breast cancer clinical pathway ... - s3.amazonaws.com2017+slides/live... · simulation • the...
TRANSCRIPT
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Breast Cancer Clinical Pathway
Committee Development
Meeting
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Agenda
Start Time Topic
8:10 am – 8:20 am Welcome, Introductions, and Objectives for the Session
8:20 am – 8:35 am Value-based Care in Breast Cancer Treatment
8:35 am – 8:45 am Welcome, Introductions, and Objectives for the Panelists
8:45 am – 9:00 am Background and Experience of Panelists
9:00 am – 9:15 am Current State of Breast Cancer
9:15 am – 9:55 am Review of Current Treatments for Metastatic Breast Cancer
9:55 am – 10:10 am Break
10:10 am – 10:25 am Q&A Session
10:25 am – 10:50 am Considerations During Pathway Development
10:50 am – 11:20 am Pathway Development for First-line Metastatic Breast Cancer
11:20 am – 11:50 am Pathway Development for Second-line Metastatic Breast Cancer
11:50 am – 12:10 pm Wrapup: Breast Cancer Treatment Pathway and Q&A
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Objectives
• Observe the development of a clinical pathway for
breast cancer
• Gain an understanding of the steps involved in
developing a clinical pathway
• Understand the variables factored into clinical pathway
development
• Witness the dialogue and discussion involved in
creating a clinical pathway
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Simulation
• The exercise you are about to observe is a simulation of a
pathway development process in breast cancer
• Clinical pathways are intended to streamline physician
prescribing patterns to improve patient outcomes while also
reducing the overall cost of care
• The steering committee for pathway generation involves
clinicians with both breadth and depth of knowledge and
experience with the particular cancer type, in this case,
breast cancer
• This program is typically double-blinded, meaning the
sponsor does not know the panel and the panel does not
know the sponsor to ensure candid and honest feedback
and discussion
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Mock Pathway
• The mock pathway simulation was developed to increase
transparency of the clinical pathway development process for
interested stakeholders
• To remove any bias from the mock pathways steering
committee clinical decision making, the programs have
historically been double-blinded in which the steering
committee members are blinded to the interested stakeholder
and the stakeholder is blinded to the specifics of the
participants
• This program is being recorded for the purposes of producing a
final report, after which the recording will be destroyed
• It is the intent of this design to generate candid feedback
regarding your opinions and experience
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Value-based Care in Breast Cancer Treatment
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Switch from Volume-based to Value-based Care: Improving Patient Health Outcomes while Reducing Cost
Adapted from: American Hospital Association. http://www.hpoe.org/second-curve.shtml. Accessed
August 31, 2017.
Volume-based Value-based
• Value = outcomes/cost
• Payment rewards population
value: quality and efficiency
• Quality impacts reimbursement
• Partnerships with shared risk
• Increased patient severity
• IT utilization essential for
population health management
• Scale increases in importance
• Realigned incentives,
encouraged coordination
• Fee-for-service reimbursement
• High quality not rewarded
• No shared financial risk
• Acute inpatient hospital focus
• IT investment incentives not
seen by hospital
• Standalone care systems can
thrive
• Regulatory actions impede
hospital-physician collaboration
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Value-based Care Reimbursement
APM = alternative payment model; MIPS = merit-based incentive payment system; QP = quality
payment.
The Society for Post-Acute and Long-Term Care Medicine. 2015. https://paltc.org/macra.
Accessed August 31, 2017.
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Oncology Care Model (OCM)
https://innovation.cms.gov/Files/slides/ocm-overview-slides.pdf
Improve health outcomes and produce higher quality and lower cost of oncology care through improvements in patient-centered
comprehensive care
Comprehensive coordinated cancer care
24/7 access to care
Patient navigation
Improve care coordination
Care management
payment
Enhanced payments
Episode based
Performance based
Quality improvement
driven by data
Application of meaningful and timely
data
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OCM Payment Model
• Based on the difference between the expected costs and the actual costs of an individual practice
• Practices must report on quality, communication, coordination, experience, and outcomes
• Must exceed minimum quality threshold to be eligible for payment
Medicare
Fee-for-
Service
Payments
Episode-
based
Payment
Performance-
based
Payment
Total
Payment
• $160 per month per
beneficiary for the
6-month period
beginning with
chemotherapy initiation
• Intended to finance care
transformation
requirements
https://innovation.cms.gov/Files/slides/ocm-overview-slides.pdf
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Welcome Panelists
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Objectives
• Discuss current treatment guidelines for breast cancer
• Characterize how breast cancer pathways are adopted into
clinical practices
• Identify the critical pieces of information that are used to
develop the pathway and any gaps in information
• Determine the likelihood of pathway implementation
• Discuss the impact of cost on pathway
• Achieve consensus on a metastatic breast cancer systemic
treatment pathway
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Agenda
Start Time Topic
8:35 am – 8:45 am Welcome, Introductions, and Objectives for the Panelists
8:45 am – 9:00 am Background and Experience of Panelists
9:00 am – 9:15 am Current State of Breast Cancer
9:15 am – 9:55 am Review of Current Treatments for Metastatic Breast Cancer
9:55 am – 10:10 am Break
10:10 am – 10:25 am Q&A Session
10:25 am – 10:50 am Considerations During Pathway Development
10:50 am – 11:20 am Pathway Development for First-line Metastatic Breast Cancer
11:20 am – 11:50 am Pathway Development for Second-line Metastatic Breast Cancer
11:50 am – 12:10 pm Wrapup: Breast Cancer Treatment Pathway and Q&A
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Simulation
• The purpose of this exercise is to simulate a national payer-
sponsored pathway development process in breast cancer
• Based on your experience, you have been selected as a
network member to serve on the steering committee to
create the pathway
• The sponsoring payer’s intent is for this to be a cooperative
pathway development process that takes into account
efficacy, toxicity, cost, and quality
• The audience is interested in not only observing the
academic process of pathway development, but also your
insight regarding barriers and incentives for network
provider pathway adoption
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Mock Pathway
• The mock pathway simulation was developed to increase
transparency of the clinical pathway development process
for interested stakeholders
• To remove any bias from the mock pathways steering
committee clinical decision making, the programs have
historically been double-blinded, in which the steering
committee members are blinded to the interested
stakeholder and the stakeholder is blinded to the specifics
of the participants
• This program is being recorded for the purposes of
producing a final report, after which the recording will be
destroyed
• It is the intent of this design to generate candid feedback
regarding your opinions and experience
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Introductions
To be in accord with this design, please refrain from using personal or practice
identifiers. Identify with first name, practice region, and practice category.
• What size is your practice?
– Solo practice, small practice (2-5 physicians), medium practice (6-10 physicians),
large practice (>10 physicians)
• In what region is your practice located?
– Northeast, Mid-Atlantic, Southeast, Southwest, Mountain, West
• What best describes your practice?
– Privately held group practice, IPA in partnership with a hospital, fully owned by a
hospital, academic practice
• How many years have you been in practice?
– ≤5, 6-10, 11-15, 16-20, ≥21
• How many unique patients with breast cancer do you actively manage in a
typical week?
• Briefly, what has been your experience in developing
clinical pathways in your practice and/or with payers?
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Current State of Breast Cancer
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Disease Overview
• 12% of women will be diagnosed with invasive breast cancer
• Only 15% of women with breast cancer have a family history of the disease and only 5%-10% are linked to known familial inherited gene mutations
– BRCA1 mutations are frequently associated with triple-negative breast cancers
• Breast cancer classifications:
http://www.breastcancer.org/symptoms/understand_bc/statistics Accessed Sept. 5, 2017.
http://www.breastcancer.org/symptoms/types/molecular-subtypes Accessed Sept. 5, 2017.
Subtype HR status HER2 status Prognosis
Luminal A HR+ HER2- Good
Luminal B HR+ HER2+ or HER2- Intermediate/Poor
HER2 type HR- HER2+ or HER2- Poor
Basal-like/Triple-negative HR- HER2- Poor
HR = hormone receptor (estrogen-receptor and/or progesterone receptor).
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Breast Cancer: Incidence by Subtype
73%
12%
10%
5%
HR+/HER2- HR-/HER2- HR+/HER2+ HR-/HER2+
Kohler BA, et al. J Natl Cancer Inst. 2015;107(6):djv048.
N = 178,125
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Treatment of Stage IV Breast Cancer
Systemic
disease or
de novo
stage IV
Bone
disease
present
Bone disease not
present
Add
bone-
modifying
agent
HR+/HER2+
HR+/HER2-
HR-/HER2+
HR-/HER2-
Molecular
profiling
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Breast Cancer NCCN Evidence
Blocks 2.2017.
https://www.nccn.org/professionals/physician_gls/pdf/breast_blocks.pdf Accessed Sept. 5, 2017.
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Breast Cancer: Survival by Subtype
Gong Y, et al. Sci Rep. 2017;7:45411. doi: 10.1038/srep45411.
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Part 1: Focus on Triple-negative Breast Cancer (TNBC)
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NCCN Guidelines: Adjuvant Therapy for HER2- Disease
Preferred Regimens
Dose Dense AC (doxorubicin/cyclophosphamide)
followed by weekly paclitaxel
Dose Dense AC (doxorubicin/cyclophosphamide)
followed by paclitaxel every 2 weeks
TC (docetaxel and cyclophosphamide)
Other Regimens
Dose Dense AC (doxorubicin/cyclophosphamide)
AC (doxorubicin/cyclophosphamide)
CMF (cyclophosphamide/methotrexate/fluorouracil)
AC followed by docetaxel every 3 weeks
AC followed by weekly paclitaxel
EC (epirubicin/cyclophosphamide)
TAC (docetaxel/doxorubicin/cyclophosphamide)
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Breast Cancer
NCCN Evidence Blocks 2.2017.
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GeparSixto Trial: Addition of Carboplatin to Neoadjuvant Therapy for Early TNBC
• Stage II-III triple-
negative breast
cancer
• Previously untreated
• Non-metastatic
carboplatin
AUC 2 min/mL weekly
+
paclitaxel
80 mg/m2 once per week
non-pegylated liposomal doxorubicin
20 mg/m2 once per week
bevacizumab
15 mg/kg IV every 3 weeks
paclitaxel
80 mg/m2 once per week
non-pegylated liposomal doxorubicin
20 mg/m2 once per week
bevacizumab
15 mg/kg IV every 3 weeks
Von Minckwitz G, et al, Lancet Oncol. 2014;15(7):747-756.
N=291
Randomize
1:1
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GeparSixto Trial: Secondary Analysis of BRCA Germline Mutation Cohort
Plus Carboplatin
(n=146)
Noncarboplatin
(n=145)
pCR 57% 41%
BRCA 1/2 mutation cohort
BRCA 1/2 mutation (n=50) 18% 17%
pCR 66% 67%
No BRCA 1/2 mutation cohort
pCR 55% 36%
Hahnen E, et al, JAMA Oncol. 2017 Jul 13. doi: 10.1001/jamaoncol.2017.1007.
[Epub ahead of print]
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NCCN Guidelines: Treatment of mTNBC
ER-, PR- and HER2-
(mTNBC) Chemotherapy
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Breast Cancer
NCCN Evidence Blocks 2.2017.
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Recently-approved Breast Cancer Therapies
http://www.fda.gov
Therapy Approval Date
Kisqali (ribociclib) 3/2017
Ibrance (palbociclib) 2/2015
Kadcyla (ado-trastuzumab emtansine) 2/2013
Afinitor (everolimus) 7/2012
Perjeta (pertuzumab injection) 6/2012
(None approved for TNBC)
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NCCN Guidelines: Recurrent or Metastatic Breast Cancer for HER2- Disease
Preferred Single Agents
Doxorubicin
Pegylated liposomal doxorubicin
Paclitaxel
Capecitabine
Gemcitabine
Vinorelbine
Eribulin
Other Single Agents
Cyclophosphamide
Carboplatin
Docetaxel
Albumin-bound paclitaxel
Cisplatin
Epirubicin
Ixabepilone
Combinations
CAF/FAC (cyclophosphamide/doxorubicin/fluorouracil)
FEC (fluorouracil/epirubicin/cyclophosphamide)
AC (doxorubicin/cyclophosphamide)
EC (epirubicin/cyclophosphamide)
CMF (cyclophosphamide/methotrexate/fluorouracil)
Docetaxel/capecitabine
GT (gemcitabine/paclitaxel)
Gemcitabine/carboplatin
Paclitaxel/bevacizumab
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Breast Cancer
NCCN Evidence Blocks 2.2017.
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NCCN Evidence Blocks Value Measures
http://www.nccn.org/evidenceblocks. Accessed August 31, 2017.
• Visual representation of “value” based on 5 key measures:
– (E) – Efficacy of Regimen/Agent
o Highly effective to palliative
– (S) – Safety of Regimen/Agent
o No meaningful toxicity to highly toxic
– (Q) – Quality of Evidence
o High-quality evidence to poor-quality/no evidence
– (C) – Consistency of Evidence
o Highly consistent (multiple trials) to anecdotal evidence only
– (A) – Affordability of Regimen/Agent (includes drug cost, supportive
care, infusions, toxicity monitoring, management of toxicity)
o Very inexpensive to very expensive
• Score of 1-5 for each category with 1 being the least favorable and 5
the most favorable, determined by NCCN panel members based on
their knowledge and clinical experience
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NCCN Evidence Blocks (Categories & Definitions)
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Breast Cancer NCCN Evidence
Blocks 2.2017.
.
Efficacy of Regimen/Agent
5 Highly effective: Cure likely and often provides long-term
survival advantage
4 Very effective: Cure unlikely but sometimes provides long-term
survival advantage
3 Moderately effective: Modest impact on survival, but often
provides control of disease
2 Minimally effective: No, or unknown impact on survival, but
sometimes provides control of disease
1 Palliative: Provides symptomatic benefit only
Safety of Regimen/Agent
5 Usually no meaningful toxicity: Uncommon or minimal
toxicities; no interference with activities of daily living (ADLs)
4 Occasionally toxic: Rare significant toxicities or low-grade
toxicities only; little interference with ADLs
3 Mildly toxic: Mild toxicity that interferes with ADLs
2
Moderately toxic: Significant toxicities often occur but life
threatening/fatal toxicity is uncommon; interference with ADLs is
frequent
1 Highly toxic: Significant toxicities or life threatening/fatal toxicity
occurs often; interference with ADLs is usual and severe
Quality of Evidence
5 High quality: Multiple well-designed randomized trials and/or meta-analyses
4 Good quality: One or more well-designed randomized trials
3 Average quality: Low quality randomized trial(s) or well-designed non-
randomized trial(s)
2 Low quality: Case reports or extensive clinical experience
1 Poor quality: Little or no evidence
Consistency of Evidence
5 Highly consistent: Multiple trials with similar outcomes
4 Mainly consistent: Multiple trials with some variability in outcome
3 May be consistent: Few trials or only trials with few patients, whether randomized
or not, with some variability in outcome
2 Inconsistent: Meaningful differences in direction of outcome between quality trials
1 Anecdotal evidence only: Evidence in humans based upon anecdotal experience
Affordability of Regimen/Agent (includes drug cost, supportive care, infusions,
toxicity monitoring, management of toxicity)
5 Very inexpensive
4 Inexpensive
3 Moderately expensive
2 Expensive
1 Very expensive
5
4
3
2
1
E = 4
S = 4
Q = 3
C = 4
A = 3
E S Q C A
Example Evidence Block
5
4
3
2
1
E = Efficacy of Regimen/Agent
S = Safety of Regimen/Agent
Q = Quality of Evidence
C = Consistency of Evidence
A = Affordability of Regimen/Agent
E S Q C A
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NCCN Guidelines: Recurrent or Metastatic Breast Cancer for HER2- Disease
A = Affordability of Regimen/Agent; C = Consistency of Evidence; E = Efficacy of Regimen/Agent;
Q = Quality of Evidence, S = Safety of Regimen/Agent.
Preferred Single Agents
Doxorubicin
Pegylated Liposomal
Doxorubicin Paclitaxel Capecitabine
Gemcitabine Vinorelbine Eribulin
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
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NCCN Guidelines: Recurrent or Metastatic Breast Cancer for HER2- Disease
Cyclophosphamide Carboplatin Docetaxel
Albumin-bound
paclitaxel
Cisplatin Epirubicin Ixabepilone
Other Single Agents
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
A = Affordability of Regimen/Agent; C = Consistency of Evidence; E = Efficacy of Regimen/Agent;
Q = Quality of Evidence, S = Safety of Regimen/Agent.
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NCCN Guidelines: Recurrent or Metastatic Breast Cancer for HER2- Disease
Combinations
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
5
4
3
2
1
E S Q C A
Docetaxel/
Capecitabine
GT
(gemcitabine/
paclitaxel)
Gemcitabine/
Carboplatin
Paclitaxel/
Bevacizumab
FEC
(fluorouracil/
epirubicin/
cyclophosphamide)
AC
(doxorubicin/
cyclophosphamide)
EC
(epirubicin/
cyclophosphamide)
CAF/FAC
(cyclophosphamide/
doxorubicin/
fluorouracil)
CMF
(cyclophosphamide/
methotrexate/
fluorouracil)
A = Affordability of Regimen/Agent; C = Consistency of Evidence; E = Efficacy of Regimen/Agent;
Q = Quality of Evidence, S = Safety of Regimen/Agent.
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Break
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Q&A Session
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Welcome Back Panelists
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Considerations During Pathway Development
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Pathway Development
Collaboration between payer and provider:
• Develop pathway based on currently available
treatments
• Discuss what factors are associated with treatment
preferences and inclusion/exclusion (eg, efficacy, safety,
practice economics, patient burden, MOA, disease
characteristics, etc)
• Facilitate participating physician consensus using the
highest level of evidence
• Intent to define minimum regimens to cover 80% of
eligible patients
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Pathway Development (Cont’d)
Collaboration between payer and provider:
• Allow room for individualized medicine and physician
discretion for best clinical practice
• Provide an efficient means of measuring and
communicating compliance
• Identify potential issues with pathway
adoption/compliance overall and with specific therapies
• Provide incentive for compliance, creating a win-win-win
scenario for patients, physicians, and the payer
• All pathways validated by external sources such as
ASCO, NCCN, etc
ASCO = American Society of Clinical Oncology.
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The Golden Rules
• Choice of treatment should always be guided by
efficacy if clinically relevant
• If efficacy between therapeutic alternatives is equal,
then toxicity might drive choice
• When efficacy and toxicity are similar among regimens,
economics should drive utilization
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General Rules of Pathways
• A clinical trial is always compliant and the preferred
therapy when available
• Palliative care and hospice are reasonable at any time
for the appropriate patient
• It is expected and is good clinical medicine for up to
20% of patients to be treated off pathways
• The treatment provided should be consistent with the
intent of the pathway
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Pathway Development for Metastatic Triple-negative Breast Cancer
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Pathway Creation First-line mTNBC
• What are the most important parameters that you consider
for patients with mTNBC?
– Overall survival
– PFS
– Response rate
– Time to response
– Duration of response
– Depth of response
– Toxicity
– Symptom relief
– Sites of metastases
– Other
mTNBC = metastatic triple-negative breast cancer; PFS = progression-free survival.
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Pathway Creation First-line mTNBC (Cont’d)
• What is the role of sequential single-agent versus
combination chemotherapy?
• What is the impact of adjuvant therapy selection on choice
for metastatic treatment?
• What is the impact of adjuvant therapy response on choice
for metastatic treatment?
mTNBC = metastatic triple-negative breast cancer.
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NCCN Guidelines: Recurrent or Metastatic Breast Cancer for HER2- Disease
Preferred Single Agents
Doxorubicin
Pegylated liposomal doxorubicin
Paclitaxel
Capecitabine
Gemcitabine
Vinorelbine
Eribulin
Other Single Agents
Cyclophosphamide
Carboplatin
Docetaxel
Albumin-bound paclitaxel
Cisplatin
Epirubicin
Ixabepilone
Combinations
CAF/FAC (cyclophosphamide/doxorubicin/fluorouracil)
FEC (fluorouracil/epirubicin/cyclophosphamide)
AC (doxorubicin/cyclophosphamide)
EC (epirubicin/cyclophosphamide)
CMF (cyclophosphamide/methotrexate/fluorouracil)
Docetaxel/capecitabine
GT (gemcitabine/paclitaxel)
Gemcitabine/carboplatin
Paclitaxel/bevacizumab
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Breast Cancer
NCCN Evidence Blocks 2.2017.
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Pathway Creation Second-line mTNBC
• What is the impact of response to first-line therapy?
• What is the impact of tolerance to first-line therapy?
• What is the impact of sites of metastases?
• What is the impact of performance status?
• What is the role of sequential single-agent vs combination
chemotherapy?
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Wrapup: Breast Cancer
Treatment Pathway
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Questions?