VIENNA, AUSTRIA—Patients with advanced gastrointestinal neuroendocrine tumors (NETs) have limited treatment options, and few oncologists specialize in this relatively rare disease. But now, results from a multicenter randomized international trial of an innovative treatment show a marked improvement in the length of time patients with mid-gut NETs live without the disease getting worse. These findings were reported at the European Cancer Congress 2015 (ECC2015).
Professor Philippe Ruszniewski, MD, head of the Department of Gastroenterology-Pancreatology, Beaujon Hospital, Clichy, France, who is also a professor at Paris Diderot University, told the Congress that results of the NETTER-1 phase III trial of 177Lu-DOTATATE (Lutathera) show a progression-free survival (PFS) that has never been shown before in this type of cancer.
“Because these patients have a real unmet medical need, this is particularly pleasing for us,” he said.
Lutathera is a member of the family of novel treatments called peptide receptor radionuclide therapy (PRRT) that target tumors with radiolabeled somatostatin analogue (SSA) peptides. The technique belongs to the larger family of molecular nuclear medicine, where trace amounts of radiopharmaceuticals are used to create images and to treat various diseases including cancer. SSAs are widely used in patients with gastrointestinal NETs to reduce symptoms such as diarrhea.
The trial recruited 230 patients from 36 sites in eight European countries and 15 centers in the United States. All patients had mid-gut NETs that metastasized, and they had already undergone SSA treatment. They were randomized to receive either Lutathera combined with the somatostatin octreotide LAR (the current standard of care for mid-gut NETs), or octreotide LAR alone. The primary end point of the trial was PFS, while secondary end points included overall survival (OS), safety, and quality of life, among others.
“Our results confirmed data from phase I and II trials,” Ruszniewski said. “At the time we analyzed the data, the median PFS for Lutathera had not been reached, whereas we could define it as 8.4 months in patients who received octreotide LAR alone. Results so far show that patients on Lutathera are achieving extra time without their disease progressing. This kind of PFS is rarely achieved in cancer. We have also been able to see that Lutathera has a good safety profile and offers these patients a good quality of life.
“From a payer’s point of view, there are significant advantages too. 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.”
Lutathera is injected intravenously, and octreotide LAR into the buttocks (deep intragluteal injection). Patients in the Lutathera group received four doses over 8 weeks, plus 30 mg of octreotide LAR every 28 days. Patients in the octreotide LAR alone group receive 60 mg of the drug every 4 weeks. PFS is analysed every 12 weeks, and patients remain in the study until their disease progresses, unacceptable toxicity, or they wish to withdraw for their own reasons.
Mid-gut NETs are rare, with an incidence generally estimated to be approximately five in every 100,000 cancers. All NETs are classified as rare diseases by regulatory authorities in the Eurepean Union and United States.
“This means that there are few drugs available to treat these patients, and why 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,” said Ruszniewski.