Creating a specialized therapy center for novel radiolabelled agent
Finding the optimal structure for new, highly specialized, radiolabelled anti-cancer drug delivery
Figure 1: Kaplan-Meier Curves for Progression-Free Survival in NETTER-1
The European Medicines Agency approved Lutathera in September 2017, and the FDA approved it at the end of January not only for midgut tumors, but also in NETs of the stomach, pancreas, colon and rectum.
The standard regimen consists of 200 mCi of lutetium Lu 177 dotatate once every 8 weeks x 4 treatments over 8 months. The drug is often given combined with a somatostatin analog, either a long-acting octreotide or lanreotide, especially in patients with carcinoid syndrome. It requires concomitant administration of aminoacid intravenous solution 30 minutes prior and at least 3 hours after therapy as well as special room shielding to prevent radioactive contamination.
One of the proposed areas for administration is the Clinical Research Unit, part of the 7th hospital floor used for clinical trial patient therapy. There is potentially one room which can accommodate one therapy patient (perhaps 2) one day a week (Friday), the other days the unit works at capacity and there would be very high potential for inducing errors either into the lutathera therapy or into the trial protocol ones. The challenges at this time are as follows:
- It is not clear how many patients will require this therapy immediately, vs. over the long term once the backlog of patients resolves.
- The cost and logistics of refurbishing the room during normal operating conditions for the Research Unit.
- The costs associated with refurbishing the room, additional staffing costs vs. reimbursement rates which are currently not yet clear.
- Alternative solutions within the hospital where the radioactive shielding is already available were not clearly evaluated and rejected-at least not to my knowledge.
- This therapy needs to be offered in the specialized higher volume centers such as ours, however, there was never any discussion or team preparation for this therapy from the CMO level.