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Novel radionuclide therapy improves PFS for GI neuroendocrine tumors
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Treatment with the peptide receptor radionuclide therapy 177-Lu-Dotatate conferred clinically meaningful and statistically significant PFS improvements among patients with advanced gastrointestinal neuroendocrine tumors, according to the results of a phase 3 study presented at European Society for Medical Oncology’s European Cancer Congress.
“Because these patients have a real unmet medical need, this is particularly pleasing for us,” Philippe Ruszniewski, MD, head of the department of gastroenterology and pancreatology at Beaujon Hospital in Clichy, France, said in a press release. “There are few drugs available to treat these patients, and … we are particularly excited to have found something with what appears to be such a long-lasting effect — the PFS we have seen has not been reached before in this type of disease and patient population.”
Advanced GI neuroendocrine tumors (NETs) comprise 25% to 40% of all NETs, according to study background. Few treatment options exist for patients who experience progression following first-line treatment with somatostatin analogue therapy.
Ruszniewski and colleagues conducted the open-label, randomized controlled phase 3 NETTER-1 trial to evaluate the efficacy of 177-Lu-Dotatate (Lutathera, Advanced Accelerator Applications) — a peptide receptor radionuclide therapy that targets tumors with radiolabeled somatostatin analogue peptides — in patients with inoperable, progressive, somatostatin receptor-positive GI NETs.
The researchers randomly assigned patients to receive 7.4 GBq of 177-Lu-Dotatate every 8 weeks or 60 mg octreotide (Sandostatin, Novartis) every 4 weeks. Patients assigned the experimental agent also received amino acid solution infusion for renal protection.
PFS served as the primary endpoint. Secondary endpoints included objective response rate, OS, time to progression, tolerability and health-related quality of life.
The study included data from 230 patients from Europe and the U.S.
Twenty-three patients assigned to 177-Lu-Dotatate died or experienced disease progression, compared with 67 patients assigned to octreotide. Median PFS had not been reached for 177-Lu-Dotatate at the time of statistical analysis; patients assigned to octreotide had a median PFS of 8.4 months (95% CI, 5.8-11; HR = 0.21; 95% CI, 0.13-0.34)
Among 201 patients with evaluable data, 19% of patients experienced complete or partial responses with 177-Lu-Dotatate vs. 3% of patients assigned octreotide (P ˂ .0004).
OS data had not yet matured at the time of the interim analysis; however, 13 patients had died in the 177-Lu-Dotatate arm vs. 22 in the octreotide arm (P ˂ .0186).
The researchers noted the safety profile of 177-Lu-Dotatate appeared consistent with earlier findings from phase 1 and phase 2 clinical trials.
“Results so far show that patients on Lutathera are achieving extra time without their disease progressing,” Ruszniewski said. “This kind of PFS is rarely achieved in cancer. We also have been able to see that Lutathera … offers these patients a good quality of life. … By the use of a scintigraphy, Lutathera enables us to identify the patients who are eligible for treatment and who should respond positively to it. This should lead to substantial savings and ensure that most patients who receive the treatment are likely to respond.” – by Cameron Kelsall
Reference:
Strosberg J, et al. Abstract 6LBA. Presented at: European Cancer Congress; September 25-29, 2015; Vienna.
Disclosure: The researchers report no relevant financial disclosures.