Bologna, Italy – A latest chemotherapy regimen for pancreatic cancer is showing promising results in a large-scale clinical trial, potentially offering a significant improvement in survival rates for patients diagnosed with the aggressive disease. The trial, known as CASSANDRA, involved the Policlinico di Sant’Orsola in Bologna and was coordinated by the IRCCS Ospedale San Raffaele in Milan.
Published recently in The Lancet, the study’s findings indicate a substantial improvement in progression-free survival compared to the current standard of care for adenocarcinoma, a type of pancreatic cancer accounting for 95 percent of malignant pancreatic tumors. The trial focused on patients with non-metastatic disease, meaning the cancer had not spread to distant parts of the body.
The research compared two chemotherapy schemes: mFOLFIRINOX, the current standard treatment and PAXG, a novel protocol developed at San Raffaele several years ago. PAXG comprises four different chemotherapeutic agents. The study, fully funded by patient associations, aimed to evaluate the efficacy of these distinct drug combinations in patients scheduled for surgical removal of the pancreatic tumor.
Results demonstrated a significantly longer progression-free survival for patients treated with the PAXG regimen compared to those receiving mFOLFIRINOX – 16 months versus just over 10 months. Progression-free survival was defined as the time until disease progression, recurrence, inoperability, increasing tumor markers, detection of metastases after surgery, or death.
“The Italian Medicines Agency (AIFA) recognized the added value of this research during the trial’s progression, requesting a transition from a phase 2 to a phase 3 study,” explained Mariacristina Di Marco, a researcher at the University of Bologna affiliated with the Oncology Department at Policlinico di Sant’Orsola and the trial’s lead investigator for the hospital. “This change signifies a potentially registrational study, one capable of altering clinical guidelines.”
The findings were also presented at the annual Congress of the American Society of Clinical Oncology (ASCO) in Chicago last June by Professor Michele Reni, director of the Oncology and Day Hospital units and the Pancreas Center’s clinical coordination program at San Raffaele.
The research team is now focusing on long-term survival data, extending beyond five years, to further assess the benefits of the PAXG regimen. “We began this study in 2019, so we currently have data on progression-free survival,” Di Marco stated. “Now, we will concentrate on long-term survival rates.”
Di Marco emphasized the collaborative effort involved in the breakthrough, particularly with the Pancreas and Endocrine Surgery unit led by Professor Riccardo Casadei at Policlinico di Sant’Orsola. “Together, we were among the first to believe in the potential of preoperative chemotherapy, and this achievement promises to significantly improve the outlook for patients,” she said.
The next steps involve international adoption of the findings and potential updates to treatment guidelines. The Policlinico di Sant’Orsola’s Clinical Trial Center continues to support research and clinical trials, offering patients access to innovative therapies.
