Alfredo Carrato, MD, PhD, on Pancreatic Cancer: Nab-Paclitaxel, Gemcitabine, and FOLFOX for Metastatic Disease
2022 ASCO Annual Meeting
Alfredo Carrato, MD, PhD, of Alcala de Henares University in Spain, discusses phase II results from the SEQUENCE trial, which showed that nab-paclitaxel, gemcitabine, and modified FOLFOX showed significantly higher clinical activity than the standard nab-paclitaxel and gemcitabine in the first-line setting of patients with untreated metastatic pancreatic ductal adenocarcinoma (Abstract 4022).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
It's a pleasure for me to show the results of the SEQUENCE trial. The SEQUENCE trial was a randomized phase two trial in pancreatic cancer patients, metastatic ones on first line and we tried to increase the efficacy of the regimens used for treating these patients. So the rational that there were two subtypes of pancreatic cancer, the basal one responded better to Nab-Paclitaxel Gemcitabine and the classical one better to FOLFIRINOX. So as it was impossible to give both regimens at the same time for toxicity issues, we decided to give them sequentially first Nab-Paclitaxel Gemcitabine, and then not FOLFIRINOX, FOLFOX because we thought that the oxaliplatin was the main drug of the combination. And on top of that, we had that Nab-Paclitaxel was given up front and it was depleting this trauma and allowing the drugs to get in touch more efficiently with the tumor cells. So we performed a phase I trial, and we were surprised because we were expecting some neurological toxicity, but no neurologic toxicity appeared and it was safe at full doses and it was published at the European General Cancer two years ago. Then we designed this randomized phase two trial, trying to increase 50% the survival of patients at one year. It was from 35% to 50%, more or less. So with these things in mind, we designed a trial in which 78 patients per arm were needed and the safety results showed that neutropenia and thrombocytopenia were higher in the experimental arm, significantly higher, 47% and 26% and the efficacy at 12 months hypothesis was met. We found that 55.5% of patients were alive at one year in the experimental arm and only 35% in the control arm, which was Nab-Paclitaxel and gem without FOLFOX. So we looked for other efficacy parameters, like time to progression free survival, overall survival, and all of them were positive. In favor of the experimental arm. We reached a median overall survival of 13.2 months versus 9.5 months in the control arm. The hazard ratio was lower to 0.65 and this was real good surprise because we have discovered a new treatment option for our patients and pancreatic cancer patients have few good news. In the last 20 years, just two trials demonstrated an increase in efficacy rates. One of them was the Nab-Paclitaxel Gemcitabine and now against this regimen, we have demonstrated a superiority in efficacy. So we are happy about that and because our patients will live longer and have another option for treatment. This is only for a core zero and one patients, it's only for well fit patients, not for performance status, middle, core two, or very old patients but when you have these patients, this regimen provides excellent results.
Related Videos
The ASCO Post Staff
Manali I. Patel, MD, MPH, of Stanford University School of Medicine, discusses clinical trial findings on the best ways to integrate community-based interventions into cancer care delivery for low-income and minority populations. Such interventions may improve quality of life and patient activation (often defined as patients having the knowledge, skills, and confidence to manage their health), as well as reduce hospitalizations and the total costs of care (Abstract 6500).
The ASCO Post Staff
Robert Hugh Jones, MD, PhD, of Cardiff University and Velindre Hospital, discusses results from an updated analysis of the FAKTION trial, which showed improved overall survival with fulvestrant plus capivasertib in women with metastatic estrogen receptor–positive breast cancer whose disease had relapsed or progressed on an aromatase inhibitor. The benefit may be predominantly in patients with PIK3CA/AKT1/PTEN pathway–altered tumors, a topic researchers continue to study in the phase III CAPItello-291 trial (Abstract 1005).
The ASCO Post Staff
Jonathan E. Rosenberg, MD, of Memorial Sloan Kettering Cancer Center, and Thomas Powles, MD, PhD, of Barts Health NHS Trust, Queen Mary University of London, discuss phase III findings from the KEYNOTE-426 trial, which appear to support the long-term benefit of pembrolizumab plus axitinib for first-line treatment of patients with advanced clear cell renal cell carcinoma (Abstract 4513).
The ASCO Post Staff
Gilberto de Lima Lopes, Jr, MD, MBA, of Sylvester Comprehensive Cancer Center at the University of Miami, and Oladimeji Akinboro, MD, MPH, of the U.S. Food and Drug Administration (FDA), discuss a data analysis, which suggests that most subgroups of patients with advanced non–small cell lung cancer with a PD-L1 score of 50% or greater who are receiving FDA-approved chemotherapy/immunotherapy regimens may have overall survival outcomes comparable to or better than immunotherapy-alone regimens (Abstract 9000).
The ASCO Post Staff
Etienne Brain, MD, PhD, of the Institut Curie, discusses phase III findings from the Unicancer ASTER 70s trial, in which patients aged 70 or older with estrogen receptor–positive, HER2-negative breast cancer and a high genomic grade index received adjuvant endocrine therapy with or without chemotherapy. The data did not find a statistically significant overall survival benefit with this treatment after surgery (Abstract 500).