oncology update april '14

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Radiotherapy plays an important role in cancer management. In recent years, treatment goals have shiſted from life preservaon to cure while maintaining of quality of life. Radiotherapy can be divided into external beam radiotherapy (EBRT), and internal radiotherapy, oſten referred to as brachytherapy. Unlike EBRT, brachytherapy involves placing a radiaon source internally, either into or immediately next to the tumor. This allows precise dose delivery. Saint Francis Cancer Treatment Center has announced the purchase of a Flexitron Aſterloader System from the Nucletron Corportaon, which will provide the ability to offer paents the opon of using brachytherapy as a treatment modality. Dr. Doug Clark, radiaon oncologist, is excited to bring this technology to the Cancer Treatment Center. “High-dose rate brachytherapy will offer our paents with certain cancers a treatment opon that is much shorter and much more comfortable than convenonal radiaon treatment,” Clark said. “A typical course of brachytherapy is completed in five days or less, compared to mulple weeks of convenonal external beam radiaon therapy.” Brachytherapy is a very precise and highly effecve form of radiotherapy that allows a physician to concentrate a high dose of radiaon in a small area, minimizing damage to nearby, healthy body ssue and organs, over a shorter treatment period. This type of treatment offers significant benefits to the paent, such as: Treatment as an outpaent rather than inpaent procedure Offering greater paent comfort during treatment Saint Francis Cancer Treatment Center Oncology Update 06 ISSUE APRIL 2014 Dr. Melhem Jabbour • Dr. Ryan Ramaekers Dr. Doug Clark • Dr. M. Sitki Copur GRAND ISLAND & HASTINGS, NEBRASKA Bringing the best cancer care to your communities 2010 Outstanding Achievement Award in this issue Saint Francis Participating in Pilot Study for Polaris Oncology SBRT now offered at Saint Francis Cancer Treatment Center Radiation Plus Hormone Therapy Extends Survival in Patients with High-Risk Prostate Cancer Saint Francis Cancer Treatment Center expands radiaon treatment opons with brachytherapy Connued on page 3 Dr. Doug Clark Radiaon Oncologist

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Page 1: Oncology Update April '14

Radiotherapy plays an important role in cancer management. In recent years, treatment goals have shifted from life preservation to cure while maintaining of quality of life.

Radiotherapy can be divided into external beam radiotherapy (EBRT), and internal radiotherapy, often referred to as brachytherapy. Unlike EBRT, brachytherapy involves placing a radiation source internally, either into or immediately next to the tumor. This allows precise dose delivery.

Saint Francis Cancer Treatment Center has announced the purchase of a Flexitron Afterloader System from the Nucletron Corportation, which will provide the ability to offer patients the option of using brachytherapy as a treatment modality.

Dr. Doug Clark, radiation oncologist, is excited to bring this technology to the Cancer Treatment Center. “High-dose rate brachytherapy will offer our patients with certain cancers a treatment option that is much shorter and much more comfortable than conventional radiation treatment,” Clark said. “A typical course of brachytherapy is completed in five days or less,

compared to multiple weeks of conventional external beam radiation therapy.”

Brachytherapy is a very precise and highly effective form of radiotherapy that allows a physician to concentrate a high dose of radiation in a small area, minimizing damage to nearby, healthy body tissue and organs, over a shorter treatment period. This type of treatment offers significant benefits to the patient, such as:

• Treatment as an outpatient rather than inpatient procedure

• Offering greater patient comfort during treatment

Saint Francis Cancer Treatment Center

Oncology Update06I S S U E

A P R I L2 0 1 4

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• Saint Francis Participating in Pilot Study for

Polaris Oncology

• SBRT now offered at Saint Francis Cancer Treatment Center

• Radiation Plus Hormone Therapy Extends Survival in Patients with High-Risk Prostate Cancer

Saint Francis Cancer Treatment Center expands radiation treatment options with brachytherapy

Continued on page 3

Dr. Doug ClarkRadiation Oncologist

Page 2: Oncology Update April '14

Saint Francis Cancer Treatment Center has been selected by Catholic Health Initiatives (CHI) to participate in a pilot program for the Polaris Oncology Distress Management System, a web-based tool created by Polaris Health Directions for addressing psychosocial and behavioral health needs.

Several Alegent Creighton Health facilities, including radiation therapy departments at Immanuel Cancer Center, Bergan Mercy Cancer Center and Midwest Cancer Center, are participating in the same pilot study but are not using the web-based tool. At the end of the four-month pilot period, digital results will be compared to paper results.

The tool consists of three components – the assessment, patient and care team report generator, and automated referrals. It was developed primarily in response to the Commission on Cancer’s (CoC) Standard 3.2, the requirement to “implement a process to integrate and monitor on-site psychosocial distress screening and referral for the provision of psychosocial care.”

The assessment works as a screener for distress, based on the National Comprehensive Cancer Network’s (NCCN) Distress Thermometer. Patients are also asked various questions about their support system, functional disability, physical symptoms and alcohol and tobacco use. Patients who score a four or higher on the Distress Thermometer are asked additional questions to more effectively identify their psychosocial needs. Branching logic also ensures that patients are only given questions that are relevant to their situation.

“We are very excited to get started with the Polaris system and take patient care to an even higher level,” said Max Norvell, Director of Oncology at Saint Francis. “Moving from a pen-and-paper tool to an intuitive online assessment will allow us to more quickly identify and address patient needs.”

The Cancer Treatment Center has received five iPads that will be equipped with the Polaris Oncology tool. To achieve compliance with CoC guidelines, patients will take the assessment three times during the course of treatment – at their first visit, at a specified point during treatment (beginning of the second cycle of chemotherapy for medical oncology patients, and midway through treatment for radiation oncology patients), and at the end of treatment.

Automatic referrals are built into the assessment to alert the care team that additional support or resources are needed. For example, if a patient indicates symptoms like unintentional weight loss or vomiting, an automatic alert is sent to the nutritionist so he or she knows to follow up with the patient. These referrals can be customized so that team members can receive the alerts by email or text, and they have the option of manually running an aggregate report at any time.

After the patient takes the assessment, reports are generated for both the patient and the care team. The patient report is typically multiple pages, and contains education and referral resources based on their assessment answers and type of cancer. The care team report is a one-page summary that includes the Distress Thermometer score, as well as global functioning and percentile ranks based on cancer patient norms for behavioral health status, depression and anxiety scales.“Having a real-time, detailed reporting system will give us a huge advantage by allowing us to keep better track of patients’ progress and whether or not they are following up with care recommendations,” Norvell said.

Saint Francis and Polaris Health Directions are currently in the process of configuring the screening tool to meet the specific needs of the Cancer Treatment Center. Testing is in progress, and the tool is expected to be rolled out by the end of April. After the four month evaluation of the program is completed, results will be compared to those of Alegent Creighton Health and a decision will be made as to whether or not to roll out the product to all network cancer centers. v

Saint Francis participating in pilot study for Distress Management

Reference: Polarishealth.com

Nurse Adrian Tasa demonstrates how to use the Polaris Oncology distress screening tool on one of the Cancer Treatment Center’s five iPads.

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Page 3: Oncology Update April '14

Since breast-conserving therapy was introduced more than 40 years ago,

significant changes in breast-imaging technology, pathology assessment and the use of systemic therapy have improved patient outcomes. These changes have resulted in a decreased rate of ipsilateral breast tumor recurrence (IBTR, also called local recurrence or in breast recurrence). This prompted the Society of Surgical Oncology (SSO), in collaboration with the American Society of Radiation Oncology (ASTRO), to undertake an evidence based consensus to provide a clear and comprehensive approach for practitioners. Experts assembled in July 2013 to examine the evidence on the relationship between the amount of tissue removed surrounding a breast cancer, called a surgical margin, and IBTR. Positive margins (ink on invasive carcinoma or ductal carcinoma in situ) are associated with a two-fold increase in the risk of IBTR compared to negative margins. This increased risk is not mitigated by favorable biology, endocrine therapy or a radiation boost. More widely clear margins than no ink on tumor do not significantly decrease the rate of IBTR. There is no evidence that more widely clear margins reduce IBTR for young patients, unfavorable biology, lobular cancers, or cancers with an extensive intraductal component. The use of no ink on tumor as the standard for an adequate margin in invasive cancer in the era of multidisciplinary therapy is associated with low rates of IBTR and has the potential to decrease re-excision rates, improve cosmetic outcomes, and decrease healthcare costs. The findings showed that evidence does not support the routine removal of larger amounts of healthy breast tissue beyond the edge of the tumor for any women, including those with aggressive triple negative breast cancer.

Reference: Annals of Surgical Oncology, http://link.springer.com/article/10.1245/s10434-014-3481-4.

Potentially PracticeChanging Data

Margins for Breast-Conserving Surgery with Whole Breast Irradiation in Stage I and II Invasive Breast Cancer Surgical Society of Oncology (SSO)- American Society of Radiation Oncology ASTRO Consensus Guideline

• Delivering treatment in minutes, not days or weeks

• Fewer side effects in general• Minimal recovery time

High-dose rate brachytherapy can be used in conjunction with other treatments or as an alternative, stand-alone option for the treatment of numerous body-site cancers, such as breast, gynecologic, lung and esophageal cancers.

Clark said the Cancer Treatment Center expects to have license approval for the new treatment by the end of March. Physics training will take place in Atlanta the second week of April, and Clark hopes to begin treating patients with brachytherapy in May.

To learn more about what types of patients are right for this therapy, please contact Dr. Clark at (308) 398-5450 or [email protected]. Educational materials for both healthcare providers and patients are available by contacting Erin Martinez at (308) 398-6787 or [email protected]. v

Brachytherapy (continued from cover)

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An example of brachytherapy source placement in the treatment of lung cancer.

Page 4: Oncology Update April '14

Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomized, multicenter, open-label, phase 3 trial

Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced

ovarian cancer. A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial. The aim of this study was to assess whether a weekly schedule of carboplatin plus paclitaxel was more effective than the same drugs given every 3 weeks. This was a multicenter, randomized, phase 3 study at 67 institutions in Italy and France. Women with FIGO stage IC—IV ovarian cancer, an ECOG performance status of 2 or lower, and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin (AUC 6 mg/mL per min) plus paclitaxel (175 mg/m2) every 3 weeks for six cycles or carboplatin (AUC 2 mg/mL per min) plus paclitaxel (60 mg/m2) every week for 18 weeks. Coprimary endpoints were progression-free survival and quality of life (assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [FACT-O/TOI] score), and analysis was by modified intention to treat. 822 patients were enrolled into the study between Nov 20, 2008, and March 1, 2012; 12 withdrew their consent immediately after randomization and were excluded, and 810 were eligible for analysis. 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule. After median

follow-up of 23 months, 449 progression-free survival events were recorded. Median progression-free survival was 17.3 months in patients assigned to treatment every 3 weeks, versus 18.3 months in women allocated to the weekly schedule (hazard ratio 0•96, 95% CI 0•80—1•16; p=0•66). FACT-O/TOI scores differed significantly between the two schedules (treatment-by-time interaction p<0•0001); with treatment every 3 weeks, FACT-O/TOI scores worsened at every cycle (weeks 1, 4, and 7), whereas for the weekly schedule, after transient worsening at week 1, FACT-O/TOI scores remained stable. Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3—4 neutropenia (167 [42%] of 399 patients versus 200 [50%] of 400 patients), febrile neutropenia (two [0•5%] versus 11 [3%]), grade 3—4 thrombocytopenia (four [1%] versus 27 [7%]), and grade 2 or worse neuropathy (24 [6%] versus 68 [17%]). Three deaths during the study were attributed to chemotherapy; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen. A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer.Reference: Pignata S et al. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomized, multicenter, open-label, phase 3 trial. The Lancet Oncol, early online publication, Feb 2014 doi:10.1016/S1470-2045(14)70049-X.

Potentially PracticeChanging Data

The majority of patients with acute myeloid leukemia (AML) who achieve complete remission (CR) relapse with conventional post remission chemotherapy. Allogeneic stem-cell transplantation (alloSCT) might improve survival at the expense of increased toxicity. It remains unknown for which patients alloSCT is preferable. Outcome of 185 matched pairs of

a large multicenter clinical trial (AMLCG99) were compared. Patients younger than 60 years who underwent alloSCT in first remission (CR1) were matched to patients who received conventional post remission therapy. The main matching criteria were AML type, cytogenetic risk group, patient age, and time in first CR. In the overall pairwise compared AML population, the projected 7-year overall survival (OS) rate was 58% for the alloSCT and 46% for the conventional post remission treatment group (P = .037; log-rank test). Relapse-free survival (RFS) was 52% in the alloSCT group compared with 33% in the control group (P < .001). OS was significantly better for alloSCT in patient subgroups with nonfavorable chromosomal aberrations, patients older than 45 years, and patients with secondary AML or high-risk myelodysplastic syndrome. For the entire patient cohort, post remission therapy was an independent factor for OS (hazard ratio, 0.66; 95% CI, 0.49 to 0.89 for alloSCT v conventional chemotherapy), among age, cytogenetics, and bone marrow blasts after the first induction cycle. AlloSCT is the most potent post remission therapy for AML and is particularly active for patients 45 to 59 years of age and/or those with high-risk cytogenetics.

Reference: Stelljes et al. Allogeneic Transplantation Versus Chemotherapy as Postremission Therapy for Acute Myeloid Leukemia: A Prospective Matched Pairs Analysis JCO February 1, 2014 vol. 32 no. 4 288-296

Potentially PracticeChanging Data

Allogeneic Transplantation Versus Chemotherapy as Postremission Therapy for Acute Myeloid Leukemia: A Prospective Matched Pairs Analysis

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Page 5: Oncology Update April '14

Enzalutamide, an orally administered androgen receptor inhibitor, improved overall survival (OS) in men with mCRPC who had received prior docetaxel therapy

(Scher et al, NEJM 367:13, 2012). This study examined whether enzalutamide could prolong OS and radiographic progression-free survival (rPFS) in asymptomatic or mildly symptomatic chemotherapy-naive men with mCRPC. In this randomized, double-blind, placebo-controlled, multinational phase 3 study, chemotherapy-naive patients with mCRPC were stratified by site and randomized 1:1 to enzalutamide 160 mg/day or placebo. OS and rPFS were co-primary endpoints and analyzed for the intent-to-treat population. Planned sample size was 1,680 with 765 deaths to achieve 80% power to detect a target OS hazard ratio (HR) of 0.815 with a type I error rate of 0.049 and a single interim analysis at 516 (67%) deaths. The co-primary endpoint of rPFS had sufficient power to detect a target HR of 0.57 and a type I error rate of 0.001 with a minimum of 410 events. A total of 1,717 men were randomized (1,715 treated) between September 2010 and September 2012. The interim analysis at 539 deaths showed a statistically significant benefit of enzalutamide over placebo with a 30% reduction in risk of death (OS: HR 0.70; 95% CI: 0.59-0.83; P< 0.0001) and an 81% reduction in risk of radiographic progression or death (rPFS: HR 0.19; 95% CI: 0.15-0.23; P< 0.0001). At the time of the analysis, 28% of enzalutamide

patients and 35% of placebo patients had died. Estimated median OS was 32.4 months (95% CI, 31.5–upper limit not yet reached) in the enzalutamide arm versus 30.2 months (95% CI, 28–upper limit NYR) in the placebo arm. Median rPFS was not yet reached (95% CI: 13.8–upper limit NYR) in the enzalutamide arm versus 3.9 months (95% CI: 3.7-5.4) in the placebo arm. Seizure events were reported in two patients. The Independent Data Monitoring Committee considered the benefit-risk ratio to favor enzalutamide and recommended stopping the study and crossing placebo patients to enzalutamide. Secondary endpoints and safety analysis will be presented. Treatment with enzalutamide significantly improves OS and rPFS in men with chemotherapy-naive mCRPC. This is important from a pragmatic perspective. Many men don’t want to take chemotherapy, especially if they are asymptomatic or mildly symptomatic. The safety observation period was three times longer with enzalutamide versus placebo, reflecting longer duration of treatment in this arm. Enzalutamide was well tolerated after 17 months of treatment, with the most common side effects (seen in ≥ 20% of patients) being fatigue (36% of enzalutamide patients, 26% of placebo patients), constipation (22% and 27%, respectively), back pain (27% and 22%), and joint pain (20% and 16%).

Reference: Beer et al. Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study J Clin Oncol 32, 2014 (suppl 4; abstr LBA1.

Clinical trials offer cancer patients promising new treatments that lead to better ways to prevent, diagnose and treat cancer. Dr. Sitki Copur said it best – “Today’s clinical trials, tomorrow’s best care.”

The Catholic Health Initiatives cancer centers of Nebraska, including Good Samaritan Cancer Center, Saint Elizabeth Cancer Institute and Saint Francis Cancer Treatment Center, have collaborated with the Nebraska Cancer Research Center of Lincoln to create a comprehensive clinical trials website.

Together, the four cancer centers had previously published a quarterly clinical trials protocol booklet, which was discontinued in favor of the online format.

For your convenience, the website contains the same information as the quarterly booklet, but in an interactive format. Users can search and cross-reference trials by name, tumor site and location, or use the open search function to search by keyword. The website’s database is updated on a monthly basis, reflecting the changes that are made at each IRB review.

Current clinical trials can be viewed at http://chinebraskaclinicaltrials.org/. For more information on the website, please contact Erin Martinez at 308-398-6787 or [email protected].

CHI-Nebraska cancer centers collaborate on clinical trials website

Enzalutamide in men with chemotherapy-naive metastatic prostate cancer (mCRPC): Results of phase III PREVAIL study

Potentially PracticeChanging Data

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SBRT now offered at Saint Francis Cancer Treatment CenterTreatment time significantly reduced for qualifying patients

Saint Francis Cancer Treatment Center is now offering 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 tumor 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 [email protected]. v

Cost-Effectiveness Analysis Comparing Conventional Versus Stereotactic Body Radiotherapy for Surgically Ineligible Stage I Non–Small-Cell Lung Cancer

25% to 35% of patients with early stage I non–small-cell lung cancer not eligible for surgery and external-beam radiation becomes their standard treatment. Conventionally fractionated radiotherapy (CFRT) is the traditional radiation treatment standard; however, stereotactic body radiotherapy (SBRT) is increasingly being adopted as an alternate radiation treatment. A recent

study reported a cost-effectiveness analysis, comparing SBRT with CFRT for stage I NSCLCv in a Canadian public payer system. Consecutive patients were reviewed using 2010 Canadian dollars for direct medical costs from a public payer perspective. A subset of direct radiation treatment delivery costs, excluding physician billings and hospitalization, was also included. Health outcomes as life-years gained (LYGs) were computed using time-to-event methods. Sensitivity analyses identified critical factors influencing costs and benefits. From January 2002 to June 2010, 168 patients (CFRT, n=50; SBRT, n=118) were included; median follow-up was 24 months. Mean overall survival was 2.83 years (95% CI, 1.8 to 4.1) for CFRT and 3.86 years (95% CI, 3.2 to not reached) for SBRT (P=.06). Mean costs for CFRT were $6,886 overall and $5,989 for radiation treatment delivery only versus $8,042 and $6,962, respectively, for SBRT. Incremental costs (incremental cost-effectiveness ratio [ICER]) per LYG for SBRT versus CFRT were $1,120 for the public payer and $942 for radiation treatment alone. Varying survival and labor costs individually (+/- 20%) created the largest changes in the ICER, and simultaneous adjustment (+/-5% to +/-30%) confirmed cost effectiveness of SBRT. Conclusion: Using a threshold of $50,000 per LYG, SBRT seems cost effective. Results require confirmation with randomized data.

Reference: Mitera G, Swaminath A, Rudoler D, et al Cost-Effectiveness Analysis Comparing Conventional Versus Stereotactic Body Radiotherapy for Surgically Ineligible Stage I Non–Small-Cell Lung Cancer Journal of Oncology Practice Publish Ahead of Print, published on March 18, 2014 as doi:10.1200/JOP.2013.001206

Potentially PracticeChanging Data

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Page 7: Oncology Update April '14

Radiation Plus Hormone Therapy Extends Survival in Patients with High-Risk Prostate Cancer

After a median observation time of 7.6 years, Scandinavian Prostate Cancer Group VII randomized trial showed a significant 12% reduction of prostate cancer-specific mortality

in patients with locally advanced or histologically aggressive prostate cancer who received three months of total androgen blockade followed by radiotherapy and continuous antiandrogen therapy compared to patients with hormonal treatment only (Widmark et al :Lancet [2009]; 373,1174). The 10 (15)-year survival results after a median observation time of 10.7 years were presented at the recent ASCO genitourinary cancer symposium. Between February 1996 and December 2002, 875 patients with locally advanced prostate cancer were randomized (Randomization ratio 1:1). Primary endpoint was prostate cancer-specific survival analyzed by intention to treat. Prostate cancer death occurred in 118 out of 439 of the antiandrogen treatment group and in 45 out of 436 men in the combination treatment group (p< 0.0001), with death due to any cause in 210 out of 439 and 161 out of 436 men (p=0.0006), respectively. The 10 (15) year cumulative prostate cancer-specific mortality was more than halved after combined treatment: 18.9% (30.7%) and 8.3% (12.4%) (HR=0.35;[p<4.1E-10 for 15 year results]), and overall mortality was 35.3% (56.7%) and 26.4% (43.4%) (HR=0.70; P=0.0006 for 15 year results), respectively. Addition of local radiotherapy to hormonal treatment in patients with non-metastatic locally advanced or high-risk prostate cancer more than halved the 10 and 15 year prostate cancer-specific mortality and substantially decreased overall mortality. The addition of radiation therapy to lifelong hormone therapy led to a doubling of prostate cancer–specific survival at 10 and 15 years compared to hormone therapy alone in men with locally advanced or high-risk prostate cancer. Overall mortality was also improved in men treated with the combination versus hormone therapy alone. Radiation plus hormone therapy should be considered a standard curative option in this setting.

Reference: Sophie D. et al. Radiation plus Hormone Therapy Extends Survival in Patients With High-Risk Prostate Cancer J Clin Oncol 32, 2014 (suppl 4; abstr 4).

Potentially PracticeChanging Data

FDA Hematology/Oncology Drug Approvals• FDA granted accelerated approval

on February 12, 2014, to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib previously received accelerated approval on November 13, 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

• FDA granted accelerated approval on January 10, 2014 to trametinib (Mekinist tablets, GlaxoSmithKline, LLC) and dabrafenib (Tafinlar capsules, GlaxoSmithKline, LLC) for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.

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Page 8: Oncology Update April '14

C O N TAC T I N F O R M AT I O N Saint Francis Cancer Treatment Center2116 West Faidley AvenueGrand Island, NE 68803(308) 398-5450ht tp : / / sa in t f ranc i sg i . o rg

This newsletter is published by

the Saint Francis Medical Center

Marketing and Communications

department. To unsubscribe, please

contact Erin Martinez, Cancer

Communications Coordinator, at

(308) 398-6787 or

[email protected].

Oncology Update Issue 06 April 2014

Providers:M. Sitki Copur, MD, FACPMedical Director of OncologyMelhem Jabbour, MD

Ryan Ramaekers, MDDoug Clark, MDDeborah Nelson, APRN, AOCNPMonica McDonald, APRNMegan 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, PharmDOncology Pharmacy SupervisorJon Olsen, PharmDMark Tharnish, PharmD

Navigators:Courtney Fuller, RN, OCNBreast Cancer Nurse NavigatorAshley Wissing, MAColorectal 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, CRNICertified Tobacco Cessation Facilitator

Community Outreach CoordinatorConnie Hameloth, RNCertified Tobacco Cessation Facilitator

Management:Max Norvell, PharmDDirector of OncologyMary Mickey, RN, OCNClinical 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