Kelley Lauren Coffman, MD, on the Design of a Study of 177Lu-DOTATATE in Well-Differentiated, High-Grade NETs

The hospitalist at Memorial Sloan Kettering Cancer Center spoke about the design of a study which evaluated the use of 177Lu-DOTATATE in patients with well-differentiated, high-grade neuroendocrine tumors.

In a study presented at the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, investigators observed a meaningful disease control rate among patients with well-differentiated, high-grade neuroendocrine tumors (NETs) who were treated with 177Lu-DOTATATE (Lutathera).

In an interview with CancerNetwork®, Kelley Lauren Coffman, MD, a hospitalist at Memorial Sloan Kettering Cancer Center, discussed the design of this study and what led her and her colleagues to its initiation.


So, to give a little bit of context about the study that we conducted, it is based upon a new therapy that was approved a couple of years ago by the FDA for patients who have neuroendocrine tumors. There was a big trial called NETTER-1 (NCT01578239) that looked at neuroendocrine tumors—primarily of origin from the stomach, small bowel, and pancreas—, and saw how they responded to this new drug called lutetium Lu 177 dotatate. The trade name is Lutathera. It’s a peptide receptor radionuclide therapy that delivers a drug to the somatostatin receptors on neuroendocrine tumors and delivers a focal dose of radiation to the tumors. So, they looked at this therapy in this trial with in a large amount [number] of [patients with] neuroendocrine tumors patients and saw quite a good benefit to it. The FDA approved it for patients with neuroendocrine tumors who had progressed on somatostatin analogues.

Our group found a question in…does this apply to all of our patients with [neuroendocrine] tumors? What about the subset of patients who are a bit more advanced? The predominant patients that who was studied in the NETTER-1 trial were the lower-grade, intermediate-grade patients. That’s where the question kind of stemmed from about this subset of patients who have high-grade, well-differentiated neuroendocrine tumors.

So, what we did is we designed a retrospective study to look at our patient population here at Memorial Sloan Kettering Cancer Center, who have gone through the cycles of [lutetium Lu 177 dotatate] over the last 2 years from 2018 to 2020. And of about 200 patients who’ve gone through that therapy, we found that about 19 fit that the criteria of [having] high-grade, well-differentiated tumor. Ws, and we looked at their pretreatment, their just general characteristics, we looked at their outcomes, we looked at toxicities, and then we looked at survival after going through this treatment.


Coffman KL, Bodei L, Le T, et al. Treatment response and clinical outcomes of well-differentiated high-grade neuroendocrine tumors to 177Lu-DOTATATE. J Clin Oncol. 2021;39(suppl 3). Abstract #: 368.