Accurate Response Assessments Vital to Cancer Treatments

When it comes to cancer treatment, part of the challenge is in gauging efficacy.

Researchers are investigating new ways to evaluate responses to cancer treatment that could provide valuable information on finding the best methods to improve patient outcomes.

In a study published in Future Oncology, researchers compared real-world charted data to radiographic measurements of lesions using Response Evaluation Criteria in Solid Tumors (RECIST). Data was collected from 59 metastatic Merkel cell cancer patients, and revealed that treatment response rates using RECIST assessments were lower.

Subjective evaluations of tumor responses through traditional methods may overestimate benefits of treatment and limit the potential of further research.

Also, target lesion measurement tools like RECIST may provide more accurate response reporting, the study concludes.

Bruce A. Feinberg, DO, vice president and chief medical officer at Cardinal Health Specialty Solutions, led the study and says precision medicine mostly comes to mind in terms of treatment, but it’s an important aspect of measuring and reporting treatment outcomes, as well.

“Precision medicine has many facets, not least among the precision with which we measure and report outcomes of treatment. To improve the precision needed to assess cancer patient response to treatment, numerous methods, processes and criteria have been adapted,” Feinberg says. “From refinements in tumor staging to the development of disease-specific radiologic criteria, solid and liquid tumor treatment assessment has evolved dramatically over the past two decades.”

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Feinberg says the development of RECIST has been one of the most significant advances, but it’s also important that these processes evolve alongside the technologies used in response assessment, like imaging methods. In patients with metastatic cancers, all sites must be considered in assessing treatment efficacy, as these assessments are all factored into outcomes measures.

Traditional data reporting is not enough when it comes to assessing treatment success, he says. Although, the study showed additional assessments could be done using data already found in patient charts.

“RECIST-based response assessments could be done retrospectively on real-world data to allow for a more direct outcome comparison between randomized controlled trial and real-world data populations,” Feinberg says. “Rather than using digital electronic medical record data abstraction algorithms or natural language processing, our process began with employing the treating physician as the medical record data abstractor.”

“Although the criteria for RECIST may not have been specified in the imaging report within the medical record, the digital images themselves are available, as both hospital and free-standing imaging centers universally employ PACS-image portals that provide treating physicians access to the digital image.”

“Because of the availability of these images, we could now ask the treating physicians who agreed to participate in the chart abstraction research if they would also be willing to perform RECIST assessment of the digital images via their PACS portal.”

Feinberg says the study proves that the RECIST process is feasible, timely and cost-effective, and could be standardized in research processes.

“Our research proved that the process was feasible, timely, cost effective, valid, and reproducible, allowing it to become standardized in our research methods.  With direct comparisons of outcome assessments between randomized controlled trails and real-world data, our biopharma clients could more confidently design trials in which real-world data could serve as a control arm for a highly orphan disease population for which a new drug label was sought, as well as for label expansion in related populations.”

Feinberg adds that cancer-related randomized controlled trials struggle in several ways, one being that just 3% of adults with cancer participate in these trials, and they are often younger, healthier and less diverse than the general population.

“Additionally, value-based care requires comparative effectiveness research, which is unlikely to be sponsored by a biopharma manufacturer but is critical to informing payer policy,” he says.

Rachael Zimlich, RN, is a writer in Columbia Station, Ohio.