by A groundbreaking study led by researchers at the Bloomberg~Kimmel Institute for Cancer Immunotherapy at the Johns Hopkins Kimmel Cancer Center has developed a pathologic scoring system that accurately predicts the survival of lung cancer patients. The new system assesses the amount of tumor remaining after patients undergo presurgical cancer treatments and can help guide patient therapy and predict their overall survival.
Published in the journal Nature Medicine, the study found that evaluating residual viable tumor (RVT) in lung cancer patients treated with immunotherapy and chemotherapy before surgery provides a reliable and efficient evaluation of treatment response. This pathologic assessment of tumors could serve as an early endpoint for clinical trials and a surrogate marker for survival, potentially expediting regulatory approvals for new therapies.
Immunotherapies, which use the patient’s immune system to target tumors, are often combined with conventional chemotherapy to shrink tumors before surgery. However, accurately gauging treatment success in early-stage lung cancer using radiologic imaging can be challenging. The study’s researchers explored an alternative approach using immune-related pathologic response criteria (irPRC) to measure the tumor’s response to immunotherapy.
The researchers analyzed data from the CheckMate 816 study, a phase 3 randomized trial that demonstrated improved event-free survival in presurgical non-small cell lung cancer patients treated with immunotherapy (nivolumab) and chemotherapy. By measuring RVT, ranging from 0% to 100%, the researchers categorized patients into three groups based on the amount of tumor remaining. This information could assist in determining the most appropriate treatment strategy for each patient subgroup.
Furthermore, the study showed that assessing RVT in lymph nodes provided additional value in predicting survival. The researchers suggest that combining pathology, radiology, and circulating tumor DNA (ctDNA) results could enhance the efficacy monitoring of treatments over time.
The pathologic scoring system developed in this study has broad applicability, as it successfully assessed various tumor types, including lung, skin, and colorectal cancers. Pathologists worldwide could benefit from a standardized scoring system to evaluate treatment response as immunotherapies become standard care.
The study was supported by Bristol Myers Squibb, Ono Pharmaceutical Company Ltd., the Bloomberg~Kimmel Institute for Cancer Immunotherapy, The Mark Foundation for Cancer Research, and the National Institutes of Health. The researchers believe that the low cost and accessibility of assessing RVT using existing tools and supplies commonly used by pathologists could make this scoring system especially advantageous in low-resource settings.
The next steps for the research team involve defining clinically significant cutoff values for RVT and further exploring the potential of combining pathology, radiology, and ctDNA results for long-term treatment monitoring.
Dr. Janis Taube, the study’s senior author, receives support from Bristol Myers Squibb, AstraZeneca, Merck, and Roche and holds a patent for a machine learning algorithm for irPRC. Any potential conflicts of interest are managed by The Johns Hopkins University in accordance with its policies.
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