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. This study is believed to be the first study of metastatic pancreatic cancer in nearly a decade to have a positive endpoint of overall survival.
Dr. Zev Weinberg, co-director of the UCLA Health GI Oncology Program and researcher at the UCLA Jonsson Comprehensive Cancer Center, is the first author of an oral abstract describing the findings presented at the ASCO Gastroenterology Symposium Jan. 20 in San Francisco.
There have been several chemotherapy regimens used to treat newly diagnosed metastatic pancreatic cancer, also called stage 4, but there have been few direct comparisons to see which regimen would lead to a longer overall survival. These trials help answer treatment questions that are so important to all who treat pancreatic cancer.”
Dr. Zev Weinberg, co-director of the UCLA Health GI Oncology Program
For the study, 770 patients were randomly assigned to one of two chemotherapy regimens. Patients in the four-drug group had an overall survival of 11.1 months, compared with 9.2 months for those in the two-drug arm. Progress-free survival also increased with the four-drug regimen—7.4 months versus 5.6 months with the two-drug regimen. Several side effects, such as diarrhea, nausea, and low potassium levels, 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 two drugs.
The four-drug regimen consisted of liposomal irinotecan, 5-fluorouracil/leucovorine and oxaliplatin – together referred to as NALIRIFOX. The two-drug treatment consists of nab-paclitaxel and gemcitabine.
“This study suggests that a more aggressive chemotherapy approach should be considered for those patients who are able to tolerate it,” Weinberg said. “Metastatic pancreatic cancer has long been recognized as a very difficult type of cancer to treat, but this study represents a potentially new reference standard for current treatment and for future research and drug development.”
The clinical trial involved patients in more than 25 countries, with Dr. Eileen O’Reilly, a gastrointestinal cancer specialist at Memorial Sloan Kettering Cancer Center, serving as the first investigator.
ASCO, the American Society of Clinical Oncology, will be holding a gastrointestinal cancer symposium January 19-21 online and at Moscone West in San Francisco.