Secondhand Smoke Exposure Linked to Adverse Pregnancy Outcomes

Roswell Park/University at Buffalo study finds significant risk for women who never smoked

BUFFALO, N.Y. — Secondhand smoking is linked with pregnancy loss, including miscarriage, stillbirth and tubal ectopic pregnancy, according to new research from scientists at Roswell Park Cancer Institute (RPCI) and the University at Buffalo (UB). The study findings, published online by the journal Tobacco Control, mark a significant step toward clarifying the risks of secondhand smoke exposure.

“This study demonstrated that pregnancy outcomes can be correlated with secondhand smoking. Significantly, women who have never smoked but were exposed to secondhand smoke were at greater risk for fetal loss,” says the study’s lead investigator, Andrew Hyland, PhD, Chair of RPCI’s Department of Health Behavior.

While there was previously some evidence that smoking during pregnancy was associated with the three outcomes of fetal loss studied here — spontaneous abortion or miscarriage (loss of a fetus before 20 weeks of gestation), stillbirth (loss of a fetus after 20 or more weeks of gestation) and tubal ectopic pregnancy — such evidence for secondhand smoke (SHS) exposure had been limited. This study is significant in two ways: One, it considered lifetime SHS exposure rather than only during pregnancy or reproductive years, taking into consideration smoke exposure in participants’ childhood and adult years. Two, the comparison group of never-smokers was limited to women without any SHS exposure, producing a truer control group compared to previous studies.

The large sample size and comprehensive assessment of SHS exposure added strength to the findings. Historical reproductive data, current and former smoking status, and details about SHS exposure over lifetime were collected from the Women’s Health Initiative Observational Study. This allowed for a study group of 80,762 women.

“The statistical power gained from the large cohort of women that was available is noteworthy,” added co-author Jean Wactawski-Wende, PhD, Professor in the Departments of Social and Preventive Medicine and Obstetrics and Gynecology, and Vice Provost for Research Advancement and Strategic Initiatives at UB. “As a result of the Women’s Health Initiative Observational Study, participants came from a broad range of geographic areas and had multiple ethnic, educational and socio-economic backgrounds. This allowed for a comprehensive assessment of detailed information on exposures, outcomes and potential confounders.”

Women with the highest levels of SHS exposure — despite never having smoked themselves — had significantly greater estimates of risk for all three adverse pregnancy outcomes, and these risks approached the risk seen among women who smoke (those who smoked more than 100 cigarettes in their lifetime). The highest levels of lifetime SHS exposure were defined by childhood exposure for longer than 10 years, adult home exposure for more than 20 years and adult work exposure for more than 10 years.

“This study offers new information for women regarding the lifetime impact secondhand smoke can have on reproductive outcomes and their ability to successfully bring a pregnancy to full term,” says Dr. Hyland. “The strength of the study also provides public-health professionals and others with information upon which to base health guidelines about the significant consequences of secondhand smoke.”

Women & Children's Hospital and Roswell Park Plan New Integrated Hematology Oncology Unit

CENTER TO BE LOCATED IN NEW JOHN R. OISHEI CHILDREN’S HOSPITAL

BUFFALO, NY — In a collaboration that will enhance the quality of care for children with cancer, Women & Children’s Hospital of Buffalo and Roswell Park Cancer Institute (RPCI) announced the first step toward building a physician-led, unified pediatric hematology-oncology program in the new John R. Oishei Children’s Hospital.

For over 40 years, the two healthcare systems have operated the pediatric hematology-oncology service for the Western New York region, with separate and complementary services offered at each hospital. With the planning for the new hospital well underway, Roswell Park Cancer Institute and Women & Children’s Hospital, a Kaleida Health facility, have initiated a physician-led planning process to develop a single center of excellence for pediatric inpatient/outpatient services.

The two institutions today signed a memorandum of understanding to plan the new center, which will be a dedicated floor of the John R. Oishei Children’s Hospital. The future hospital will be located at Ellicott and High Streets on the Buffalo Niagara Medical Campus.

“We’ve been developing plans for enhancing our program under one roof for many years,” says Martin L. Brecher, MD, Chair of Pediatrics at Roswell Park Cancer Institute, Chief of Hematology Oncology at Women & Children’s Hospital and Chief of Pediatric Hematology-Oncology in the Department of Pediatrics at the University at Buffalo. “Each institution contributes unique expertise and services to children and young adults with cancer and blood disorders such as sickle cell disease, hemophilia and anemia. The new hospital presents a great opportunity to develop a true pediatric Center of Excellence.”

Women and Children’s Hospital of Buffalo is submitting its Certificate of Need (CON) application for the new hospital to the New York State Department of Health on November 2nd. Roswell Park anticipates submitting the Certificate of Need for the Pediatric Hematology Oncology Center by the end of the year.

“This partnership between the two organizations is an excellent example of the many opportunities the new John R. Oishei Children’s Hospital on the Buffalo Niagara Medical Campus is granting,” said Teresa Quattrin, MD, Chair, Department of Pediatrics, Professor of Pediatrics, SUNY at Buffalo, and Pediatrician-in-Chief, Chief, Division of Endocrinology-Diabetes, Women & Children’s Hospital of Buffalo. “We look forward to continuing to create this integrated Hematology & Oncology Unit to further enhance the care provided to patients and their families throughout Western New York and beyond.”

It is anticipated that RPCI will hold a long-term lease for the Center and will be responsible for medical direction. Currently, Women & Children’s Hospital of Buffalo provides specialty pediatric services essential to the care of these children including surgery, anesthesia, intensive care, and diagnostic imaging. Roswell Park provides oncology clinical leadership and services including radiation therapy, certain highly-specialized diagnostic services, blood and marrow transplants and clinical trials. The planned Center will continue to capitalize on the unique expertise of both institutions.

“In order to have an outstanding program for children with cancer and blood diseases, we need a very strong and comprehensive children’s hospital in partnership with a very strong and excellent cancer institute,” said James R. Kaskie, President and CEO of Kaleida Health. “Roswell Park Cancer Institute and the new John R. Oishei Children’s Hospital have joined forces in a collaborative model to further expand and improve the diagnosis, treatment and research programs available locally for children and their families who face this most difficult of diseases. Together, and in conjunction with the University at Buffalo academic programs, we will jointly operate a center of excellence for children with cancer and blood diseases where expert clinical services are provided, innovative and pioneering research is advanced to find a cure and improve treatment options, and current and future health care professionals are trained and educated.”

The proposed center will incorporate inpatient beds, an outpatient clinic, isolation beds for blood and bone marrow transplant/high-dose therapy patients, and infusion facilities for chemotherapy and blood products, all in a protected environment on the top floor of the new hospital.

“Management of cancer is best provided in facilities where hospital inpatient beds and outpatient facilities are in close proximity. The relocation of the children’s hospital to the medical campus provides the opportunity to pull together what have been two physically separate outpatient and inpatient units into a single, expanded service comprehensive facility to serve the needs of children of all ages with blood diseases and cancer. There are many advantages associated with the development of a single pediatric cancer center. The planning, implementation and operation of this facility is a complex endeavor that will require substantial time and effort on the part of our respective administrative leaders and clinical faculty,” says Donald L. Trump, MD, President and CEO of Roswell Park Cancer Institute.

Both institutions and their respective Boards of Directors recognize that the relocation of Women & Children’s Hospital of Buffalo to the medical campus presents a unique opportunity to take an excellent pediatric hematology oncology program and make it extraordinary by bringing all the services together in a new state-of-the-art hospital. Philanthropic support for the hospital and for the pediatric hematology oncology center will be required to make the program consolidation a reality.

About Women & Children’s Hospital of Buffalo
Women & Children’s Hospital of Buffalo, a Kaleida Health facility and teaching hospital for the University at Buffalo School of Medicine and Biomedical Sciences, is the regional center for comprehensive and state-of-the-art pediatric, neonatal, perinatal and obstetrical services in Western New York and beyond. For more information, please go online at www.wchob.org.

About Kaleida Health
Kaleida Health is the largest health care provider and largest private employer (9,500 employees) in Western New York. More than one million patient visits are recorded annually at the Buffalo General Medical Center, DeGraff Memorial Hospital, Gates Vascular Institute, Millard Fillmore Suburban Hospital, Women and Children’s Hospital of Buffalo, plus the health system’s 90 clinics and health care centers. Kaleida Health operates HighPointe on Michigan and the DeGraff Memorial Hospital skilled nursing facility, plus the nation’s oldest – and original – Visiting Nursing Association. Kaleida Health also operates a major laboratory division as well as the Millard Fillmore Ambulatory Surgery Center. The organization is also affiliated with Great Lakes Health, the entity integrating Kaleida Health, Erie County Medical Center (ECMC) Corporation and the University at Buffalo. Kaleida Health’s economic impact on Western New York exceeds $2.2 billion annually. For more information, go tohttp://www.kaleidahealth.org.

New Research Uncovers Promising New Biomarker for Aggressiveness of Prostate Cancer

Roswell Park-led effort found increased levels of serum glutamate in both primary and metastatic prostate tumors

BUFFALO — Research out of Roswell Park Cancer Institute (RPCI) supports the adoption of a new biomarker to measure the aggressiveness of primary prostate tumors. A team of investigators from three institutions, led by Shahriar Koochekpour, MD, PhD, Associate Professor of Cancer Genetics, Urology and Oncology in RPCI’s Department of Cancer Genetics, has for the first time produced data showing that levels of serum glutamate, a naturally occurring nonessential amino acid that plays a key role in cancer metabolism, are increased in patients with primary and metastatic prostate cancer.

Collaborators included James L. Mohler, MD, Gissou Azabdaftari, MD, and Kristopher Attwood, PhD, from RPCI; Robert L. Vessella, PhD, from the University of Washington School of Medicine; and Oliver Sartor, MD, from Tulane Cancer Center and the Tulane University School of Medicine. In a study involving 366 men, the team measured serum glutamate levels in 60 healthy adult males, 197 with primary prostate cancer and 109 with metastatic castration-resistant prostate cancer — cancer that progresses following androgen depletion therapy.

“Comparing normal, primary and metastatic prostate cancer tissues, we discovered that glutamate receptor is expressed at very high levels in primary and metastatic tumors, but at very weak or undetectable levels in benign prostate tissues,” notes Dr. Koochekpour. “And serum glutamate was detected at increased levels proportional to Gleason score, the standard index for rating prostate cancer aggressiveness and prognosis in patients with primary tumors.”

The researchers also demonstrated, for the first time, that glutamate deprivation significantly decreases the growth, migration and invasiveness of prostate cancer cell lines, suggesting potential clinical applications. They also report that the glutamate antagonist riluzole (Rilutek), a well-tolerated oral medicine used for mood and anxiety disorders, depression and amyotrophic lateral sclerosis (ALS), induces cell death while inhibiting the progression and motility of human prostate cancer cells.

“We detected one major difference between African-Americans and Caucasians in the study,” Dr. Koochekpour notes. “In African-Americans, serum glutamate levels were higher among those men with metastatic disease than in those with primary prostate cancer, and we didn’t see that trend in Caucasian men. This finding may implicate a role for glutamate metabolism in inter-racial disparities of prostate cancer.”

Dr. Koochekpour and colleagues are currently conducting a preclinical study assessing the effectiveness of riluzole in preventing growth of human prostate cancer cells in animal models, and hope to build on these results in the clinical setting within the next 12-18 months. The paper, “Serum Glutamate Levels Correlate with Gleason Score and Glutamate Blockade Decreases Proliferation, Migration, and Invasion and Induces Apoptosis in Prostate Cancer Cells,” was published October 16 in Clinical Cancer Research and can be accessed at http://clincancerres.aacrjournals.org/content/early/2012/10/10/1078-0432.CCR-12-1308.

Investigational Brain Cancer Vaccine to Be Tested in Phase I Roswell Park Study

Peptide vaccine targets cancer survival protein, putting tumor cells in a Catch 22

BUFFALO — A new clinical research study at Roswell Park Cancer Institute (RPCI) will test a first-of-its-kind cancer “vaccine” that may prove effective against many forms of solid-tumor cancers. The vaccine, to be investigated in a trial involving patients with brain cancer, generates an immune response that appears to put the target molecule, the cancer survival protein survivin, into a bind it can’t escape.

The peptide vaccine, developed at Roswell Park by Robert Fenstermaker, MD, and Michael Ciesielski, PhD (photograph below) is based upon a specially engineered small protein molecule called a “peptide mimic.” Dr. Fenstermaker is principal investigator of the phase I clinical research study, which will test the safety and immunological effects of the vaccine in patients with two types of brain cancer: glioblastoma multiforme (GBM) and anaplastic glioma. Called SurVaxM, the injectable vaccine will initially be given in four doses to nine patients.

Survivin, produced by at least 80% of cancers, is a protein that helps cancer cells to survive under stressful conditions. It is present only in diseased cells, which are caught in an unwinnable situation when exposed to the vaccine.

“SurVaxM puts cancer cells in a Catch 22,” says Dr. Fenstermaker, who is Chair of RPCI’s Department of Neurosurgery and Director of the Institute’s Neuro-Oncology Program. “The vaccine kills tumor cells that express survivin. If the cells turn survivin off to escape the vaccine, they’re essentially committing suicide.”

The engineered peptide used in the vaccine is able to stimulate an immune response because the cancer recognizes it as a foreign molecule.

“We arrived at this peptide through reverse immunology,” notes Dr. Ciesielski. “We knew we wanted to target survivin because it is expressed by so many tumors. We looked at many survivin peptides trying to find the best one to use as our vaccine. Once we identified one that looked promising, we engineered it to be more potent and produce a better response by enlisting multiple arms of the immune system.”

In preclinical studies, the vaccine was effective against several cancers, including gliomas and prostate, ovarian, breast and kidney tumors that produce survivin. Studies in which human glioma, lymphoma and leukemia cells were exposed to the vaccine outside the body also produced a strong response. “In those earlier studies, the response was persistent,” Dr. Ciesielski says. “It appears that the vaccine continues to provide lasting immunity after the tumor has been eliminated.”

Roughly 15,000 people are newly diagnosed with glioblastomas and anaplastic gliomas in the U.S. every year. These cancers are very difficult to treat, and are often fatal.

“Survival rates for malignant gliomas have improved modestly over the last two decades, but better therapies are desperately needed,” Dr. Fenstermaker says. “We’re anxious to move ahead with this study and, hopefully, go on to larger studies in the years ahead, but we first have to show that this is a safe and well-tolerated drug for a group of terrible diseases.”

Because they enlist the body’s own cells to fight cancer, immune-based therapies generally have few adverse side effects. The trial is the fourth clinical research study launched through RPCI’s Center for Immunotherapy this year.

The study is National Cancer Institute trial no. NCT01250470. For more information about SurVaxM and this new phase I research study, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

Ciesielski and Fenstermaker credit early seed funding from donations with helping to move their research forward and generating additional dollars in new grant funding from organizations such as the National Institutes of Health/National Cancer Institute (R21 NS049309-01) and the American Cancer Society. Additional support from The Jayne and Phil Hubbell Family was instrumental in advancing the team’s research.

A Video interview with Drs. Fenstermaker and Ciesielski available at https://vimeo.com/48443468. For additional photos and multimedia, including B-roll video, send request to:annie.deck-miller@roswellpark.org.

RPCI Researcher, Local Teen Available to Discuss Surgeon General’s Report on Tobacco Use Among Youth

WHAT: U.S. Surgeon General’s Report “Preventing Tobacco Use among Youth and Young Adults,” released today, calls on the nation to make the next generation tobacco-free.

A young person from the Amherst Youth Board and a Roswell Park Cancer Institute (RPCI) faculty member will provide local information regarding tobacco retail advertising and discuss its impact on children

WHO:             Maansi Bansal-Travers, PhD, Behavioral Research Scientist at RPCI, and Marc Cohen, Amherst Youth Board member and Senior at Williamsville East High School

WHEN:           Thursday, March 8 and Friday, March 9

To schedule an appointment, call 716-845-4919 or email deborah.pettibone@roswellpark.org

BACKGROUND:

Surgeon General Report: Key Messages:

• Smoking kills more than 1,200 Americans every day. And every tobacco-related death is replaced by two new smokers under the age of 25.
• More than a million dollars an hour is spent to market tobacco products in this country.
• Rates of decline for cigarette smoking have slowed in the last decade and rates of decline for smokeless tobacco use have stalled completely

Roswell Park Research

• Tobacco retail outlets are more densely concentrated in low income census tracts than high income census tracts
• 64.4% of all City of Buffalo schools have a tobacco retail outlet within 1,000 feet.

The full report is available at: www.surgeongeneral.gov and www.cdc.gov/tobacco

Roswell Park Researchers Publish Findings on Agent Shown to Enhance Immunotherapy

Conclusions from study of entinostat combination to be tested in kidney, prostate cancer clinical trials

BUFFALO, NY — Preclinical research by a team from Roswell Park Cancer Institute (RPCI) has demonstrated for the first time the way in which a class I histone deacetylase (HDAC) inhibitor, entinostat, appears to boost the effectiveness of cancer immunotherapy for treatment of some solid tumors. The findings support conclusions from earlier studies and also suggest that the approach merits further testing in clinical settings.

In a study involving models of renal and prostate cancer, recently published in the peer-reviewed scientific journal PLoS One, a team led by Roberto Pili, MD, Professor of Oncology, Chief of the Genitourinary Section and Co-leader of the Genitourinary Program, Department of Medicine, demonstrated the novel immunomodulatory effect through which entinostat, manufactured by Syndax Pharmaceuticals, Inc., appears to enhance the antitumor activity of Interleukin-2 (IL-2) for kidney cancer and of a survivin cancer vaccine (SurVaxM), developed at RPCI by Michael Ciesielski, PhD, and Robert Fenstermaker, MD, of the Department of Neurosurgery, for prostate cancer.

“Entinostat has an immunomodulatory effect on regulatory T cells, which are like brakes for the immune system and are present in many tumors,” Dr. Pili explains. “By suppressing these suppressor cells, entinostat releases the brakes and helps the immunotherapies to work better.”

The combination of a vaccine with approaches to deplete or suppress regulatory T cells, the researchers write, “represents a rational strategy in prostate cancer therapy” and one that “also has promising potential to be effective in other immunotherapies and in different tumors.”

Li Shen, PhD, a postdoctoral associate in the Department of Medicine, was lead author on the study. Drs. Ciesielski and Fenstermaker were also contributing authors, as were Swathi Ramakrishnan, Kiersten M. Miles, PhD, Leigh Ellis, PhD, and Paula Sotomayor, Department of Medicine; and Protul Shrikant, PhD, Department of Immunology.

The PLoS One article is titled “Class I Histone Deacetylase Inhibitor Entinostat Suppresses Regulatory T Cells and Enhances Immunotherapies in Renal and Prostate Cancer Models,” and can be accessed online at:http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0030815.

A clinical study testing the combination of entinostat with IL-2 in renal-cell cancer is underway at RPCI and other sites. For more information about that study, which is currently accruing participants, go to: http://www.roswellpark.org/clinical-trials/list/145208-0.

Additional clinical studies of the combination of entinostat and other immunotherapies are planned in prostate cancer and other solid tumors.

Roswell Park Cancer Institute Again Included on ‘Great Oncology Programs’ List

Annual Becker’s Hospital Review feature highlights leaders in research, prevention, treatment and education

BUFFALO, NY — Roswell Park Cancer Institute (RPCI) has once again been included on Becker’s Hospital Review’s annual list of centers that serve as leaders in cancer research, prevention, treatment and education. In selecting facilities for its “Great Oncology Programs” feature, the Becker’s editorial team analyzed data from such sources as U.S. News and World Report, HealthGrades, Thomson Reuters, the National Cancer Institute, the American College of Surgeons and the American Nurses Credentialing Center.

RPCI is one of 70 hospitals and health systems recognized this year for providing full-spectrum care and support services, access to clinical trials, cutting-edge oncology treatment and groundbreaking research.

“Roswell Park was the country’s first cancer center and remains the first and only facility in upstate New York designated as a comprehensive cancer center by the National Cancer Institute,” Becker’s notes in its description of RPCI. “Its patient satisfaction scores are consistently well-above the national average. In the past 10 years, the center has added more than 1,000 new jobs, dedicated an entire hospital facility to Phase I cancer research and formed international strategic partnerships with researchers.” 

Becker’s Hospital Review’s 2012 Great Oncology Programs list, including a longer profile of RPCI, can be found at:http://www.beckershospitalreview.com/lists/hospitals-and-health-systems-with-great-oncology-programs.html

RPCI has frequently been recognized for high-quality care and overall excellence. The Institute was again recognized in U.S. News and World Report’s 2011-12 Best Hospitals list for Cancer Care; holds Magnet Recognition Program designation from the American Nurses Credentialing Center; has been named one of the eight best hospitals in the nation for complex or “extremely difficult” cancer cases by AARP The Magazine; and has received other special commendations from BlueCross BlueShield, Optum Health, The Scientist magazine and others.

Becker’s Hospital Review is a bimonthly news publication with approximately 18,500 readers.

Roswell Park Cancer Institute Announces Vaccine for Cancer

Dendritic cell vaccine, manufactured in unique RPCI facility, trains body’s defenses to remember, destroy cancer cells

STORY HIGHLIGHTS: 

New dendritic cell vaccine designed to kill cancer cells, prevent relapse

Vaccine will be made at RPCI using a unique FDA-approved process

First study to test a dendritic vaccine given in combination with rapamycin

MEDIA CONTACT: 

Annie Deck-Miller, Senior Media Relations Manager
716-845-8593; annie.deck-miller@roswellpark.org

Tuesday, January 24, 2012

The Center for Immunotherapy at Roswell Park Cancer Institute (RPCI) has launched a phase I clinical research study of a dendritic cell vaccine designed to both eradicate cancer cells and prevent disease relapse. Developed at RPCI, the NY-ESO-1 dendritic cell vaccine will be manufactured in the Institute’s new Therapeutic Cell Production Facility using a unique FDA-approved process — making RPCI the first research facility in the U.S. to use a custom-made barrier isolator for vaccine cell production, and the first in the world to use this system in an approved, government-regulated study.

Dendritic cells are the gatekeepers of the human immune system, defending against invaders like bacteria, viruses and cancer. The vaccine to be produced at RPCI will be the first to incorporate a particular form of NY-ESO-1, antiDEC205-NY-ESO-1. “Armed with this specialized protein, the treated cells are then given back to the patient as a vaccine designed to recruit an army of killer immune cells that seek out and destroy cancer,” explains Kunle Odunsi, MD, PhD, Director of RPCI’s Center for Immunotherapy (CFI) and the study’s Principal Investigator.

The new study is also unique in that it’s the first to test a dendritic vaccine given in combination with rapamycin, a compound used to prevent rejection of solid-organ transplant. The study just launched will capitalize on a striking recent scientific discovery by Protul Shrikant, PhD, of the Department of Immunology at RPCI, who found that in low doses, rapamycin confers a previously unknown benefit — it prevents the immune system from using up its cancer-killing T-cells in one quick burst. “We have shown for the first time that rapamycin has the capacity to produce immune cells that have memory attributes,” explains Dr. Odunsi, who is also Chair of RPCI’s Department of Gynecologic Oncology. “The immune cells are trained to live longer and to always remember that cancer cells are bad and should be attacked and killed.”

The ability to stretch out the attack for a long-term, durable response suggests that the vaccine may be effective in preventing disease recurrence. The new NY-ESO-1 dendritic cell vaccine is expected to show great promise in patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lung, melanoma, ovarian, prostate, sarcoma and uterine tumors.

The NY-ESO-1 vaccine, tailor-made for each patient, will be produced in RPCI’s Therapeutic Cell Production Facility (TCPF) under the direction of Yeong “Christopher” Choi, PhD, who notes: “We believe that our facility’s custom-made barrier isolator, the unit in which the vaccines are manufactured, is the first of its kind.” The barrier isolator — an Xvivo System processing chamber designed to RPCI’s specifications by BioSpherix, Ltd., Lacona, NY — maintains strict control of the unit’s temperature and atmospheric gases, critical for optimal production of dendritic cell vaccines.

“Those conditions, and the sterile vaccine-manufacturing environment, are rigidly maintained throughout the entire process,” says Dr. Choi. “The Xvivo — which at about 70 square feet is basically a clean room in a box — acts as a physical barrier that protects the cell-therapy product from outside contaminants, resulting in a safer, more predictable manufacturing process.”

The potential of therapeutic vaccines is attracting increasing interest in the field of oncology. Last year, the FDA approved the first therapeutic cancer vaccine, Provenge® (sipuleucel-T), for men with advanced prostate cancer. RPCI’s Center for Immunotherapy is awaiting FDA approval to launch additional cancer vaccine trials, including a vaccine for malignant glioma (a type of brain tumor) and another vaccine for patients with ovarian, fallopian tube, and primary peritoneal cancer.

“This trial will be only the beginning of a very robust program of activity in the area of using the human immune system to fight cancer,” adds Dr. Odunsi. “Our production process holds tremendous potential for applications related to stem-cell therapy and regenerative medicine, and I believe we’re uniquely positioned at RPCI to have the tools, infrastructure and multidisciplinary collaboration to capitalize on these ideas and opportunities both effectively and efficiently.”

The clinical research study will enroll 18-20 eligible patients whose tumors express a specific antigen, known as NY-ESO-1. Apart from the adult male testis, NY-ESO-1 is not expressed in normal tissues of the body, but is expressed in cancers. This may help decrease the risk of side effects from the vaccine, because it should target only the tissues that express NY-ESO-1.

Dr. Odunsi, who developed the NY-ESO-1 vaccine, led previous trials evaluating its effectiveness in treating ovarian cancer. Christine Sable of Lancaster, Pennsylvania, enrolled on one of those studies in February of 2004, after undergoing surgery and chemotherapy for advanced-stage ovarian cancer. Although she faced a 75-80% chance that the cancer would return, her immune system responded strongly to the vaccine, and she has remained cancer-free in the seven years since then, with no side effects.

To learn more about the clinical research studies of the NY-ESO-1 dendritic cell vaccine, call 1-877-ASK-RPCI (1-877-275-7724).

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

More information:

B-roll video (QuickTime H.264 1920x1080, 329 MB) available for download at:https://files.me.com/rpcicreative/wn2kxt.mov

About this clinical trial: http://www.roswellpark.org/clinical-trials/list/191511

WNY Genome Project and What It Means to You

Imagine being able to examine your genetic makeup to determine if you are likely to develop a disease. Imagine being able to receive treatment and medication designed specifically for you in the most effective dose.

One of the most important aspects of modern medicine is genetics, or the science of genes and heredity and what makes us different from one another. The genetic makeup (genome) for one individual is the entirety of that person’s hereditary information.  Now imagine the ability to compile and analyze the genome of an entire community to examine the predispositions of its members to common diseases like cancer, diabetes, heart disease, multiple sclerosis, lupus or hypertension (high blood pressure).

In December Roswell Park Cancer Institute (RPCI) was granted $5.1 million by Governor Cuomo to lead a project that will do just that, and Donald L. Trump, MD, RPCI President and CEO, is thrilled. He predicts, “The RPCI Genome Project will significantly enhance our ability to develop personalized, more effective medical care plans and treatments for citizens of Western New York and beyond, but it is just a beginning.” 

Dr. Trump explains, “The project will begin with cancer, where we already have experience and infrastructure, including a large database of individuals. One goal is to individualize and personalize treatments. For example, anticoagulant drugs may be dosed differently based on how each individual metabolizes the drug. Another is tamoxifen, a well-documented drug for breast cancer prevention. We need to determine which patients are most likely to benefit from specific drugs and determine appropriate individualized dosages to minimize side effects. Ultimately, the goal is to expand our capability well past cancer and develop effective and customized treatments for all individuals.”

With this pilot funding, 1,000 area residents will be asked to donate a blood sample and provide detailed medical information. Patients’ privacy will be fully protected and their data will not be shared with insurance companies or serve as a basis for denying coverage based on their predisposition to a disease. In fact, only the health care provider and the individual themselves will have access to the information.

So what else is so exciting about the project? Dr. Trump says, “It will mean many jobs for Western New Yorkers, significantly boosting our economy.” Meanwhile, recruitment for a Project leader is underway, and people with cancer expertise, data collection and analysis will also be needed. Dr. Trump adds, “We also know that it will attract more money to our region, as happened with the genome project in Tampa, Florida at the H. Lee Moffitt Cancer Center, where the Merck Pharmaceutical company invested $100 million in a similar endeavor.”

So why was Western New York selected? Dr. Trump says it’s because of our region’s cutting-edge science and technology, broad partnerships with many constituents, and the potential for job growth and economically rewarding partnerships.

Dr. Trump and Deputy Director Candace Johnson, PhD, will lead the RPCI Genome Project as Co-Principal Investigators. Partners include the University at Buffalo, Kaleida Health, the Catholic Health System, Erie County Medical Center, HealthNow/BlueCross BlueShield, Independent Health, Univera Healthcare, The P2 Collaborative and HEALTHeLINK. For more information visit roswellpark.org, call 1-877-ASK-RPCI or send an email inquiry to askrpci@roswellpark.org.

Support Available for Those Looking to Start New Year Tobacco-Free

BUFFALO, NY — There are close to 3 million smokers in New York State, and about three-quarters of them say they want to quit. A new advertising campaign will remind New Yorkers about the risks of smoking and the free, 24/7 services that can help them keep a resolution to quit tobacco for good.

The campaign consists of two television commercials that will air throughout January. The ads, Doesn’t Kill and Emphysema, show the physical damage cigarettes can cause to people who smoke. Local New Voice Club members who have had their voice box removed as a result of smoking are living examples of the impacts highlighted in the ads. “It’s very depressing to live like this,” says Joe Corbi, one of three New Voice Club members featured in companion videos. “It’s changed my life financially and emotionally, and has affected my family.”

The ads also direct smokers to the services available through the New York State Smokers’ Quitline (1-866-NY-QUITS). The Quitline, based at Roswell Park Cancer Institute (RPCI), provides free quit coaching and nicotine patches to New York residents who want to stop smoking or using tobacco. The spots, along with companion videos featuring interviews with New Voice Club members who offer smokers quit advice and encouragement and share their experience of losing their ability to speak as a result of past tobacco use, can be viewed at the Quitline website: http://www.nysmokefree.com/Subpage.aspx?P=50&P1=5030.

“So many tobacco users are ready to quit and finally overcome their nicotine addiction at this time of year; support from friends family and the Smokers’ Quitline can make the difference in helping them quit for good,” says Andrew Hyland, PhD, Chair of RPCI’s Department of Health Behavior and Director of the New York State Smokers’ Quitline.

Services available through the Quitline include a free nicotine patch starter kit, quit coaching, self-help materials, motivational messages and daily tips. The Quitline can be reached at 1-866-NY-QUITS (1-866-697-8487) Monday through Thursday, 9 a.m. until 9 p.m., and Friday through Sunday, 9 a.m. until 5 p.m. (taped messages of support available in off-hours). An online smoke-free community is available 24/7 athttp://www.nysmokefree.org, and additional tips and resources can be found at http://www.facebook.com/NYQuits andhttps://twitter.com/nysmokefree.

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or emailaskrpci@roswellpark.org.

Editor’s note: Experts from Roswell Park Cancer Institute and members of the New Voice Club of the Niagara Frontier are available to discuss cessation and the effects of tobacco use. Contact Annie Deck-Miller at 716-845-8593 or annie.deck-miller@roswellpark.org to schedule an interview.

RPCI EARNS LEAPFROG TOP HOSPITAL RECOGNITION, ASCO QUALITY CERTIFICATION

Two prestigious quality designations are latest commendations of RPCI from national organizations

  

BUFFALO, NY — Roswell Park Cancer Institute (RPCI) has again been recognized at the national level for providing high-quality, patient-centered care. One of only three National Cancer Institute-designated comprehensive cancer centers in New York State, RPCI this month received Leapfrog Top Hospital recognition for the second consecutive year and earned Quality Oncology Practice Initiative (QOPI) Certification from the American Society of Clinical Oncology (ASCO).

The Leapfrog Top Hospital designation puts RPCI in a class representing just 5% of eligible hospitals — 65 from a field of nearly 1,200. The Leapfrog Group, a coalition of public and private employers, selects hospitals for the designation based on an annual national survey measuring performance in areas such as error prevention and nurse and physician staffing — the most complete picture available of a hospital’s record on quality and patient safety.

“For the second year in a row, Roswell Park Cancer Institute has achieved the highest distinction for quality and patient safety that any hospital in America can achieve. We are proud to count them among the select group of 2011 Leapfrog Top Hospitals,” said Leah Binder, CEO of The Leapfrog Group. “As the demand for information about hospital quality grows, hospitals like Roswell Park that participate in Leapfrog’s annual hospital survey are providing a great service to their community by making important information readily available.”

Launched by ASCO in 2006, the QOPI enables medical facilities to examine the quality of care they provide to patients based on evidence-based guidelines and established quality measures. Its rigorous set of more than 100 quality measures was developed by practicing oncologists and quality experts, and spans the continuum of cancer care. The QOPI Certification Program was launched in 2010. RPCI is one of approximately 100 facilities nationally to earn the certification, and one of only seven in New York State.

“Consistency is one of the most important aspects of high-quality delivery of care,” said Donald L. Trump, MD, FACP, RPCI President and CEO. “To be recognized by national organizations as respected as the Leapfrog Group and ASCO, we have to not only be able to provide great and safe care but to have a proven track record of doing so routinely.”

RPCI has frequently been recognized for high-quality care and overall excellence. The Institute was again recognized in U.S. News & World Report’s 2011-12 Best Hospitals list for Cancer Care; holds Magnet Recognition Program designation from the American Nurses Credentialing Center; has been named one of the eight best hospitals in the nation for complex or “extremely difficult” cancer cases by AARP The Magazine; and has received other special commendations from BlueCross BlueShield, Optum Health, The Scientist magazine and others.

About The Leapfrog Group, ASCO and RPCI:

The Leapfrog Group is a coalition of public and private purchasers of employee health coverage founded a decade ago to work for improvements in health care safety, quality and affordability.  The annual survey is the only voluntary effort of its kind.  More information is available at http://www.leapfroggroup.org.

The American Society of Clinical Oncology (ASCO) has more than 30,000 members and is the world’s leading professional organization representing physicians who care for people with cancer. For more information, go tohttp://www.asco.org.

For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

National Expert To Headline RPCI Seminar On Role Of Research In Nursing

BUFFALO, NY — Roswell Park Cancer Institute (RPCI) welcomes the region’s nurses to a free half-day program featuring a keynote address from a national expert. Linda Burnes Bolton, DrPH, RN, FAAN, Vice President and Chief Nursing Officer of Cedars-Sinai Health System and Research Institute, will keynote “Nursing Research: Producing Evidence to Advance Health” Wednesday, November 16 from 8 a.m. to noon in the Hohn Auditorium, Research Studies Center, RPCI.

Burnes Bolton, who in April was named to Modern Healthcare Magazine’s Top 25 Women in Healthcare list, is also Vice Chair of the Institute of Medicine Committee on the Robert Wood Johnson Foundation Initiative on the Future of Nursing. In her address, she will share her vision of a healthcare system that makes quality care accessible to diverse populations, promotes wellness and disease prevention, improves health outcomes and provides compassionate care across a person’s lifespan, detailing the Institute of Medicine’s recommendations on the future of nursing and addressing knowledge gaps in nursing research.

A panel discussion will follow, led by several regional and state nursing leaders:

• Maureen Kelly, RN, MS, OCN, NEA-BC CNO, Chief Nursing Officer at RPCI
• Barbara Zittel, RN, PhD, Nursing Consultant
• Mary Lou Rusin, RN, EdD, ANEF, Nursing Department Chairperson, Daemen College
• Frances Crosby, RN, EdD, MS, BS, Department Chair and Associate Professor of Nursing, Niagara University
• Mary Beth Campo, RN, MS, NEA-BC, Chief Nursing Executive, Kaleida Health
• Davina Porock, RN, PhD, Interim Dean, Professor and Associate Dean for Research and Scholarship, University at Buffalo School of Nursing

The seminar will begin with a poster session and continental breakfast from 8 a.m. to 9:30 a.m. Burnes Bolton’s keynote address will begin at 10 a.m., with the panel discussion following from 11 a.m. to noon. Attendees can earn one continuing nursing education credit through the Oncology Nursing Society.

Free parking is available at First Niagara Center, Washington Street at Perry Street. Free shuttle service will be provided for attendees from 7:30-9:30 a.m. and noon-1:00 pm. (The RPCI parking ramp is reserved for patients.)

To reserve a seat, call 716-845-3436 or send an e-mail to wendy.raber@roswellpark.org by November 9.

RPCI NAMES NEW MEDICAL DIRECTOR FOR PHOTODYNAMIC THERAPY CENTER

BUFFALO, NY — Nestor Rigual, MD, FACS, has been appointed Medical Director of the Photodynamic Therapy Center at Roswell Park Cancer Institute (RPCI). Photodynamic therapy (PDT) was developed at RPCI, and the PDT Center is a worldwide leader in its use for treating many types of cancer.

PDT, developed in the mid-1980s by Thomas Dougherty, PhD, Chief Emeritus of the Center, is a targeted anticancer treatment — one that kills tumor cells without permanently damaging surrounding tissue. It involves the administration of a nontoxic drug that settles in tumor cells, followed by the application of laser light to the tumor, thereby activating the drug and killing the cancer. At RPCI, it is used to treat various types of cancer, including cancers of the skin, lung, breast, esophagus, colon and rectum.

Dr. Rigual is a Professor of Oncology in the Department of Head & Neck/Plastic and Reconstructive Surgery. He will provide leadership in PDT translational research, establish clinical conferences for physicians to discuss protocols and PDT patients, train physicians in the practice of PDT, and develop a new multidisciplinary PDT clinic.

“Dr. Rigual brings expertise, enthusiasm and energy to this new position, and I am confident that he will bring new and innovative ideas to the clinical program in PDT,” said RPCI President and CEO Donald L. Trump, MD, FACP.

Dr. Rigual earned his medical degree from the University of Oklahoma College of Medicine, and completed residencies at UB and the University of Oklahoma Health Sciences Center.

We Want Our Change.

Over 130 teens came together in Buffalo to send a clear message: They have seen enough in-store tobacco marketing, and they want their change. Recruiting replacement smokers, also known as kids, is a building block for big tobacco’s marketing strategy. Recent surveys have shown kids are consistently targeted by flashy cigarette advertising in local stores.
On August 11, 2011, Reality Check youth from across New York State rallied together to send the message that dangerous tobacco marketing should be removed from stores where kids shop. The more in-store advertising they see, the more likely they are to smoke. Communities are eager to protect kids from dangerous influences. Curbing flashy advertising and large tobacco displays whenever they walk into their local convenience store is an important step.
Research in the U.S. and abroad suggests that exposure to in-store tobacco promotions is a primary cause of youth smoking. Very few adult smokers begin after high school, with 90 percent of adult smokers starting at or before age 18.
In-store promotions are a major cause of youth smoking. A National Cancer Institute study concluded that exposure to cigarette advertising causes nonsmoking adolescents to initiate smoking and to move toward becoming regular smokers. Another study found young people are more likely to be influenced by cigarette advertising than by peer or parental smoking. A 2008 analysis found a direct relationship between increased teen smoking and the density of tobacco retailers around schools, while a paper published earlier this year found a direct relationship between the frequency that a kid visited stores containing tobacco advertising and his or her risk of becoming a smoker.
As a result of the recent Family Smoking Prevention and Tobacco Control Act (FDA law) and the Master Settlement Agreement (MSA), retail stores are one of the last places where tobacco companies can expose kids to their advertising. Consequently, tobacco companies spend billions of dollars each year marketing their deadly products at the point of sale. This is done by controlling dominant display space in retail stores and through in-store advertising. Both are typically found around the cash register, sometimes referred to within the industry as the “goal post” because it is the one place in the store where everyone must go. Tobacco companies invest a lot at these locations in creating so-called “power walls,” large, visually appealing displays of products intended to attract the interest of customers.
The 16 Reality Check Programs in New York work with many other groups such as the American Cancer Society, Roswell Park Cancer Institute and the University of California to educate the community about tobacco issues such as in-store marketing. Teens encourage the community to take action to limit youth exposure to this dangerous and deadly influence.
Reality Check is the youth component of the NYS Tobacco Control Program. Teens 13-18 work to educate the community about the manipulative marketing tactics of the tobacco industry and bring about policy changes that help protect children and teens from its influence. To learn more, contact your local Reality Check program or visit www.realitycheckofny.com.
Alan Rubeck, Erie-Niagara Reality Check: 716-359-6067, arubeck@e1b.orgKasheef Moore, Reality Check Youth Advocate: 716-931-4235, kasheef@gmail.com
For more information contact Deborah Pettibone, Erie-Niagara Tobacco-Free Coalition: 716-868-6182, deborah.pettibone@roswellpark.org,

Roswell Park Hosts Regional Launch of Television Campaign

The NYS Department of Health (DOH) gave Western New Yorkers a look at its new campaign highlighting the price smokers pay for their addiction at a new ad campaign highlighting the price smokers pay for their addiction. The 30 second spots which began August 1 urge smokers to call the NYS Quitline. The campaign was funded by a federal grant that illustrate the physical impacts that two longtime smokers suffered as a result of tobacco use. Representatives from the American Heart Association (AHA) joined with the Tobacco Cessation Center and DOH for the launch of the campaign, highlighting the connections between smoking and heart disease. Dr. Michael D. Banas, a cardiologist with Buffalo Heart Group, said that quitting is the number-one thing a smoker can do for his or her health. He said cigarette smoking increases the risk of coronary heart disease by itself. When it acts with other factors such as high blood cholesterol, high blood pressure, physical inactivity, obesity and diabetes it greatly increases risk. The Quitline, 1-866-NY-QUITS (1-866-697-8487) is a free resource available to all New York State residents, and offers a range of services including a free starter kit of nicotine patches and trained Quitline specialists who help smokers develop quit plans. Call hours are Monday through Thursday 9 a.m. until 9 p.m. and Friday through Sunday 9 a.m. until 5 p.m. Taped messages offer support and help for quitting smoking during off hours, while the Smokers Quitsite, www.nysmokefree.com, is available 24 hours a day.

Dietary-Intervention Study for Prostate Cancer Accruing Patients

Two researchers from Roswell Park Cancer Institute (RPCI) have opened a clinical trial that will assess the impact of dietary change to control prostate cancer. The Mens Eating and Living (MEAL) study led by co-investigators James Mohler, MD, and James Marshall, PhD, is both the first to assess the effects of radical dietary intervention on men with prostate cancer and the only current clinical investigation involving men placed on active surveillance in lieu of active treatment for low-risk prostate cancer.
This multisite trial will test the results of assigning men with small, low-grade prostate tumors to an intervention designed to encourage a diet low in animal products. The MEAL trial is now open at RPCI and other sites through several cooperative oncology groups sponsored by the National Cancer Institute. Dr. Mohler is Senior Vice President for Translational Research and Chair of the Department of Urology, and Dr. Marshall is Senior Vice President for Cancer Prevention and Population Sciences.
Their team will identify 450 men with prostate cancer from across the country, all considered to be at low risk for developing advanced prostate cancer. All participants will change their dietary intake, but half will more significantly change their diet, assisted by a telephone intervention.
Research has shown that a diet low in animal products like meat and dairy and high in fruits and vegetables is associated with lower incidence of prostate cancer. Drs. Marshall and Mohler and colleagues led a similar six-month pilot study launched in 2004.
Dr. Marshall says the MEAL trial promises to be a very strong study based in biological and behavioral changes. He says that the pilot study suggests that we can change diets and can see the progress in diet records but, more importantly, by means of blood-based nutritional biomarkers.
The research is supported by the National Cancer Institute, the Department of Defense and The Prostate Cancer Foundation. The MEAL trial will have two important collaborators--J. Kellogg Parsons, MD, MHS, and John Pierce, PhD, both researchers with the Moores Center, UC San Diego.
Patients ask their urologist if there anything they can do to slow or stop its growth and ask if they should change their diet. And this trial should give us much clearer and perhaps even definitive answers, according to Dr. Mohler. To learn more about the MEAL trial, including eligibility criteria, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

Cigarette Packaging Needs To Change

BUFFALO, NY — The messages that cigarette pack labels convey to smokers and nonsmokers have been evaluated by Roswell Park Cancer Institute (RPCI) researchers in three studies published in the June 2011 issue of the American Journal of Preventive Medicine. The conclusion from these studies is that manufacturers have deceived consumers about the risks of their products for years and that remedial actions are needed so consumers can make informed decisions about the products that they purchase.

“Tobacco companies have used attractive packaging and persuasive images to market their products for decades. These studies support efforts by the FDA to regulate cigarette pack labeling,” said lead author Maansi Bansal-Travers, PhD, Behavioral Research Scientist at RPCI.

Tobacco manufacturers have effectively used cigarette pack design, colors and descriptive terms to create the illusion that filtered and so-called light/mild cigarettes are safer than unfiltered and full-flavor cigarettes, when this is not the case. Beginning in June 2010, regulations contained in the Family Smoking Prevention and Tobacco Control Act have prohibited tobacco companies from using descriptive terms such as “light,” “mild” or “low” in advertising and on cigarette packaging. “While the removal of these obviously misleading terms was a good first step, we discovered that cigarette manufacturers have circumvented the regulation by using different terms such as ‘gold’ and ‘silver’ and changing the colors on packs to continue to mislead consumers about their products,” said Dr. Bansal-Travers.

The paper titled “What Do Cigarette Pack Colors Communicate to Smokers in the U.S.?” found that both colors and descriptors are perceived by smokers to communicate health-risk information. The authors recommend that color-coding be restricted in the same way that descriptors have been to reduce consumer misperceptions.

The paper titled “The Impact of Cigarette Pack Design, Descriptor, and Warning Labels on Risk Perception in the U.S.” found that larger graphic health warnings that convey negative messages are the most effective in communicating health risks to adults and that packs with descriptors such as “smooth” or “silver,” or in specific colors, misleadingly conveyed lower health risks to consumers. The authors concluded that manufacturers should be barred from using any labeling that might be misperceived by consumers and that all cigarettes be sold in standardized plain packs.

The third paper, titled “Correcting Over 50 Years of Tobacco Industry Misinformation,” analyzed proposed corrective statements required by U.S. federal court in the Department of Justice case against cigarette manufacturers. The study found that the proposed corrective statements were effective in correcting false beliefs about smoking and health. The authors also recommended that these statements be printed on cigarette packs and at the point of sale.

K. Michael Cummings, PhD, MPH, Chair of the Department of Health Behavior at RPCI, added, “These studies reveal how consumers are likely to respond to government-mandated changes in package labeling and offer insights and recommendations about how to correct decades of misleading product marketing, so that consumers can make more informed choices about the products they purchase.”

The paper abstracts are available at http://www.ajpmonline.org/article/S0749-3797%2811%2900161-9/abstract, http://www.ajpmonline.org/article/S0749-3797%2811%2900166-8/abstract and http://www.ajpmonline.org/article/S0749-3797%2811%2900163-2/abstract.

Learn more at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.

Roswell First in US To Be Accredited As Training Institute for Robot-Assisted Surgery

Roswell Park Cancer Institute (RPCI) has become the first institution in the United States to be accredited as a Training Institute in Robot-Assisted Surgery by the Société Internationale d’Urologie (SIU). The accreditation allows RPCI to participate in the SIU scholarship program for young urologists, a cornerstone of the association’s educational mission. These highly regarded awards provide three-month Robot-assisted Mini-fellowships including laparoscopic and robot-assisted skills development and case observership to promising physicians early in their careers.For more information, visit RPCI’s website at http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org.