Individualised177Lu-DOTATATE treatment of neuroendocrine tumours based on kidney dosimetry.
OBJECTIVE
To present data from an interim analysis of a Phase II trial designed to determine the feasibility, safety, and efficacy of individualising treatment based on renal dosimetry, by giving as many cycles as possible within a maximum renal biologically effective dose (BED).


METHODS
Treatment was given with repeated cycles of 7.4 GBq177Lu-DOTATATE at 8-12-week intervals. Detailed dosimetry was performed in all patients after each cycle using a hybrid method (SPECT + planar imaging). All patients received treatment up to a renal BED of 27 ± 2 Gy (α/β = 2.6 Gy) (Step 1). Selected patients were offered further treatment up to a renal BED of 40 ± 2 Gy (Step 2). Renal function was followed by estimation and measurement of the glomerular filtration rate (GFR).


RESULTS
Fifty-one patients were included in the present analysis. Among the patients who received treatment as planned, the median number of cycles in Step 1 was 5 (range 3-7), and for those who completed Step 2 it was 7 (range 5-8); 73% were able to receive >4 cycles. Although GFR decreased in most patients after the completion of treatment, no grade 3-4 toxicity was observed. Patients with a reduced baseline GFR seemed to have an increased risk of GFR decline. Five patients received treatment in Step 2, none of whom exhibited a significant reduction in renal function.


CONCLUSIONS
Individualising PRRT using renal dosimetry seems feasible and safe and leads to an increased number of cycles in the majority of patients. The trial will continue as planned.
Department of Oncology and Pathology, Clinical Sciences, Lund University, Lund, Sweden. anna.sundlov@med.lu.se.|Department of Oncology, Skåne University Hospital, SE-221 85, Lund, Sweden. anna.sundlov@med.lu.se.
Anna
http://orcid.org/0000-0003-1565-3496
A
Sundlöv
Department of Medical Radiation Physics, Clinical Sciences, Lund University, Lund, Sweden.
Katarina
K
Sjögreen-Gleisner
Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Johanna
J
Svensson
Department of Medical Radiation Physics, Clinical Sciences, Lund University, Lund, Sweden.
Michael
M
Ljungberg
Department of Oncology, Skåne University Hospital, SE-221 85, Lund, Sweden.
Tomas
T
Olsson
Department of Radiation Physics, University of Gothenburg, Gothenburg, Sweden.|Department of Medical Physics and Biomedical Engineering, Sahlgrenska University Hospital, Gothenburg, Sweden.
Peter
P
Bernhardt
Department of Oncology and Pathology, Clinical Sciences, Lund University, Lund, Sweden.|Department of Oncology, Skåne University Hospital, SE-221 85, Lund, Sweden.
Jan
J
Tennvall
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007668:Kidney / Q000528:radiation effects*; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000532:radiotherapy*; D015282:Octreotide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000627:therapeutic use*; D057285:Precision Medicine; D011874:Radiometry
D009942:Organometallic Compounds; C447941:lutetium Lu 177 dotatate; D015282:Octreotide
177Lu-DOTATATE; Dosimetry; Neuroendocrine; PRRT; Renal function