A four-drug chemotherapy regimen provided longer overall survival than a two-drug combination in a Phase 3 clinical trial for metastatic pancreatic ductal adenocarcinoma. The study is believed to be the primary metastatic pancreatic cancer study in nearly a decade to have a positive endpoint for overall survival.
Dr. Zev Wainberg, co-director of the UCLA Health GI Oncology Program and a researcher at UCLA Jonsson Comprehensive Cancer Center, is first creator of the oral abstract describing the outcomes presented on the ASCO Gastrointestinal Cancers Symposium Jan. 20 in San Francisco.
There have been several chemotherapy regimens used to treat newly diagnosed, metastatic pancreas cancer, also called stage 4, but there have been few head-to-head comparisons to see which regimen would produce an extended overall survival. These trials help answer critically essential treatment questions for all who treat pancreas cancer.”
Dr. Zev Wainberg, Co-Director of the UCLA Health GI Oncology Program
For the study, 770 patients were randomly assigned to one among two chemotherapy regimens. Patients within the four-drug group had an overall survival of 11.1 months, compared with 9.2 months for those within the two-drug arm. Progression-free survival also increased with the four-drug therapy – 7.4 months versus 5.6 months with the two-drug regimen. Several uncomfortable side effects, equivalent to diarrhea, nausea and low levels of potassium, were more common in patients taking the four-drug treatment, but anemia and low levels of white blood cells were more common in those taking the 2 drugs.
The four-drug regimen consisted of liposomal irinotecan, 5-fluorouracil/leucovorin and oxaliplatin – together known as NALIRIFOX. The 2-drug therapy consisted of nab-paclitaxel and gemcitabine.
“This study indicates that the more aggressive chemotherapy approach must be considered for those patients who’re capable of tolerate it,” Wainberg said. “Metastatic pancreas cancer has long been recognized as a really difficult sort of cancer to treat, but this study represents a possible recent reference standard for current treatment and for future research and drug development.”
The clinical trial included patients in greater than 25 countries, with Dr. Eileen O’Reilly, a GI cancer specialist at Memorial Sloan Kettering Cancer Center, serving as senior investigator.
ASCO, the American Society of Clinical Oncology, will hold the Gastrointestinal Cancers Symposium Jan. 19-21 online and at Moscone West in San Francisco.
Source:
University of California – Los Angeles Health Sciences