Saint Francis Cancer Treatment Center

Oncology Update04I S S U E

O C T2 0 1 3

Dr. Melhem Jabbour • Dr. Ryan RamaekersDr. Doug Clark • Dr. M. Sitki Copur

GRAND ISLAND & HASTINGS, NEBRASKA

B r i n g i n g t h e b e s t c a n c e r c a r e t o y o u r c o m m u n i t i e s

2010 Outstanding Achievement Award

in this issue• Neurosurgery at Saint Francis

• Highlights from the 2013 ASCO Breast Cancer Symposium

• Stereotactic body radiation therapy now offered at Saint Francis

• Pomalidomide Improves Survival in Relapsed/Refractory Multiple Myeloma

Fuller Takes over Role of Breast Nurse NavigatorSaint Francis Cancer Treatment Center would like to introduce Courtney Fuller, RN, OCN, as the new breast cancer nurse navigator. She has taken over the role previously held by Jacque Langford, who recently moved to Omaha. Courtney joined the Saint Francis Medical Center team in 1992, and has spent much of that time working as a registered nurse. For the past 13 years, she has worked in oncology, first as chemotherapy/infusion nurse, and most recently as a clinical research nurse.

Courtney’s role as the nurse navigator is to facilitate multidisciplinary care (MDC) coordination for all new breast cancer patients. MDC involves a coordinated effort between medical oncology, radiation oncology, radiology, pathology and surgery to make

sure patients are educated about their options and able to make an informed decision about treatment prior to any surgery taking place. Courtney will be with the patient at as many of these appointments as possible, as her schedule permits. Seeing all involved physicians up front and having the assistance of the navigator has shown to decrease the anxiety of the patient and increase their understanding of treatment options.

Multidisciplinary care coordination has many other benefits to the patient, including rapid work-up, coordination of appointments and treatment plan, organization of the patient’s care, facilitation of ongoing educational and psychosocial services, and symptom management. The nurse navigator is a constant resource for the patient throughout her breast cancer treatment and into survivorship.

Courtney Fuller, RN, OCN

Recent Hematology/Oncology Drug Approvals by FDA:• FDA approved paclitaxel protein-bound particles (albumin-bound) (Abraxane for injectable suspension, Abraxis

BioScience, LLC, a wholly owned subsidiary of Celgene Corporation), in combination with gemcitabine for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas. September 6, 2013

• FDA approved Valchlor (mechlorethamine) gel; Ceptaris Therapeutics; For the treatment of Stage IA/IB mycosisfungoides-type cutaneous T-cell lymphoma August 2013

• FDA approved afatinib (Gilotrif tablets, Boehringer Ingelheim Pharmaceuticals, Inc.), for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. The safety and efficacy of afatinib have not been established in patients whose tumors have other EGFR mutations. Concurrent with this action, FDA approved the therascreen EGFR RGQ PCR Kit (QIAGEN) for detection of EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. July 12, 2013

• FDA approved denosumab (Xgeva injection, for subcutaneous use, Amgen Inc.) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. June 13, 2013

Continued on page 2

Neurosurgery at Saint FrancisNeurosurgical services are an important part of the multidisciplinary team at Saint Francis Cancer Treatment Center. Whether a patient is diagnosed with a primary brain or spinal cord tumor, or has experienced metastasis to these areas, most required surgeries can be handled locally by the neurosurgery team of Dr. Josh Anderson and Dr. Sun Ik Lee. While there are a few specific types of

imaging that can only be done at the University of Nebraska Medical Center, there’s nothing within the standard of care of treatment that can’t be done for patients at Saint Francis, allowing central Nebraska patients to stay close to home.

“Whether we’re doing an ‘awake’ surgery to make sure that the tumor is taken out as completely as possible without any loss of neurological function, or craniotomies for large tumors of the brain, or tumors of the spinal cord or of the spine itself, any of those things can be done at Saint Francis,” Anderson said. “We have the high level of technology, including three-dimensional imaging, that is necessary in the vast majority of cases. There are a very small percentage of cases that can’t be handled here.”

Dr. Anderson adds that Saint Francis has a very good relationship with UNMC, and in the event that a patient needs treatment that can’t be done in Grand Island, he is happy to refer that patient to the Medical Center.

“We pride ourselves in being able to take care of whatever we can, but also to understand that if we think it’s something that is better served at the Medical Center, then we’re not going to try to take care of it here just for the sake of doing that; we’re going to make sure they get the best care.”

Dr. Lee, who joined Grand Island Specialty Clinic in July, is impressed with the level of technology available in Grand Island.

“I’m very impressed with how supportive Saint Francis is – they have very good technology, and they continually upgrade the equipment. For surgeons and patient safety, I believe it’s very important that the hospital is supportive in this area.”

One of the special technologies available to Saint Francis patients is 3-D Navigation. This technology directs the surgeon much like a navigation system in a vehicle, guiding them to precisely where they need to make the incision. The result is a smaller incision, lower rate of infection, and faster recovery time for the patient.

Dr. Anderson describes the technique as being essentially the same as stereotactic radiosurgery, a procedure used in radiation oncology.

“3-D Navigation is used a little differently in the OR vs. radiation therapy, but the neurosurgeon is a key part of the planning of both,” Anderson said. “It’s what we do on a day-to-day basis, and what makes us an important part of the cancer multidisciplinary team. With more people involved, we are able to treat the tumor as fully as possible while doing little damage to the normal brain area.”

In addition to oncology, Dr. Anderson and Dr. Lee provide a full spectrum of neurosurgical services. For more information on services provided at Saint Francis, please visit, www.grandislandspecialtyclinic.org. Both Dr. Anderson and Dr. Lee can be reached at (308) 398-8993. v

It is with great pleasure that we introduce the newest member of the neurosurgery team at Saint Francis Medical Center, Sun Ik Lee, MD. Dr. Lee joined the staff July 1.

Dr. Lee earned his medical degree from Loma Linda University School of Medicine in California. He completed an internship in general surgery and a fellowship

in neurosurgery at Tulane University Hospital and Clinic in New Orleans. Dr. Lee also served in the United States Army, where he was stationed in Korea. He joins Joshua Anderson, MD, in the neurosurgery program at Grand Island Specialty Clinic.

Dr. Sun Ik Lee

Dr. Joshua Anderson

The process for utilizing the nurse navigator is simple. All positive biopsy results from Saint Francis Medical Center and Grand Island Imaging Center are faxed to Courtney, who will then contact the patients’ primary care physicians and offer her assistance. Her job is to coordinate the appointments with all necessary specialists and make sure they are scheduled as quickly as possible after diagnosis. Physicians whose patients have a positive biopsy that was not done at Saint Francis or the Imaging Center are welcome to contact Courtney to arrange for her to assist their patients.

For more information on the nurse navigation and multidisciplinary care coordination programs, or to refer a patient for these services, please contact Courtney at (308) 398-3218 or cfuller@sfmc-gi.org. v

Fuller Takes over Role of Breast Nurse NavigatorContinued from cover

Pomalidomide Improves Survival in Relapsed/Refractory Multiple Myeloma 455 patients with refractory or relapsed and refractory multiple myeloma were randomly assigned 2:1 to receive 28-day cycles of oral pomalidomide (4 mg/d on days 1–21) plus low-dose dexamethasone (40 mg/d on days 1, 8, 15, and 22) (n = 302) or high-dose dexamethasone (40 mg/d on days 1–4, 9–12, and 17–20) (n = 153) until disease progression or unacceptable toxicity. Eligible patients have had received at least two previous treatments of bortezomib (Velcade) and lenalidomide (Revlimid) that failed. The primary endpoint was progression-free survival. After a median follow-up of 10.0 months, median progression-free survival was 4.0 months with pomalidomide plus low-dose dexamethasone vs 1.9 months with high-dose dexamethasone. Median progression-free survival was significantly longer with pomalidomide plus low-dose dexamethasone irrespective of previous treatment in subgroup analyses, including in patients refractory to lenalidomide (3.9 vs 1.9 months), refractory to both bortezomib and lenalidomide (3.7 vs 2.0 months), intolerant of bortezomib (4.0 vs 2.0 months), with lenalidomide as their last treatment (4.6 vs 1.9 months), and with bortezomib as their last treatment (3.8 vs 1.9 months). Median overall survival was significantly longer in the pomalidomide plus low-dose dexamethasone group (12.7 vs 8.1 months) including in patients refractory to lenalidomide (12.7 vs 8.0 months), and patients with lenalidomide as their last therapy (12.3 vs 7.3 months).

Reference: San Miguel J et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomized, open-label, phase 3 trial The Lancet Oncology, Early Online Publication, 3 September 2013

Potentially PracticeChanging Data

Although androgen deprivation therapy is considered the mainstay of treatment for recurrent or

metastatic prostate cancer, the side effects can be difficult which include hot flashes, fatigue, loss of libido and erectile dysfunction, increased risk of bone mineral density loss, decreased muscle mass, and decreased insulin sensitivity which leads to increased risk of diabetes and cardiovascular disease. Enzalutamide is a novel oral androgen receptor inhibitor approved by the FDA for treatment of men with castration-resistant prostate cancer and disease progression after docetaxel therapy. The phase II open-label, multicenter study evaluated enzalutamide as monotherapy in patients with hormone-naive prostate cancer for which androgen deprivation therapy is indicated. Patients were treated with enzalutamide monotherapy for 25 weeks. The study included 67 men, with a median age of 73 years, mean body mass index of 22.6 kg/m2, median baseline PSA of 18.2 ng/mL, and median duration of prostate cancer since diagnosis of 1 year; 50% had Gleason 7 scores and 25% had Gleason 8 to 10 scores at entry. Approximately 38% had metastasis at study entry, and about one-third had had a prior prostatectomy. The primary endpoint was PSA response (at least an 80% decline in PSA level). Monotherapy with enzalutamide achieved marked and rapid PSA declines in 92.5% of patients. Median PSA decrease was –99.6%. A total of 62 of 67 (92.5%) achieved the primary endpoint of PSA decline > 80% at week 25, including patients with and without metastasis at baseline. Among 16 patients evaluable for objective responses with measurable disease, the complete plus partial response rate was 50%. Side effects were much more favorable with enzalutamide

Reference: Smith MR et al. Efficacy and safety of enzalutamide monotherapy in hormone-naive prostate cancer. 2013 ASCO Annual Meeting. Abstract 5001. Presented June 3, 2013

Enzalutamide Monotherapy Highly Active in Patients with Prostate Cancer Who Have Had No Prior Hormone Therapy

Potentially PracticeChanging Data

Highlights from the 2013 ASCO Breast Cancer Symposium, September 7-8, 2013

Radiation in DCISDCIS is a precancerous lesion that could progress to breast cancer. Most women with DCIS undergo surgery, often followed by radiation therapy, to reduce the risk of recurrence. Concern has been raised that radiation to the general region of the heart can increase the risk of cardiovascular disease (CVD. A large population-based study based on data from 10,468 women diagnosed with DCIS under the age of 75 years in the Netherlands suggests that radiation does not increase the risk of CVD in women with DCIS compared to the general population and to DCIS patients treated with surgery alone. These results should be reassuring to women and their physicians who include radiotherapy in treatment plans. This is the first large study to evaluate long-term effects of radiotherapy for DCIS on both the incidence of CVD and associated deaths.Reference: Boekel et al. Radiation therapy for DCIS is safe and does not appear to increase the risk of cardiovascular disease. ASCO Breast Cancer Symposium, September 7-8, 2013, San Francisco, CA.

MRI in DCISThere are no official guidelines for perioperative use of MRI, but some centers order it routinely to detect additional cancers and to confirm or expand on data attained from mammograms or ultrasounds. The study analyzed rates of Loco Regional Recurrence (LRR) and Contralateral Breast Cancer (CBR) in 2321 women who underwent a lumpectomy between 1997 and 2010 at Memorial Sloan Kettering Cancer

Center (MSKCC). 596 women had an MRI before or immediately following lumpectomy, and 1725 did not. Follow-up was a median of 59 months. No significant difference in the 5-year LRR rates was found (8.5% vs 7.2%). In an analysis adjusted for patient characteristics and risk factors associated with recurrence, MRI was not associated with lower rates of LRR. Additionally, no significant differences were seen in the 5-year rates of CBC (3.5 years in both groups). Reference: Pilewskie. et al. Routine MRI at the time of surgery for DCIS does not affect recurrence rates. ASCO Breast Cancer Symposium, September 7-8, 2013, San Francisco, CA.

Perceptions of Breast Cancer RiskIn a large survey of almost 10,000 women undergoing mammography screening, more than 90% inaccurately estimated their lifetime risk of developing breast cancer. Results were evenly split between women who over-estimated and those who under-estimated their personal risk. Alarmingly, 40% of survey respondents said they had never discussed their personal risk of breast cancer with a doctor. The survey included 9873 women aged 35 to 70 years who had a mammogram at 1 of 21 centers on Long Island, NY. Twenty-five survey questions covered demographics, breast cancer risk factors, including personal and family history of breast cancer, and any prior breast cancer risk assessments and discussions. Survey questions were adapted from the NCI Breast Cancer Risk Assessment Tool used to estimate the risk of developing invasive

breast cancer. The actual lifetime risk of developing breast cancer was calculated for each respondent and then compared with that woman’s personal estimate; if the difference from the calculated value was greater than 10%, it was labeled as inaccurate. Only 707 women (9.4%) correctly estimated their risk; 3359 women (44.7%) underestimated their risk and 3454 (45.9%) overestimated it. In general, Caucasian women were more likely to overestimate their risk, while women in minority groups were more likely to underestimate it. The level of overall understanding about breast cancer risk was low.Reference: Herman et al. Perceptions of Breast Cancer risk. ASCO Breast Cancer Symposium, September 7-8, 2013, San Francisco, CA.

861 patients with metastatic pancreatic cancer were randomized to receive either the combination of Abraxane

plus gemcitabine (n=431) or gemcitabine alone (n=430). The major efficacy outcome measure was OS and additional outcome measures were progression-free survival (PFS) and overall response rate (ORR). The median age of the patients was 63 years (range 27-88 years) with 42% age 65 years or older, 58% were men, and the Karnofsky performance was 90 or 100 in 60%. Nearly half (46%) of the patients had three or more sites of metastatic disease and 84% had liver metastases. The trial demonstrated a statistically significant prolongation of OS for patients randomized to receive the combination of Abraxane plus gemcitabine. The median

OS was 8.5 months in the Abraxane plus gemcitabine arm and 6.7 months in the single agent gemcitabine arm. A significant improvement in PFS was also observed with median PFS of 5.5 months in the Abraxane plus gemcitabine arm and 3.7 months in the gemcitabine arm. Objective response rates were 23% and 7% in the Abraxane plus gemcitabine and single agent gemcitabine arms, respectively. The recommended dose and schedule for Abraxane is 125 mg/m2 and for Gemcitabine 1000 mg/m2 administered as an intravenous infusion on days 1, 8 and 15 of each 28-day cycle until disease progression.

Reference: Von Hoff DD et al. LBA #148: Final results of a randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas. MPACT trial. Jan 2013, ASCO 2013 Gastrointestinal Cancers Symposium in San Francisco, CA.

Weekly nab-paclitaxel plus gemcitabine in metastatic adenocarcinoma of the pancreas

Stereotactic Body Radiation Therapy now offered at Saint FrancisDr. Douglas Clark, the newest addition to the oncology team, began seeing patients at Saint Francis Cancer Treatment Center on July 29. Because of Dr. Clark’s specialized training, the Cancer Treatment Center is now able to offer Stereotactic Body Radiation Therapy (SBRT) to qualifying patients.

SBRT is a radiation therapy technique in which a high dose of radiation is delivered to a very precise area using numerous beam angles, sparing surrounding healthy tissues and decreasing toxicity to the patient. With traditional radiation therapy, healthy tissue around the tumor can be affected during treatment, and the dosing is administered daily over a period of four to eight weeks. SBRT offers a huge advantage to the patient, with dosing that typically consists of three to five treatments over a one- to two-week time period.

Stereotactic Body Radiation Therapy is used to treat both primary and metastatic tumors and unlike conventional external beam radiation, it allows treatment to areas that have been previously irradiated. It is useful in treating early stage lung cancer, particularly when the patient is inoperable, and it is an excellent tool for treating metastases involving the brain, spine, and liver. It also permits retreating bone metastases, particularly when the pelvis and spinal vertebral bodies are involved.

Some tumors in the brain can be treated with a single fraction of therapy and this approach is referred to as Stereotactic Radiosurgery, though no actual surgery or incisions are involved. Because it is so focused, it allows the radiation therapy team to pinpoint the treatment.

The high doses involved are very effective at eradicating small cancers in the brain and the multitude of beams utilized disperses the incoming radiation dose, thus sparing normal brain tissue and minimizing long-term cognitive impact on the patient.

Not every patient is a good candidate for Stereotactic Body Radiation Therapy or Stereotactic Radiosurgery and numerous factors determine whether a patient is suitable for these treatments. To learn more about Stereotactic Body Radiation Therapy, or to find out if your patient may be a good candidate, contact Dr. Clark at (308) 398-5450 or DClark@sfmc-gi.org. v

Potentially PracticeChanging Data

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Oncology Update Issue 04 October 2013

Providers:M. Sitki Copur, MD, FACP

Medical Director of OncologyMelhem Jabbour, MD

Ryan Ramaekers, MDDoug Clark, MDRita Hays, APRN, AOCNPDeborah Nelson, APRN, AOCNPMegan Schriner, PA

Clinical Trials:Sarah Einspahr, RNMary Gulzow, CRA, CCRPRebecca Hadenfeldt, BSNJennifer Scott, BSN, OCNAlicia Wicht, CRA

Center for Translational Research Heather Benzel, RN, CCRP

Pharmacists:Angie Obermiller, PharmD

Oncology Pharmacy SupervisorJon Olsen, PharmDMark Tharnish, PharmD

Navigators:Courtney Fuller, RN, OCN

Breast Cancer Nurse NavigatorAshley Wissing, MA

Colorectal Cancer Navigator

NutritionistMaureen Hilderbrand, RD, LMNT

Genetic Counselor:Kim Brussow, CGC

Tumor RegistryLeslie Mlinar, CTRPatty Tripp, CTR, RHIT

Patient & Family Counselor:Mary Ann Kalinay, MS, LMHP

Oncology Project CoordinatorAnn Tvrdy, MSN, CRNI

Certified Tobacco Cessation Facilitator

Community Outreach CoordinatorConnie Hameloth, RN

Certified Tobacco Cessation Facilitator

Management:Max Norvell, PharmD

Director of OncologyMary Mickey, RN, OCN

Clinical Manager, Medical OncologyMarlene Hinrichs, MA (R) (T)

Clinical Manager, Radiation Therapy

Meet our team

Locations:

Saint Francis Cancer Treatment Center2116 West Faidley AvenueGrand Island, NE 68803(308) 398-5450

Saint Francis Cancer Treatment Center2nd Street & Marian RoadHastings, NE 68901(402) 461-5588

Visit us online:

SaintFrancisGI.org