Christelle de la Fouchardiere, MD, on Pancreatic Ductal Adenocarcinoma: Phase III Trial Results With Gemcitabine Plus Paclitaxel
ESMO Congress 2022
Christelle de la Fouchardiere, MD, of France’s Centre Léon Bérard, discusses phase III findings from the PRODIGE 65–UCGI 36–GEMPAX UNICANCER study, which evaluated whether the combination of gemcitabine and paclitaxel improves overall survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma after FOLFIRINOX failure or intolerance (Abstract LBA60).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
The GEMPAX study is a phase III randomized trial comparing in patients with metastatic pancreatic ductal adenocarcinoma second-line therapy with gemcitabine and paclitaxel versus gemcitabine alone. The primary endpoint of this study was overhaul survival. Patients included were having metastatic pancreatic ductal adenocarcinoma, they were having experienced disease progression of failure after FOLFIRINOX, and maintaining a good ECOG performance status. They were randomized with a 2:1 ratio between GEMPAX, the weekly combination of gemcitabine and paclitaxel, 3 weeks over 4 versus gemcitabine alone. They stopped treatment at disease progression or toxicity. There were four stratification factors, ECOG PS, CA19-9 at baseline, first-line PFS, and neutrophil to lymphocyte ratio.
The main results of this study is that we didn't observe any significant benefit in overall survival with the addition of paclitaxel to gemcitabine versus gemcitabine alone in this setting. But this is the first prospective phase III trial evaluating second-line therapy after FOLFIRINOX and we observe a good improvement of progression-free survival, a significant one, and also a significant increase in overall response rate, which is highly clinically relevant in this poor prognosis disease. Furthermore, we observed more treatment discontinuation in the GEMPAX arm and also imbalance in third-line therapies that could explain the absence of overall survival benefit.
Then, we think that gemcitabine plus paclitaxel may be the standard second-line therapy after FOLFIRINOX failure or intolerance in metastatic pancreatic ductal adenocarcinoma patients. A substantial proportion of patients in this study received third-line therapies, reflecting the eye medical need, and also the requiring further clinical trials for this pathology.
Related Videos
The ASCO Post Staff
Antonio Marra, MD, of Memorial Sloan Kettering Cancer Center, discusses a mutational signature analysis that reveals patterns of genomic instability linked to resistance to endocrine therapy with or without CDK4/6 inhibition in patients with estrogen receptor–positive/HER2-negative metastatic breast cancer (Abstract 210O).
The ASCO Post Staff
Jean-Pascal Machiels, MD, PhD, of Belgium’s Cliniques universitaires Saint-Luc (UCLouvain), discusses the primary results of the phase III KEYNOTE-412 study of pembrolizumab plus chemoradiation therapy (CRT) vs placebo plus CRT for patients with locally advanced head and neck squamous cell carcinoma (Abstract LBA5).
The ASCO Post Staff
Ana Oaknin, MD, PhD, of Barcelona’s Vall d’Hebron University Hospital, discusses an analysis of long-term survival from the EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial. Cemiplimab-rwlc is the first immunotherapy to demonstrate an overall survival benefit as a second-line monotherapy for patients with recurrent or metastatic cervical cancer previously treated with platinum-based chemotherapy but not immunotherapy. The benefit was sustained in this population (Abstract 519MO).
The ASCO Post Staff
Sapna P. Patel, MD, of The University of Texas MD Anderson Cancer Center, discusses the latest findings from the SWOG S1801 trial, which showed that using single-agent pembrolizumab as neoadjuvant therapy improved event-free survival compared to adjuvant therapy in high-risk resectable stage III–IV melanoma (Abstract LBA6).
The ASCO Post Staff
Axel Bex, MD, PhD, of the Netherlands Cancer Institute, discusses phase III findings from the IMmotion010 study, which evaluated the efficacy and safety of atezolizumab vs placebo in patients with renal cell cancer who are at high risk of disease recurrence following nephrectomy (Abstract LBA66).
