Humphrey Cancer Center at North Memorial

Humphrey Cancer Center
Annual Report 2005
Lung Cancer

We are proud to present the 2005 annual report of the North Memorial Cancer Program. Our program is accredited by the American College of Surgeons, and is therefore required, on an annual basis, to publish this report. The report presents data regarding the number of cancer patients seen in our institution in 2005, and has reports from a variety of departments in our cancer center, including our Cancer Registry, Research Department, and Radiation Oncology. We also are presenting a detailed study of Lung Cancer at North Memorial over the past ten years, looking at epidemiology, staging, treatment and survival. Finally, we report a study of our experience with percutaneous lung nodule biopsies from 2003-2004.

2005 was a very important year for our Cancer Center. In the fall, the new North Memorial Outpatient Center opened. This new center houses Outpatient Imaging, the Humphrey Cancer Center Medical Oncology clinic, and Radiation Oncology in one new facility. This offers a major convenience for our patients and their families. The clinics were designed to maximize patient comfort and provide a peaceful, relaxing environment. Included in this report is a description of the new Elekta Synergy linear accelerator, at our new radiation facility. This is a truly state of the art machine allowing computer controlled "image guided radiotherapy" to be administered, minimizing toxicity, yet maximizing delivery of radiation to the cancer target. At our imaging center we have added a new fused PET/CT Scanner, allowing us to provide the latest in cancer imaging technology for our patients. We welcome any individuals who would like to tour this impressive new facility.

We received two $100,000 Susan Kohmen foundation grants, this year, to support our Cancer Center. One was to help purchase a new digital mammography machine, a major benefit for women who come though our Imaging Center. The second grant is funding a unique research program through our stellar Genetics Program, under the medical direction of Dr. Tom Amatruda.. We are developing a tool to screen all women with breast cancer seen at our institution, identifying systematically those who are appropriate for referral for potential life saving genetic counseling. We continue to be very active in clinical research, both through the Twin Cities wide Community Clinical Oncology Program (CCOP), and through our own research center with over 100 clinical research protocols available to our patients.

I hope you will take the time to examine the information on lung cancer at North Memorial in this report, and to read Dr. Tim Larson's analysis of this data. It is amazing to me that over just a period of ten years, we have gone from having only 43% of our lung cancer patients be women, to 52% (over half!!). The "you've come along way baby" marketing programs to increase women' s smoking behavior have had their terrible expected consequence.

Finally, with the efforts of North Memorial's foundation (and the hard work of Joe Boston and Joan Manolis), and a dedicated board, chaired by Bill McGreavy, we raised nearly $2 million in donated funds to support our new cancer center and its programs. In addition, one of our patients, Michelle Morey, founded "Pay it Forward", a very special fund to assist women with cancer deal with their non-medical expenses. A very successful (and fun!) fundraiser was held at the Medina Ballroom, and many patients are already directly benefiting from this amazing program. North Memorial is also very proud of our association with the Susan Kohmen foundation and "The Race for the Cure". Our cancer center was also the beneficiary of funds raised at a motorcycle rally, in honor of a former patient (Celeste Hawkins), and of the Whiz Bang Days race sponsored by the city of Robbinsdale. We welcome your participation in our giving campaigns. The funds directly benefit our patients and their loved ones, as they deal with this difficult illness.

Harold Londer, M.D.
Medical Director     

A message from Chris Lemme, administrative director

As the new administrative director for oncology services, it's been an honor and privilege to work with the physicians and staff of the Humphrey Cancer Center. There is great passion in our team to provide remarkable, high quality care and service to the patients we serve.

It has been a time of great excitement in our programs that is setting the stage for our future. We have added a new medical oncologist at each of our three cancer center locations in just over a year, which has helped us address the growing need for the medical oncology and hematology services we provide. In addition, we continue to strive toward enhancing the patient experience by promoting the integration and collaboration of multiple medical specialties and support services through one common purpose.

We are proud to announce the opening of a new cancer center at our Robbinsdale location. Not only does the new cancer center represent expanded space and capacity with double the square footage, but it also enhances patient convenience by co-locating diagnostic imaging and radiation oncology into the same Outpatient Center facility. The design is focused on creating a calming environment by use of warm earth tones and soothing lighting. We also hope to expand our complementary therapies as we move forward.

While a new facility is great, it's our people that make the care experience truly remarkable for our patients. This is definitely true of the physicians and staff who care for those that have been diagnosed with lung cancer. This disease has received a great deal of attention as celebrities such as Peter Jennings and Dana Reeve became the topic of many news stories and headlines in 2005. It's yet another reminder that cancer does not discriminate based on celebrity or socioeconomic status. We are on a never-ending journey to provide patient outcomes that exceed national averages in not only lung, but in all disease categories.

Christopher R. Lemme, MHA
Director, Oncology Services 
Humphrey Cancer Center     

Summary of the Tumor Registry Lung Cancer Data

Our analysis included the available tumor registry data from the past ten years. During that time, several changes occurred in the world of thoracic oncology. Innovative screening strategies involving spiral chest CT for lung cancer were investigated. New clinical staging tools such as PET/CT fusion imaging, endoscopic and bronchoscopic ultrasound directed FNA have quickly evolved. Surgical techniques such as minimally invasive video assisted thoracotomy and muscle sparing thoracotomy are decreasing morbidity. State of the art radiotherapy is targeting higher doses of radiation directly to the tumor and less to the surrounding healthy tissues. Novel drugs and biologics have found their way into the oncology treatment suite. All of this has added great potential - and complexity - to the care of patients with lung cancer. As we examined the data we decided to subdivide the ten year period into two five year blocks. Our rationale was that by aggregating the data into two historical cohorts, meaningful trends might emerge and the robustness of our conclusions increased. Where possible we reviewed data from the most recent past to see how this compared with those seen nationally. We hope you will find our results herein both interesting and informative.

Radiologic Directed Needle Biopsy of Pulmonary Lesions
During the years 2003 and 2004, 252 needle biopsies were performed. The positive diagnostic rate of lung cancer was approximately 70%. The great majority of nonmalignant biopsies were acute or chronic inflammation, occasionally with granulomas. There were only a few false negatives and no false positives.

Histology and Epidemiology
At North Memorial there has been a significant rise in the number of patients newly diagnosed with NSCLC in the last five years compared to the five years previous to that (831 in 2000-2004 vs. 604 in 1995-1999). In contrast over the same time period, the number of new cases of small cell lung cancer has remained relatively stable (145 vs. 151). Thus, small cell lung cancer is becoming proportionally smaller despite no overall change in incidence. Tobacco use remains the principal risk factor driving this epidemic. It is interesting to note, however, that at the time of diagnosis of NSCLC, slightly more patients were former rather than current smokers. The median age at diagnosis was 70 and has not changed over time. Fully half of our lung cancer patients therefore are geriatric by definition. Yet, this population is underrepresented in most published clinical studies. In 2002 there were 195 new cases of lung cancer diagnosed at NMHC which was approximately seven percent of all patients diagnosed in Minnesota that year. (This is the most recent year for which data is available for Minnesota.)
Anual Cancer Case chart

Trends by Gender
Analyzing the increase in NSCLC at North Memorial by gender reveals that most of the growth is disproportionately represented by women. There were 227 more patients diagnosed with NSCLC at North Memorial between the time period 2000 -2004 compared to 1995-1999. Of this increase, 173 were women (66% increase) versus 54 men (16% increase). To the contrary, SCLC has remained generally stable in both sexes with a slight decline seen in men (-16%). There were no significant differences between women and men in age or stage at the time of diagnosis.

Never Smokers
Data regarding tobacco use has been collected since 2002. We specifically examined the data from 2002-2004 for any trends. During this period, there were a total of 491 patients diagnosed with NSCLC. Thirty-six of these patients never smoked. Four of them actually were diagnosed with carcinoid tumors (two were female and two were male) and one woman had a neuroendocrine tumor which likely was an atypical carcinoid. Interestingly, of the remaining 31 patients, 24 were women. They, in fact, exemplify a newly described demographic subset of lung cancer. These women tend to be younger. Their histology favors adenocarcinoma, adenocarcinoma with bronchoalveolar features or pure bronchoalveolar carcinoma. This new face of NSCLC is in fact garnering growing attention in the lay media as well as in the medical journals. Dana Reeves, wife of the late actor Christopher Reeves, is a recent tragic example. The clinical recognition and investigation of this population has led to important therapeutic discoveries and therapeutic advances. For example, we now know they have a significantly higher response rate to a recently FDA approved oral agent named Erlotinib (Tarceva). Some of these clinical responses can be quite pronounced and prolonged. Erlotinib targets the tyrosine kinase function of the epidermal growth factor transmembrane receptor. This receptor often contains mutations in the intracellular portion of the protein where Erlotinib binds. Mutations of this type are seen more frequently in the patients just described: female never-smokers, with non-squamous histology as well as those of Asian ancestry.

Treatment of NSCLC (For years 2003 and 2004)
Localized disease

The mainstay of stage I and II NSCLC remains surgical removal either by lobectomy or pneumonectomy. From 2003 to 2004, 71 patients out of 118 with early stage NSCLC underwent definitive surgical resection. Thirty of the remaining forty-seven patients alternatively received external beam chest radiotherapy as definitive local treatment. Of the 71 patients who underwent surgical resection, 77% were performed by one physician with the remaining procedures being distributed among six others. Therefore, comparison of surgical procedures and outcomes by surgeon lack any statistical significance. Fifty-four of the procedures were lobectomies, four were pneumonectomies and thirteen were wedge resections. Review of the 55 lobectomies/pneumonectomies performed by the most active surgeon reveals that all but four included mediastinal node dissection. The four patients that did not undergo mediastinal node dissection could not for reasons related to their poor medical status. (This is important because there is mounting evidence that thorough mediastinal node dissection is associated with improved surgical outcomes). We reviewed the history of all patients who underwent wedge resections. We verified that the indication for wedge resection was insufficient pulmonary reserve for more definitive surgery, i.e. lobotomy or pneumonectomy.

Several published studies over the past few years have conclusively demonstrated a modest survival advantage for postoperative chemotherapy compared to surgery alone in early stage NSCLC. Counseling and offering adjuvant chemotherapy following lobectomy/pneumonectomy is now the community standard. Approximately 51 of the 98 patients with Stage I disease were sub classifiable as Stage IA (primary tumor less than 3 cm). These patients should not routinely be offered adjuvant chemotherapy based on current evidence. Of 10 patients with Stage II disease who underwent resection, six did receive adjuvant chemotherapy.
Top Cancer Diagnoses at North Memorial

Regionally Advanced Disease
The optimal approach to patients with regionally advanced disease (Stage III) is controversial. There is a lack of consensus as to which modalities, in which combination and which sequence is optimal. In addition, the patients are very heterogeneous with respect to tumor burden and distribution within the thorax. For example, patients with Stage III NSCLC can vary from those with relatively favorable prognosis (i.e. pathologically detected minimal microscopic spread to a single ipsilateral mediastinal lymph node discovered only incidentally after surgery) to the other extreme of unresectable malignant pleural effusion which carries a prognosis more akin to that of metastatic disease.

The range of approaches taken to treat Stage III NSCLC is illustrated by the most recent year for which we have survival data, 2003-2004. Thirteen out of twenty-three patients with Stage IIIA disease underwent surgery as part of their treatment plan, while fifteen received chest radiotherapy. Six of the above received both. Seven further patients declined all active treatment. Of the twenty-three patients receiving active therapy, all but six received systemic chemotherapy. The estimated three-year survival by Kaplan-Meier method was approximately 20%. In our series of patients, 55 were staged as IIIB. Stage IIIB NSCLC rarely is addressed surgically. Nevertheless, eight did undergo surgery. These most likely were exploratory and led to the patient's upstaging. Fifteen received chemotherapy alone. This group was predominantly patients with malignant pleural effusions. Ten patients received no treatment. Twenty two patients received radiation therapy and fourteen of those were also given chemotherapy. The three-year Kaplan-Meier survival estimate for Stage IIIB was nine percent.

Metastatic Disease
The mainstay of treatment for Stage IV NSCLC is chemotherapy, biologics and targeted use of radiotherapy for palliation of symptomatic metastatic lesions. The national median survival is between 9-12 months, with one year survival of 30-40%. Our one year survival data for 2003-2004 is 33%. It is worthwhile to point out that not all patients with metastatic NSCLC received chemotherapy. Of our 104 patients with metastatic NSCLC, twenty-eight did not receive chemotherapy for the following reasons: seven died shortly after diagnosis, ten patients were counseled by their physicians not to undergo chemotherapy (an oncologist was involved in eight of those), ten patients declined treatment and thirteen never saw an oncologist.

Treatment of Small Cell Lung Cancer
The proportion of SCLC patients with limited stage disease (disease confined to the thorax encompassable by a single radiation field) for 2003-2004 was 25% which is typical for this disease. Only five of fifteen received standard therapy consistent with National Comprehensive Cancer Network guidelines, however. Three more patients (20%) had acceptable and definitive local treatment by surgical resection followed by chemotherapy. Another three patients, (20%) did not receive any therapy at all. That left four patients who inexplicably received chemotherapy alone without any form of local treatment. In addition, our database was not set up to record whether a patient received prophylactic cranial irradiation or not. This is now a standard and potential benchmark of quality care. Only survival data for 1995-2001 is available. This shows a 20%, five year survival for limited stage disease. Again this is in line with national results. Treatment for extensive stage disease is palliative in nature with very rare cases of long term survival. Treatment is usually with chemotherapy alone. Median survival for extensive stage disease for 1995-2001 was five months.

Comparison to National Trends and Outcomes
The findings from our analysis of the North Memorial tumor registry data generally reflect those of the nation with some exceptions. Nationally, lung cancer incidence in women has finally leveled off after many years of increase. (Of note, by 1987, the cancer mortality rate for lung cancer had surpassed breast cancer to become the number one cancer killer in women.) In contrast, men have seen a decline nationally in the incidence rate of lung cancer since the early 1990's. Despite these overall trends, in the United States, more men than women are diagnosed with lung cancer. Surprisingly, however, over the last five years at North Memorial the opposite is seen. Women have significantly outnumbered men both in absolute-terms as well as by percentage of growth.

Another exception at North Memorial is the trend of an increasing number of men diagnosed and treated for NSCLC in the face of the declining numbers in the rest of the country. This likely reflects changes in local demographics and referral patterns to our institution. In addition, patients are diagnosed at a slightly earlier or localized stage (and therefore potentially resectable) at North Memorial (38%), compared to the rest of the country (31%). From 1995-2001 our five-year survival rates match or exceed the national benchmarks for NSCLC stage for stage. However, in comparison to the rest of Minnesota, our results show a slightly inferior five-year survival for Stages I and II NSCLC, but slightly better survival outcome for Stages III and IV. (Again these are for 1995-2001 which is the most recent time period where national or state data are available).

Conclusions
North Memorial has remained in the forefront of community based hospital programs addressing the needs of patients with lung cancer. Our services for thoracic oncology are in increasing demand despite the overall declining trend nationally. Interestingly we are seeing growing numbers of women with lung cancer as well as a small but unique group of patients who never smoked. Our treatment outcomes are on par with those published nationally. Looking forward, we will continue to strive to maintain and improve the excellent quality of our program. New benchmarks need to be added to our data collection such as the percentage of patients with SCLC who are treated with prophylactic cranial irradiation. Through research, multidisciplinary care and acquisition of cutting-edge technologies, we endeavor to bring forward the most promising and innovative treatments available to benefit our patients.

Acknowledgements
I wish to recognize the tireless and superlative assistance of our tumor registrars, Mary Lou Mismash, Kathy Winters, Tina Swanson and Jennifer Newman. You are this annual report's unsung heroes. Not only do you help us communicate these results to our local medical community, but you also collect, analyze and safeguard the mountains of data that leads to new findings and improved patient care nationally. Our deepest thanks.

Tim Larson, MD

Cancer Registry Report

The North Memorial Cancer Registry collects, manages and analyzes data on patients diagnosed with cancer. All patients at North Memorial who are diagnosed or treated for cancer are entered into the registry. Each patient abstract contains a great deal of information used in a variety of ways. Examples include comparisons of various forms of treatment for a specific cancer site, date of first recurrence of cancer, treatment given and in-depth studies to evaluate current methods of diagnosis, treatment and disease control.

We are currently in our 27th year of operation, with 28,644 cases in the registry. A total of 1,410 cases were added in 2004 which is comparable with the caseload from 2003. Data collected is submitted to the National Cancer Database and the Minnesota Cancer Surveillance System.

At this time, we have 9,344 patients under active follow-up. The Humphrey Cancer Center is accredited by the Commission on Cancer as a Comprehensive Community Cancer Program, requiring us to maintain successful follow-up of 90 percent. Currently we are at a 93 percent rate of successful follow-up. The registry continues to evaluate data quality by performing a 10 percent audit on all cases abstracted for the year.

This year's annual report focuses on lung cancer and includes many important statistics and information that we hope you will find interesting and educational.

Tina Swanson, RHIT, CTR
Cancer Registry Coordinator

Elekta Synergy

The addition of an Elekta Synergy linear accelerator to our new department represents a major technologic advance that will result in direct benefit to our patients - image guided radiotherapy.

Until recently, the delivery of radiation therapy relied on assumptions about target location, based on an initial simulation that could be a week or more old at the time of treatment. The latest radiation delivery techniques, such as intensity modulated radiotherapy (IMRT), are based on delivering higher doses of radiation to smaller treatment volumes. Accurate and precise targeting is critical to success. Daily set up uncertainty and organ motion can potentially lead to a geographic miss of the target or over treatment of adjacent critical structures.

The Elekta Synergy system allows us to use image guidance to improve the precision and accuracy of radiotherapy. The Synergy system uses x-ray volume imaging (XVI) to generate a CT quality image on a daily basis, prior to the delivery of radiation to the patient. The daily image can be compared to our initial plan, and adjustments to the set up can be made which ensure the daily dose is administered exactly where it is needed. This approach allows for more accurate treatment delivery and, therefore, allows us to safely increase doses to higher levels than before.

Image guided radiotherapy truly represents a major advance in technology. We are excited to be implementing the Synergy system at North Memorial.

Kurt Nisi, MD
North Radiation Therapy

Research at Humphrey Cancer Center

The Humphrey Cancer Center is an active research center with both an internal research program and a twenty-three year membership with the Metro-Minnesota Community Clinical Oncology Program (Metro-MN CCOP). Both the internal research program at Humphrey Cancer Center and the Metro-MN CCOP provide staff and research to all three affiliated clinics located at North Memorial in Robbinsdale, Unity Professional Building in Fridley and Mercy Professional Building in Coon Rapids.

The goal of the research program is to offer novel treatment opportunities for our patients and to provide cutting-edge care close to home. Research plays an integral part in optimizing cancer therapy by obtaining and reporting vital information required to identify effective treatments and treatment strategies.

In 2005, a total of 371 patients were enrolled in clinical trials through Humphrey Cancer Center, an increase of more than 50% from 2004. CCOP enrollment comprised roughly 75% of patient enrollment in clinical trials. The internal research program at Humphrey Cancer Center was lead under the directorship of Martin M. Oken, MD. Dr. Oken was on staff from early 2003 until he recently retired in early 2006. The Humphrey Cancer Research Program has grown to include three research nurses, a research assistant, a medical secretary and the program manager, in addition to a CCOP research nurse and a Data Manager based at the North Memorial site .

Enrollment of patients in lung cancer clinical trials has been a priority for Tim Larson, MD, Medical Director of the Lung Program. Dr. Larson completed enrollment onto his study evaluating doublet therapy with Epirubicin and Irinotecan in the First Line Treatment of Extensive Stage Small Cell Lung Cancer. This Phase I/II study was written by Dr. Larson and funded by Pharmacia/Pfizer Oncology. Data analysis is ongoing and Dr. Larson is expected to publish his findings within the year. Additionally, Dr. Larson has several clinical trials open for the treatment of non-small cell lung cancer with novel agents as well as new combinations of existing cancer therapy drugs.

As we move into 2006, the Research Program is dedicated to finding and providing novel research options for our patients.

Pamala A. Pawloski, Pharm.D.,CCRC
Manager, Cancer Research and Tumor Registry

Quality Resource Coordinator

Kathy Vinson coordinates quality projects for both Oncology and Clinic Services. Her job duties include engaging staff on how to improve delivery of care, creating and using measurement tools to help validate change, helping clinic managers prepare staff for change, and sharing audit results with staff and physicians to reinforce change that has or has not occurred. Hired in 2005, Kathy has helped with the following projects in oncology during the past year.

Quality Oncology Practice Initiative (QOPI) sponsored by the American Society of Clinical Oncologists. QOPI uses chart abstraction to see if a clinic meets certain key standards when delivering care in clinics. Two chart audits are conducted yearly and Humphrey Cancer Center results are compared to other oncology practices nationwide.

Patient Flow. Kathy conducted a variety of studies to gather information about the amount of time it takes from when patients check in to the time infusion starts. She also looked at schedules to see when the majority of patients have appointments with doctors, lab and chemo and how this may impact patient flow.

JCAHO. Kathy worked with the clinic managers to put together a structure for meeting JCAHO requirements. She conducted mock surveys so staff could practice answering questions that a JCAHO surveyor might ask; she put together educational materials for the clinic managers to use in staff meetings to reinforce key information about our organization; and she worked with staff in conducting chart audits to see if medical records meet requirements for management of medical information. All of these efforts prepare staff for continuous readiness for an unannounced 2007 JCAHO survey.

Kathy Vinson
Quality Resource Coordinator