publication date: May. 22, 2020

Clinical Roundup

Flatiron Health, Foundation Medicine, Genentech to launch novel prospective lung cancer clinical study

Flatiron Health, Foundation Medicine, and Genentech, a member of the Roche Group, in partnership with community and academic oncology practices, have launched a novel, low-interventional study to assess and improve clinical trials for patients living with advanced lung cancer.

The Prospective Clinico-Genomic study (NCT04180176) will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline and simplify the execution of clinical trials for advanced lung cancer.

The PCG Study, funded and sponsored by Genentech, is a feasibility study with secondary aims to better understand how genomic changes in a patient’s tumor may predict response or impact resistance to treatment in people diagnosed with metastatic non-small cell lung cancer or extensive stage small cell lung cancer by building a linked data- and bio-repository.

Flatiron’s prospective real-world data collection technology will be leveraged for this study, which will enroll approximately 1,000 patients. These patients will undergo serial liquid biopsies using Foundation Medicine’s liquid biopsy assay to assess genomic changes in their cancer over the course of treatment.

The clinical, genomic, imaging and outcomes data will be a part of a comprehensive data platform that is designed to accelerate research.

“Through technology-driven innovation, we have realized our vision of building a platform that enables meaningful clinical research while also minimizing the burden on clinicians and research teams,”  Bobby Green, chief medical officer at Flatiron Health, said in a statement. “This includes features such as centralized and remote study monitoring, streamlined patient identification, and technology-assisted abstraction to eliminate duplicate data entry and the need to use a separate electronic data capture system.”

Since launching the study in December 2019, 14 practices from Flatiron’s network were activated: Alabama Oncology, Cancer & Hematology Centers of Western Michigan, Clearview Cancer Institute, Fort Wayne Medical Oncology and Hematology, Hematology Oncology Associates of Central New York, Hematology Oncology Associates of Fredericksburg, Highlands Oncology Group, Jackson Oncology Associates in Mississippi, New York Cancer & Blood Specialists, Oklahoma Cancer Specialists and Research Institute, RCCA-Central Jersey, Southeast Nebraska Cancer Center, Virginia Cancer Institute, and West Cancer Center. Additional research sites are planned over time. 

“Clinical trials are critically important to advancing cancer research, but the way trials are run has in many ways not changed in decades, and continues to be burdensome and time-consuming,” Lee Schwartzberg, chief medical officer at OneOncology, and physician at West Cancer Center. “The PCG Study has the potential to help transform how clinical trials are conducted, ultimately making research more feasible for all sites and increasing the number of trial opportunities for patients. We hope that the study design and technology deployed in PCG will ultimately become standard practice and used across a wide swath of trials.”

At this year’s ASCO virtual scientific program, Genentech, Flatiron, Foundation Medicine and co-authors will present the study design and objectives in a Trials-In-Progress abstract titled, “A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer.”

 

Advanced prostate cancer rates continued to rise after USPSTF guideline change

Five years after the U.S. Preventive Services Task Force recommended against prostate-specific antigen-based screening for all men, rates of advanced prostate cancer continued to increase in men 50 and over in the U.S., according to a new study.

The study, led by American Cancer Society investigators, says the rise in cancers that had spread beyond the prostate gland was accompanied by drops in early-stage disease during the same time period. The study appears in the Journal of the National Cancer Institute.

The USPSTF began recommending against prostate-specific antigen-based screening for men 75 and older in 2008, and for all men in 2012. In 2018, USPSTF recommended individual decision-making for men 55 to 69, and said men 70 and over should not be screened.

National self-reported survey data found past-year routine PSA testing rates among men 50 and over declined from 40.6% in 2008 to 38.3% in 2010, to 31.5% in 2013, and remained unchanged in 2015.

Previous studies reported that prostate cancer incidence rates in the U.S. declined for local-stage disease and increased for regional- and distant-stage disease soon after the USPSTF recommendations against routine screening. The new study looked at whether these patterns persisted in the longer-term, through 2016.

Researchers, led by Ahmedin Jemal, used data from the U.S. Cancer Statistics Public Use Research Database to look at trends—annual percent change—in invasive prostate cancer incidence from 2005 to 2016 in men 50 and older, stratified by stage, age group, and race/ethnicity.

The researchers found that for all races/ethnicities combined, incidence for local-stage disease decreased by 6.4% per year from 2007-2016 in men 50 to 74. In men 75 and older, incidence declined by 10.7% per year from 2007-2013 then stabilized during 2013 to 2016.

In contrast, incidence for prostate cancer spread beyond the gland (regional- and distant-stage disease) increased in both age groups during the study period. Distant-stage incidence in men 75 and older increased by 5.2% per year from 2010-2016.

“These data illustrate the trade-off between higher screening rates and more early-stage disease diagnoses (possibly overdiagnosis and overtreatment) and lower screening rates and more late-stage (possibly fatal) disease,” write the authors. “Several modeling studies, however, showed that the harms associated with higher PSA screening rates can be mitigated while preserving the benefit of screening through PSA-stratified strategies including longer screening interval based on baseline PSA, higher PSA threshold for biopsy referral in older men, and restricting routine testing to men aged ≤70 years.”

The study did not cover the period after 2018, when USPSTF recommendations changed again to include screening as an option for men 55 to 69, and against screening for men 70 and over. The impact of that most recent change on prostate cancer rates has yet to be seen, as cancer registry data is not yet available.

 

Study: Text messages are ineffective reminders to maintain AI regimens

Text messages were not effective in reminding breast cancer patients to maintain their aromatase inhibitor regimens, a study conducted by SWOG shows.

SWOG Cancer Research Network Vice Chair Dawn Hershman, director of the Breast Cancer Program at NewYork-Presbyterian and Columbia University Irving Medical Center’s Herbert Irving Comprehensive Cancer Center, led the study, which was published in the Journal of Clinical Oncology.

The study is the first large, long-term, randomized trial to test any intervention aimed at directly improving AI adherence. Hershman and her team enrolled 724 post-menopausal women with early-stage breast cancer into the study from 40 SWOG sites across the United States. Every woman had been taking AIs for at least a month, and would continue to take the pills at least 36 months under their doctors’ orders.

Of the women enrolled, 348 received brief, twice-weekly text messages reminding them to take their medication or reminding them of the benefits of taking their medication. Another 354 did not receive the texts. Patients and physicians both reported on drug adherence—and women took routine urine tests to screen for AI biomarkers. After 36 months, there was no difference between the two groups. The percentage of women who remained AI adherent was 55%—the same number for both groups, no matter how adherence was measured.

Hershman, who presented preliminary results of her study at the 2019 ASCO annual meeting, said the take-home message is not that text messages are ineffective tools in the fight for cancer drug adherence.

“Persuading patients to take AIs, or any long-term cancer drug, will likely require a more personalized approach, one that includes many interventions and supportive efforts to provide relief from symptoms and also provide encouragement and support for patients,” Hershman said in a statement. “Texts alone don’t do the trick.”

Hershman’s study was funded by NCI grant award CA189974 and in part by the Conquer Cancer Foundation and the Breast Cancer Research Foundation.

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