2013OncologyAnnualReport

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2013 Oncology Annual ReportTable of ContentsIntroduction 3

Spotlight on New Medical Oncologist 4

Cancer Registry Report 5 – 8

Analysis of Lung Cancer Care at Baptist Health Lexington

Using Cancer Registry Data 9 – 17

Lung Cancer Conference 18

ALK Molecular Testing Advances Treatment Outcomes

for Non-Small Cell Lung Cancer 19 – 20

A First for Baptist Health Lexington 21

Baptist Health Lexington Cancer Research Program 22 – 24

Lung Cancer Screening Now Recommended for Smokers and Ex-smokers 25 – 26

IntroductionRussell Eldridge, MD, Medical OncologistChairman, Oncology Department

Dear Friends and Colleagues,

In 2013, Baptist Healthcare System became known as Baptist Health. The same is true for all our hospitals throughout Kentucky. Baptist Health includes seven acute-care hospitals with more than 2,100 licensed beds across the state of Kentucky. As part of this change, Central Baptist Hospital became Baptist Health Lexington. By uniting our hospitals with a common name, we are working to ensure everyone across the state understands we are one family of doctors and hospitals.

The physicians and staff at Baptist Health Lexington are proud of our progress in 2013. While our name has changed, our goal to provide the highest quality, patient-centered, compassionate care in a community setting has stayed the same. In this issue, you will have a chance to review some of the latest developments in our cancer program, including our multidisciplinary lung cancer program and our active research program.

We are pleased to introduce Dr. Amy Schell, our new medical oncologist with Baptist Lexington Oncology Associates, as well as Megan Brafford, PharmD, BPOC, our new oncology-certified pharmacist. Both Dr. Schell and Dr. Brafford have been outstanding additions to our medical staff and multidisciplinary teams. Additionally, Amanda Henson, MSHA, MBA, FACHE has been promoted from the Executive Director of Oncology Services to the position of Vice President over Oncology Services.

Finally, we are looking forward to the completion of the $200 million expansion project currently underway on the Baptist Health Lexington campus. The first two floors of this seven-story building will be home to a dedicated comprehensive cancer center, which will include outpatient radiation and medical oncology, multidisciplinary clinics, infusion services, a research center, as well as cancer support services and resources including laboratory, pharmacy, genetics and nurse navigators.

At Baptist Health Lexington we appreciate your continued trust in us as your oncology providers. I hope you find this 2013 Annual Report informative.

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Spotlight on New Medical OncologistAmy Schell, MD

Amy Schell, MD joined Baptist Lexington Oncology Associates November 1, 2013. Dr. Schell is Board Certified by the American Board of Internal Medicine. She graduated from the University of Kentucky College of Medicine. Dr. Schell completed her residency in Internal Medicine and went on to do a fellowship in Hematology and Oncology at Dartmouth-Hitchcock Medical Center.

Cancer Registry ReportThe Cancer Registry at Baptist Health Lexington continues to collect and maintain data on all patients diagnosed and/or treated for cancer at our facility. Maintaining our registry ensures that health officials have accurate and timely information, while securing the availability of data for treatment, research, and educational purposes. Confidentiality of patient identifying information and related medical data is strictly maintained. Aggregate data are analyzed and published without any patient identifiers.

Local, state, and national cancer agencies use registry data to make important public health decisions related to limited public health funds. Registry data is valuable to researchers interested in the etiology, diagnosis, and treatment of cancer. Current lifetime follow-up maintained by the registry provides accurate survival information as well as serves as a reminder to physicians and patients to schedule regular clinical examinations.

2012 BHLEX Case Counts

In 2012, a total of 1,678 cases were reported by the Cancer Registry at BHLEX. Of these, 56.09% (941) patients were diagnosed with their disease at BHLEX and received all or part of their first course treatment here. A total of 34.03% (571) patients were diagnosed elsewhere but received all or part of their first course treatment at BHLEX. Patients who were initially diagnosed and treated elsewhere but received subsequent treatment at BHLEX for recurrent disease accounted for 5.13% (86) of our cases. And 4.77% (80) of patients were initially diagnosed at BHLEX but were treated elsewhere for their disease.

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Newly Diagnosed and/or Treated Cases at BHLEX 2001-2012

The number of newly diagnosed and/or treated (analytic) cases reported at BHLEX slightly decreased from 2011 to 2012, by 2.15% (35 cases).

2012 Comparison of Top Five Sites – Male & Female*

According to the 2012 American Cancer Society’s Cancer Facts & Figures, approximately 1,638,910 new cancer cases would be diagnosed in the US in 2012, excluding carcinoma in situ of any site except urinary bladder and basal and squamous cell skin cancers. The risk of being diagnosed with cancer increases with age, with most cases occurring in adults who are middle aged or older. About 77% of all cancers are diagnosed in persons 55 years of age or older. About 577,190 Americans were expected to die of cancer in 2012, more than 1,500 people per day. Cancer is the second most common cause of death in the US, exceeded only by heart disease, and accounts for nearly 1 of every 4 deaths.

*Data obtained from the 2012 ACS Cancer Facts & Figures, Kentucky Cancer Registry, and BHLEX Cancer Registry

1116   1083   1057  1192   1194   1230  

1401   1416   1397  1514  

1627   1592  

2001  

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2012  

   

Newly  Diagnosed  and/or  Treated  Cases  at  BHLEX  2001-‐2012  

     

The  number  of  newly  diagnosed  and/or  treated  (analytic)  cases  reported  at  BHLEX  slightly  decreased  from  2011  to  2012,  by  2.15%  (35  cases).          

   

2012  Comparison  of  Top  Five  Sites  –  Male  &  Female*    

             

 According  to  the  2012  American  Cancer  Society’s  Cancer  Facts  &  Figures,  approximately  1,638,910  new  cancer  cases  would  be  diagnosed  in  the  US  in  2012,  excluding  carcinoma  in  situ  of  any  site  except  urinary  bladder  and  basal  and  squamous  cell  skin  cancers.    The  risk  of  being  diagnosed  with  cancer  increases  with  age,  with  most  cases  occurring  in  adults  who  are  middle  aged  or  older.    About  77%  of  all  cancers  are  diagnosed  in  persons  55  years  of  age  or  older.    About  577,190  Americans  were  expected  to  die  of  cancer  in  2012,  more  than  1,500  people  per  day.    Cancer  is  the  second  most  common  cause  of  death  in  the  US,  exceeded  only  by  heart  disease,  and  accounts  for  nearly  1  of  every  4  deaths.    *Data  obtained  from  the  2012  ACS  Cancer  Facts  &  Figures,  Kentucky  Cancer  Registry,  and  BHLEX  Cancer  Registry    

1116   1083   1057  1192   1194   1230  

1401   1416   1397  1514  

1627   1592  

US   KY   BHLEX    14%   19%   26%   Trachea,  Bronchus,  Lung  29%   16%   14%   Prostate  9%   11%   14%   Colon  and  Rectum  5%   7%   8%   Malignant  Melanoma  

4%   3%   4%  Non-‐Hodgkin's  

Lymphomas  39%   44%   33%   All  Other  Sites  

  BHLEX   KY   US  Breast   33%   29%   29%  Trachea,  Bronchus,  Lung   16%   15%   14%  Endometrium  (corpus  uteri)   9%   5%   6%  Colon  and  Rectum   7%   9%   9%  Thyroid   5%   4%   5%  All  Other  Sites   30%   38%   37%  

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5-Year Comparative Analysis of Top Ten Sites at BHLEX 2008-2012

SUMMARY: The top three cancer sites for Baptist Health Lexington have remained consistent over the past 5 years. This correlates directly with state and national top cancer sites. These three sites have been the focus of program development for Baptist Health Lexington, ensuring our program has the latest technologies, as well as the additional support services needed to elevate the care for these patients. Of the top 3 sites, the incidence rate decreased for both lung and breast cancers while the incidence rate for colon cancer increased. This may be attributed to our effort to educate the public on screening and early detection of colon cancer.

2012 Top Five Cancer Sites at BHLEX by Best Collaborative/AJCC Stage

In 2012, the majority of lung cancer cases at BHLEX were diagnosed at stages I (28.1%) and IV (39.2%). Similar to national trends, the majority of patients diagnosed with lung cancer have advanced, late stage disease. It is a goal of our multidisciplinary lung cancer program to raise awareness about the causes of lung cancer and to educate Kentuckians on ways to decrease their risk of developing lung cancer. Our Lung Nurse Navigator serves as a guide to patients from screening through survivorship as we provide comprehensive care to patients at all stages of disease. We are also working to diagnose lung cancers in earlier stages with our Lung Cancer Screening program. Our program monitors patients at high risk for developing lung cancer by promoting early detection and treatment.

BHLEX continued to diagnose the majority of breast cancer cases at early stages: stage 0 (21.0%), stage I (41.5%), and stage II (22.6%). This early detection is due to our efforts at BHLEX towards education and awareness for screening and early detection, as well as our high-quality breast imaging center. Our breast center has earned the Breast Imaging Center of Excellence award from the American College of Radiology. This designation is awarded to breast imaging centers that

2008 2009 2010 2011 2012Trachea/Bronchus/Lung 298 333 277 342 316Breast ( female & male) 304 259 344 318 313Colon/Rectum/Anus 131 130 117 132 164Prostate 72 50 51 103 95Malignant Melanoma 93 106 106 100 85Endometrium (corpus uteri) 52 62 76 70 85Thyroid 61 54 60 45 57Non-Hodgkin’s Lymphomas 46 48 64 58 57Pancreas 26 21 32 21 30Bladder 26 24 34 23 18

Site Total Stage 0 Stage I Stage II Stage III Stage IV Stage Cases UnknownTrachea/Bronchus/Lung 316 1 89 25 71 124 6Breast (Female & Male) 313 66 130 71 27 15 4Colon/Rectum 158 24 31 39 38 19 7Prostate 95 0 0 72 21 2 0Malignant Melanoma 85 5 43 23 7 2 5TOTALS 967 96 293 230 164 162 22

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achieve excellence by seeking and earning accreditation in all of the ACR’s voluntary breast-imaging accreditation programs and modules, in addition to the mandatory Mammography Accreditation Program. BHLEX is also a member of the NAPBC, signifying our dedication to the improvement of quality care and outcomes of patients with diseases of the breast.

Our breast center is staffed with highly dedicated and skilled breast imaging radiologists. With the use of our advanced imaging technology available in our breast center, these radiologists are able to detect cancer in its earliest stages. Baptist Health Lexington also participates in numerous community events throughout the year focused specifically on educating women about the importance of regular screenings. We offer annual screening mammography services at all six of our outpatient diagnostic centers allowing for convenient screening close to home. Our efforts to educate the public about early diagnosis, along with our high quality breast imaging center, is making a difference in earlier diagnosis.

Most colorectal cases were diagnosed at stage II (24.6%) and III (24.0%), though diagnosis at other stages ranged between 12.0% and 19.6%. Overall, BHLEX diagnosed more cases of colorectal cancer than in any of the previous 5 years. This may be due in part to our concerted effort to educate the public on screening and early detection of colon cancer. All patients older than 50 admitted to the hospital who have not had a screening colonoscopy were educated on the importance of screening and early diagnosis. Like with breast cancer, Baptist Health Lexington also participates in numerous community events focused on educating the public on the importance of screening and diagnosing colon cancer in the early and more treatable stages. This education, along with the use of our GI nurse navigator has raised awareness to the public about screening and early detection.

About three-fourths of prostate cases were diagnosed at stage II (75.7%). As a result of widespread PSA testing, most patients are being diagnosed with earlier stage, asymptomatic clinically localized prostate cancer.

In 2012, over half of malignant melanoma cases were diagnosed at stage I (50.5%). Melanoma is one of our top 5 tumor sites at Baptist Health Lexington. This is most likely due to the outstanding reputation among the community of one of our surgical oncologists who frequently treats melanoma.

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Analysis of Lung Cancer Care at Baptist Health LexingtonUsing Cancer Registry DataGoal: Evaluation of Lung Cancer statistics and care at BHLEX

Criteria: Data includes records of newly diagnosed and/or treated patients at BHLEX. Comparative analyses utilizing National Cancer Data Base data.

Sources: BHLEX Cancer Registry Data, National Cancer Data Base, American Cancer Society 2012 Cancer Facts & Figures, SEER data, CDC

Reviewer: Gary Earle, MD, Cardiothoracic Surgery

New Cases: According to the ACS Facts & Figures, approximately 226,160 new cases of lung cancer would be diagnosed in the US in 2012. The incidence rate has been declining in men over the past two decades, from a high of 102 (cases per 100,000 men) in 1984 to 72 in 2008. In women, the rate has just begun to decrease after a long period of increase. On average, rates for new lung and bronchus cancer cases have been falling at a rate of 1.3% each year over the last 10 years. At BHLEX, the number of lung cases diagnosed and/or treated has fluctuated from 2001-2012. In 2012 we saw an 8% decline in the number of cases from the previous year. Kentucky continues to rank No. 1 in the US in both incidence and mortality from lung and bronchus cancers.

Lung Cases Diagnosed and/or Treated at BHLEX 2001-2012

Risk Factors: Cigarette smoking is by far the most important risk factor for lung cancer; risk increases with both quantity and duration of smoking. Cigar and pipe smoking also increase risk. Exposure to radon gas released from soil and building materials is estimated to be the second leading cause of lung cancer in Europe and North America. Other risk factors include occupational or environmental exposure

52   56   51   58   51   31   53   44   46   38   48   46  

296   282  244   256  

287  278   282   254  

287  239  

294   270  

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ber  of  Cases  

Lung  Cases  Diagnosed  and/or  Treated  at  BHLEX  2001-‐2012  

Trachea/Bronchus/Lung  -‐  Small  Cell  

Trachea/Bronchus/Lung  -‐  Non-‐Small  Cell  

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to secondhand smoke, asbestos (particularly among smokers), certain metals (chromium, cadmium, arsenic), some organic chemicals, radiation, air pollution, and paint (occupational). Risk is also probably increased among people with medical history of tuberculosis. Genetic susceptibility plays a contributing role in the development of lung cancer, especially in those who develop the disease at a younger age.

At BHLEX, 75% of patients with non-small cell lung cancer were diagnosed at age 60 years of age or older, and 93% of patients were diagnosed at age 50 or older. These findings are consistent with the NCDB data.

At BHLEX, 69% of patients with small cell lung cancer were diagnosed at age 60 years of age or older, and 93% of patients were diagnosed at age 50 or older. Again, these findings are consistent with the NCDB data.

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Early Detection/Stage: Recently published results from a large clinical trial showed that annual screening with chest X-ray does not reduce lung cancer mortality. Newer tests, such as low-dose spiral computed tomography (CT) scans and molecular markers in sputum, have produced promising results in detecting lung cancers at earlier, more operable stages in high-risk patients. Results from the National Lung Screen Trial, a clinical trial designed to determine the effectiveness of lung cancer screening in high-risk individuals, showed 20% fewer lung cancer deaths among current and former heavy smokers who were screened with spiral CT compared to standard chest X-ray. However, it is not known how relevant these results are to individuals with a lesser smoking history compared with the study participants, who had a history of very heavy smoking– the equivalent of at least a pack of cigarettes per day for 30 years. In addition, the potential risks associated with screening, including cumulative radiation exposure from multiple CT scans, and unnecessary lung biopsy and surgery, have not yet been evaluated. It will take some time to develop formal guidelines based on a careful evaluation of the benefits, limitations, and harms associated with screening an asymptomatic population at high risk for lung cancer. In the interim, the American Cancer Society has issued lung cancer screening guidance for adults who would have met the criteria for participation in the screening trial. For more information, visit cancer.org/healthy/findcancerearly.

At BHLEX, 31% of non-small cell lung cancer patients were diagnosed at stage I and 20% at both stages III and IV, consistent with the NCDB data.

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At BHLEX, 27% of small cell lung cancer patients were diagnosed at stage III and 41% at stage IV, again consistent with the NCDB data.

Late diagnosis of lung cancer can be attributed to multiple factors. Only recently have there been recommendations for screening or early detection in high-risk individuals. There are no recommendations for screening individuals at average risk. Secondly, most patients present with symptoms. However, symptoms such as persistent cough, exertional dyspnea, and recurrent pneumonia or bronchitis often can be subtle and attributed to chronic symptoms of smoking.

In 2012, Baptist Health Lexington began a Lung Cancer Screening Program for those at high risk for the development of lung cancer. The program is recommended for people who are current smokers (or have quit within the last 15 years) aged 55 to 79 years old who have a smoking history of 30 pack-years or greater. Based on results from the National Lung Screening Trial, those who are considered to be at high risk for the development of lung cancer will have a low-dose CT scan every year. Our hope is that we will be able to identify those at risk, screen, diagnose and treat patients when their cancer is in its earliest stages providing them with the best opportunity for survival. Baptist Health Lexington has a wide array of diagnostic technologies available including:

Imaging Tests CT or CAT (computed axial tomography) scans MRI (magnetic resonance imaging) scans PET (positron emission tomography) scans

Fine Needle Aspiration (FNA) A small needle is placed into the tumor. Suction is used to remove a small amount of tissue, which is then looked at under a microscope. A CT scan guides the physician to the nodule.

Navigational Bronchoscopy A biopsy done by passing a tube through the patient’s mouth or nose, down into the windpipe and into the lungs where the tumor is located. The physician can evaluate the airways at the same time.

Endobronchial Ultrasound (EBUS) A kind of bronchoscopy with an ultrasound probe that sends sound waves throughout the chest cavity, allowing a physician to look at the area on an ultrasound monitor. The physician can then take tissue samples from a nodule.

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Mediastinoscopy An incision is made in the neck and a lighted instrument inserted to examine the area between the lungs known as the mediastinum.

Video-Assisted Thoracoscopy (VATS) A tiny camera is inserted through the airway on a thin, tube-like instrument. The physician can remove as much tissue as is necessary for testing.

Wedge Resection A surgical procedure to remove a triangular section of tissue, including a nodule or tumor. A wedge resection removes the smallest possible amount of tissue.

Treatment: Lung cancer is classified as small cell (14%) or non-small cell (85%) for the purposes of treatment. Based on type and stage of cancer, treatments include surgery, radiation therapy, chemotherapy, and targeted therapies such as bevacizumab (Avastin), erlotinib (Tarceva), and crizotinib (Xalkori). For localized non-small cell lung cancers, surgery is usually the treatment of choice, and survival for most of these patients is improved by giving chemotherapy after surgery. Because the disease has usually spread by the time it is discovered, radiation therapy and chemotherapy are most often used, sometimes in combination with surgery. Advanced stage non-small cell lung cancer patients are usually treated with chemotherapy, targeted drugs, or some combination of the two. Chemotherapy alone or combined with radiation is the usual treatment of choice for small cell lung cancer; on this regimen, a large percentage of patients experience remission, though the cancer often returns.

At BHLEX, more patients with non-small cell lung cancer were treated with radiation only, compatible with the NCDB data.

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At BHLEX, most patients with small cell lung cancer were treated with chemotherapy or a combination of radiation and chemotherapy, again compatible with the NCDB data.

Treatment decisions for patients with lung cancer are determined by disease stage and tumor characteristics. Although these are not absolute indicators because other patient characteristics and the presence of co-morbid disease must be considered as well.

At Baptist Health Lexington, we offer the latest radiation therapy, chemotherapy, and surgical techniques, as well as access to clinical trials. We work with a multidisciplinary team to customize treatment options to deliver the most advanced, least invasive treatments available for lung cancer, while specializing in techniques and therapies to help preserve lung function. We follow established standards of care and plan individualized treatments based on the type and stage of lung cancer, as well as the health of our patients.

Radiation TherapyCyberKnife – a painless, non-invasive radiation treatment that uses image-guided robotics to destroy tumors using multiple beams of high-energy radiation. The cumulative effect of all the beams at the target results in the tumor receiving a very high dose of radiation while nearby normal tissue is preserved.

External Beam Radiation Therapy (EBRT) – delivers high-energy rays to tumors, allowing radiation to be delivered from any angle and shapes radiation beams to the contour of the tumor. Our radiation oncologists use EBRT to target a tumor with higher, more precise doses of radiation, while minimizing damage to healthy tissue and nearby organs.

Chemotherapy Our medical oncologists use the newest forms of chemotherapy and other types of targeted drug therapy as the foundational treatment for lung cancer of all types. In order to be nearer and more convenient to our patients, Baptist Health provides chemotherapy to our lung cancer patients at our main campus in Lexington as well as satellite locations at Brannon Crossing in Nicholasville and Meridian Way in Richmond. Our Outpatient Infusion Center nurses are experts in administering chemotherapy and caring for patients with lung cancer and have earned national oncology nursing certification.

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Surgery Our lung surgeons are among the most skilled and recognized in the region, performing a large number of traditional and minimally invasive surgeries for lung cancer each year. With traditional surgery, the surgeon makes an incision in the chest, spreading the ribs to remove the tumor. In minimally invasive and robotic surgery, a surgeon can make much smaller incisions that allow tools to go inside the chest cavity. Many patients in need of lung surgery are referred for a minimally invasive surgery, known as a Video-Assisted Thoracoscopic Surgery (VATS), which allows the surgeon to use a camera to “see” the operation site while manipulating the instruments inside the chest. A surgeon may also use the da Vinci Surgical System (robotic surgery) to perform minimally invasive surgery using a camera and a computer console that allows the surgeon to manipulate robotic arms to remove the tumor.

Clinical Trials Clinical trials conducted at Baptist Health allow patients to stay in their own community and continue to see the healthcare providers they are familiar with while having the opportunity to participate in clinical trials. Patients who enroll in our cancer research participate in treatment regimens at the forefront of lung cancer care.

Survival: The 1-year relative survival for lung cancer increased from 37% in 1975-1979 to 43% in 2003-2006, largely due to improvements in surgical techniques and combined therapies. However, the 5-year survival rate for all stages combined is only 16%. The 5-year survival rate is 52% for cases detected when the disease is still localized, but only 15% of lung cancers are diagnosed at this early stage.

This graph shows observed survival for NSCLC for cases diagnosed between 2003-2006 in the NCDB.

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This graph shows observed survival for NSCLC for cases diagnosed between 2003-2006 at Baptist Health Lexington. The 5-year survival for small cell lung cancer (6%) is lower than that for non-small cell (17%).

This graph shows observed survival for SCLC for cases diagnosed between 2003-2006 in the NCDB.

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This graph shows the observed survival for SCLC for cases diagnosed between 2003-2006 at Baptist Health Lexington

Treatment of early-stage disease can produce cures, with five-year survival from treated stage I lung cancer as high as 52%. Unfortunately, less than 15% of lung cancers are localized at the time of diagnosis. Most lung cancers are diagnosed in advanced stages, and five-year relative survival rate in patients with metastatic disease is 4%.

CONCLUSION: Lung cancer accounts for more deaths than any other cancer in both men and women. More than half the people with lung cancer will die within just one year of diagnosis. Kentucky leads the nation in both lung cancer incidence and lung cancer deaths. In Kentucky, lung cancer kills more Kentuckians every year than the next eight most common cancers combined. Much of this can be attributed to smoking, the main cause of all lung cancer. Elimination of tobacco use, ultimately, will do the most to decrease incidence. However, even if efforts to eliminate smoking today were successful, lung cancer would continue to kill people for decades because more former smokers than active smokers are diagnosed.

Baptist Health Lexington is well equipped to care for lung cancer patients in the state of Kentucky. From navigational bronchoscopy to CyberKnife to the latest in targeted therapies as well as clinical trials we are proud to provide multidisciplinary quality patient care. We continue to be invested in offering both the technology and the team of professionals who can achieve the best possible outcomes and highest quality care for our patients.

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Lung Cancer ConferenceGary Earle, MD

Lung cancer is the leading cause of cancer death in men and women in the United States each year. Kentucky leads the nation in lung cancer incidence and mortality rates. Of course, these facts are closely associated with Kentucky’s smoking prevalence. The overall five year survival of patients with lung cancer is approximately 15 percent, and this number has changed very little in the past 50 years.

Most patients who are diagnosed with lung cancer have advanced disease and can only be offered palliative measures. Early detection and proper staging are the hallmarks of any cancer treatment

program and are enhanced with the technology of our navigational bronchoscopy and endobronchial ultrasound utilized by our pulmonologists. New surgical techniques, such as robotic chest surgery and video-assisted surgery, which are available at Baptist Health Lexington, allow patients to have their surgical resection with less pain and morbidity.

For those patients with inoperable lung cancer due to severe emphysema or multiple co-morbidities, our radiation oncologists may offer additional treatment options, such as, CyberKnife, which is focused radiation therapy, to potentially cure lung cancer in this group of patients.

Due to the various services offered along the continuum of care for these patients, Baptist Health Lexington’s Multidisciplinary Lung Cancer Program decided to implement a lung cancer conference. The conference meets bi-monthly, to discuss individualized treatment options for patients with lung cancer.

Our multidisciplinary team includes: • medicaloncologists• thoracicsurgeons• radiationoncologists• interventionalradiologists• pulmonologists• pathologists• palliativecareteammembers

• geneticcounselors• oncologydietitians• chaplains• clinicalresearchcoordinators• lungcancernursenavigator• cancerregistry

Our multidisciplinary approach allows various healthcare professionals the option to participate in the patient’s care. For example, the oncology research coordinators are able to identify potential subjects for clinical trials prior to any surgical intervention.

The coordination of care among the team ensures that all providers concur with how the patient will be treated. The multidisciplinary team works seamlessly behind the scenes to expedite care, helping our patients and their families feel they made the right choice by coming to Baptist Health Lexington.

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ALK Molecular Testing Advances Treatment Outcomes for Non-Small Cell Lung CancerMegan Brafford, Pharm.D.Clinical Oncology Pharmacy Specialist Genetic testing is playing an increasingly important role in cancer diagnosis and treatment. The echinoderm microtubule-associated protein-like 4 gene fused with anaplastic lymphoma kinase (EML4-ALK) oncogene is an independent driver of cancer cell proliferation in approximately 2-7% of patients with non-small cell lung cancer (NSCLC). This affects about 10,000 patients in the United States. There is a higher prevalence in patients that have never smoked or were light smokers, have histology of adenocarcinoma lung cancer, and are younger age.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommends that all advanced or metastatic NSCLC that is determined by histology to be non-squamous or not otherwise specified undergo biomarker testing for ALK gene rearrangement. Patients with squamous cell carcinoma from a small biopsy specimen and have never smoked are recommended to undergo biomarker testing for ALK gene rearrangement.

The College of American Pathologists, International Association for the Study of Lung Cancer and Association for Molecular Pathology have similar recommendations regarding ALK testing being recommended for lung adenocarcinomas and mixed lung cancers with an adenocarcinoma component, regardless of histologic grade in the setting of lung cancer resection specimens. In the case of limited specimen size where an adenocarcinoma component is not evident but cannot be ruled out, clinical criteria (young age, lack of smoking history) may be used to select patients for testing. However, patients with lung adenocarcinoma should not be excluded from testing on the basis of clinical characteristics.

The medication therapy chosen for NSCLC is partially based upon ALK gene testing. Crizotinib (Xalkori©) is an oral ALK inhibitor that is FDA approved in locally advanced or metastatic ALK-positive NSCLC. Crizotinib selectively inhibits ALK tyrosine kinase, which reduces proliferation of cells expressing the genetic alternation. Crizotinib is dosed 250 mg by mouth twice daily and continued until treatment is no longer clinically beneficial. In clinical trials, crizotinib resulted in an objective response rate of 50-61% at 8 weeks with median response duration of 42-48 weeks in patients with advanced NSCLC who have ALK rearrangements and have progressed on previous therapy. Survival rates at one and two years were 74% and 54%, respectively.

Crizotinib has relatively few side effects. The most common adverse reactions observed were vision disorders, edema, nausea, diarrhea, vomiting, and constipation. Light to dark accommodation difficulties were report in 65% of patients. An increase in LFTs was found in up to 15% of patients, with 7% being Grade 3 or 4. A few patients did have life-threatening pneumonitis. Patients have responded rapidly to crizotinib with improvement in NSCLC symptoms (cough, dyspnea, pain) although median time to progression on crizotinib is less than one year.

In the past year at Baptist Health Lexington, twenty-four patients had molecular testing completed for the ALK gene rearrangement. The hospital laboratory sends a paraffin block of the patient’s tissue to Integrated Oncology for testing by fluorescence in situ hybridization (FISH) testing using dual-labeled break-apart probes which is considered the gold standard. It takes approximately 7 to 10 days to obtain the results from the outside laboratory. Of the patients at Baptist Health Lexington that had ALK gene testing, 96% had advanced or metastatic NSCLC and one patient had colon

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cancer as the primary malignancy with metastases to the lungs. At Baptist Health Lexington, there has been a dramatic increase in the number of patients that have undergone molecular testing in order to appropriately choose medication therapy for NSCLC.

References1. NCCN Clinical Practice Guidelines in Oncology. National Comprehensive Cancer Network. http://www.nccn.org/

professionals/physician_gls/pdf/nscl.pdf. Accessed October 7, 2013.2. Lindeman NI, Cagle PT, Beasley MB, et al. Molecular testing guideline for selection of lung cancer patients for EGFR

and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. J Thorac Oncol. 2013;8)7):823-859.

3. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-1703.

4. Camidge DR, Bang YJ, Kwak EL, et al. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol 2012;13:1011-1019.

5. Shaw AT, Yeap BY, Solomon BJ, et al. Impact of crizotinib on survival in patients with advanced, ALK-positive NSCLC compared with historical controls [abstract]. J Clin Oncol 2011;29(Suppl 15):Abstract 7507.

6. Bang YJ. Treatment of ALK-positive non-small cell lung cancer. Arch Pathol Lab Med 2012;136:1201-1204.7. Choi YL, Soda M, Yamashita Y, et al. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N

Engl J Med 2010;363:1734-1739,

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A First for Baptist Health LexingtonMegan Brafford, Pharm.D.

At the end of 2012, Baptist Health Lexington recruited its first Clinical Oncology Pharmacy Specialist. Megan Brafford, Pharm.D., a Certified Oncology Pharmacist, joined the team in August 2013 after completing her Oncology Pharmacy Residency at the Medical University of South Carolina. Dr. Brafford received her undergraduate degree from the University of Georgia and her Doctor of Pharmacy from Samford University in Birmingham, Alabama.

At the end of 2012, only 90 pharmacists across the United States completed their residencies in hematology/oncology. Approximately

78% went to practice in the hospital setting or hospital-based cancer center, 17.5% practice in physician’s privately owned clinics, 3.5% in specialty retail pharmacy, and 1% in academics. Baptist Health Lexington is fortunate to have one of these highly specialized oncology pharmacists in its cancer program.

Clinical Oncology Pharmacists bring a valuable skill set to the patient care team, particularly at a time when treatments for cancer are becoming more personalized and complex. A clinical oncology pharmacist can help cancer teams make the most effective treatment selections, provide assistance in managing treatments, perform ongoing research on treatment options, educate patients and providers on treatment guidelines, as well as lead quality improvement projects benefiting overall cancer care. They also are trained to help educate patients on the risks and benefits of intravenous and oral chemotherapy.

Dr. Brafford brings a wealth of knowledge to our patient care team and we look forward to having her help us to continue elevating the care we provide our patients at Baptist Health Lexington.

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Baptist Health Lexington Cancer Research ProgramIn 2013, the research program focused on finding studies that meet the treatment needs of the patients served by Baptist Health Lexington treating oncologists. The research program found several studies that met the treatment need of this population and would give more options to both the patient and treating physician.

The Matisse study is conducted at many centers in the US using a new drug in combination with the standard carboplatin and etoposide in patients who have not received chemotherapy for their extensive-stage small cell lung cancer. The study opended in August of 2012 with Firas Badin, MD, serving as Principal Investigator at Baptist Health Lexington. By April 2013 the sponsor of the study halted enrollment to review the data with the expected date to reopen the study to occur early in 2014. BHLEX enrolled 6 patients and was the second highest enrolling site in the study.

The second study is supported by the National Cancer Institute (NCI) through the ALLIANCE against cancer cooperative group. The study known as CALGB 30801 is looking at adding celecoxib (Celebrex) to the standard treatment for patients with advanced non-small cell lung cancer to see if it adds benefit to the standard chemotherapy. Lee G. Hicks, MD, is the Principal Investigator at BHLEX. The research program at BHLEX has enrolled 2 patients in the last year and is currently screening patients for this study to assist ALLIANCE in reaching their overall enrollment goal of 300 patients across the United States.

Firas Badin, MD serves as Principal Investigator on a second extensive stage small-cell lung cancer study sponsored by ONYX Therapeutics Inc. This worldwide study is for patients who have not received treatment for their extensive-stage small-cell lung cancer. The study will determine whether adding the drug carfilzomib to standard chemotherapy will be of benefit. This trial has just opened at BHLEX and enrolled the first patient in the world early in November of 2013.

Our program continues to follow patients for long-term survival data and outcomes in these studies that have completed enrollment:

• RTOG0123:aPhaseIIRandomizedTrialwithCaptoprilinPatientswhohaveReceivedRadiationTherapy +/- Chemotherapy for Stage II –IIIB Non-Small Cell Lung Cancer, Stage I Central Non-Small Cell Lung Cancer, or Limited-Stage Small Cell Lung Cancer (IRB# 662), Marta Hayne, MD – Principal Investigator

• MAGRIT109493:AStudytoTesttheEfficacyofanImmunotherpeuticinPatientswithResectableMAGE-A3-postive Non-Small Cell Lung Cancer (IRB# 900), Lee G. Hicks, MD – Principal Investigator

We are very excited about the growth of the BHLEX cancer research program under the Medical Directorship of surgical oncologist Peter S. Tate, MD during the past two decades. The program is part of the BHLEX Clinical Research Center and started with three medical oncologists, one coordinator and one surgical oncologist in 1995. Today the program serves five locations throughout central and western Kentucky (Lexington, Richmond, Nicholasville, Corbin and Madisonville). Through the support of eight medical oncologists, one surgical oncologist, two gyn-oncologists and two radiation oncologists serving as active investigators the clinical trials program has grown to support approximately 60 clinical trials a year, with 28 of those available for patient participation. To assist this network of physicians and locations the BHLEX Cancer Research Program includes two

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Certified Clinical Research Coordinators that coordinate study-related activities for more than 175 research subjects, a Data Coordinator, 3 administrative staff and a dedicated Director.

Baptist Health Lexington understands the only way to continue to find better treatments to fight cancer and manage symptoms is by supporting clinical trials. Clinical trials are a systematic way of gathering the necessary information to improve health and health care. Many of the treatments used today to treat cancers came from information learned through past clinical trials/studies. To learn more about clinical trials you can log onto www.overpoWErCANcer.org or www.cancer.gov/clinicaltrials.

Baptist Health Lexington Cancer Research Program Participating InvestigatorPeter S. Tate, MD – Cancer Research Medical Director, Surgical Oncology

Medical OncologyLee G. Hicks, MD (Lexington, Nicholasville)Russell Eldridge, MD (Lexington)Firas Badin, MD (Lexington, Richmond)Ari Padmanabhan, MD (Lexington, Nicholasville)Amy Schell, MD (Lexington, Richmond)Frank Domurat, MD (Corbin)Michael White, MD (Corbin)Ali Kanbar, MD (Madisonville)

Radiation OncologyAlan Beckman, MD (Lexington)Marta Hayne, MD (Lexington)

GYN/OncologyElvis Donaldson, MD (Lexington)Hope Cottrill, MD (Lexington)

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Fiscal Year ActivityScreened – 198 patients Completed Study Related Visits – 581 Enrolled – 53 patientsConsented – 66 patients Coordinating Studies – 66 Following – 182 patients

Enrollment Activity

0  

50  

100  

150  

200  

250  

300  

350  

1   2   3   4   5  

Screened  

Consented  

Enrolled  

2009 2010 2011 2012 2013

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Lung Cancer Screening now recommended for Smokers and Ex-SmokersAccording to data from the Centers for Disease Control and Prevention, lung cancer is by far the deadliest cancer in the U.S., accounting for 47.4 deaths/100,000 persons based on 2010 data. For comparison, female breast cancer, number 2 on the list, kills 21.9 people/100,000. Unfortunately, Kentucky is at the epicenter of this disease, ranking first among all states with a death rate of 73.8/100,000.

Despite the grim mortality numbers, the majority of lung cancer types, if caught early enough in their course, are potentially curable with surgery. Because the key to survival is often early detection, researchers have long sought techniques to detect cancer earlier. Various methods, such as standard chest X-rays, have been evaluated and have unfortunately not proven to be adequately effective at detecting cancers at an early, curable stage.

More recently, the National Lung Screening Trial (NLST) evaluated the use of low-dose CT scanning to screen for lung cancer in high-risk individuals. The study included 53,454 smokers and ex-smokers who were randomly assigned to receive either a chest X-ray or a low-dose CT scan annually for 3 years. The results showed that the group who received CT scans had a 20 percent decrease in mortality from lung cancer than the group who received chest X-rays.

Since the NLST was published in August 2011, several groups have recommended screening high risk smokers and ex-smokers with CT scans, including the American College of Chest Physicians, the American Thoracic Society, the American Society of Clinical Oncology, the American Cancer Society and others. Most recently, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation statement recommending screening of “healthy persons with a 30 pack-year history of smoking who are ages 55 to 79 years and have smoked within the past 15 years.” This is important because recommendations of the USPSTF typically become standard of care in the U.S.

Here at Baptist Health, we responded to the findings of the NLST last year by implementing a lung cancer screening service. The service is available through our Lexington, Corbin and Richmond locations. Initiation of the screening program involved the development and distribution of educational materials and patient brochures, and instituting a system to ensure timely referrals.

If a positive finding is noted on a screening CT scan, the referring physician is notified. If the referring physician chooses, our physicians at Baptist Pulmonary and Critical Care Associates will evaluate the case and direct or perform further diagnostic testing, which may include additional imaging, minimally invasive diagnostic testing, or referrals for surgical biopsy and/or resection. Our lung nurse navigator plays an essential role, both in supporting the patient and ensuring smooth transitions between phases of screening, diagnosis, and treatment.

Given the significant impact of lung cancer, especially in Kentucky, screening for early lung cancer with low-dose CT scans holds promise to save many lives. If you are an active smoker, the number one action you can take to reduce your risk of lung cancer is to quit smoking. In addition, active smokers and those with a significant past smoking history should consider discussing the option of low-dose CT scanning for lung cancer screening with their primary care provider.

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Candidates for lung screening should currently have NO signs/symptoms or history of lung cancer or previous abnormal CT scans of the chest and also meet the following criteria:

• Age55-75andhavea30-pack-yearhistoryofsmokingANDarestillsmokingorhavequitlessthan15 years ago

OR

• Age50orolderandhavea20-pack-yearhistoryofsmokingANDhaveoneadditionalriskfactorfor lung cancer: cancer history, lung disease history, family history of lung cancer, radon exposure or occupational exposure.

To determine your pack-year history, multiply the number of years you have smoked by the average number of packs per day you smoke.

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