Medscape Medical News reports that results have been received from the OCCLURANDOM Phase 2 trial which is the first randomized trial investigating the antitumor effect of the peptide receptor radionuclide therapy or PRRT with lutetium octreotate (OCLU) a targeted radionuclide (atom).
Patients with advanced, progressive, inoperable pancreatic cancer were enrolled in the trial.
The trial was conducted in ten French medical facilities. It was the first such trial in this patient cohort. Patients were enrolled over five years with a median follow-up of forty months.
twelve-month progression-free survival of eighty percent in the OCLU group as opposed to forty-two percent in the sunitinib group.
The U.S. FDA approved sunitinib in 2006. The drug was originally approved to treat metastatic renal cell carcinoma and GIST. Sunitinib was a second choice for patients who were unable to tolerate imatinib or had failed to respond to the drug.
According to trial records, the Phase 2 trial is the first PRRT trial involving patients diagnosed with progressive, advanced, SSTR +pancreatic NETS.
Enrollment Criteria
Patients qualify for enrollment if they have had progressive disease over the past twelve months and were treated with cytotoxic chemotherapy, kinase inhibitors, or somostatin to control hormone levels.
It was noted that most patients were found to have grade two or three pancreatic NETS which are pancreatic neuroendocrine tumors. These tumors can occur in hormone-producing cells found in the pancreas.
Liver involvement
Over twenty-five percent of patients in the study had liver issues. The mean age of patients was sixty-three years and fifty-two patients were female.
The patients were randomly assigned to four infusions of OCLU for eight weeks or to sunitinib at 37.5mg. daily until intolerance or progression.
Other anticipated endpoints were tumor response, safety, quality of life, and progression-free survival.
Regarding the Radionuclide Cycles
The majority of patients (89.5%) received four cycles of OCLU. Treatment was halted among the OCLU patients due to progression in only 5.4%. This compares with 74.4% among the sunitinib group.
Adverse Events
Forty-five of the eighty-four patients experienced Grades three and four adverse events which included eighteen among the OCLU group and twenty-seven patients in the sunitinib arm.
Five people in the OCLU arm and ten in the sunitinib arm experienced hematologic events.
The researchers agreed that further research is necessary in order to determine the most effective treatment sequence.
