Achieving Value in Cancer Care: ASCO’s Top5 and Beyond

Achieving Value in Cancer Achieving Value in Cancer Care:Care:

ASCO’s Top5 and BeyondASCO’s Top5 and Beyond

Jeffery C. Ward, M.D.Jeffery C. Ward, M.D.

ASC0 2012 Top 5 PresentationASC0 2012 Top 5 Presentation

Thomas J. Smith, MD

Medical Oncologist

Sidney Kimmel Comprehensive Cancer CenterBaltimore, MD

Douglas W. Blayney, MD

Professor of Medicine, Stanford

University School of MedicineAnn & John

Doerr Medical Director, Stanford

University Cancer CenterStanford, CA

Derek Raghavan, MD,

PhD, FACPMedical OncologistPresident Levine Cancer InstituteCharlotte, NC

Patricia A. Ganz, MD

Professor, UCLA Schools of Medicine

& Public Health Division of Cancer

Prevention and Control Research

Jonsson Comprehensive Cancer Center

Los Angeles, CA

Therese M. Mulvey, MD

Medical OncologistSouthcoast Center for

Cancer CareFall River, MA

ASCO’s Top 5 ListASCO’s Top 5 List

For patients with advanced solid-tumor cancers who are unlikely to benefit, For patients with advanced solid-tumor cancers who are unlikely to benefit, do not provide unnecessary anticancer therapy, such as chemotherapy, but do not provide unnecessary anticancer therapy, such as chemotherapy, but instead focus on symptom relief and palliative care. instead focus on symptom relief and palliative care.

Do not use PET, CT and radionuclide bone scans in the staging of early Do not use PET, CT and radionuclide bone scans in the staging of early prostate cancer at low risk for metastasis. prostate cancer at low risk for metastasis.

Do not use PET, CT and radionuclide bone scans in the staging of early Do not use PET, CT and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis. breast cancer at low risk for metastasis.

For individuals who have completed curative breast cancer treatment For individuals who have completed curative breast cancer treatment and have no physical symptoms of cancer recurrence, routine blood and have no physical symptoms of cancer recurrence, routine blood tests for biomarkers and advanced imaging tests should not be used to tests for biomarkers and advanced imaging tests should not be used to screen for cancer recurrences. screen for cancer recurrences.

Avoid administering colony stimulating factors (CSFs) to patients Avoid administering colony stimulating factors (CSFs) to patients undergoing chemotherapy who have less than a 20 percent risk for undergoing chemotherapy who have less than a 20 percent risk for febrile neutropenia febrile neutropenia

Do Not Routinely Give Chemotherapy to Patients Do Not Routinely Give Chemotherapy to Patients with Poor Performance Status (PS), ECOG 3 or 4with Poor Performance Status (PS), ECOG 3 or 4

Patients with poor PS have more toxicity and markedly less Patients with poor PS have more toxicity and markedly less chance of response.chance of response.

Not every cancer, but for Not every cancer, but for most patients with solid tumorsmost patients with solid tumors, , ASCO and National Comprehensive Cancer Network (NCCN) ASCO and National Comprehensive Cancer Network (NCCN) guidelines call for a switch to palliative (non-chemotherapy) guidelines call for a switch to palliative (non-chemotherapy) care when the ECOG PS ≥ 3.care when the ECOG PS ≥ 3.- ECOG 3 is “in bed ECOG 3 is “in bed or chairor chair more than 50% of the time.” more than 50% of the time.”

- Simple question: Simple question: “Did this person walk unaided into clinic?” “Did this person walk unaided into clinic?”


ExceptionsExceptions- patients with functional limitations caused by other conditions patients with functional limitations caused by other conditions

that result in a low performance status (PS) or that result in a low performance status (PS) or

- those with disease characteristics (e.g., mutations) that suggest those with disease characteristics (e.g., mutations) that suggest a high likelihood of response to therapy. a high likelihood of response to therapy.

Changing the focus to symptom control should be Changing the focus to symptom control should be accompanied by appropriate palliative and hospice care.accompanied by appropriate palliative and hospice care.


This is disease specificThis is disease specific‒ With breast cancer, eribulin improved overall survival from 10.6 With breast cancer, eribulin improved overall survival from 10.6

to 13.1 months compared to alternative 4to 13.1 months compared to alternative 4thth line treatments. line treatments.

‒ But with NSCLC the chance of response is small, only 2% with But with NSCLC the chance of response is small, only 2% with 33rdrd line, and 0% with 4 line, and 0% with 4thth line chemotherapy, with no OS benefit. line chemotherapy, with no OS benefit.

In general for patients with solid tumors nth line chemotherapy In general for patients with solid tumors nth line chemotherapy will be toxic, rarely helpful, expensive, and avoid planning for will be toxic, rarely helpful, expensive, and avoid planning for transitions to hospice.transitions to hospice.


The NCCN and ACSO NSCLC guidelines recommend non-The NCCN and ACSO NSCLC guidelines recommend non-chemotherapy based palliative care if the PS is ≥ 3.chemotherapy based palliative care if the PS is ≥ 3.

The NCCN breast cancer guidelines suggest no further The NCCN breast cancer guidelines suggest no further cytotoxic therapy and transition to palliative care when the cytotoxic therapy and transition to palliative care when the cancer has had no response to 3 sequential regimens.cancer has had no response to 3 sequential regimens.

ASCO has ASCO has alwaysalways recommended that treatment not be given recommended that treatment not be given unless there is a definable benefit.unless there is a definable benefit.

Solutions: Solutions: Documentation, and Use QOPIDocumentation, and Use QOPI

Always document ECOG PS.Always document ECOG PS.

Use QOPI to monitor practice Use QOPI to monitor practice patterns about chemotherapy patterns about chemotherapy near the end of life. near the end of life.

When oncologists were given When oncologists were given feedback about their own feedback about their own practice patterns, practice patterns, chemotherapy near the end of chemotherapy near the end of life dropped from 50% to 20%.life dropped from 50% to 20%.

Blayney D, et al. JCO 2009Blayney D, et al. JCO 2009

ConclusionsConclusions

Patients with poor performance status or resistant disease rarely Patients with poor performance status or resistant disease rarely benefit from chemotherapy near the end of life, and do suffer benefit from chemotherapy near the end of life, and do suffer toxicity.toxicity.

Routinely measure the # of “lines” of treatment and response, and Routinely measure the # of “lines” of treatment and response, and the ECOG PS.the ECOG PS.

Have a hospice information visit earlier in the disease course, with 3 Have a hospice information visit earlier in the disease course, with 3 to 6 months to live, to include hospice as an ASCO-recommended to 6 months to live, to include hospice as an ASCO-recommended best practice and to make the transition easier.best practice and to make the transition easier.

Don’t Perform PET, CT and Bone Scan in Breast Don’t Perform PET, CT and Bone Scan in Breast Cancer Patients at Low Risk for MetastasesCancer Patients at Low Risk for Metastases

Key to determining studies is the careful history and physical Key to determining studies is the careful history and physical examination.examination.

Probe for symptoms suggesting metastases.Probe for symptoms suggesting metastases. Probe for signs of locally advanced breast cancer.Probe for signs of locally advanced breast cancer. Decision for imaging studies outside guidelines or clinical trial Decision for imaging studies outside guidelines or clinical trial

should be carefully reviewed with the patient, and based on her should be carefully reviewed with the patient, and based on her symptoms and her physical findings.symptoms and her physical findings.

Non-indicated scans can lead to unnecessary anxiety, testing and Non-indicated scans can lead to unnecessary anxiety, testing and morbidity.morbidity.

In the era of effective adjuvant therapy, micro metastases are likely In the era of effective adjuvant therapy, micro metastases are likely to be effectively treated.to be effectively treated.


No evidence of survival improvement.No evidence of survival improvement.

No benefit in asymptomatic individuals with newly identified ductal No benefit in asymptomatic individuals with newly identified ductal carcinoma in situ (DCIS), or clinical stage I or II breast cancer.carcinoma in situ (DCIS), or clinical stage I or II breast cancer.

Can lead to harm throughCan lead to harm through- Unnecessary invasive procedureUnnecessary invasive procedure- over-treatment,over-treatment,- unnecessary radiation exposure, and unnecessary radiation exposure, and - misdiagnosis.misdiagnosis.

Features of Localized Prostate CancerFeatures of Localized Prostate Cancer

Most cases at low risk of metastasis:Most cases at low risk of metastasis:‒ BoneBone‒ NodesNodes

More than 50% of men older than 65 years of age have More than 50% of men older than 65 years of age have clinically silent presence of prostate cancer – it doesn’t harm clinically silent presence of prostate cancer – it doesn’t harm most of these men.most of these men.

Many cases of prostate cancer deteriorate slowly or not at all.Many cases of prostate cancer deteriorate slowly or not at all.

There are predictors of rapid growth and spread of prostate There are predictors of rapid growth and spread of prostate cancer, which physicians use to help plan the approach to cancer, which physicians use to help plan the approach to testing and treatment.testing and treatment.

Definition of Low-risk Prostate CancerDefinition of Low-risk Prostate Cancer

Criteria that Correlate with Negative Staging Tests:Criteria that Correlate with Negative Staging Tests:

Absence of SymptomsAbsence of Symptoms T1 tumors (status of T2 tumors?)T1 tumors (status of T2 tumors?) PSA < 10 ng/ml at presentationPSA < 10 ng/ml at presentation Gleason’s Score of ≤ 6Gleason’s Score of ≤ 6

Experience with Unnecessary Staging Tests for Experience with Unnecessary Staging Tests for Prostate CancerProstate Cancer

Palvolgyi, et al. (2011)Palvolgyi, et al. (2011)

1,598 men studied1,598 men studied

519 with low-risk CAP had 519 with low-risk CAP had bone scansbone scans PSA < 10 ng/mlPSA < 10 ng/ml CS T1-T2CS T1-T2 Gleason score < 7Gleason score < 7

132 underwent bone scans132 underwent bone scans

0 positive0 positive

Choi, et al. (2011)Choi, et al. (2011)

6,444 men studied6,444 men studied

2,330 (36%) had multiple scans2,330 (36%) had multiple scans

Only 1% positiveOnly 1% positive

Consistent with international Consistent with international resultsresults

NO consistent pattern of test – NO consistent pattern of test – geographic variationgeographic variation

Increase with social/economical Increase with social/economical statusstatus IncomeIncome Greater high school educationGreater high school educationPalvolgyi et al. Urology 2011; 77:1330-1336

Choi et al. J. Urol., 2011, 185: 1645-1649

Experience with Unnecessary Staging Tests for Experience with Unnecessary Staging Tests for Prostate CancerProstate Cancer

Lavery et al. (2011)Lavery et al. (2011)

677 men with low risk CAP677 men with low risk CAP 48% had 1 study48% had 1 study 30% had 2 studies30% had 2 studies 3% had 3 studies3% had 3 studies

349 had no imaging349 had no imaging

96% of CT scans were negative (0 96% of CT scans were negative (0 positive at surgery)positive at surgery)

0 changes in clinical management from 0 changes in clinical management from scansscans

328 patients328 patients Imaging: $644,392Imaging: $644,392 Surgery: $654,507Surgery: $654,507

Institutional Charges:Institutional Charges: CT a/p: $1,480CT a/p: $1,480 Bone scan: $512Bone scan: $512 MRI: $2,500MRI: $2,500

Medicare Reimburse:Medicare Reimburse: CT a/p: $976.98CT a/p: $976.98 Bone scan: $299.01Bone scan: $299.01 MRI: $823.32MRI: $823.32

Lavery et al. Urology, 2011, 77: 274-279.


Low-risk early-stage prostate cancer, defined by PSA < 10 Low-risk early-stage prostate cancer, defined by PSA < 10 ng/ml and Gleason’s score ng/ml and Gleason’s score << 6, has a low risk of metastasis. 6, has a low risk of metastasis.

Staging tests do not improve outcomes of treatment for this Staging tests do not improve outcomes of treatment for this clinical problem.clinical problem.

Extensive staging is:Extensive staging is:– UnnecessaryUnnecessary– ExpensiveExpensive– Exposes patients to unnecessary radiation.Exposes patients to unnecessary radiation.

Surveillance Testing after Curative Treatment of Surveillance Testing after Curative Treatment of Breast CancerBreast Cancer

Serum Tumor Markers and ImagingSerum Tumor Markers and Imaging

What is the role of a surveillance test in cancer follow-up, and What is the role of a surveillance test in cancer follow-up, and when does it ad value for patient outcomes or mortality?when does it ad value for patient outcomes or mortality?

What do we know about surveillance in breast cancer patients What do we know about surveillance in breast cancer patients treatment with curative intent?treatment with curative intent?

What follow-up strategies are recommended for this patient What follow-up strategies are recommended for this patient population?population?

What Do We Know About Surveillance Testing What Do We Know About Surveillance Testing after Breast Cancerafter Breast Cancer

Data from clinical trials, conducted in the 1980’s and 1990’s Data from clinical trials, conducted in the 1980’s and 1990’s demonstrated that routine monitoring with chest films, radionuclide demonstrated that routine monitoring with chest films, radionuclide liver and bone scans did detect a recurrence earlier than clinical liver and bone scans did detect a recurrence earlier than clinical evaluation, and was abandoned as part of routine follow-up.evaluation, and was abandoned as part of routine follow-up.

Two randomized trials conducted in the 1990’s did not find a Two randomized trials conducted in the 1990’s did not find a difference in survival outcomes for women who had routine clinical difference in survival outcomes for women who had routine clinical office visits and mammograms compared to women who had more office visits and mammograms compared to women who had more intensive monitoring with blood work, chest films, scans and intensive monitoring with blood work, chest films, scans and ultrasounds.ultrasounds.

ASCO Guideline 2006Rojas et al. Cochrane Review 2005

What Do we Know About Surveillance Testing What Do we Know About Surveillance Testing after Breast Cancerafter Breast Cancer

Tumor markers used in breast cancer monitoring (CEA, CA 15-3, Tumor markers used in breast cancer monitoring (CEA, CA 15-3, CA 27.29) have not been shown in randomized trials to effect CA 27.29) have not been shown in randomized trials to effect survival outcome, i.e. that detection of recurrence earlier makes a survival outcome, i.e. that detection of recurrence earlier makes a difference.difference.

The rate of false negative or false positive findings for these The rate of false negative or false positive findings for these markers is not known.markers is not known.

Normal or abnormal tumor marker results can contribute to false Normal or abnormal tumor marker results can contribute to false reassurance or increased anxiety for patients, as well as reassurance or increased anxiety for patients, as well as unnecessary medical evaluations.unnecessary medical evaluations.

What about Imaging Tests?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 early-stage 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 What Should I Advise My Patient Who Has Had Curative Treatment for Breast CancerCurative Treatment for Breast Cancer

Report any new or persistent symptoms (e.g. cough, pain, new Report any new or persistent symptoms (e.g. cough, pain, new lumps, dyspnea) for medical evaluation.lumps, dyspnea) for medical evaluation.

Have regular oncology follow-up visits every 3-6 months in the first Have regular oncology follow-up visits every 3-6 months in the first three years; every 6 months for the next 2 years.three years; every 6 months for the next 2 years.

Have annual follow-ups after 5 years that can be continued with a Have annual follow-ups after 5 years that can be continued with a primary care provider, ensuring that a breast examination and primary care provider, ensuring that a breast examination and mammogram are done annually.mammogram are done annually.

Don’t have routine blood work for breast cancer monitoring after Don’t have routine blood work for breast cancer monitoring after initial treatments.initial treatments.

Have bone density monitoring and lipid measurements if aromatase Have bone density monitoring and lipid measurements if aromatase inhibitor therapy is taken.inhibitor therapy is taken.


Don’t performDon’t perform surveillance testing (biomarkers) or imaging (PET, surveillance testing (biomarkers) or imaging (PET, CT and radionuclide bone scans) for asymptomatic individuals who CT and radionuclide bone scans) for asymptomatic individuals who have been treated for breast cancer with curative intent. have been treated for breast cancer with curative intent.

Do performDo perform regular interval history and physical examinations, regular interval history and physical examinations, including clinical breast examination, and schedule annual breast including clinical breast examination, and schedule annual breast mammograms.mammograms.

Do promptly evaluateDo promptly evaluate any clinical symptoms that are suspicious for any clinical symptoms that are suspicious for a recurrence, using blood work, tumor markers and imaging as a recurrence, using blood work, tumor markers and imaging as appropriate.appropriate.

Eliminate the Use of White Cell Stimulating Factors in Eliminate the Use of White Cell Stimulating Factors in Patients Who Are Not at High Risk for this ComplicationPatients Who Are Not at High Risk for this Complication

Febrile Neutropenia (FN) is a life threatening emergency.Febrile Neutropenia (FN) is a life threatening emergency.

‒Increased cost associated with treatment of febrile neutropenia.Increased cost associated with treatment of febrile neutropenia.

‒Morbidity can be significant.Morbidity can be significant.

‒Mortality ranges from 10%-90% depending on associated comorbidities.Mortality ranges from 10%-90% depending on associated comorbidities.

Granulocyte Colony Stimulating Factors (G-CSFs) reduce the Granulocyte Colony Stimulating Factors (G-CSFs) reduce the duration and severity of febrile neutropenia.duration and severity of febrile neutropenia.

‒Increased cost with use of these agents.Increased cost with use of these agents.

‒Decreased morbidity and mortality with use of G-CSFs.Decreased morbidity and mortality with use of G-CSFs.

What is appropriate use?

GuidelinesGuidelines

2006 ASCO Guideline:2006 ASCO Guideline: Use Use Granulocyte Colony Granulocyte Colony Stimulating Factors (G-CSFs)Stimulating Factors (G-CSFs) when the risk of febrile neutropenia is when the risk of febrile neutropenia is greater than 20%.greater than 20%.

““In some situations, primary prophylaxis with CSFs is essential and In some situations, primary prophylaxis with CSFs is essential and recommended to alleviate the toxicity of certain ‘dose dense’ recommended to alleviate the toxicity of certain ‘dose dense’ chemotherapy regimens”.chemotherapy regimens”.

Factors that increase risk of FN greater than 20%Factors that increase risk of FN greater than 20%

Age greater than 65Age greater than 65

Poor performance statusPoor performance status

Prior episodes of FNPrior episodes of FN

Prior chemotherapy or radiationPrior chemotherapy or radiation

Poor nutritional statusPoor nutritional status

Other comorbiditiesOther comorbidities

Risk StratificationRisk Stratification

High risk of FN – greater than 20% risk

Most non-Hodgkin Lymphoma regimensDose 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


Granulocyte Colony Stimulating Factors (G-CSFs) are essential to Granulocyte Colony Stimulating Factors (G-CSFs) are essential to deliver correct dose and schedule to patients with solid tumors in deliver correct dose and schedule to patients with solid tumors in some settings in the curative intent.some settings in the curative intent.

‒‒ Dose dense AC-TDose dense AC-T

Individualized therapy in curative intent setting for other solid tumors Individualized therapy in curative intent setting for other solid tumors and NHL.and NHL.

Currently more than half of all patients receiving G-CSFs are being Currently more than half of all patients receiving G-CSFs are being given them in an inappropriate manner based on evidence and given them in an inappropriate manner based on evidence and guidelines.guidelines.

‒‒ Goldilocks PhenomenonGoldilocks Phenomenon

Cost is escalating:Cost is escalating: Peg-filgrastim $4,800 per dose.Peg-filgrastim $4,800 per dose.

Unsustainable.Unsustainable.

Facilitating AccountabilityFacilitating Accountability

Fundamental assumption: the EMRFundamental assumption: the EMR

ASCO quality improvement efforts:ASCO quality improvement efforts:– Quality Oncology Practice Initiative (QOPI)Quality Oncology Practice Initiative (QOPI)– CancerLink-ASCO rapid learning initiative-CancerLink-ASCO rapid learning initiative-

data in real timedata in real time– Metrics: review metrics with oncologistsMetrics: review metrics with oncologists

Payers provide incentive for practice Payers provide incentive for practice patterns that enhances valuepatterns that enhances value

Reactions by StakeholdersReactions by Stakeholders(anecdotal-not necessarily representative(anecdotal-not necessarily representative))

Physicians: oncologists quite supportive-”it Physicians: oncologists quite supportive-”it assists me in the exam room”assists me in the exam room”

Patients: “does this mean grandma can’t get Patients: “does this mean grandma can’t get her last chance?”her last chance?”– Advocates: skeptical but understanding, and do get Advocates: skeptical but understanding, and do get

the big picturethe big picture

Payers: Supportive but quietly soPayers: Supportive but quietly so

Industry: do not get in the way of genomic Industry: do not get in the way of genomic analysis, and accessibility to targeted therapiesanalysis, and accessibility to targeted therapies

ASCO’s Task Force: ASCO’s Task Force: Current/Future InitiativesCurrent/Future Initiatives

Broad educational initiatives: Broad educational initiatives: – Patients: CancerNetPatients: CancerNet– Professionals: Journal articles, Commentaries, Professionals: Journal articles, Commentaries,

Educational Programming, Physician Advisory Educational Programming, Physician Advisory ToolTool

Integrate the Top 5 into QOPI and start Integrate the Top 5 into QOPI and start measuring impact of changemeasuring impact of change

Develop Top 6-10Develop Top 6-10

Tackle high cost/low value drugsTackle high cost/low value drugs

Challenges to Move the NeedleChallenges to Move the Needle

Economic imperatives: Economic imperatives: eliminate misaligned eliminate misaligned incentives between physicians and payersincentives between physicians and payers– Advocate for new models of compensationAdvocate for new models of compensation

emphasize value (optimized health outcomes for lowest emphasize value (optimized health outcomes for lowest cost)cost)adherence to guidelines which, in the presence of high adherence to guidelines which, in the presence of high value evidence can yield to pathwaysvalue evidence can yield to pathwaysReward good performanceReward good performance

– Essential to assure practice environments with Essential to assure practice environments with adequate infrastructure to deliver high value careadequate infrastructure to deliver high value care

Oncology “homes”Oncology “homes”

Documents

Achieving Value in Cancer Care: ASCO’s Top5 and Beyond