On Saturday, February 29, 2020, the Northside Hospital Cancer Institute (NHCI) hosted a continuing education symposium entitled “New Frontiers in Lung and Thoracic Cancers: Improving Patient Care With a Multidisciplinary Approach.” The meeting was held at the Whitley Hotel in Buckhead, Atlanta, and

was attended by physicians, advanced practice providers, nurses, pharmacists, other health care providers and industry representatives from the Southeast. Co-chairs Shady Eldaif, MD, and Venkatesh Lakshminarayanan, MD, PhD, opened the meeting with an overview of the impressive volume of patients with lung or thoracic cancers who seek treatment in the Northside Hospital (NH) system.

Features of the symposium included didactic presentations with videos and the latest data on topics such as minimally invasive surgery for lung cancer, advances in the management of anterior mediastinal tumors and new horizons in lung cancer screening and treatments for advanced disease; lively panel discussions and debates, including management of early-stage lung cancer and therapy approaches for locally advanced non-small cell lung cancer (NSCLC); and provocative questions from attendees. Moreover, symposium attendees had the opportunity to engage one-on-one with the local steering committee and world-renowned faculty (Figure 1). The highly interactive and engaging nature of the meeting provided attendees with a comprehensive multidisciplinary update of lung and thoracic cancers.

Leading Experts in Lung and Thoracic Cancers Present at the NHCI Symposium

Northside Hospital Cancer Institute: 404-531-4444northside.com/cancer-institute

IN THIS ISSUE:In the News: Updates for Clinicians

p2 2020 Atlanta Precision Oncology Symposium Recap by: Rodolfo Bordoni, MD

p2 Virtual Community Engagement Among Women Receiving Palbociclib by: Cheryl Jones, MD

Conference Highlights from ASH and SABCS

p3 ASH Highlights by: Melhem Solh, MD

p4 SABCS Highlights

p5 Commentary by: Gena Volas-Redd, MD

p5 NCCN Policy Summit by: Katherine Easton, LCSW, OSW-C

Elevating the Patient Experience at NHCI

p6 Fast MRI by: Lynn Baxter, MD

Clinical Trials and Research

p7 Lung Cancer Immunotherapy Trials by: W. Hamilton Williams, MD

Provider Features

p8 RN Nurse of the Year for Hall County and New Physician in Canton

Upcoming Continuing Education & Community Events

p8 Community Events

p8 Cancer Prevention

Spring 2020 | Volume 7, Issue 2

FACULTY

Shady Eldaif, MD Atlanta Cardiac and Thoracic Surgical Associates

Rodolfo Bordoni, MD Georgia Cancer Specialists

John Gouldman, MD Atlanta Cardiac and Thoracic Surgical Associates John Moore, MD Atlanta Cardiac and Thoracic Surgical Associates

Pete Possert, MD Northside Radiation Oncology Consultants

CO-CHAIRS STEERING COMMITTEE

Venkatesh Lakshminarayanan, MD, PhD Pulmonary & Critical Care of Atlanta

Howard Silverboard, MD Pulmonary & Critical Care of Atlanta

Lijo Simpson, MD Atlanta Cancer Care W. Hamilton Williams, MD Radiation Oncology of Atlanta

Figure 1. Faculty and Steering Committee for NHCI Symposium

Thomas D’Amico, MD Duke Cancer Center

Corey Langer, MD University of Pennsylvania

Richard Lazzaro, MD Lenox Hill Hospital

Sanja Percac-Lima, MD Massachusetts General Hospital

Ramesh Rengan, MD University of Washington

Mark Socinski, MD AdventHealth Cancer Institute

Gregory Videtic, MD Cleveland Clinic Lerner College of Medicine of Case Western Reserve University

Momen Wahidi, MD, MBA Duke University Medical Center

Robert Winn, MD Virginia Commonwealth University Massey Cancer Center

For COVID-19 updates please visit northside.com/cancer-institute

Spring 2020 | Volume 7, Issue 2

CANCER CARE NEWS 2

IN THE NEWS: Updates for Clinicians2020 Atlanta Precision Oncology Symposium RecapBy: Rodolfo Bordoni, MD

Virtual Community Engagement Among Women Receiving Palbociclib for HR+/HER2- Metastatic Breast Cancer (MBC): Data from the MADELINE StudyBy: Cheryl Jones, MD

The second annual Atlanta Precision Oncology Symposium, chaired by Rodolfo Bordoni, MD of

Georgia Cancer Specialists and NHCI, was held on Saturday, February 8, 2020 at the Hotel at Avalon in Alpharetta. Attendees of this pioneering meeting had the opportunity to hear from distinguished experts regarding the use of precision therapy in gastrointestinal cancer, melanoma and hematologic malignancies.

The malignant hematology session, moderated by Lawrence Morris, MD of The Blood and Marrow Transplant Group of Georgia, included notable faculty and presentations. Noopur Raje, MD, director of the center for multiple myeloma at Massachusetts General Hospital Cancer Center, presented her groundbreaking research on anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. The melanoma session, moderated by David Lawson, MD of Emory University and Winship Cancer Institute, included Ahmad Tarhini, MD, director of cutaneous clinical and translational research at H. Lee Moffitt Comprehensive Cancer Center and Research Institute, who presented practice-changing advances in the adjuvant treatment of high-risk stage III melanoma.

Finally, the GI malignancies session was moderated by Howard Hochster, MD, of Rutgers Cancer Institute of New Jersey. He also discussed the clinical utility of PD-L1 expression when considering I-O therapy for gastric cancer. Another highlight of the day was the lunch & learn session which focused on the implementation of precision medicine in community-based oncology programs presented by Edward S. Kim, MD, chair of solid tumor oncology and investigational therapeutics at Levine Cancer Institute in Charlotte, North Carolina.

Precision oncology (including targeted therapy and immunotherapy) is more relevant now than ever in the management of cancer patients with a variety of malignancies. According to a survey of “Public Perspectives on Personalized Medicine” conducted for the Personalized Medicine Coalition (PMC), 82% of adults in the United States are interested in more information about the field and 34% of Americans have heard of personalized or precision medicine.1 Additionally, a report released by the PMC, entitled, “Personalized Medicine at FDA: The Scope & Significance of Progress in 2019,” noted that personalized medicines have continued to top 20% of FDA approvals for the past six years.2

As the FDA continues to approve targeted agents and awareness and education amongst patients continues to increase, health care providers must stay abreast of the newest treatments and FDA approvals in order to ensure that their patients are presented with any and all appropriate treatment options. The event was well attended by health care providers throughout the state and region. The third annual symposium was announced at the conclusion of this year’s symposium and will be held on Saturday, January 30, 2021.

1. Public Perspectives on Personalized Medicine: A Survey of U.S. Public Opinion. May 2018. personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/Public_Perspectives_on_PM1.pdf. Accessed on February 24, 2020.

2. Personalized Medicine at FDA: The Scope & Significance of Progress in 2019. personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_The_Scope_and_Significance_of_Progress_in_2019.pdf. Accessed on February 24, 2020.

(continued on page 3)

CDK4/6 inhibitors have revolutionized the management of advanced hormone receptor (HR)-positive (+), HER2-negative (-) breast cancer over the last few years, and clinical trials of new therapies often incorporate quality of life (QOL) questionnaires at designated time points. With the improvements and availability of technology, a novel mobile application (app) was developed to capture patient reported outcomes (PROs) for QOL at daily, weekly and monthly intervals.

This mobile app provided education and permitted engagement of patients with their peers in a virtual patient community support group. It also allowed for the reporting of day-to-day and longitudinal effects of this new class of medications in a real-world setting. MADELINE is an observational, multicenter study of women with HR+/

HER2- advanced or MBC who were followed for six months to evaluate patient-reported QOL after initiating the CDK4/6 inhibitor, palbociclib, combination therapy or another approved treatment in the United States. NHCI was one of 23 sites across the United States who participated and enrolled patients in this study.

The accessibility and convenience for patients to report their experiences and symptoms of mood, fatigue and pain in real time and for the trial to augment that information with the data from clinical visits provided important insight to this new class of medications as they first became available to patients. Eighty-three percent of the patients who participated in the mobile app found it to be beneficial, especially in the areas of new drug information and information regarding advanced

Spring 2020 | Volume 7, Issue 2

CANCER CARE NEWS 3

arm, but trends suggest improvement with acalabrutinib, though the differences did not reach statistical significance. More importantly, the PFS benefits were achieved while maintaining “a favorable tolerability and safety profile.”1-3

Further follow-up is necessary to confirm the improvements in outcomes achieved with acalabrutinib therapy.

1. US Food and Drug Administration. Available at: fda.gov/drugs/resources-information-approved-drugs/project-orbis-fda-approves-acalabrutinib-cll-and-sll. Accessed 2/26/2020.

2. Sharman JP, et al. Blood. 2019;134 (Supplement_1): 31.

3. ASH Clinical News. Available at: ashclinicalnews.org/on-location/ash-annual-meeting/acalabrutinib-treatment-superior-obinutuzumab-plus-chlorambucil-treatment-naive-cll/. Accessed 2/26/2020.

20192,3 and the International Society for Pharmacoeconomics and Outcomes Research in Denmark in 2019.4 An abstract has been submitted for the American Society of Clinical Oncology 2020 Annual Meeting.

1. McRoy L, et al. Presented at the San Antonio Breast Cancer Symposium; December 6-10, 2016; San Antonio, TX. Abstract #OT3-03-01.

2. Richardson D, et al. Presented at the San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, TX. Poster #P1-19-35.

3. Richardson D, et al. Presented at the San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, TX. Poster #P1-19-41.

4. Richardson D, et al. Presented at the International Society for Pharmacoeconomics and Outcomes Research Conference; November 4, 2019; Copenhagen, Denmark. Poster #PCN465.

IN THE NEWS: Updates for CliniciansVirtual Community Engagement Among Women (continued from page 2)Virtual Community Engagement Among Women (continued from page 2)breast cancer in general. Patient acceptance and engagement in this technology was very positive. More than 50% of the patients stated that they would like to continue utilizing the mobile app for the social connection and support after the 6-month clinical trial period ended.

The ability to utilize the mobile app for patient reporting of side effects and outcomes will continue to increase and lead to ongoing improvement in QOL because trends and symptoms will be identified sooner in the community clinical setting. Results from this trial have been presented in poster format at the San Antonio Breast Cancer Symposium in 20161 and

Conference Highlights – American Society of Hematology (ASH) Annual Meeting and San Antonio Breast Cancer Symposium (SABCS)ASH Highlights

Acalabrutinib Treatment Superior to Obinutuzumab Plus Chlorambucil in Treatment-Naïve CLL: Updates From the Phase 3 ELEVATE-TN TrialBy: Melhem Solh, MD

QUAZAR Phase 3 Trial: Oral Formulation of Azacitidine Extends Survival in AMLBy: Melhem Solh, MD

Chronic lymphocytic leukemia (CLL) is the most prevalent adult leukemia, and although incurable, chemoimmunotherapy prolongs survival and remission durations in most patients. In November 2019, acalabrutinib, a highly selective, irreversible inhibitor of the bruton tyrosine kinase (BTK), was approved by the FDA for the treatment of CLL as monotherapy or in combination with obinutuzumab for patients with previously untreated disease.1

Approval was based in part on interim results from the ELEVATE-TN study that was recently presented at the 2019 ASH Annual Meeting.2 This 3-arm, phase 3 randomized trial in 535 patients demonstrated that acalabrutinib alone and in combination with obinutuzumab significantly improves progression-free survival (PFS) compared to chlorambucil/obinutuzumab in treatment-naïve CLL (Table 1). Although the study was not powered to detect a difference between the acalabrutinib arms, the combination appeared to outperform the single agent.

The benefit of acalabrutinib was observed across subgroups, including patients with del(17p), a particularly high-risk mutation. Overall survival (OS) has not been reached in any

Older patients with acute myeloid leukemia (AML) may readily respond to intensive induction chemotherapy, but those responses are often not sustained, and OS remains poor in this population. Until recently, OS benefits have not been observed with post-remission maintenance therapy. However, during a late-breaking

abstract session at the 2019 ASH Annual Meeting, Andrew Wei, MBBS, PhD, of the Alfred Hospital in Melbourne, Australia, reported potentially practice-changing results from the QUAZAR phase 3 trial.1 QUAZAR compared an oral formulation of azacitidine (CC-486) with placebo in 472

Treatment Arm Regimen 30-Month

PFS Rates

Arm 1 (n=179) Acalabrutinib PO 90%

Arm 2 (n=179) Acalabrutinib PO + Obinutuzumab IV x 6 cycles 82%

Arm 3 (n=177) Obinutuzumab IV + Chlorambucil PO x 6 cycles 34%

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Table 1. Progression-Free Survival (PFS) Rates

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IN THE NEWS: Updates for Clinicians

patients aged 55 and older with de novo or secondary AML in first remission with or without having received consolidation. Patients were not candidates for hematopoietic stem cell transplantation.

Oral azacitidine was associated with a significantly prolonged median OS compared with placebo and a 30% reduction in the risk of disease progression or death; relapse-free survival was also significantly prolonged. Moreover, the benefit of oral azacitidine was observed across prespecified subgroups including those with minimal residual disease, poor cytogenetics, or age > 65 years. The safety profile of oral azacitidine was similar to that of the injectable formulation.

HER2+ breast cancer is associated with a shorter survival time, higher risk of recurrence and an increased incidence of brain metastases. While systemic therapies for these patients have improved, the incidence of brain metastases has increased and may occur in up to 50% of patients during the course of their disease. Because there is no standard of care following second-line ado-trastuzumab emtansine in patients with HER2+ MBC, common options include lapatinib with trastuzumab or capecitabine, trastuzumab with chemotherapy, or clinical trials. Once brain metastases develop in HER2+ patients, treatment typically includes surgical

Oral azacitidine has the potential to become an integral part of AML therapy in older patients. “CC-486 is the first therapy to provide statistically significant and clinically meaningful improvement in both OS and relapse-free survival, with or without consolidation.”2 Some limitations of the study include a comparison with placebo and increased utilization of therapeutic approaches other than intensive induction chemotherapy (e.g., hypomethylating agents in combination with venetoclax or mutation-targeted agents).

1. Wei AH, et al. Blood. 2019;134 (Supplement_2): LBA-3.

2. ASH Clinical News. Available at: ashclinicalnews.org/on-location/ash-annual-meeting/quazar-oral-azacitidine-maintenance-improves-survival-transplant-ineligible-aml/. Accessed 2/26/2020.

resection and stereotactic or whole brain radiotherapy. Tucatinib is an oral, investigational tyrosine kinase inhibitor with high selectivity for HER2 while exhibiting minimal inhibition of EGFR. Phase 1 data combining tucatinib with trastuzumab/capecitabine have shown encouraging results, including in patients with brain metastases.1-3

At the 2019 SABCS, investigators from The University of Texas MD Anderson Cancer Center presented results from the HER2CLIMB randomized trial, which showed the addition of

QUAZAR Phase 3 Trial (continued from page 3)

demonstrated efficacy measures “substantially higher than that seen in any other study of patients with pretreated HER2+ MBC”.3

Trastuzumab deruxtecan was considered manageable; however, it is noteworthy that interstitial lung disease occurred in 13% of patients, most of which were grade 1 or 2.1,2 Due to the clinically meaningful results of this trial, trastuzumab deruxtecan is poised to become a new standard of care in pretreated HER2+ MBC and has also been granted priority review status by the FDA.

1. Modi S, et al. NEJM. 2020;382:610-621.

2. Krop IE, et al. SABCS. 2019;abstract GS1-03.

3. ADC Review. Available at: adcreview.com/news/sabcs-2019-destiny-breast01-trial-of-trastuzumab-deruxtecan-shows-positive-results-in-her2-metastatic-breast-cancer/. Accessed 2/25/2020.

SABCS HighlightsDESTINY-Breast01: Trastuzumab Deruxtecan Shows Positive Results in HER2+ Metastatic Breast Cancer (MBC)

Adding Tucatinib to Trastuzumab and Capecitabine Extends Survival for Advanced HER2+ Breast Cancer Patients

Roughly 15% to 20% of MBC patients overexpress HER2. While anti-HER2 targeted therapies are the standard of care in the first- and second-line treatment settings, resistance ultimately occurs and the options for patients beyond second-line therapy are limited and offer minimal benefit with response rates ranging from 9% to 31% and PFS times of three to six months.1 Trastuzumab deruxtecan is an antibody-drug conjugate designed with a higher drug-to-antibody ratio compared to currently available antibody-drug conjugates, such as ado-trastuzumab emtansine, a standard treatment in the second-line setting. Furthermore, trastuzumab deruxtecan is attached to a topoisomerase I inhibitor rather than a microtubule inhibitor as the cytotoxic agent.

Recently, the phase 2 single-arm DESTINY-Breast01 trial was presented at the SABCS and was simultaneously published in the New England Journal of Medicine. Investigators evaluated HER2+ MBC patients who had received a median of six prior lines of therapy, including ado-trastuzumab emtansine. Trastuzumab deruxtecan demonstrated durable activity in a highly pretreated patient population (Table 2).1,2 According to Ian Krop, MD, of the Dana-Farber Cancer Institute and one of the investigators of the trial, trastuzumab deruxtecan

Overall Response Rate 60.9%Disease Control Rate 97.3%Duration of Response 14.8 monthsMedian PFS 16.4 months

Table 2. DESTINY-Breast01: Summary of Results

(continued on page 5)

PFS, progression-free survival

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IN THE NEWS: Updates for Clinicians

tucatinib to trastuzumab/capecitabine significantly improved PFS and OS compared to the addition of placebo, including in patients with brain metastases (Table 3). Rashmi Murthy, MD, one of the study authors, noted how unique this trial design is in allowing patients with untreated or previously treated but progressing brain metastases to be enrolled as this population is typically excluded from clinical trials. "Brain metastasis is a

common clinical problem developing in up to half of patients during the disease course, but there are limited systemic treatment options as most drugs have difficulty crossing the blood brain barrier," said Murthy.1-3

Dr. Murthy added that “these results are unprecedented for late-line therapy in advanced breast cancer, and are a major advance for patients who have significant unmet medical need. Tucatinib in combination with trastuzumab and capecitabine should be the new standard of care for patients pretreated with multiple anti-HER2 agents including patients with brain metastases.”

1. Murthy RK, et al. NEJM. 2020;382:597-609.

2. Murthy RK, et al. SABCS. 2019;abstract GS1-01.

3. eCancer. Available at: ecancer.org/en/news/17066-sabcs-2019-adding-tucatinib-to-drug-combination-extends-survival-for-advanced-her2-positive-breast-cancer-patients. Accessed 2/25/2020.

Adding Tucatinib to Trastuzumab and Capecitabine (continued from page 4)

Tucatinib Placebo P Value

PFS, all patients (1-year), % 33.1 12.3 <0.001

PFS, brain mets (1-year), % 24.9 0 <0.001

Median PFS all patients, months 7.8 5.6 NR

Median PFS in brain mets, months 7.6 5.4 NR

OS (2-year), % 44.9 26.6 0.005

Median OS, months 21.9 17.4 NR

Table 3. HER2CLIMB: Summary of Results

CommentaryBy: Gena Volas-Redd, MD

The 2019 SABCS was indeed a very exciting time in the area of HER2+ MBC. Results of three

randomized clinical trials were presented that will change our practice patterns in HER2-refractory disease. Data from HER2CLIMB (tucatanib), DESTINY-Breast01 (trastuzumab deruxtecan), and the SOPHIA trial (margetuximab) were presented and yielded positive PFS data in the third-line treatment setting.

The HER2 CLIMB trial examined the novel drug tucatanib, an investigational small molecule tyrosine kinase inhibitor with high selectivity for HER2. This phase III trial, presented by investigators from MD Anderson Cancer Center, showed that the addition of tucatanib to trastuzumab/capecitabine significantly improved PFS and OS compared to the placebo/trastuzumab/capecitabine combination. This trial was also

designed to allow patients with untreated or previously treated brain metastases with progressive disease to be enrolled. Central nervous system (CNS) progression/failure is a well-documented dilemma in advanced HER2+ disease and affects a large proportion of women even in the face of stable systemic disease. The tucatanib/trastuzumab/capecitabine combination yielded a 33.1% 1-year PFS rate (p<.001) versus placebo at 12.3%. The PFS for brain metastases in the study cohort was 24.9% for 1-year PFS (p<.001) compared to zero for the placebo group. The 2-year OS was 44.9% versus 17.4% (p=.005). These results are overwhelmingly positive and will change practice patterns especially in patients with brain metastases. We are all anxiously anticipating the FDA approval of this drug combination to allow for added years of survivorship to our patients with refractory HER2+ breast cancer and especially those with brain metastases.

National Comprehensive Cancer Network Policy Summit - Delivering Value in Oncology Care: Examining Patient-Centered CareBy: Katherine Easton, LCSW, OSW-C

The word “value” in oncology care carries a number of different meanings for patients, providers, payers and other stakeholders. The theme of NCCN’s 2019 Patient Advocacy Summit, Delivering Value for Patients Across the Oncology Ecosystem, examined the gap between value-based care from a patient perspective versus physicians and the health care system. This year’s program featured panelists representing national patient advocacy groups, as well as policy makers, the pharmaceutical industry, health insurance payers, social workers and other advocates.

Paul Kluetz, MD, deputy director of the Oncology Center of Excellence for the FDA, provided a historical perspective on the transformation and growth of cancer treatments in the last 50 years. The continued rise in genetic testing and bimolecular studies impacting the oncology care roadmap has led to the development of smaller and smaller subsets of individuals that may benefit from any given treatment. These recent developments represent real advances in treating cancer, but they may not represent value from a cost or QOL

(continued on page 6)

NR, not reported; PFS, progression-free survival; OS, overall survival

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IN THE NEWS: Updates for Clinicians

Elevating the Patient Experience at NHCI

standpoint. The movement to incorporate and integrate patient perspective into drug development and decision-making involves the cooperation of parties involved not only in clinical trial design but for the continued definition of what patient-centered value represents. Measuring symptoms, function, acute hospitalizations, ED visits, the need for supportive care and the ability to work are all metrics that can be analyzed and may impact patient-reported outcomes and risk-benefit analysis for patients. Currently, measures of PFS and OS clinical decision-making in clinical trials.

So how can patient value data be best captured and integrated into a care plan? Integrating the patient voice, having the provider assume responsibility for care and the cost of care, tying reimbursement payments to patient experience and eliminating unnecessary care are considered possible avenues to developing patient-centered and value-based care delivery models. Best practices demonstrating value include the use of multidisciplinary teams, integration of care within the medical record, competition within institutions and bringing these best practice models to where the majority of patients are seen, in community cancer centers, not limited to the large, research and academic institutions.

Financial toxicity continues to be the biggest determinate of the patient’s perception of value. Transparency regarding the cost of treatment and anticipated outcomes, such as expected OS, all contribute to patient value (Figure 2). Patients’ perception of high-value care includes QOL, care coordination, survivorship care and limited travel burden. Utilization of patient and nurse navigators, oncology social workers and transportation assistance programs continue to offer high return on investment and are valuable to patients. Patients value time, interaction and communication with their teams but reporting and documentation burdens result in less time for meaningful patient-provider engagement. The ability to measure value for patients will continue to be the focus of the structure and landscape of delivering high-quality oncology care.

National Comprehensive Cancer Network Policy Summit (continued from page 5)

Integrate patient/family

voice

Individualized care

Mitigate disparities

Transparency regarding cost to outcomes

Patient Value

Figure 2. Value for Patients

Fast MRIBy: Lynn Baxter, MD

Last July, breast density became a much-discussed topic throughout Georgia when Margie’s Law went

into effect. This legislation mandates that patients with dense breast tissue identified on a mammogram be notified of this in their lay results via a letter containing very specific verbiage, such as, “dense breast tissue can make it more difficult to detect breast cancer through a mammogram” and that “dense breast tissue may increase your risk for breast cancer.” The required content of the letter also encourages the patient to “use this information to talk to your health care provider about whether other supplemental tests in addition to your mammogram may be appropriate for you.”

While we at NH fully support any opportunity for patients to become more informed of their health status (including their breast density), we understand that this specific verbiage could be troubling for some, particularly when faced with the fact that these supplemental tests are usually not covered by insurance. For this reason, NH, a national leader in breast cancer diagnosis and treatment, has made new advanced technologies available throughout our system including the Abbreviated Breast MRI, known here as “Fast MRI,” at an affordable rate.

Mammography continues to be the gold standard for the early detection of breast cancer, and any additional tests that a woman considers should be done in addition to, not instead of, mammography. The recommendation for annual screening mammography for all women starting at age 40 does not change with this law. Before considering additional imaging, a woman should optimize the benefits of her mammogram. Digital breast tomosynthesis (also known as 3D mammography) has been shown to find up to 40% more cancers than traditional 2D mammography and significantly decreases the percentage of patients who are recalled for additional screening. Tomosynthesis can find additional cancers in women of all breast densities, and NH is making 3D mammography accessible across its entire service area. However, even with this advanced mammographic technology, some cancers can still be obscured, especially in women with extremely dense breast tissue.

For women who have an increased risk for developing breast cancer in their lifetime, complete breast MRI is still recommended and is often covered by insurance. Fast MRI is intended for women who are concerned about their

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Elevating the Patient Experience at NHCI

Clinical Trials and Research

density (identified through mammography) and who have no additional risk factors. Studies, including the ACRIN 6666 randomized controlled trial, have shown that the highest cancer detection rate is found with the combination of mammography and MRI. It should be noted that adding ultrasound to this combination did not increase cancer yield and substantially increased false positive findings.

If you are a provider with additional questions, please contact our NH Radiology Associates breast radiologists by calling the Physician Access Center at 404.649.6600. To schedule a Fast MRI, contact the NH radiology scheduling department at 404.851.6577.

Fast MRI (continued from page 6)

Lung Cancer Immunotherapy Trials By: W. Hamilton Williams, MD

Early detection of lung cancer is key to maximizing successful therapy, whether with surgery or

radiation therapy. The publication of recent clinical trials has demonstrated the benefit of lung cancer screening with more early stage disease detected and an improvement in survival compared with usual best practices. Treatment of small, early cancers results in greater success rates and overall survival than later stage disease. Additionally, more options are now available for the successful treatment of early stage lung cancer than before. Although surgical resection is considered optimal therapy, many elderly patients or those with comorbid conditions are not surgical candidates. Radiation therapy has enjoyed substantial advances over the last decade: whereas traditionally fractionated radiation therapy resulted in modest local control of early lung nodules, about 30-40% long term, trials evaluating stereotactic body radiation therapy (SBRT) have demonstrated excellent local control rates, with survival ultimately dictated by the cancer’s behavior and the patient’s overall medical condition.

Unfortunately, up to 20% of patients treated with SBRT will progress locally, or recur regionally and distantly, including development of additional lung nodules, perhaps arising from a field defect related to long-term pre-cancerous changes due to smoking and other exposures. Pre-clinical research has indicated a strong role for the immune system in modulating the response to high dose SBRT for early stage lung cancer. In experimental models examining mice lacking a competent immune system, the rates of control and successful treatment appear substantially lower than those mice with an intact immune system. It is thought that when stereotactic radiation destroys cancer cells, antigens are released that can prime the immune system, “auto-vaccinating” the patient, and help to attack and control the tumor. Such observations have prompted interest in harnessing the body's immune system, and clinical trials are now examining this concept.

The value of immunotherapy in clinically localized lung cancer treated with radiation therapy was recently reported in the PACIFIC trial.1 This trial examined patients with more advanced stage III disease, considered unresectable for cure. In the PACIFIC trial, patients were randomized to be treated with either standard of care chemotherapy and radiation

followed by adjuvant chemotherapy, or chemotherapy and radiation followed by immunotherapy with durvalumab. The experimental arm demonstrated a durable and significant benefit in both PFS and OS for the addition of durvalumab, and is now considered the standard of care for locally advanced lung cancer. This is the first trial in years to make a major impact on survival in lung cancer patients.

Based on the pre-clinical research documented above, the PACIFIC-4 trial, sponsored by the Radiation Therapy Oncology Group and AstraZeneca, focuses attention on early stage, node negative patients who are not surgical candidates and have tumors small enough to be treated with stereotactic radiotherapy. The PACIFIC-4 trial randomizes patients between stereotactic radiation only or stereotactic radiation followed by two years of durvalumab, the immunotherapy drug used in the PACIFIC trial. It is hoped that this trial will demonstrate improvement in both local control and regional/distant failure. It may be especially important in larger tumors with a greater chance of relapse.

As noted above, the PACIFIC trial has shown excellent results with the addition of immunotherapy in the setting of locally advanced but potentially resectable stage II-IIIB non-small-cell lung cancer (NSCLC). Building on this framework, NHCI has opened CheckMate 77T. This Phase 3 randomized study compares up-front chemotherapy plus immunotherapy using nivolumab versus up-front chemotherapy plus placebo, followed by surgical resection and adjuvant treatment with nivolumab or placebo. The purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage NSCLC.

Both the PACIFIC-4 and Checkmate 77T studies are potentially practice-changing. The PACIFIC-4 trial has specific criteria and credentialing required for the radiation treatment. For this reason, the following centers are credentialed to administer radiation: NH Atlanta, NH Forsyth and NH Cherokee. Please contact any of our department members if you are aware of patients who may benefit.

Gray JE, et al. ASCO. 2019;abstract 8526.

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CANCER CARE NEWS 8

1000 Johnson Ferry Road NE Dept. 796

Atlanta, GA 30342

Upcoming Continuing Education & Community Events

CANCER PREVENTION

COMMUNITY EVENTS

American Lung Association Freedom from Smoking Clinic Next 6-Week Session Start Date: May 19, 2020 at 1 p.m. Classes are available at various locations on or near NH campuses and by video conference for remote participants northside.com/evc/Page.asp?PageID=EVC000212

Sarcoma Foundation of America Race to Cure Sarcoma @ Suwanee Town Center Park in Suwanee, GA June 6, 2020 @ 7:30 a.m. Curesarcoma.org/atlanta

NHCI-Sponsored Cancer Walk/Events

Due to the changing circumstances related to COVID-19, events are subject to change.

Provider FeaturesVictoria Thompson, RN, manager of the outpatient oncology infusion center for Northeast Georgia Diagnostic Clinic (NGDC) was awarded RN Nurse of the Year for Hall County. Congratulations, Victoria!

G. Andrew Helms, MD, FACS, FCCP is a board-certified thoracic surgeon now practicing with Atlanta Cardiac and Thoracic Surgical Associates in Canton. Dr. Helms is a skilled robotic surgeon and his clinical interests include lung cancer, thymic

malignancies and esophageal cancer. He has over 10 years of experience in performing minimally invasive thoracoscopic procedures.

Virtual Programs Offered by Cancer Support Community Atlanta

To provide ongoing support for cancer patients and their loved ones during the coronavirus outbreak, Cancer Support Community Atlanta is offering the following virtual programs: support groups, education, nutrition and stress reduction. Visit their website (cscatlanta.org) and Facebook

page (facebook.com/cancersupportcommunityatlanta), for information as well as live and recorded programs. Many virtual programs, including yoga, are also available for Northside Hospital staff.

American Lung Association Fight for Air Climb @ 191 Peachtree Tower in Atlanta, GA June 20, 2020 @ 8 a.m. action.lung.org/site/TR?pg=informational&sid=9151&fr_id=18653