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UPCI Secures Federal Contract For Up To $10M in Preclinical Cancer Drug Development Work

The University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCancer, secured a highly prestigious contract from the National Cancer Institute (NCI) to perform preclinical research crucial to the development of new cancer drugs. This commitment could bring up to $10 million in research projects to UPCI over the next five years.

The contract cements UPCI’s role in all five stages of NCI’s drug development process, with UPCI researchers now holding funding mechanisms in drug screening, preclinical research, and Phase I, II and III clinical trials.

“It is exceedingly rare for an academic cancer institute to have funding in every one of these NCI drug development stages,” said Nancy E. Davidson, MD, director of UPCI. “By being involved in every stage of NCI drug development, UPCI is able to truly consider and understand each part, bringing extra knowledge and value to every cancer drug research project we perform. Contracts like this are a crucial part of how we get the best therapies to our patients.”

Julie Eiseman, PhD, DABT, professor of pharmacology and chemical biology, and Jan Beumer, PharmD, PhD, DABT, associate professor of pharmaceutical sciences and medicine, both of UPCI, are co-principal investigators on the new NCI preclinical research contract. They also hold a previous NCI preclinical contract, which will conclude next year.

Under the new preclinical contract, UPCI will perform the research necessary to collect drug pharmacology data and determine the most efficacious routes and doses of proposed cancer drugs so that they can be used in human clinical trials.

“What sets UPCI apart is that we provide an added value by being able to think outside the box,” said Dr. Beumer, who also is co-principal investigator on the NCI phase I clinical trial grant at UPCI. “We can connect these preclinical studies with the clinical trials that will follow and make suggestions to help both phases be as efficient and effective as possible.”

The researchers do not yet know specifically what potential drugs they’ll be investigating or which cancers they’ll ultimately be intended to tackle.

“That’s what we help to determine,” said. Dr. Eiseman. “In the past we’ve evaluated potential drugs for use in cancers of the colon, breast, pancreas, and head and neck, among others. It’s a team effort. No one person could develop these therapies alone.”

The Contract Number is HHSN2612016000221; the NCI Control Number is N02CM-2016-00022.

‘Starving’ Immune Cell Discovery Points to Cancer Immunotherapy-Boosting Strategies

The microenvironment that supports a cancerous tumor also starves the immune cells that the body sends in to destroy the cancer, University of Pittsburgh Cancer Institute (UPCI) scientists revealed in a discovery that holds the potential to significantly boost the performance of breakthrough immunotherapy drugs.

The UPCI team showed that when immune T cells enter the tumor microenvironment, their mitochondria—which act as mini-factories inside cells, making energy and crucial reagents a cell needs to survive—begin to shrink and disappear, indicating that the T cell is out of fuel and can’t do its tumor-destroying job. The finding, reported online today and scheduled for next week’s issue of the journal Immunity, opens the door to several potential clinical approaches that could help keep T cells functioning and boost the body’s ability to fight cancer.

“Immunotherapy to stimulate the body’s immune system has increasingly become the way we treat people with aggressive cancers. It’s effective for a subset of patients, but the truth is that only about 20 to 40 percent of patients will respond to the treatment, and it is still unclear why,” said senior author Greg M. Delgoffe, PhD, assistant professor of immunology and member of the Tumor Microenvironment Center at UPCI, partner with UPMC CancerCenter. “It’s a huge question in the cancer immunotherapy field, and we think we’ve found a big part of the answer.”

As tumors grow, they build a microenvironment, which develops its own blood supply and keeps the tumor thriving, protected and voraciously consuming all available nutrients.

When T cells enter the microenvironment, it’s as if they’re “automobiles that suddenly had the emergency brake applied; they can’t keep driving,” explained Dr. Delgoffe. Immunotherapies, like those that target negative regulators on the T cell surface, take these brakes off. “However, what we’re discovering in many cases is that even though the brakes have been taken off, there isn’t any fuel in the tank,” Dr. Delgoffe said. Or—in scientific terms—the lack of mitochondria in the tumor-infiltrating T cells keeps them from functioning.

“This is an exciting discovery because we already have various strategies to ‘fill the fuel tank’ and support T cell function in the tumor microenvironment,” said Dr. Delgoffe.

In laboratory experiments and tests with mice, Dr. Delgoffe and his team found that when they boosted the mitochondria in the T cells, they were better able to clear the tumor.

Dr. Delgoffe is partnering with other scientists to test various mitochondria-boosting strategies, including using drugs that already have proven safe in humans, such as those for type 2 diabetes, to stimulate T cell metabolism. He’s also working with existing immunotherapy studies to further modify the T cells so that their metabolism functions better in the tumor microenvironment.

Additional authors on this research are Nicole E. Scharping, BSc, Ashley V. Menk, BSc, Rebecca S. Moreci, BA, Ryan D. Whetstone, MS, PhD, Rebekah E. Dadey, BS, Simon C. Watkins, PhD, and Robert L. Ferris, MD, PhD, all of Pitt.

This work was supported in part by Sidney Kimmel Foundation for Cancer Research grant SKF-015-039 and National Institutes of Health grants 1S10OD016236-01, P50 CA097190 (UPCI Head and Neck Specialized Program of Research Excellence (SPORE)) and P50CA121973 (UPCI Skin Cancer SPORE).

Advertising by US Cancer Centers Soars Over Past Decade, New Analysis Shows

Cancer centers promoting their services dramatically increased their advertising spending from 2005 to 2014, with the bulk of the spending by for-profit organizations, according to the results of a study published Monday.

Researchers at Indiana University (IU) School of Medicine and the University of Pittsburgh School of Medicine and Graduate School of Public Health reported that 890 cancer centers spent $173 million for advertising in 2014, and just 20 centers accounted for 86 percent of the spending.

One company, Cancer Treatment Centers of America, a for-profit firm with a national network of five hospitals, spent $101.7 million, 59 percent of the total. In contrast, 25 of the nation’s 60 National Cancer Institute (NCI)-designated cancer centers spent no money on advertising, and of those that did, half spent less than $4,000, the authors said.

Of the 20 centers that accounted for the bulk of spending, five were for-profit institutions, 17 were Commission on Cancer-accredited and nine were NCI-designated centers.

The report was published Monday by the journal JAMA Internal Medicine.

“Spending on cancer center advertising has more than tripled since 2005, and a small percent of cancer centers are responsible for the majority of spending. Patients should be aware that cancer centers that spend the most on advertising may not necessarily provide the highest quality of cancer care,” said study first author Laura Vater, MPH, a fourth-year medical student at the IU School of Medicine.

Additional work is needed to better understand how advertising may affect the cost and quality of care, she said.

In a 2014 study published in the Annals of Internal Medicine, Vater and colleagues analyzed the content of cancer center advertising and concluded that “clinical advertisements by cancer centers frequently promote cancer therapy with emotional appeals that evoke hope and fear while rarely providing information about risks, benefits, costs or insurance availability.”

For the new study, the researchers used data from Kantar Media, an agency that tracks advertising and calculates expenditures. They obtained data for television, magazine, radio, newspaper, billboard and internet advertising. The expenditures were adjusted to 2014 U.S. dollars using the Consumer Price Index.

The researchers also identified the centers that were NCI-designated, accredited by the Commission on Cancer, were not-for-profit versus for-profit organizations, and by location.

Spending in all advertising categories grew from 2005 to 2014, led by television where $37 million was spent in 2005, rising to a peak of $107 million in 2011. Television spending declined somewhat after that, but still stood at $87 million in 2014. Print media spending rose from $11 million to $34 million. In a time when internet advertising was growing, cancer center online ads were among them—internet display advertisements rose from $300,000 in 2005 to $9 million in 2014.

“More work is needed to understand the effects of cancer center advertising on the web, as more and more people search for health information online,” said senior author Yael Schenker, MD, assistant professor in the Pitt School of Medicine. “One concern is that when advertisements are listed at the top of internet search results, patients may have trouble finding and recognizing good information.”

After Cancer Treatment Centers of America, the two biggest advertisers in 2014 were MD Anderson Cancer Center, which spent $13.9 million, and Memorial Sloan Kettering Cancer Center at $9.1 million.

The authors noted that the expenditure calculations could be low because advertising in cancer-specific magazines was not included, nor was advertising by affiliated organizations designed to encourage charitable donations.

The research was supported by a National Institutes of Health grant KL2TR000146 and by a University of Pittsburgh Department of Medicine Junior Scholar Award.

In addition to Vater and Dr. Schenker, researchers contributing to the study were Julie M. Donohue, PhD, of the University of Pittsburgh Graduate School of Public Health, and Seo Young Park, PhD, of the University of Pittsburgh Department of Medicine.

CMS Selects UPMC Oncologists and UPMC Health Plan to Participate in New ‘Oncology Care Model’ Pilot

UPMC CancerCenter oncologists and the UPMC Health Plan have been selected as one of nearly 200 physician group practices and 17 health insurance companies to participate in an innovative federal program designed to enhance quality and coordination of care for cancer patients, while lowering costs.

The five-year Oncology Care Model (OCM) pilot payment project, overseen by the Centers for Medicare and Medicaid Services (CMS), aims to align physician incentives with improvements in the effectiveness and efficiency of cancer care delivery.  As part of CMS’s broader move to pay physicians for “value” instead of volume, the program aims to reduce unnecessary hospitalizations and emergency room visits by helping patients with improved coordination of and access to key services.

The participating UPMC practice, Oncology Hematology Associates (OHA), is one of the largest integrated community networks of cancer care specialists in the country, providing the latest advances in cancer prevention, detection, diagnosis and treatment. OHA has more than 19 sites throughout western Pennsylvania and has over 168,000 patient visits a year.

“As one of the largest integrated health care provider-payer systems in the country, UPMC has been a leader in developing new models of accountable, patient-focused care,” said Peter Ellis, M.D., deputy director for clinical services at UPMC CancerCenter. “By taking part in this pilot, we believe that UPMC CancerCenter can also play a leading role in developing a model for affordable, high-quality cancer care that can be replicated across the country.”

The UPMC Health Plan is supporting the new model through its own incentives and support services, part of a systemwide effort to transform the delivery of care.

“The UPMC Health Plan, as part of an integrated delivery system, is committed to partnering with CMS to demonstrate how value-based cancer care can improve quality and effectiveness for our members,” said Stephen Perkins, MD, chief medical officer of commercial and Medicare services for the UPMC Health Plan.

Cancer is one of the most common diseases in the United States, with more than 1.6 million individuals receiving a cancer diagnosis each year. According to CMS, a large majority of those diagnosed are over 65 and are Medicare beneficiaries.

To participate in the OCM, oncology providers and insurers must meet multiple requirements, including robust patient navigation, advanced use of an electronic health record, round-the-clock access to clinicians and enhanced outcomes reporting.

The UPMC CancerCenter already meets the majority of the requirements and is enhancing programs to ensure patients receive well-coordinated cancer care. Every cancer patient will receive a detailed cancer care plan to guide his or her treatment. This will cover diagnosis, treatment goals, quality-of-life considerations, care coordination and psychosocial concerns. Following treatment, patients will be provided a survivorship care plan, which includes a summary of treatment delivered and ongoing care, schedules for future visits and testing, as well as management of treatment-related effects. OHA is also improving a nurse triage function and implementing additional management tools to reduce unnecessary hospitalizations and emergency room visits.

The names of the practices and payers participating in the OCM, and more information about the model, can be found on the model’s website: http://innovation.cms.gov/initiatives/Oncology-Care/. The Oncology Care Model begins on July 1 and runs through June 30, 2021.

UPMC First in Region to Use Next Generation Gamma Knife for Brain Tumors

UPMC is the first hospital in the region and the third institution in the United States to treat patients with the Leksell Gamma Knife Icon®. Using a stereotactic radio surgery system (SRS), a type of radiation therapy that condenses the Gamma Knife’s high-power energy on a small area, the machine enables physicians to perform non-invasive, computer-driven, bloodless brain surgery to destroy tumors and vascular malformations once considered inoperable. Despite the name, SRS does not require surgical incisions.

“UPMC’s history of innovation in radiosurgery began in 1987 when we installed North America’s first unit, which we have used to treat more than 14,000 patients,” said L. Dade Lunsford, MD, director of the Center for Image-Guided Neurosurgery. Dr. Lunsford trained in Sweden under Professor Lars Leksell, the inventor of SRS and the Gamma Knife.

“Each of the five previous generations of Gamma Knife units has improved efficiency and allows us to provide a highly effective option for the many patients who receive treatment each year at UPMC,” Dr. Lunsford said. “With the option of a frame-based or frameless approach for non-invasive cranial immobilization, Icon gives us a new way to treat a wide array of complex neurological conditions, including brain tumors, vascular disease, facial nerve pain and functional disorders.”

The Icon’s SRS uses MRI and other radiological images to identify and target precise locations within the brain to ensure dosage is appropriately distributed to the area, regardless of the position of the patient’s head. This minimizes side effects and enables treatment of larger tumors and those close to critical brain structures.

The Center for Image-Guided Neurosurgery began treating patients with the Leksell Gamma Knife Icon in May. The Center serves as an international training and outcomes analysis site, using the latest generation of radio-surgical technologies and treats more than 650 patients per year. UPMC has trained more than 2,000 surgeons, radiation oncologists, medical physicists and other health care providers in the use of brain radiosurgery during the past 20 years.

Dr. Lunsford is a consultant for and stockholder in Stockholm, Sweden-based Elekta AB, maker of the Gamma Knife Icon system.

Broccoli Sprout Extract May Protect Against Oral Cancer Recurrence

Potent doses of broccoli sprout extract activate a “detoxification” gene and may help prevent cancer recurrence in survivors of head and neck cancer, according to a trial by the University of Pittsburgh Cancer Institute, partner with UPMC CancerCenter, confirming preliminary results presented last year at the American Association for Cancer Research Annual Meeting.

It is the first study demonstrating that the extract protects against oral cancer, with the results of human, animal and laboratory tests reported today in the journal Cancer Prevention Research. This research is funded through Pitt’s Specialized Program of Research Excellence grant in head and neck cancer from the National Cancer Institute.

“With head and neck cancer, we often clear patients of cancer only to see it come back with deadly consequences a few years later,” said lead author Julie Bauman, MD, MPH, co-director of the UPMC Head and Neck Cancer Center of Excellence. “Unfortunately, previous efforts to develop a preventative drug to reduce this risk have been inefficient, intolerable in patients and expensive. That led us to ‘green chemoprevention’—the cost-effective development of treatments based upon whole plants or their extracts.”

Cruciferous vegetables, such as broccoli, cabbage and garden cress, have a high concentration of the naturally occurring molecular compound sulforaphane, which previously has been shown to protect people against environmental carcinogens.

Dr. Bauman and her colleagues treated human head and neck cancer cells in the laboratory with varying doses of sulforaphane and a control, and compared them to normal, healthy cells that line the throat and mouth. The sulforaphane induced both types of cells to increase their levels of a protein that turns on genes that promote detoxification of carcinogens, like those found in cigarettes, and protect cells from cancer.

In a small preclinical trial, 10 healthy volunteers drank or swished fruit juice mixed with broccoli sprout extract for several days. The volunteers had no significant problems tolerating the extract and the lining of their mouths showed that the same protective genetic pathway activated in the laboratory cell tests was activated in their mouths, meaning that the sulforaphane was absorbed and directed to at-risk tissue.

Dr. Bauman also collaborated with senior author Daniel E. Johnson, PhD, professor of medicine at Pitt and a senior scientist in the UPCI Head and Neck Cancer Program, to see how the extract performed in mice predisposed to head and neck cancer. The mice who received the sulforaphane developed far fewer tumors than their counterparts who did not receive the extract.

The results of the mouse, human and lab studies have been so successful that Dr. Bauman has started a larger clinical trial in volunteers previously cured of head and neck cancer. These participants are taking capsules containing broccoli seed powder, which is more convenient to take regularly than the extract mixed with juice.

“Head and neck cancers account for approximately 3 percent of all cancers in the US, but that burden is far greater in many developing countries,” said Dr. Bauman. “A preventative drug created from whole plants or their extracts may ease the costs of production and distribution, and ultimately have a huge positive impact on mortality and quality of life in people around the world.”

Additional authors on this research are Yan Zang, PhD, Malabika Sen, PhD, Changyou Li, PhD, Lin Wang, MD, Daniel P. Normolle, PhD, and Thomas W. Kensler, PhD, all of Pitt; Patricia A. Egner, MS, and Jed W. Fahey, ScD, both of Johns Hopkins University; and Jennifer R. Grandis, MD, FACS, of the University of California at San Francisco.

This work was supported by National Institutes of Health grants P50CA097, R01CA190610, and P30 CA4747904; and by the Lewis B. and Dorothy Cullman Foundation.

Early Detection, Smaller Cancer Among Benefits of Skin Cancer Screening at Primary Care Visits

Skin cancer screenings performed by primary care physicians (PCPs) during routine office visits improve the detection of potentially deadly melanomas and find them in earlier stages, according to new research from the University of Pittsburgh School of Medicine.

The results will be presented today at the 52nd annual American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

“Our findings suggest that PCP screening is an effective way to improve early detection of melanoma, which could potentially save lives,” said lead author Laura Ferris, MD, PhD, associate professor, Department of Dermatology, Pitt School of Medicine and member of the Melanoma Program, University of Pittsburgh Cancer Institute.

Rates of melanoma, the most dangerous form of skin cancer, are on the rise, and skin cancer screenings are one of the most important steps for early detection and treatment, said Dr. Ferris. Typically, patients receive skin checks by setting up an appointment with a dermatologist.

The goal of the new UPMC screening initiative, which was modeled after a promising German program, was to improve the detection of melanomas by making it easier for patients to get screened during routine office visits with their PCPs, explained Dr. Ferris.

PCPs completed training on how to recognize melanomas and were asked to offer annual screening during office visits to all patients aged 35 and older. In 2014, during the first year of the program, 15 percent of the 333,788 eligible UPMC patients were screened in this fashion.

On average, the melanomas detected in the group who received a screening at a primary care visit were nearly twice as thin as those detected in the group that was not screened by a PCP. Thinner melanomas have a better prognosis than thicker ones that are more advanced, so the new findings suggest PCP screening is able to find melanomas at an earlier, more treatable stage, said Dr. Ferris.

In addition, only 5 percent of people in the screening group had especially worrisome melanomas that were thicker than 1 millimeter—which are more likely to metastasize and require a biopsy of a nearby lymph node—while 20 percent of the unscreened group did.

“The PCP screenings prevented a lot of people from needing more aggressive therapy. Additionally, we did not see a high rate of false positive biopsies, in which no skin cancer was present, nor did we see a high rate of unnecessary dermatology referrals or skin surgeries, all of which suggest that the program did not simply drive up health care costs needlessly,” Dr. Ferris said.

Another important finding was that nearly half of the screened patients were men, who are more likely to get and die from melanoma than women but have been underrepresented in other skin cancer screenings published to date. “It’s exciting that our approach improves detection in this especially vulnerable population,” said Dr. Ferris.

Funding for this study was provided by a National Cancer Institute Specialized Program of Research Excellence (SPORE) grant in skin cancer (5P50CA121973-08).

Additional members of the research team included Melissa Saul, MS, Francis Solano, MD, Erica Neuren, BA, Jian-Min Yuan, MD, PhD, and John Kirkwood, MD, all of UPMC; Martin Weinstock, MD, PhD, of Brown University; and Allan Geller, MPH, RN, of Harvard University.

Immunotherapy Improves Survival, Quality of Life in Rapidly Progressing Head and Neck Cancer

Immunotherapy doubles overall survival and improves quality of life, with fewer side effects, in a treatment-resistant and rapidly progressing form of head and neck carcinoma, reports a large, randomized international trial co-led by investigators at the University of Pittsburgh Cancer Institute (UPCI). The new trial was considered so successful that it was stopped early to allow patients in the comparison group to receive the new drug.

Findings from the international CheckMate-141 phase III clinical trial were presented today at the 52nd annual American Society of Clinical Oncology (ASCO) meeting in Chicago. A subset of the results were previously presented at the American Association for Cancer Research meeting in April of this year.

“These exciting results indicate that there is a new standard of care option for a population of head and neck cancer patients with no other treatment options,” said the trial’s international co-chair Robert Ferris, MD, PhD, UPMC Endowed Professor, and chief of the Division of Head and Neck Surgery and co-leader of the Cancer Immunology Program at UPCI.

The new drug, nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It currently is approved to treat certain types of cancers, including melanoma and lung cancer.

The trial enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who had not responded to platinum-based chemotherapy, a rapidly progressing form of the disease with an especially poor prognosis, said Dr. Ferris. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.

The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent of the standard chemotherapy group.

Nivolumab treatment also doubled the number of patients whose tumors shrunk, and the number whose disease had not progressed after six months of treatment. Importantly, these benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group.

In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, while those in the chemotherapy group reported a decline.

While nivolumab improved survival rates in the overall study population, it appeared to be most successful in patients whose tumors were positive for the human papillomavirus (HPV). This is important because the fraction of head and neck cancers attributable to HPV infection has increased by 250 percent over the past several decades, Dr. Ferris explained.

“Unfortunately, most patients in this trial still experienced a progression of their cancer, demonstrating that we still have a lot of work to do. But, the future appears brighter than ever before because there is a new class of agents, immunotherapies, which we now know can prolong survival and improve quality of life, with few side effects, in head and neck cancer,” said Dr. Ferris.

The research team currently is working to identify new biomarkers that will allow them to develop a better understanding of how drug resistance develops, and how to best design effective combinations of medications that may improve patient responses.

The trial’s other co-chair is Maura Gillison, MD, PhD, from Ohio State University. Additional U.S. institutions that participated in the trial include University of Texas MD Anderson Cancer Center, Stanford Cancer Institute, University of Chicago, University of Michigan, and Dana-Farber Cancer Institute. International collaborators are located at Centre Leon Berard, Centre Antoine Lacassagne, and Institut Gustave Roussy, all in France; Fondazione IRCCS Istituto Nazionale Tumori, in Italy; The Institute of Cancer Research, in the United Kingdom; University Hospital Essen, in Germany; and National Cancer Center Hospital East and Kobe University Hospital, both in Japan.

The trial was funded by the drug manufacturer, Bristol-Myers Squibb, who is now seeking FDA approval for the use of nivolumab in head and neck carcinoma.

Immunotherapy Effective Against Some Types of Sarcoma

An existing cancer immunotherapy drug reduces tumor size in some types of rare connective tissue cancers, called sarcomas, report researchers at the University of Pittsburgh Cancer Institute (UPCI). Additional analyses of tumor biopsies and blood samples, which will help the researchers better understand which sarcoma subtypes will benefit most from the new treatment, are underway.

Interim results from the phase II clinical trial were presented today at the 52nd annual American Society of Clinical Oncology (ASCO) annual meeting in Chicago by principal investigator Hussein Abdul-Hassan Tawbi, MD, PhD, formerly of UPCI and current associate professor, University of Texas MD Anderson Cancer Center.

Sarcoma is a rare disease, encompassing less than 1 percent of adult cancers, and the available treatments are limited, so the need for new therapies is high, explained the current lead investigator for the Pittsburgh site, Melissa Burgess, MD, assistant professor of medicine at UPCI.

“This is a pivotal trial for sarcoma, the first and largest trial to be conducted using this specific immunotherapeutic approach. What makes this trial special is that we collected biopsies and blood samples to really study how the treatment is working or not working in these patients. These immune monitoring studies will offer unique insights into the biology of immunotherapy in sarcoma,” Dr. Burgess said.

Immunotherapies work by using a patient’s own immune cells to target cancer cells. The new trial examined the safety and effect of pembrolizumab, which currently is approved for use in advanced melanoma and certain types of advanced lung cancer, on tumor size in four types of soft tissue sarcomas and three types of bone sarcomas.

UPCI, the first of 12 sites to enroll subjects, contributed approximately one quarter of the 80 total patients. Patients received the drug every three weeks. Tumor assessments began at eight weeks and were conducted every 12 weeks thereafter. The trial enrolled on a rolling basis, and is still in progress, so in these results, not all patients have received the drug for the same amount of time.

About 20 percent of patients in the combined soft tissue sarcoma group showed a reduction in tumor size during at least one time point. However, when the researchers looked at the sarcoma subtypes individually, they found one with especially promising results: 44 percent of patients with undifferentiated pleomorphic sarcoma experienced a reduction in tumor size. Encouraging improvements in tumor size also were found in two subtypes of bone sarcomas, osteosarcoma and chondrosarcoma, Dr. Burgess noted.

“Unfortunately, these early results suggest that there is limited efficacy of pembrolizumab in the patient population as a whole. However, it’s promising that the drug seems to be beneficial in specific sarcoma subtypes. Our ongoing immune monitoring studies will allow us to better characterize the patients who will most benefit from this therapy for future clinical trials,” said Dr. Burgess.

Additional co-authors of the trial trial include Denise K. Reinke, MS, NP, MBA, of SARC, which coordinated the trial; John Crowley, PhD, of Cancer Research and Biostatistics; Brian Van Tine, MD, PhD, of Washington University in St. Louis; James Hu, MD, of University of Southern California Norris Comprehensive Cancer Center; Scott Schuetze, MD, and Laurence Baker, DO, of University of Michigan; Sandra D’Angelo, MD, of Memorial Sloan Kettering Cancer Center; Steven Attia, DO, of Mayo Clinic Jacksonville, Dennis Priebat, MD, of MedStar Washington Hospital Center; Scott Okuno, MD, of Mayo Clinic, Rochester; Richard Riedel, MD, of Duke University Medical Center, Lara Davis, MD, of Oregon Health and Sciences University; Sujana Movva, MD, of Fox Chase Cancer Center; Damon Reed, MD, of Moffitt Cancer Center; Robert Maki, MD, PhD, of Tisch Cancer Institute; and Shreyaskumar Patel, MD, of University of Texas MD Anderson Cancer Center.

Funding for the trial was provided by Merck & Co., the maker of pembrolizumab, Sarcoma Alliance for Research Through Collaboration, Sarcoma Foundation of America and QuadW Foundation. Funding for the ongoing studies was partially provided by local philanthropic support group Pittsburgh Cure Sarcoma.

UPCI-Led International Trial Changing Standard of Care for Advanced Breast Cancer

Surgery to remove the primary tumor in women diagnosed with stage IV breast cancer, followed by the standard combination of therapies, adds months to the patients’ lives, compared with standard therapy alone, an international clinical trial led by a University of Pittsburgh Cancer Institute (UPCI) professor revealed.

The results of the phase III randomized, controlled trial will be presented Saturday at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. The study was selected for the society’s “Best of ASCO,” an effort to condense the research “most relevant and significant to oncology” into a two-day program to increase global access to cutting-edge science.

“Our findings will change the standard of care for women newly diagnosed with stage IV breast cancer,” said principal investigator Atilla Soran, MD, MPH, clinical professor of surgery, University of Pittsburgh School of Medicine, and breast surgical oncologist with UPMC CancerCenter. “We’ve shown that surgery to remove the primary tumor—either through lumpectomy or mastectomy—followed by standard therapy, is beneficial over no surgery.”

Dr. Soran began the trial in 2007, ultimately recruiting a total of 274 women newly diagnosed with stage IV breast cancer from 25 institutions. Half the women received standard therapy, which avoids surgery and consists of a combination of chemotherapy, hormonal therapy and targeted therapy, while the other half first had surgery to remove their primary breast tumor, followed by the standard therapy.

At about 40 months after diagnosis, the women who received the surgery plus standard therapy lived an average of nine months longer than their counterparts who received standard therapy alone. Nearly 42 percent of the women who received surgery lived to five years after diagnosis, compared with less than 25 percent of the women who did not receive surgery.

The trial also showed that surgery in younger women with less aggressive cancers resulted in longer average survival than in women with more aggressive cancers that had spread to the liver or lungs.

“Our thinking is similar to how you might approach a battle against two enemies,” said Dr. Soran. “First you quickly dispatch one army—the primary tumor—leaving you to concentrate all your efforts on battling the second army—any remaining cancer.”

This research was primarily funded by the Turkish Federation of Societies for Breast Diseases. The study received scientific advisement from UPMC and assistance with statistical analysis from epidemiologists at the University of Pittsburgh Graduate School of Public Health.

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