Norton Cancer Institute is the only site in Louisville offering lutetium Lu 177 dotatate (Lutathera), a second-line treatment targeting advanced-stage neuroendocrine tumors in adult patients.

The drug is indicated when a patient starts to lose response to the first-line therapies, lanreotide (Somatuline) and octreotide acetate (Sandostatin).

“This is a great option. People tend to tolerate it well, and it buys them quite a bit more time,” Michael F. Driscoll, M.D., director of the gastrointestinal malignancy program at Norton Cancer Institute.

Lutathera is the first radioactive drug approved to treat cancers of the pancreas or gastrointestinal tract, known as GEP-NETs. Lutathera is not used to treat pancreatic adenocarcinoma.

The new drug is made up of a radioactive isotope, Lu-177, attached to dotatate, a molecule that binds to GEP-NET cells that have a somatostatin receptor on their surface. The drug enters these cells, and the radiation interrupts their ability to divide.

Specialized licensing and training required

“It’s very specific, unlike radiation technology that radiates the tumor and also the surrounding tissue,” Dr. Driscoll said.

To administer Lutathera, health care facilities must be licensed and undergo specialized training to obtain the radioactive isotope. Physicians, too, are licensed and specially trained.

The drug received Food and Drug Administration approval in 2018 after studies showed Lutathera improved progression-free survival. One study found 65% of patients who received Lutathera were progression-free at 20 months, compared with fewer than 10% in the control arm.

“I think it has worked very well to achieve stability in NET cancers that are losing response to standard of care Lanreotide/Octreotide treatment,” Dr Driscoll said.  A study of more than 360 patients in the Netherlands with GEP-NETS who received lutetium Lu 177 dotatate found complete or partial tumor shrinkage in 16% of patients.

Treatment with lutetium Lu 177 dotatate

Lutathera is administered by IV infusion. A patient receives a total of four infusions, given every eight weeks. After Lutathera treatment, the patient goes back on Sandostatin.

As a group, pancreatic neuroendocrine tumors are not as aggressive as pancreatic adenocarcinoma. After patients lose response to first-line drugs, the pace of the disease process tends to pick up. The tumors tend to become deadly when they become metastatic, according to Dr. Driscoll.

Most patients are good candidates for Lutathera treatment. Studies found serious side effects are rare and include bone marrow suppression. Other serious but rare side effects include the blood and bone marrow disorders secondary myelodysplastic syndrome and acute leukemia.

Patients with bone marrow syndrome or who are starting with low levels of blood cells should not take the drug.

Because Lutathera treatment involves radiation exposure, women who are pregnant or breastfeeding should avoid Lutathera. The drug also may cause infertility and contributes to a patient’s cumulative radiation exposure, which is associated with an increased cancer risk.