Amal Thommil: NCCN Guidelines for MRD
Amal Thommil, Senior Associate at DeciBio, shared an article by Tomoko Akaike, et al. on LinkedIn:
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We saw ctDNA-MRD specifically with limit of detection < 1 ppm included in the DLBCL guidelines (as a category 2B recommendation) recently, but also ctDNA was recently included in the Merkel Cell Carcinoma NCCN guidelines as category 2A (congratulations to the Natera team)!
As I’ve mentioned before, I was really interested in the wording used in the recommendation:
Specifically, the NCCN footnote says “Circulating tumor (DNA) can assess disease burden in both virus-positive and virus-negative MCC and typically becomes positive prior to or at the time of clinically evident recurrence. For surveillance, this test is often obtained every 3 months.” This is footnoted for additional workups of “laboratory studies as clinically indicated.” The term MRD or minimal residual disease is not mentioned, and similarly no commentary on limit of detection needed.
I still do find it surprising that this preceded any guidelines in CRC, where NCCN still mentions “circulating tumor (ctDNA) is emerging as a prognostic marker; however, there is currently insufficient evidence to recommend routine use of ctDNA assays outside of a clinical trial.” The CRC setting also appears to have more established actionability (and reimbursement) than this MCC case (though perhaps COBRA’s failure and ALTAIR not reaching statistical significance in stages I-III increased uncertainty in CRC).
Is it possible that NCCN guidelines are more lenient / open for MCC, given MCC’s aggressive and rarer nature?
Or perhaps ctDNA is a desired alternative to frequent surveillance imaging (especially whole-body PET/CT), as suggested in the study. Regardless, I’m happy to see MRD (or maybe “ctDNA monitoring” is more appropriate for this use case – I know terminology is important to some) increasing in NCCN guidelines, and I am optimistic to see even more MRD developments through 2025!”
Circulating Tumor DNA Assay Detects Merkel Cell Carcinoma Recurrence, Disease Progression, and Minimal Residual Disease: Surveillance and Prognostic Implications.
Authors: Tomoko Akaike, et al.
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