR consensus development conference, NIH[pt] OR consensus development conferences as topic[MeSH] OR consensus development conferences, NIH as topic[MeSH] OR “consensus development”[TIAB] OR health planning guidelines[MeSH] OR guideline[pt] OR practice guideline[pt] OR practice guidelines as topic[MeSH] OR “practice guideline”[TIAB] OR “practice guidelines”[TIAB] OR health planning guidelines[MeSH] OR "standard of care"[TIAB] OR “evidence-based medicine”[TIAB] OR “evidence based medicine”[TIAB] OR “evidence-based care” OR “evidence-based practice”[TIAB] OR cochrane database syst rev[ta] OR acp j club[ta] OR health technol assess[ta] OR clin evid[ta])))) NOT (editorial[pt] OR editorial[TIAB] OR letter[pt] OR newspaper article[pt]) NOT (case reports[pt] OR case report[TIAB]) NOT (animals[MeSH] NOT humans[MeSH]) AND ("1966/01/01"[PDat] :"2013/05/06"[PDat]) AND English[la]
132 potentially relevant abstracts identified
53 abstracts reviewed
79 papers were duplicates of papers found by ASCO systematic review for treatment of HER2+ MBC
0 papers reviewed in full text, Modified Delphi
Process
53 papers were excluded •20 not study design of interest
•8 not population of interest of interest
•1 intervention not of interest
•19 narrative reviews •5 other
DATA SUPPLEMENT 4: Clinical Questions
Question A. Does the approach to local therapy of brain metastases differ in patients with HER2-positive breast cancer? For patients with single brain metastasis, favorable prognosis? For patients with limited metastases [2-4 metastases] and favorable prognosis? For patients with diffuse disease/extensive metastases and with favorable prognosis? For patients with diffuse disease/extensive metastases and with poor prognosis? For patients with progressive intracranial metastases despite initial therapy? In the setting of brain recurrence and radiation? Question B. How should systemic therapy be managed in patients with HER2-positive brain metastases (including how to manage systemic therapy when the brain is the only site of progression versus when progression in both brain and elsewhere)?
Question C. Is there a role for systemic therapy specifically to treat brain metastases in HER2-positive breast cancer?
Question D. Should patients with HER2-positive breast cancer be screened for development of brain metastases?
DATA SUPPLEMENT 5: Multiple Chronic Conditions Table
10 Most Common Co-occurring Chronic Conditions Among Female Medicare beneficiaries with Breast Cancer (N = 905,843) , 2011
Beneficiaries less than 65 years (N = 64,525) Beneficiaries 65 years and older (N = 841,318)
N % N %
Breast cancer prevalence 2.5 Breast cancer prevalence 5.6
Top 10 co-morbidities Top 10 co-morbidities
Hypertension 35,427 54.9 Hypertension 591,193 70.3
Hyperlipidemia 27,124 42.0 Hyperlipidemia 467,880 55.6
Depression 25,791 40.0 Arthritis 345,144 41.0
Arthritis 22,753 35.3 Anemia 293,470 34.9
Anemia 22,700 35.2 Ischemic heart disease 268,437 31.9
Diabetes 21,427 33.2 Diabetes 244,453 29.1
Ischemic heart disease 15,170 23.5 Cataracts 218,508 26.0
COPD 10,507 16.3 Heart failure 162,938 19.4
Chronic kidney disease 10,201 15.8 Depression 155,950 18.5
Heart failure 9,851 15.3 Chronic kidney disease 150,495 17.9
Notes:
Prepared by IPG/OIPDA on May 15, 2013.
Data Source:CMS administrative claims data, January 2011- December 2011, from the Chronic Condition Warehouse (CCW), ccwdata.org.
Population: Female Medicare beneficiaries enrolled in fee-for-service (FFS) coverage of both Parts A and B for the entire year. Beneficiaries who were enrolled at any point during the year in a
Medicare Advantage (MA) plan were excluded as were beneficiaries who first became eligible for Medicare after January of the calendar year. Beneficiaries who died during the year were included up to their date of death if they meet the other inclusion criteria. Beneficiaries less than 65 years of age are primarily receiving Medicare due to a disability.
Chronic Condition Measures: For these tables, chronic conditions were identified through
Medicare administrative claims. Medicare beneficiaries were considered to have a chronic condition if the CMS administrative data had a claim indicating that they were receiving a service or treatment for the specific condition. The data tables include information for beneficiaries with one of twenty-eight chronic conditions identified in the CCW. Detailed information on the identification of chronic conditions in the CCW is available at http://www.ccwdata.org/chronic-conditions/index.htm. The list of 28 conditions include:
Acquired hypothyroidism, Acute myocardial infarction, Alzheimer's Disease (including related Disorders or senile dementia), Anemia, Asthma, Atrial fibrillation, Autism, Benign prostatic hyperplasia, Breast cancer, Colon cancer, Endometrial cancer, Lung cancer, Prostate cancer, Cataract, Chronic kidney disease, COPD, Depression, Diabetes, Glaucoma, Heart failure, Hip/pelvic fracture, Hypertension, Hyperlipidemia, Ischemic heart disease, Osteoporosis, Arthritis (OA and RA), Schizophrenia (and other psychotic disorders) and Stroke.
Unpublished data provided by the Office of Information Products and Data Analytics, Centers for Medicare & Medicaid Services, May 2013
DATA SUPPLEMENT 6: Patient and Clinician Communication (Expanded Discussion) This section is based on patient and clinician experience and selected literature, but was not part of the systematic review of the literature. A separate literature search did not find data specific to the management of patients with HER2-positive metastatic disease. Although there are differences between issues facing patients with different types of metastatic solid tumors, clinicians are encouraged to refer to a similar discussion in ASCO’s Stage IV NSCLC guideline (2009)1 and to literature on risk communication for patients with cancer.2 A patient who is newly diagnosed with metastatic disease versus one for whom first- and or second- or great-line treatment has failed will likely to face some different issues, although clinical teams are encouraged to discuss the option of clinical trials regardless. Clinicians should consider issues relevant to communicating with patients with metastatic breast cancer, including the importance of evidence-based treatment, issues for patients and families of those with brain disease; suggestions for clinician communication, including referring to patients to cancer.net links, psycho-social support, and introducing concepts of concurrent palliative and anti-tumor therapy.1,3-5
Research in discussing specific issues with patients with HER2-positive metastatic disease is still needed. Teams should be prepared to present the statistics in this guideline in a format tailored to the patient/caregiver’s learning style. Discussions with patients should include key subjects. Suggested sample talking points are provided below.
Sample talking points tailored to the patient’s situation are included in the table below:
Explanation of metastatic breast cancer and the objectives of treatment (prolonging life versus curative).
Treatment options, including clinical trials, with potential benefits, side effects and risks,
The availability of supportive care.
Importance of considering chronic conditions such as CHS in choosing treatments
Explanation of treatment failure and lines of treatment, including for patients with brain metastases
The multiple members of the clinical team who may implement these recommendations, including medical oncologists, oncology nurses, radiation oncologists, neurosurgeons, palliative care clinicians, psychosocial professionals, etc.
General principles of patient communication:
Encourage the patient to take notes and/or to bring a family member or friend with them to future appointments.
Explanation of diagnosis.
Be prepared to discuss statistics and life expectancy in a simple way that can be understood by someone who is not used to scientific statistics.
Be prepared to listen and ascertain factors that may influence a patient’s treatment choice (age of patient, if are children involved, if the patient is facing a first-line or second line or greater diagnosis, etc.)
Offer referrals to resources such as psychosocial, educational, and if needed palliative/end of life, as well as those that can provide information about cost and insurance coverage.
Sample Talking Points
Patient Group Key Communication Points
Newly metastatic patients Your cancer has now appeared beyond your breast, it has become metastatic.
We currently have no cure for metastatic BC.
However, we have a number of drugs that are likely to extend your life.
We will start with the ones with the best track record, but when they stop working we will try newer drugs.
All of these drugs have some side effects, but there are often thing we can do (e.g., change the dose or schedule or provide other drugs) to reduce the side effects.
You should be sure to let me know about all of your symptoms, some of which may be related to your cancer and others to the treatment. We will do everything we can to maximize both your quality and quantity of life.
Also, there are always new drugs that are being tested. Anytime along the way, you may want to enroll in a clinical trial of one of these. I am going to give some reading material about clinical trials. During one of your next visits we should talk about one for which you may be eligible.
Additional metastases Previous points, plus:
As we discussed, you have metastatic HER2-positive BC for which we have a number of effective treatments.
However, also as we discussed, while the first treatment you received controlled your cancer for a time, it is no longer working.
There are other drugs that we can try. Ordinarily, each new treatment is effective for a time, but then the cancer changes to “out smart” that drug. Generally, each new treatment works for a shorter and shorter time, but this is not always the case.
Also, there are always new drugs that are being tested. We should start seriously considering finding a good clinical trial for you.
No remaining approved drugs As we discussed, eventually we would run out of approved drugs to treat your cancer. Unfortunately, that time has come.
We will do everything we can to keep you as comfortable as possible, but we have no proven way to get the cancer back under control.
Women in your situation sometimes choose to be in clinical trials of new drugs.
Brain Metastases – Medical Oncologist
Your cancer has now spread to your central nervous system— brain and/or spinal cord.
While quite effective for treating cancer in other parts of the body, many of the drugs we use to treat HER2-positive breast cancer are not effective in the nervous system. In cases like yours we can often control the cancer, at least for some time, with radiation and/or surgery.
I will continue to use drugs to try to control the cancer in the rest of your body.
I will also set up a consultation with a neurosurgeon plus or minus a radiation oncologist who will be able to discuss way we can deal with the cancer in your brain. We may also speak with a palliative care clinician.
brain Metastases - Neurosurgeon/Radiation Oncologist
When a patient has one or more metastases in the Central Nervous System, we can try to treat it with surgery or radiation, depending, in part, on the size and number of metastases.
When a metastasis is isolated to a few places, we use surgery or direct high-dose radiation to those spots.
We sometimes also provide lower dose radiation to the whole brain since there are often also often small metastases in other areas.
We sometimes use whole brain radiation alone when there are many metastases, plus or minus direct high-dose radiation.
Unfortunately, we can only provide a limited amount of radiation to the brain, and eventually we will not be able to control the cancer in your central nervous system.
The exact course of treatment that I recommend for you is based on the position, size, and location of your central nervous system metastases and other factors specific to you. DATA SUPPLEMENT 7: Consensus Rating Panel Members with Disclosures
Table 1. Consensus Ratings Group members
Consensus Panel Member Institution Specialty
Kimberly L. Blackwell, MD Duke University Medical Center Medical Oncology
G. Thomas Budd, MD Cleveland Clinic Medical Oncology
Fatima Cardoso, MD Champalimaud Cancer Center Medical Oncology
Lisa A. Carey, MD University of North Carolina Medical
Oncology/Hematology Angelo Di Leo, MD, PhD Sandro Pitigliani Medical
Oncology Unit
Medical Oncology
Melissa S. Dillmon, MD Harbin Clinic LLC Medical
Oncology/Hematology Matthew G. Ewend, MD University of North Carolina At
Chapel Hill
Sara A. Hurvitz, MD University of California At Los Angeles Oncology
Medical Oncology
Reshma Jagsi, MD University of Michigan Radiation Oncology
Nora Anita Janjan,
MD,MPSA,MBA,FACP,FAC
Retired Radiation Oncology
Maria C. Katapodi, PhD, FAAN, RN University of Michigan, Division of Acute, Critical, and Long Term Care Nursing
Nursing
Douglas Kondziolka, MD, MSc New York University Neurosurgery
Michael Lim, MD Johns Hopkins Hospital Neurosurgery
Minetta C. Liu, MD Mayo Clinic Cancer Center Medical Oncology
Ingrid A. Mayer, MD, MSc Vanderbilt University Medical Center
Medical
Oncology/Hematology
Lisa Meier McShane, PhD National Cancer Institute Biometric Research
Robert A. Moss, MD Private Practice Medical Oncology
Beverly Moy, MD Massachusetts General Hospital
Gillette Center for Womens Cancers
Medical Oncology
Thomas H. Openshaw, MD Cancer Care of Maine Medical Oncology
Christopher O. Ruud, MD Texas Oncology Medical Oncology
Raymond Sawaya, MD University of Texas MD Anderson
Cancer Center
Neurosurgery
Alexander J. Solky, MD Interlakes Oncology and
Hematology PC
Medical
Oncology/Hematology
Vered Stearns, MD Johns Hopkins Oncology Center Radiation Oncology
Catherine H. Van Poznak, MD University of Michigan Medical Oncology
Gail H. Vance, MD Indiana University School of
Medicine
Medical Molecular Genetics
Dan Sayam Zuckerman, MD Mountain States Tumor Institute Medical
Oncology/Hematology
Wanda Lucas, MBA Georgetown Lombardi
Comprehensive Cancer Center
Table 2.Consensus Ratings Group. Disclosures of Potential Conflicts of Interest
Member Employment or
Leadership Position
Consultant or Advisory
Role Stock Ownership Honoraria Research Funding
Expert
Testimony Other Remuneration Kimberly L. Blackwell Cellgene Genentech Novartis Genomic Health G. Thomas Budd Amgen Exagen Genentech Pfizer Genentech Genomic Health Johnson & Johnson
Genentech Immunicon
Johnson & Johnson Pfizer Sanofi Wyeth Fatima Cardoso Abraxis BioScience AstraZeneca Celgene Eisai GlaxoSmithKline Johnson & Johnson Novartis Pfizer Roche Abraxis BioScience AstraZeneca Celgene Eisai GlaxoSmithKline Johnson & Johnson Novartis Pfizer Roche AstraZeneca Novartis Lisa A. Carey AstraZeneca(U) Blue Cross and Blue Shield of North Carolina Board of Trustees Genentech(U) GlaxoSmithKline(U) Novartis(U) Sanofi (U) Genentech GlaxoSmithKline Sanofi Oncology Abraxis BioScience(B) AstraZeneca Abraxis BioScience(B) AstraZeneca
Pfizer Roche Sanofi Pfizer Roche Sanofi Melissa S. Dillmon Johnson & Johnson(B) Matthew G. Ewend Laurie E. Gaspar Gabriel N. Hortobagyi Allergan Amgen Antigen Express Galena Biopharma Genentech Novartis(U) Novartis Sanofi Novartis Sara A. Hurvitz Novartis, Boehringer Ingelheim, Genentech(U) Roche/Genentech, GSK, sanofi aventis, Novartis
Travel paid for international conferences at which I presented (Novartis, Roche/Genentech)
Reshma Jagsi Eviti(L) Abbott Laboratories
Nora Anita Janjan ASTRO(U, L) Conquer Cancer Foundation(U, L) Conquer Cancer Foundation(U, L) Conquer Cancer Foundation(U, L) National Center for Policy Analysis(U, L) RSNA(U, L) Texas Radiation Advisory Board(U, L) British Petroleum Dunes CMP Healthcare Oncology Publishing
Missouri River Chapter AAPM
Texas Medical Association Physicians Oncology Education Program The ASCO Post US Oncology
Maria C. Katapodi Douglas Kondziolka
North American Gamma Knife Consortium
Michael Lim Stryker
BrainLAB MGI Pharma Stryker Minetta C. Liu Agendia BiPar/sanofi-aventis Eisai Genentech MedImmune Myriad Genetics Veridex Eisai GlaxoSmithKline Veridex Eisai Genentech Geron GlaxoSmithKline Novartis Sanofi Veridex Wanda Lucas Ingrid A.
Mayer Novartis Novartis
Lisa Meier McShane Robert A. Moss Alexion Pharmaceuticals Celgene Genentech Millennium Bristol-Myers Squibb(I) Onyx(B) Pharmacyclics(B) Alexion Pharmaceuticals Genomic Health MGI Pharma Millennium Novartis Pharmion Alexion Pharmaceuticals Boehringer Ingelheim Dendreon Generon Millennium Point Therapeutics Taiho Pharmaceutical Tesaro Beverly Moy Thomas H. Openshaw
Sawaya Alexander J. Solky
Vered Stearns AstraZeneca
Abbott Biotherapeutics Abraxis BioScience Merck Novartis Pfizer Catherine H. Van Poznak Amgen Novartis Gail H. Vance Dan Sayam Zuckerman
DATA SUPPLEMENT 8: Glossary of Terms
Distant brain failure: additional new metastases arising in location separate from original
Local brain failure: metastases treated at time of presentation
Improvement in local control – examples e.g., typically tumor diameter/volume, decrease, stable, increase > 25% REFERENCES (not in the primary guideline)
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2. Fagerlin A, Zikmund-Fisher BJ, Ubel PA: Helping patients decide: ten steps to better risk communication. J Natl Cancer Inst 103:1436-43, 2011
3. Butow PN, Dowsett S, Hagerty R, et al: Communicating prognosis to patients with metastatic disease: what do they really want to know? Support Care Cancer 10:161-8, 2002
4. Hagerty RG, Butow PN, Ellis PA, et al: Cancer patient preferences for communication of prognosis in the metastatic setting. J Clin Oncol 22:1721-30, 2004
5. Lux MP, Bayer CM, Loehberg CR, et al: Shared decision-making in metastatic breast cancer: discrepancy between the expected prolongation of life and treatment efficacy between patients and physicians, and influencing factors. Breast Cancer Res Treat 139:429-40, 2013
6. Ramakrishna N, Temin S, Chandarlapaty S, et al: Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline,. J Clin Oncol, doi
