Lutathera Slows Disease Progression in Midgut Neuroendocrine Tumors


A novel drug, 177Lutetium-DOTATATE (Lutathera), significantly lowered the risk for disease progression or death among patients with previously treated, advanced midgut neuroendocrine tumors.

A novel drug, 177Lutetium-DOTATATE (Lutathera), significantly lowered the risk for disease progression or death among patients with previously treated, advanced midgut neuroendocrine tumors, according to the phase III results of the NETTER-1 trial.

Compared with patients treated with octreotide LAR 60 mg, treatment with 177Lutetium-DOTATATE resulted in about an 80% decreased risk for progression or death, according to data presented at a presscast ahead of the 2016 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, held January 21–23 in San Francisco (abstract 194).

“While there have been few available systemic treatment options for patients progressing under somatostatin analogues, Lutathera has a major therapeutic benefit for this patient population,” said study author Jonathan R. Strosberg, MD, a medical oncologist at the Moffitt Cancer Center in Tampa, Florida.

According to Strosberg, many patients with midgut neuroendocrine tumors receive first-line treatment with a somatostatin analog such as octreotide. However, there are currently limited second-line therapeutic options for patients whose disease progresses on this treatment.

This phase III trial tested 177Lutetium-DOTATATE, a peptide receptor radionuclide therapy that combines hormone therapy and radiotherapy. The study included 230 patients with inoperable, progressive disease and randomly assigned them to four administrations of 177Lutetium-DOTATATE 7.4 GBq every 8 weeks or octreotide LAR 60 mg every 4 weeks.

At data analysis, 23 patients in the 177Lutetium-DOTATATE group had confirmed disease progression or death compared with 67 patients in the octreotide group. Median progression-free survival, the trial’s primary endpoint, was not yet reached among patients assigned the novel therapy compared with 8.4 months among patients assigned octreotide LAR (95% CI, 5.8–11 months; P < .0001). This equated to a 79% reduction in risk for progression or death among patients assigned 177Lutetium-DOTATATE (HR, 0.21; 95% CI, 0.13–0.34).

“With roughly a year and a half duration of follow-up thus far, we can see in the Kaplan Maier curve that the expected median progression-free survival is likely to be longer than 3 years in the experimental arm,” Strosberg said.

Significantly more patients assigned 177Lutetium-DOTATATE had tumor responses compared with patients assigned octreotide (18% vs 3%; P = .0008). There was one complete response and 17 partial responses in the 177Lutetium-DOTATATE arm compared with 3 partials responses in the octreotide arm.

An interim analysis of overall survival data showed 13 deaths had occurred among patients assigned 177Lutetium-DOTATATE compared with 22 in the octreotide group (P = .0186); however, Strosberg noted that in an interim analysis the threshold for statistical significance is .001, meaning this difference is not significant, but is suggestive of an improvement in overall survival.

Commenting on these results Smitha Krishnamurthi, MD, ASCO Spokesperson and the moderator of the presscast said, “Lutetium DOTATATE showed impressive ability to slow the growth of midgut neuroendocrine tumors that progressed on somatostatin analogue therapy. Also notable was that Lutetium DOTATATE resulted in a response rate of 18% in these tumors which are typically unresponsive to systemic therapy.”

Related Videos
Rates of obesity appear to correlate with increasing incidence of cancer in young populations, according to Monique Gary, DO, MSc, FACS.
Data from a ctDNA analysis of the phase 3 INTRIGUE study indicate that KIT mutational status may be associated with response to certain Tyrosine kinase inhibitors in GIST, according to an expert from the Yale Cancer Center in New Haven, Massachusetts.
Future research into the management of unresectable hepatocellular carcinoma may involve combining local therapies with checkpoint inhibitors like durvalumab and tremelimumab, according to Ghassan K. Abou-Alda, MD.
Patients with unresectable hepatocellular carcinoma who have recurrent disease following surgery or locally advanced diseases who will likely progress on local therapy may have an opportunity to benefit from tremelimumab and durvalumab following its FDA approval, according to Ghassan K. Abou-Alfa, MD.
Ghassan K. Abou-Alfa, MD, discusses the importance of improving access to novel therapies and combinations for patients with hepatocellular carcinoma across the world.
Ghassan K. Abou-Alfa, MD, spoke about the recent approval of tremelimumab plus durvalumab for patients with unresectable hepatocellular carcinoma, based on results from the phase 3 HIMALAYA trial.
Howard A. Burris, MD, highlighted previous findings of the phase 3 TOPAZ-1 trial assessing durvalumab plus gemcitabine and cisplatin vs placebo plus gemcitabine and cisplatin in advanced biliary tract cancer and patient-reported outcomes (PRO)data that were presented at 2022 ASCO.
Shubham Pant, MD discusses key findings from a basket trial examining the use of erdafitinib in patients with gastrointestinal cancers.
Related Content