Achieving Value in Cancer
Care:
ASCO’s Top5 and Beyond
Jeffery C. Ward, M.D.
ASC0 2012 Top 5 Presentation
Thomas J.
Smith, MD
Medical
Oncologist
Sidney Kimmel
Comprehensive
Cancer Center
Baltimore, MD
Douglas W.
Blayney, MD
Derek
Raghavan, MD,
PhD, FACP
Professor of
Medicine,
Medical Oncologist
Stanford
President Levine
University School
Cancer Institute
of Medicine
Charlotte, NC
Ann & John
Doerr Medical
Director, Stanford
University
Cancer Center
Stanford, CA
Patricia A.
Ganz, MD
Therese M.
Mulvey, MD
Professor, UCLA
Schools of
Medicine
& Public Health
Division of Cancer
Prevention and
Control Research
Jonsson
Comprehensive
Cancer Center
Los Angeles, CA
Medical
Oncologist
Southcoast
Center for
Cancer Care
Fall River, MA
ASCO’s Top 5 List
For patients with advanced solid-tumor cancers who are unlikely to benefit,
do not provide unnecessary anticancer therapy, such as chemotherapy, but
instead focus on symptom relief and palliative care.
Do not use PET, CT and radionuclide bone scans in the staging of early
prostate cancer at low risk for metastasis.
Do not use PET, CT and radionuclide bone scans in the staging of early
breast cancer at low risk for metastasis.
For individuals who have completed curative breast cancer treatment
and have no physical symptoms of cancer recurrence, routine blood
tests for biomarkers and advanced imaging tests should not be used to
screen for cancer recurrences.
Avoid administering colony stimulating factors (CSFs) to patients
undergoing chemotherapy who have less than a 20 percent risk for
febrile neutropenia
Do Not Routinely Give Chemotherapy to Patients
with Poor Performance Status (PS), ECOG 3 or 4
 Patients with poor PS have more toxicity and markedly less
chance of response.
 Not every cancer, but for most patients with solid tumors,
ASCO and National Comprehensive Cancer Network (NCCN)
guidelines call for a switch to palliative (non-chemotherapy)
care when the ECOG PS ≥ 3.
- ECOG 3 is “in bed or chair more than 50% of the time.”
- Simple question:
“Did this person walk unaided into clinic?”
Do Not Routinely Give Chemotherapy to Patients
with Poor Performance Status (PS), ECOG 3 or 4
 Exceptions
- patients with functional limitations caused by other conditions
-
that result in a low performance status (PS) or
those with disease characteristics (e.g., mutations) that suggest
a high likelihood of response to therapy.
 Changing the focus to symptom control should be
accompanied by appropriate palliative and hospice care.
Do Not Routinely Give Chemotherapy to Patients
with Poor Performance Status (PS), ECOG 3 or 4
 This is disease specific
‒ With breast cancer, eribulin improved overall survival from 10.6
to 13.1 months compared to alternative 4th line treatments.
‒ But with NSCLC the chance of response is small, only 2% with
3rd line, and 0% with 4th line chemotherapy, with no OS benefit.
 In general for patients with solid tumors nth line chemotherapy
will be toxic, rarely helpful, expensive, and avoid planning for
transitions to hospice.
Do Not Routinely Give Chemotherapy to Patients
with Poor Performance Status (PS), ECOG 3 or 4
 The NCCN and ACSO NSCLC guidelines recommend nonchemotherapy based palliative care if the PS is ≥ 3.
 The NCCN breast cancer guidelines suggest no further
cytotoxic therapy and transition to palliative care when the
cancer has had no response to 3 sequential regimens.
 ASCO has always recommended that treatment not be given
unless there is a definable benefit.
Solutions:
Documentation, and Use QOPI
 Always document ECOG PS.
 Use QOPI to monitor practice
patterns about chemotherapy
near the end of life.
 When oncologists were given
feedback about their own
practice patterns,
chemotherapy near the end of
life dropped from 50% to 20%.
Blayney D, et al. JCO 2009
Conclusions
 Patients with poor performance status or resistant disease rarely
benefit from chemotherapy near the end of life, and do suffer toxicity.
 Routinely measure the # of “lines” of treatment and response, and
the ECOG PS.
 Have a hospice information visit earlier in the disease course, with 3
to 6 months to live, to include hospice as an ASCO-recommended
best practice and to make the transition easier.
Don’t Perform PET, CT and Bone Scan in Breast
Cancer Patients at Low Risk for Metastases
 Key to determining studies is the careful history and physical





examination.
Probe for symptoms suggesting metastases.
Probe for signs of locally advanced breast cancer.
Decision for imaging studies outside guidelines or clinical trial
should be carefully reviewed with the patient, and based on her
symptoms and her physical findings.
Non-indicated scans can lead to unnecessary anxiety, testing and
morbidity.
In the era of effective adjuvant therapy, micro metastases are likely
to be effectively treated.
Conclusions
 No evidence of survival improvement.
 No benefit in asymptomatic individuals with newly identified ductal
carcinoma in situ (DCIS), or clinical stage I or II breast cancer.
 Can lead to harm through
-
Unnecessary invasive procedure
over-treatment,
unnecessary radiation exposure, and
misdiagnosis.
Features of Localized Prostate Cancer
 Most cases at low risk of metastasis:
‒ Bone
‒ Nodes
 More than 50% of men older than 65 years of age have
clinically silent presence of prostate cancer – it doesn’t harm
most of these men.
 Many cases of prostate cancer deteriorate slowly or not at all.
 There are predictors of rapid growth and spread of prostate
cancer, which physicians use to help plan the approach to
testing and treatment.
Definition of Low-risk Prostate Cancer
 Criteria that Correlate with Negative Staging Tests:




Absence of Symptoms
T1 tumors (status of T2 tumors?)
PSA < 10 ng/ml at presentation
Gleason’s Score of ≤ 6
Experience with Unnecessary Staging Tests for
Prostate Cancer
Palvolgyi, et al. (2011)
Choi, et al. (2011)
1,598 men studied
6,444 men studied
519 with low-risk CAP had
bone scans
PSA < 10 ng/ml
CS T1-T2
Gleason score < 7
2,330 (36%) had multiple scans
132 underwent bone scans
0 positive
Palvolgyi et al. Urology 2011; 77:1330-1336
Choi et al. J. Urol., 2011, 185: 1645-1649
Only 1% positive
Consistent with international
results
NO consistent pattern of test –
geographic variation
Increase with social/economical
status
Income
Greater high school education
Experience with Unnecessary Staging Tests for
Prostate Cancer
Lavery et al. (2011)
677 men with low risk CAP
48% had 1 study
30% had 2 studies
3% had 3 studies
349 had no imaging
96% of CT scans were negative (0
positive at surgery)
Institutional Charges:
CT a/p:
$1,480
Bone scan: $512
MRI:
$2,500
Medicare Reimburse:
CT a/p:
$976.98
Bone scan: $299.01
MRI:
$823.32
0 changes in clinical management from
scans
328 patients
Imaging: $644,392
Surgery: $654,507
Lavery et al. Urology, 2011, 77: 274-279.
Conclusions
 Low-risk early-stage prostate cancer, defined by PSA < 10
ng/ml and Gleason’s score < 6, has a low risk of metastasis.
 Staging tests do not improve outcomes of treatment for this
clinical problem.
 Extensive staging is:
– Unnecessary
– Expensive
– Exposes patients to unnecessary radiation.
Surveillance Testing after Curative Treatment of
Breast Cancer
 Serum Tumor Markers and Imaging
 What is the role of a surveillance test in cancer follow-up, and
when does it ad value for patient outcomes or mortality?
 What do we know about surveillance in breast cancer patients
treatment with curative intent?
 What follow-up strategies are recommended for this patient
population?
What Do We Know About Surveillance Testing
after Breast Cancer
 Data from clinical trials, conducted in the 1980’s and 1990’s
demonstrated that routine monitoring with chest films, radionuclide
liver and bone scans did detect a recurrence earlier than clinical
evaluation, and was abandoned as part of routine follow-up.
 Two randomized trials conducted in the 1990’s did not find a
difference in survival outcomes for women who had routine clinical
office visits and mammograms compared to women who had more
intensive monitoring with blood work, chest films, scans and
ultrasounds.
ASCO Guideline 2006
Rojas et al. Cochrane Review 2005
What Do we Know About Surveillance Testing after
Breast Cancer
 Tumor markers used in breast cancer monitoring (CEA, CA 15-3, CA
27.29) have not been shown in randomized trials to effect survival
outcome, i.e. that detection of recurrence earlier makes a difference.
 The rate of false negative or false positive findings for these markers
is not known.
 Normal or abnormal tumor marker results can contribute to false
reassurance or increased anxiety for patients, as well as
unnecessary medical evaluations.
What about Imaging Tests?
Chest and abdominal CT scans or whole-body PET
scans have not been evaluated as surveillance
strategies for follow-up of early-stage breast cancer.
With the low prevalence of distant recurrence in earlystage breast cancer, and the high risk of false positive
and incidental findings, there is no evidence to support
the use of routing imaging tests.
What Should I Advise My Patient Who Has Had
Curative Treatment for Breast Cancer
 Report any new or persistent symptoms (e.g. cough, pain, new
lumps, dyspnea) for medical evaluation.
 Have regular oncology follow-up visits every 3-6 months in the first
three years; every 6 months for the next 2 years.
 Have annual follow-ups after 5 years that can be continued with a
primary care provider, ensuring that a breast examination and
mammogram are done annually.
 Don’t have routine blood work for breast cancer monitoring after
initial treatments.
 Have bone density monitoring and lipid measurements if aromatase
inhibitor therapy is taken.
Conclusions
 Don’t perform surveillance testing (biomarkers) or imaging (PET,
CT and radionuclide bone scans) for asymptomatic individuals who
have been treated for breast cancer with curative intent.
 Do perform regular interval history and physical examinations,
including clinical breast examination, and schedule annual breast
mammograms.
 Do promptly evaluate any clinical symptoms that are suspicious for
a recurrence, using blood work, tumor markers and imaging as
appropriate.
Eliminate the Use of White Cell Stimulating Factors in
Patients Who Are Not at High Risk for this Complication
Febrile Neutropenia (FN) is a life threatening emergency.
‒Increased cost associated with treatment of febrile neutropenia.
‒Morbidity can be significant.
‒Mortality ranges from 10%-90% depending on associated comorbidities.
Granulocyte Colony Stimulating Factors (G-CSFs) reduce the
duration and severity of febrile neutropenia.
‒Increased cost with use of these agents.
‒Decreased morbidity and mortality with use of G-CSFs.
What is appropriate use?
Guidelines
2006 ASCO Guideline: Use Granulocyte Colony
Stimulating Factors (G-CSFs) when the risk of febrile neutropenia is
greater than 20%.
“In some situations, primary prophylaxis with CSFs is essential and
recommended to alleviate the toxicity of certain ‘dose dense’
chemotherapy regimens”.
Factors that increase risk of FN greater than 20%
Age greater than 65
Poor performance status
Prior episodes of FN
Prior chemotherapy or radiation
Poor nutritional status
Other comorbidities
Risk Stratification
High risk of FN – greater than 20% risk
Most non-Hodgkin Lymphoma regimens
Dose dense AC-T
Intermediate risk of FN – 10%-20%
Most doublets for adjuvant lung cancer
Low risk of FN – less than 10%
Most palliative single agents for solid tumors
Conclusions
 Granulocyte Colony Stimulating Factors (G-CSFs) are essential to
deliver correct dose and schedule to patients with solid tumors in
some settings in the curative intent.
‒ Dose dense AC-T
 Individualized therapy in curative intent setting for other solid tumors
and NHL.
 Currently more than half of all patients receiving G-CSFs are being
given them in an inappropriate manner based on evidence and
guidelines.
‒ Goldilocks Phenomenon
 Cost is escalating:
Peg-filgrastim $4,800 per dose.
Unsustainable.
Facilitating Accountability
Fundamental assumption: the EMR
ASCO quality improvement efforts:
– Quality Oncology Practice Initiative (QOPI)
– CancerLink-ASCO rapid learning initiativedata in real time
– Metrics: review metrics with oncologists
Payers provide incentive for practice
patterns that enhances value
Reactions by Stakeholders
(anecdotal-not necessarily representative)
Physicians: oncologists quite supportive-”it
assists me in the exam room”
Patients: “does this mean grandma can’t get
her last chance?”
– Advocates: skeptical but understanding, and do
get the big picture
Payers: Supportive but quietly so
Industry: do not get in the way of genomic
analysis, and accessibility to targeted
therapies
ASCO’s Task Force: Current/Future
Initiatives
Broad educational initiatives:
– Patients: CancerNet
– Professionals: Journal articles,
Commentaries, Educational Programming,
Physician Advisory Tool
Integrate the Top 5 into QOPI and start
measuring impact of change
Develop Top 6-10
Tackle high cost/low value drugs
Challenges to Move the Needle
Economic imperatives: eliminate misaligned
incentives between physicians and payers
– Advocate for new models of compensation
emphasize value (optimized health outcomes for lowest
cost)
adherence to guidelines which, in the presence of high
value evidence can yield to pathways
Reward good performance
– Essential to assure practice environments with
adequate infrastructure to deliver high value care
Oncology “homes”