Final results of a phase 2A study for the treatment of metastatic neuroendocrine tumors with a fixed activity of 90Y-DOTA-D-Phe1-Tyr3 octreotide.
BACKGROUND
The objective of this study was to assess the efficacy of (90)Y-DOTA-D-Phe1-Tyr3 octreotide ((90)Y-DOTATOC) therapy with a fixed activity of 2.56 GigaBequerels bimonthly in patients with advanced stage, well differentiated neuroendocrine carcinomas.


METHODS
In total, 38 patients were enrolled in this phase 2A protocol. All patients had gastroenteropancreatic neuroendocrine tumors in sharp clinical and radiologic progression despite previous surgery, chemotherapy, and biotherapy. Their survival rate after therapy with (90)Y-DOTATOC was compared with a chronologic control group of patients who had received biotherapy and chemotherapy and with results from a previous similar study. The progression-free survival rate after peptide receptor radionuclide therapy with (90)Y-DOTATOC was determined for all patients until they had documented disease progression according to Response Criteria in Solid Tumors, tumor-related death, or censoring.


RESULTS
Seventeen patients (43.6%) had a partial response, 10 patients (25.6%) had stable disease, and 11 patients (28.2%) had progressive disease. A statistically significant difference was observed (P < .001) between the response to (90)Y-DOTATOC treatment and the response to biotherapy with somatostatin analogs and chemotherapy and also between the current results and the results from a previous similar study (P < .05). At the time of the current evaluation with ongoing follow-up for 30 patients, the median progression-free survival was 22.3 months.


CONCLUSIONS
The results from this phase 2 study indicated that the treatment of metastatic neuroendocrine tumors with fixed (90)Y-DOTATOC activity is useful and safe.
Division of Nuclear Medicine, Carlo Poma Civic Hospital, Mantua, Italy. giordano.savelli@aopoma.it
Giordano
G
Savelli
Francesco
F
Bertagna
Fabio
F
Franco
Ludovica
L
Dognini
Giovanni
G
Bosio
Elena
E
Migliorati
Carlo
C
Rodella
Giorgio
G
Biasiotto
Giovanni
G
Bettinsoli
Chiara
C
Minari
Alberto
A
Zaniboni
Chiara
C
Ferrari
Paola
P
Tomassetti
Vittorio
V
Ferrari
Raffaele
R
Giubbini
D000328:Adult; D000368:Aged; D018278:Carcinoma, Neuroendocrine / Q000000981:diagnostic imaging* / Q000473:pathology; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology; D011877:Radionuclide Imaging; D019233:Retreatment; D015996:Survival Rate; D015021:Yttrium Radioisotopes / Q000627:therapeutic use*
D015021:Yttrium Radioisotopes; D015282:Octreotide; C106246:Edotreotide