PHOENIX, Ariz. — May 18, 2022 — For cancer patients nearing the end of standard of care treatment, data gleaned from their tumor genome and tissue samples can be an invaluable resource for seeking out future care. But how do patients safely access these data and obtain analyses to guide future personalized care?

A unique study pairing researchers from the Translational Genomics Research Institute (TGen), part of City of Hope, with one cancer patient is now underway to help answer that question. Rick Stanton, a former engineer and advanced prostate cancer patient, is at the center of TGen’s Patient Engagements, Operational Practices, and Laboratory Environment Standardization (PEOPLES) protocol.

The protocol, led by TGen’s Nicholas Schork, Ph.D., along with Laura Goetz, M.D., M.P.H. and Edward Kalpas, M.D., M.P.H., is designed to help Stanton aggregate his personal cancer assay data and perform subsequent analyses that could lead to a treatment that will save his life. Schork and colleagues want the protocol to offer a safe path for more patients who want to take control of their data.

“For many people who are in the later stages of their cancer, the treatment guidelines no longer apply,” said Schork. “Our motivation for this study was thinking about what data we could bring to the table to help the patients and interested physicians make decisions about the next steps.”

The data could help as patients consult with their physicians about new treatments or ongoing clinical trials that might test relevant drugs, or be used in open cancer ‘hackathons’ where groups of researchers sift through a patient’s data for possible treatment options.

“Our protocol is not meant to be a substitute for anything physicians are working on with their patients,” Schork said, “but hopefully the data can help patients feel more empowered as they go through this very complicated and life-threatening process.”

There is existing legislation, FDA programs like the Expanded Access Program, and a growing general interest in a “right to try” experimental therapies when all else fails that advocates for patients seeking the use of experimental drugs for conditions not treatable by current drugs “and we think of the protocol as a very low level version of this. Why can’t patients at least look at the more basic data arising from various assays that have been run on them?” he added. “If we’re OK with people trying drugs at end of life, we should at the very least be OK with them trying to explore their data for information that may help lead to a drug.”

“Physicians can feel threatened when patients want to explore experimental testing strategies, because they (the physicians) often don't know how to order, let alone interpret, such tests. Dr. Kalpas and I want to encourage our colleagues to embrace such efforts and see the PEOPLE's protocol as a first step in normalizing this process for medical professionals,” Goetz said.

Why The Right to Data Matters

The TGen researchers work directly with Stanton to devise strategies to organize, present and analyze his personal tumor data in ways that could broaden the possibilities for his future treatment. “There’s no real precedent for how a patient should receive research data like this, so we’ve been working through these issues with the patient,” said Schork.

Stanton, with a background in bioinformatics and cancer genetics, is far from the “typical” patient, so the right way to deliver data to him may not work for all patients. Even Stanton has looked for ways to better visualize what his data mean. He is working on a “battle map” that describes complex concepts such as immunotherapy, molecular signaling pathways and the tumor microenvironments, “and then how the measurements of a patient lay over that map and where and how it makes the most sense to intervene,” he said.

The protocol seeks to find ways to handle the immense amounts of raw data generated by analyses such as tumor DNA sequencing. Sequencing tends to focus on a few molecular targets already known to respond to drugs, “but are there other things in that sequence data that could identify things to focus on now?” Schork asked. “That’s something we’re finding to be a challenge, but it creates opportunities for how we might convey or provide this information to a patient.”

Where Will The Data Take You?

Stanton also emphasized the need for patients to have data on their biopsied tissue for use in future tests. “It’s a very important resource, but most patients really don’t know how much tissue they have, where it went, how they access it and what it could be used for.”

Through the protocol, Stanton has become interested in spatial analyses of his cancer, which pairs sequencing data and tissue analyses to get a better look at where immune cells are located within his tumor. Few patients undergo these analyses, although they could be useful in predicting the tumor’s response to emerging immunotherapies. “So, I’m pushing for access to that through the PEOPLES protocol,” he said.

One of the main goals of the protocol is to demonstrate a safe and ethical way for patients to take ownership of and share their personal data in ways that expand their treatment options. For instance, Stanton has shared his data as part of an advanced prostate cancer hackathon organized by Brad Power, the founder of CancerHacker Lab.

“What Rick and the hackathons have been opening up for advanced cancer patients in general is more testing to guide personalized treatment decisions,” said Power. “What we are uncovering is that there is a potential to go beyond DNA sequencing to make greater use of RNA sequencing and the transcriptome and even proteomics to identify other treatment options. We are also finding that it is also possible to get the raw sequencing files to do even more detailed analyses.”

As Stanton and the TGen scientists continue their weekly meetings, at the halfway mark of the study, Stanton said the protocol has placed emphasis on the importance of collecting and analyzing data for cancer patients. “It really brings this to light,” he said, “because what the PEOPLES protocol and TGen have enabled is a suite of analyses and multiple shots on goal that could save my life.”

“We don’t doubt that there are patients out there who are perfectly willing to put this decision-making into their physicians’ hands and trust them completely,” said Schork. “But in an era of big data and the right to try, why not make an effort to try to cater to the interests of patients that would like to go a little bit deeper?”

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