Fred Hutch at ASCO: HPV vaccine uptake in U.S., immunotherapy and sarcoma, financial toxicity of cancer, health care disparities and more

Fred Hutchinson Cancer Research Center’s latest findings in immunotherapy, prevention of cancer-linked viruses, health care disparities and more will be showcased at the annual meeting of the American Society of Clinical Oncology. The conference, “Caring for Every Patient, Learning from Every Patient,” will be held May 31-June 4 in Chicago. See highlights below.

Reporters seeking additional information, interviews or referral to experts who can comment on other ASCO news may contact the Fred Hutch media relations team: media@fredhutch.org, 206.667.2210. For help at ASCO, contact Molly McElroy (mwmcelro@fredhutch.org, 206.941.8146) from the Fred Hutch media relations team. She will be at the conference and available to assist with scheduling interviews.

HPV vaccine in U.S.
Why is HPV vaccine uptake so low in the United States? In this educational session, Dr. Parth Shah, a behavioral scientist and pharmacist in Fred Hutch’s health care economics group, Hutchinson Institute for Cancer Outcomes Research, or HICOR, will discuss several studies and provide an overview of the challenges in implementing the HPV vaccine in the U.S. An important area: Identifying strategies that have been working to improve acceptance rates. Shah recently led a study, published in Pediatrics, that evaluated which messages were most successful at addressing parents’ concerns and questions about the HPV vaccine.
Sunday, June 2, 8-8:15 a.m.

Immunotherapy / Sarcoma
A Phase I/II study of pembrolizumab (pem) and doxorubicin (dox) in treating patients with metastatic/unresectable sarcoma. Patients with advanced soft-tissue sarcomas treated with the chemotherapy doxorubicin alone have a media progression-free survival of 4.6 months and a response rate of 14%. The Hutch;s Dr. Seth Pollack, a sarcoma expert, led a Phase I/II study using the immunotherapy agent pembrolizumab with doxorubicin. Progression-free survival was significantly improved compared with historical controls, and a trend suggested improved overall survival. While the combined therapies did not meet the target response rate of 29%, the majority of patients had tumor regression, and a 22% response rate was observed. With the recent failure of a different therapy for sarcoma, this treatment, which was well-tolerated by patients in the study, may provide a new option for patients with sarcoma, Pollack says, and he hopes to use the results to generate a multicenter trial.
Monday, June 3, 11:30-11:42 a.m.

Bone marrow transplantation and survivorship
Late infectious complications in hematopoietic cell transplantation survivors. Dr. Eric Chow, a pediatric oncologist who researches cancer survivorship with a focus on childhood cancer survivors and blood stem cell transplantation survivors of all ages, helped lead a study to compare the incidence of infection rates in three groups: cancer patients who underwent hematopoietic cell transplantation, or HCT, at least two years earlier, other cancer patients at least two years after treatment; and the general population. With a median follow-up of six years, the incidence rate ratio of all infections was 65 in HCT survivors, 40 in non-HCT cancer survivors, and 7 in the general population. Performing detailed analyses of the types and incidences of infections, the researchers found that bacterial and fungal infections were each 70% more common in HCT than in non-HCT cancer survivors, and infections attributed to staphylococcus, streptococcus and non-Candida fungi were twice as common in the HCT group. Increased relative infection risks persisted even five-plus years after treatment. Chow and colleagues conclude that care providers for long-term HCT survivors should maintain high vigilance for infections and ensure that vaccination and prevention guidelines are carefully followed.
Monday, June 3, 8-11 a.m.

Financial toxicity of cancer
Design and accrual of S1417CD: Development of a prospective financial impact assessment tool in patients with metastatic colorectal cancer . This major in-progress study assessing financial outcomes is being conducted by the SWOG Cancer Research Network as part of the National Cancer Institute Community Oncology Research Program. The Hutch’s Dr. Veena Shankaran, co-director of Fred Hutch’s health care economics research group, HICOR, is leading this study, which aims to determine the incidence of treatment-related financial hardship. Such hardship is defined as experiencing at least one of these: debt accrual, selling/refinancing a home, 20% or greater income decline or borrowing money. The study started enrolling patients in April 2016 and closed in February 2019 after reaching its enrollment goal of 374 patients. A total of 380 patients enrolled. Follow-up will conclude in 12 months, with results to follow. Shankaran next plans to launch a randomized study assessing the impact of financial navigation on household finances.
Saturday, June 1, 1:15-4:15 p.m.

Health care disparities
Sex differences in adverse event reporting in SWOG chemotherapy, biologic/immunotherapy and targeted-agent cancer clinical trials. Women have more adverse events from chemotherapy than men, but few studies have explored the impact of gender on adverse effects of biologic/immunotherapies or targeted therapies. Dr. Joseph Unger, a biostatistician and health services researcher who studies cancer outcomes and disparities in cancer research, led a SWOG Cancer Research Network analysis of severe or worse adverse events by gender in SWOG Phase 2 and Phase 3 clinical trials from 1980 from 2018. This was one of the largest adverse-events studies ever conducted using data from federally funded cancer trials. Examining nearly 37,000 patients experiencing more than 500,000 adverse events, they found a greater severity of both symptomatic and objective —especially hematologic — adverse events in women. This finding indicates broad-based gender differences in adverse-event reporting do exist, a provocative finding that raises several intriguing hypotheses. Unger and SWOG colleagues say differences were particularly pronounced among patients receiving biologic/immunotherapies, suggesting that the study of adverse events from these agents was a high priority.
Monday, June 3, 1:15-4:15 p.m.

Clinical trials
The impact of NCI-sponsored network group clinical trials on guideline care and new drug indications. The Hutch’s Dr. Joseph Unger, a biostatistician and health services researcher who studies the impact of national cancer research processes, led a SWOG Cancer Research Network analysis that examined the influence on clinical practice of the members of the National Cancer Institute’s National Clinical Trial Network, or NCTN, a network that includes SWOG and four other groups that comprise the oldest and largest publicly funded cancer research network in the U.S. Unger and his team evaluated Phase 3 cancer clinical trials that SWOG coordinated or participated in from 1980 to 2017 and found that nearly half of all such trials influenced clinical care guidelines or new drug approvals. Among the conclusions: “Compared to the costs of a new drug approval in pharmaceutical companies — typically estimated at - $1 billion — the amount invested by federal funders to provide this valuable evidence was modest. These findings highlight the major role of the NCTN’s clinical trial program in advancing oncology practice.”
Saturday, June 1, 1:15-4:15 p.m.

ASCO News – Biosimilars: More or less effective than original biologics?
Biosimilars: Are they as effective as the original biologics? Could they sometimes be more effective? To receive Food and Drug Administration approval, biosimilars must demonstrate that there are no clinically meaningful differences in efficacy, safety or potency compared to the original biologic. But all biologic therapies — both biologics and biosimilars — are subject to changing over time due to changes in components or manufacturing processes. In one ASCO poster presentation on a retrospective, observational study, researchers report an apparent downward shift in antibody-dependent cell-mediated cytotoxicity activities in certain lots of the original drug coinciding with a significant difference in three-year, event-free survival certain — favoring the biosimilar. Overall survival was not significantly affected, but a trend also favored the biosimilar. Dr. Gary Lyman, a breast cancer oncologist and senior lead of Health Care Quality and Policy at HICOR, is one of the contributors to the poster presentation is available for interviews.
Sunday, June 2, 8-11 a.m.

NOTE: Fred Hutch and its scientists who contributed to these discoveries may stand to benefit from their commercialization. See links above to ASCO abstracts for more details on individual researchers’ disclosures.

The clinical trials referenced above involve investigational products and/or therapies that have not been approved for commercial marketing by the U.S. Food and Drug Administration or any other regulatory authority. Results may vary and encouraging results from early-stage clinical trials may not be supported in later-stage clinical trials. No conclusions should be drawn from the information in this report about the safety, efficacy or likelihood of regulatory approval of these investigational products and/or therapies.

At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network.