People with advanced urothelial cancers — most of whom have bladder cancer — now have a new first-line treatment that will extend their survival for the first time in almost 40 years. The new treatment, approved by the Food and Drug Administration (FDA) on December 15, combines pembrolizumab, an immunotherapy agent, with enfortumab vedotin, an antibody drug conjugate.
The FDA had previously approved the drug combination in April for people who are ineligible for cisplatin-containing chemotherapy, a much smaller group of people. Bladder cancer is the fifth most common cancer.
Data from a phase three clinical trial, presented at the European Society of Medical Oncologists in October, showed that the experimental therapy nearly doubled the median survival to 31.5 months, compared to an average survival of just 16.5 months in the standard chemotherapy arm. Progression-free survival also doubled.
Furthermore, a slowing of the progression rate after 18 months in almost 40% of the experimental arm suggests that some people may live much longer. Historically, only 5% of advanced bladder cancer patients survived five years.
by D'Ann George, program development coordinator, Duke Cancer Institute Development (Dec. 8, 2023)
THE "BEFORE" PHOTO Fifteen men volunteered to shear their whiskers for the cause, including five firemen from Morrisville, several Duke clinicians, a bartender from Fullsteam, and a retired police detective from New York City.
FESTIVE Bob Young, in the holiday spirit, at Beer and Beards for Bros
This year’s Beer and Beards for Bros, held for the first time since 2019, raised nearly $10,000 for research at the Duke Cancer Institute Center for Prostate and Urologic Cancers. By all appearances, the event, held at Fullsteam Brewery on Dec. 1, raised even more fun than funds.
The 15 men who volunteered to shear their whiskers for the cause included five firemen from Morrisville, several Duke employees, a bartender from Fullsteam, dads with adorable children clinging to them, and a retired detective from the New York City Police Department, who was the first to part with his mustache.
Even the auctioneer, Sam Poley, got into the action and bid off his own beard. Poley said he volunteered his time and talent in memory of his late father, who was treated for prostate cancer at Duke.
Mohawks, Leopard Skins, and Pink Flamingos
Auction winners directed a team of stylists from the Arrow “guaranteed shorter hair” barbershop on how they wanted the men shaved. Their crowning achievement came when one of the firemen incentivized the audience to bid higher by agreeing to “go full mohawk.”
Before the night was over, all of the men shamelessly shed their street clothes to don frippery chosen by auction winners from a table of costumes.
The bartender, who sported the thickest, blackest beard of them all, looked jarring in his blonde curly wig and white bedazzled frock.
Travis Henry, MD, a Duke radiologist, dressed as a fluffy bear. Medical oncologist Mike Harrison, MD, wore a shirt emblazoned with giant pink flamingos and a red headband attached to a messy blonde wig.
But the highest bid — almost $2,000 — went to Raj Gupta, MD, a DCI radiologist who sported a leopard coat and a white mink scarf. His dashing ensemble was chosen by his two young daughters, who placed the winning bid.
Police Officer Wins “Most Hilarious” Contest
The NYPD detective, Bob Young, struggled to squeeze into a strapless, red sparkly dress with a blue-and-white starred petticoat, which he topped off with reindeer antlers embellished with multi-colored Christmas lights.
Young easily won the prize for “most hilarious.” But the sequins did not stop him from kicking off the event with a moving speech about why prostate cancer research and excellent clinical care mean so much to him.
First Responders and Genitourinary Cancers
"People usually get prostate cancer in their 60s, but the 9/11 responders were getting it in their 30s and 40s,” said Young.
As president of the 50135 club, a benevolent association for retired police officers in Raleigh, Young said that "Beer and Beards for Bros" was the first charitable event that he has attended since the pandemic.
Likewise, the five firemen who attended said that the shave-off was their first post-pandemic philanthropic event. Nick Young, president of the association, heard about the event from his fiancé, Sarah Omwenga, RN, an oncology nurse at Duke.
Young said that testicular, thyroid, and throat cancer are prevalent among firefighters due to the chemical exposures they face on the job.
“We’re coming back next year,” said the elder Young. “And we’re bringing friends. There are 120 retired policemen in my club. And 20 of them have cancer. I want the ones with prostate cancer to be seen at Duke.”
From the Archives
Daniel George, MD, visits Pedro Williams barbershop for a complimentary shave down before growing out his facial hair in November. (photo from 2015)
FLASHBACK: In 2012, Michael Harrison, MD, Andrew Armstong, MD, MSc, Dan George, MD, and Judd Moul, MD, pose following their November grow out.
In observance of national lung cancer awareness month, the Duke Cancer Institute Smoking Cessation Program (Quit at Duke) presents "Ask, Advise, Refer and Prescribe: Strategies for Talking to Cancer Patients About Tobacco Use" — a DCI COEE -hosted "Conversations with Our Community" event held in partnership with the North Carolina Oncology Navigator Association, the North Carolina Department of Health & Human Services, the North Carolina Advisory Committee on Cancer Coordination and Control, and the University of North Carolina at Chapel Hill, Eshelman School of Pharmacy.
This virtual training course (for CE credit) is available to members of the North Carolina Oncology Navigator Association (NCONA), healthcare professionals, and community health workers and will take place on November 28, 2023 from noon to 1:30 PM.
Speakers
Sarah Arthur, MBA, Comprehensive Cancer Control Program Manager, Cancer Prevention and Control Branch, North Carolina Department of Health and Human Services
Ronny A. Bell, PhD, MS, Fred Eshelman Distinguished Professor and Chair, Division of Pharmaceutical Outcomes and Policy Eshelman School of Pharmacy, University of North Carolina at Chapel Hill
Megan Keith, MSW, LCSW, Tobacco Treatment Specialist, Duke Smoking Cessation Program
Joyce Swetlick, MPH, Director of Tobacco Cessation, QuitlineNC, North Carolina Department of Health and Human Services
Jean Sellers, RN, MSN, Executive Director, North Carolina Oncology Navigator Association
(Moderator) Kearston L. Ingraham, MPH, Assistant Director, Duke Cancer Institute's Community Outreach, Engagement, and Equity program
Objectives
Describe tobacco use rates in North Carolina and cancer population;
Identify causal relationship between continued tobacco use and cancer risk recurrence and worsened cancer treatment outcomes;
Describe effective methods of tobacco use treatment; and
Summarize Ask, Advise, Refer model to engage patients in tobacco use treatment, including using a validated question to assess tobacco use.
Registration is free and required. This event is open to all community members, so please share with others. Virtual seats are limited, so please register by November 27, 2023 at 5:00 pm EST.
After registration is completed, a Zoom link for the webinar will be provided the day of the event.
On September 29, community members, including cancer survivors and caregivers, learned about the latest clinical advances in the treatment of kidney, prostate, and bladder cancers during a live discussion among faculty/oncologists from the Duke Cancer Institute Center for Prostate & Urologic Cancers.
Speakers included: William Berry, MD; Daniel George, MD; Michael Harrison, MD; Zach Reitman, MD, PhD; Ankeet Shah, MD; Michael Abern, MD; Andrew Armstrong, MD, MSc; Ryan Fecteau, MD, PhD; Christopher Hoimes, DO; Shahla Bari, MBBS; and Hannah McManus, MD.
In a special session of the symposium William Berry, MD, was celebrated for his five-decade career in Medicine — beginning and ending at Duke — and interviewed by George. Berry, a DCI medical oncologist specializing in treating bladder, kidney, prostate, and testicular cancer, joined Duke on January 1, 1974, and will officially retire on Dec. 31, 2023. He earned his MD at Duke in 1973.
Together, the 2023 Duke Cancer Institute Center for Prostate & Urologic Cancers Symposium (9/29/23) and Tackle Cancer Tailgate (9/30/23) raised $64,000 for prostate and urologic cancer research.
This slide was shown as part of a tribute to William Berry, MD, to illustrate Duke in the 1970s when he began his medical career.
The formation of the Precision Cancer Medicine Initiative (PCMI) two years ago — a partnership between Duke Cancer Institute, the Department of Pathology, and Duke University Health System Clinical Laboratories — has made it possible to maximize the organization, availability, and interoperability of Duke cancer patients’ clinical and tumor genomic information for the benefit of cancer care and research into new treatments. It boasts an increasingly active weekly Molecular Tumor Board and a growing Molecular Registry of Tumors.
Last year Duke’s leadership in this field was recognized when Duke Cancer Institute was invited to join the elite international American Association for Cancer Research Project GENIE (Genomics, Evidence, Neoplasia, Information, Exchange) consortium, whose registry contains clinical-grade cancer genomic sequencing data from nearly 71,000 patients with 80 major cancer types — among the largest publicly available genomic datasets released to date. These data include age, sex, primary diagnosis, and type of cancer analyzed. There’s data from nearly 11,000 patients with lung cancer, greater than 9,700 patients with breast cancer, and nearly 7,000 patients with colorectal cancer.
Pathologist Shannon McCall, MD, leader of PCMI Research Initiatives, director of the Duke BioRepository & Precision Pathology Center (BRPC), and the Duke site principal investigator for Project GENIE, was involved in founding the Precision Cancer Medicine Initiative two years ago and encouraging DCI to support it.
“I was totally on fire to get this started,” she recalled. “We have so many big thinkers at Duke who say let’s think about data and what’s possible, but what we’ve done here with the Molecular Tumor Board and joining Project GENIE that I’m so proud of is that this group has really dug in … We’ve made a real difference.”
McCall gives enormous credit to Michael Datto, MD, PhD, medical director for DUHS Clinical Laboratories and director of the Duke University Health System Clinical Molecular Diagnostics Laboratory, and DUHS clinical informatics architect Christopher Hubbard, who designed, built and coded DCI’s in-house secure and searchable electronic Frameshift Molecular Registry of Tumors (or Frameshift MRT) that now stores clinical-grade cancer genomic sequencing data from more than 3,900 patients, across more than 40 cancers. (In general, metastatic lung cancer patients are the biggest beneficiaries of comprehensive molecular profiling tests. That’s because targeted therapies already exist for many of the most common molecular alterations seen in these patients. Metastatic breast cancer patients are the next largest group, followed by metastatic colorectal cancer patients. Even in cancer types where the possibility of a match is low, the tests may still be worth doing.)
“The GENIE thing didn’t happen by itself; we had to build the data infrastructure to make it happen,” said McCall, adding that DCI director of Bioinformatics, Kouros Owzar, PhD, and programmer Jeremy Gresham consulted with her and Department of Pathology programmer Michael Fox to ensure the Precision Cancer Medicine Initiative team was on the right track to upload Frameshift MRT data to AACR GENIE.
Duke Cancer Institute has so far contributed de-identified genomic sequencing data from 1,000 patients to the Project GENIE database.
As a member of the GENIE Consortium, DCI investigators benefit from early access to GENIE data. Data doesn’t become publicly available until six months after submission, but it’s immediately available to consortium members.
Jonathan Bell, MMCi, MEng, a data scientist and MD candidate at Duke, was hired at the end of August as bioinformatician for the Precision Cancer Medicine Initiative to help structure the clinical data in the MRT database and organize DCI’s annual data submissions to GENIE.
“We are thrilled that the Duke Cancer Institute is part of AACR Project GENIE,” said Shawn M. Sweeney, PhD, director, AACR Project GENIE Coordinating Center. “The Duke team has already made significant contributions to the project, in addition to data, which became publicly available in July 2019. We look forward to doing even more with Duke and the other 18 GENIE Participating Institutions."
As important as Frameshift MRT is for many DCI patients, it’s critical, McCall said, that researchers also have access to this wider GENIE data set, especially in rare and hard-to-treat cancers, so that DCI can help even more patients.
“When we spot a rare mutation in a patient’s tumor, we might ask, “Has that particular mutation been seen before?” said McCall. “We need the power of those 70,000 records to find out.”
On October 31, the AACR GENIE project announced a big expansion — a “BioPharma Collaborative” — that DCI, as a consortium member, is expected to join in year three of the five-year project.
Christopher Hoimes, DO, joined the genitourinary oncology program at Duke Cancer Institute as Associate Professor of Medicine where he will serve as clinical investigator with a focus on GU cancers, experimental therapeutics, and early phase trials.
Hoimes has expertise in immunotherapy and biomedical engineering to advance cancer treatment and diagnostics. As director of GU malignancies at the Case Comprehensive Cancer Center at Seidman in Cleveland, OH, he built research teams that integrated radiologists, pathologists, and urologists with experts in biomedical engineering for novel imaging and drug development approaches. He has particular interest in clinical and preclinical applications of nanomaterials for drug delivery and imaging, antibody-drug conjugates, and immunoengineering. As a clinical investigator in Phase I and genitourinary malignancies, Hoimes serves as principal investigator of over 12 active Phase I, II and III trials. He served on the NCCN guidelines panel for bladder and penile cancers, serves on the SITC expert consensus panel for immunotherapy in bladder cancer, and was a founding member of the NCCN panel on cancer immunotherapy and related complications.
“We are excited to bring Chris’s tremendous knowledge and experience and collaborative approach in genitourinary cancers, and bladder cancer in particular, to our group,” said Daniel George, MD, director of genitourinary oncology at Duke Cancer Institute. “As an international expert in bladder cancer clinical research, Chris led early trials that supported the first indication of immune-conjugated therapy in bladder cancer. He is currently co-leading a Phase III trial of neoadjuvant chemotherapy immunotherapy in invasive bladder cancer, as well as studying several novel approaches to combining these strategies in unmet needs for patients with advanced bladder cancer. His research will increase the treatment options for patients at Duke and our region. Additionally, he is also well trained in cancer immunology and provides another interface for us with our DCI Center for Cancer Immunotherapy, as well as with our School of Engineering.”
Recognized as a global leader in genitourinary cancers, Hoimes was recently nominated for the Master Clinician Award (2019), awarded the ECOG Symposium Young Investigator Award, and received the Department of Defense Prostate Cancer Young Investigator Award. He presented abstracts at the European Society of Medical Oncology (ESMO) Annual Meetings, American Society of Clinical Oncology (ASCO) Annual Meetings and the American Urological Association (AUA) Annual Meetings. Additionally, he also authored multiple articles published in the Journal of Clinical Oncology, the Journal of Urology and the New England Journal of Medicine.
Hoimes is board certified in Medical Oncology and Internal Medicine and was previously on faculty at Case Western Reserve University and Yale University. He received his medical degree from New York College of Osteopathic Medicine and completed Internal Medicine Residency and Chief at Penn State University and fellowship in Medical Oncology at Yale University School of Medicine.
