The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) is set to launch a new statewide clinical research initiative with support from Pelotonia.
Led by Peter Shields, MD, David Carbone, MD, PhD, and Mary Ellen Wewers, PhD, the study takes aim at the No. 1 cancer killer among men and women: lung cancer.
An estimated 224,390 people are diagnosed with lung cancer annually across the United States, and up to 85 percent of all lung cancers are non-small cell lung cancers (NSCLC). Each year, more people die from lung cancer than colon, breast and prostate cancers combined.
Known as “Beating Lung Cancer – in Ohio” (BLC-IO), this new statewide lung cancer clinical research initiative is supported by a $3 million grant from Pelotonia. Recruitment will take place over three years starting in March 2017.
The study has two aims: to evaluate the impact of advanced gene testing and expert advice on lung cancer treatment and subsequent patient survival; and to improve smoking cessation rates among smokers with lung cancer and their family members. Improvements in patient quality of life will be assessed in both study aims. Key partners include Foundation Medicine, a leading cancer gene testing company, and the Addario Lung Cancer Foundation, which was established in 2006 to support lung cancer patients and fund lung cancer research.
Study Design and Aims
The initiative will draw upon the existing network of more than 50 partner hospitals from communities across the state of Ohio built as part of the Ohio Colorectal Cancer Prevention Initiative (OCCPI). This was the first statewide research initiative funded by Pelotonia that successfully screened more than 3,000 newly diagnosed colorectal cancer patients in Ohio for Lynch syndrome, an inherited genetic disorder that dramatically increases a person’s risk for colorectal and other cancers.
More than 2,000 newly diagnosed, stage 4 non-small cell lung cancer patients are expected to enroll to the BLC-IO trial during the three-year recruitment period. Patients enrolled to the study will receive free testing for more than 300 genes in their cancer specimens. Local treating physicians will receive expert support for how to interpret the patient test results and what treatments could be used.
“One of the most important goals of this effort is to help lung cancer patients across Ohio and their local treating physicians access advanced genomic testing to help identify promising treatment options,” says Michael Caligiuri, MD, director of the OSUCCC and CEO of The James.
Genomic-Driven Treatment Decisions
Previously published data suggests that up to 64 percent of lung cancer patients have genetic mutations that can be specifically targeted and treated with Food and Drug Administration-approved therapies or drugs in clinical trial testing.
“Lung cancer is most often diagnosed in a metastatic (stage 4) state, so getting patients on the right treatment – the first time – is absolutely critical. We know advanced genomic testing can help us identify the patients most likely benefit from a targeted therapy, which is oftentimes a pill and well tolerated, versus traditional chemotherapies not specifically targeted to that patient’s genetic mutations,” says Carbone, director of the OSUCCC – James Thoracic Cancer Center and co-principal investigator of BLC-IO.
This testing, however, is not universally utilized in clinical care, says Carbone, who notes that only about 60 percent of patients in Ohio even receive one or two gene mutation genomic analysis prior to beginning therapy. Few patients receive the seven gene testing recommended by the National Comprehensive Cancer Network (NCCN) or for PD-L1, another marker useful for selection of first line immunotherapy treatment.
“This initiative will help us give more patients advanced genomic and PD-L1 testing then determine how that knowledge affects treating oncologists’ clinical decision making and overall survival for patients affected by non-small cell lung cancer,” adds Carbone. “Knowledge does not have its full impact on patients unless it is made available to them in the community through their local provider. Unfortunately, this advanced testing is currently not covered by any of the major payers in Ohio.”
Smoking Cessation for Patient and Family
The second component of this trial will provide all lung cancer patients who are current smokers and their family members with smoking cessation support for up to three years.
“Smoking addiction is a chronic, relapsing disease and many factors contribute to a person’s success or failure to kick the habit long-term. Science has shown us that smokers with cancer have more toxicity, shorter survival and some drugs work less effectively,” says Shields, deputy director of the OSUCCC – James and co-principal investigator of the BLC-IO. “It’s very hard to provide strong smoking cessation support in any oncology practice. We need to do better in supporting our cancer patients who smoke – and doing that needs to involve family members who smoke, too.”
In this portion of the study, researchers will test different models for smoking cessation support among lung cancer patients and their families, working in collaboration with the patients’ primary physicians.
“For the families, we believe there is a strong potential to save many years of life – and millions of dollars associated with cancer treatment later – by helping people reduce their risk for lung and many other cancers through smoking cessation,” adds Shields.
Ohio is ranked in 11th for cancer mortality and more Ohioans report smoking cigarettes (22 percent) compared to the national average (18 percent) – the leading risk factor for lung cancer as well as a leading risk factor for many other cancers.
“With funding from Pelotonia, we were able to build a strong network of hospitals across Ohio to serve as a model for collaborative cancer research,” adds Caligiuri. “We are honored and excited to continue the momentum that has been built through expanded research collaborations with our hospital partners throughout the state to reduce the burden of cancer that affects people from all our communities.”
Funding and Collaborators
Funding support comes from Pelotonia, a grassroots cycling event that has raised more than $130 million for cancer research at The OSUCCC – James. Foundation Medicine will provide genomic testing for the study.
BLC-IO involves researchers from Ohio State’s colleges of medicine, nursing and public health, as well the Addario Lung Cancer Foundation (private foundation), Foundation Medicine (genomic medicine company), ALCMI (international research consortium), Memorial Sloan Kettering, University of Southern California, Pelotonia and the Columbus Community Clinical Oncology Program.
Information for this story was provided by Ohio State.