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.
The ASCO Post Staff
Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute, and Laurence Albiges, MD, PhD, of France’s Gustave Roussy Cancer Centre, discuss phase III findings showing that cabozantinib in combination with nivolumab and ipilimumab reduced the risk of disease progression or death compared with the combination of nivolumab plus ipilimumab in patients with previously untreated advanced renal cell carcinoma of IMDC (the International Metastatic RCC Database Consortium) intermediate or poor risk. However, the combination of cabozantinib, nivolumab, and ipilimumab vs nivolumab plus ipilimumab did not demonstrate an overall survival benefit to patients (Abstract LBA8).
The ASCO Post Staff
Thomas Powles, MD, PhD, of Barts Health NHS Trust, Queen Mary University of London, and Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, discuss two important phase III studies on renal cell cancer (RCC) presented at ESMO 2022: IMmotion010, which examined the efficacy and safety of atezolizumab vs placebo as adjuvant therapy in patients with RCC at increased risk of recurrence after nephrectomy; and CheckMate 914, which compared nivolumab monotherapy or nivolumab combined with ipilimumab vs placebo in patients with localized disease who underwent radical or partial nephrectomy and who are at high risk of relapse. (Abstract LBA4 & LBA66).
The ASCO Post Staff
Richard S. Finn, MD, of the Geffen School of Medicine at the University of California, Los Angeles, discusses primary phase III results from the LEAP-002 study of pembrolizumab, an anti–PD-1 therapy, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor, vs lenvatinib monotherapy in patients with advanced hepatocellular carcinoma (Abstract LBA34).
The ASCO Post Staff
Paul A. DiSilvestro, MD, of Women & Infants Hospital and the Warren Alpert Medical School of Brown University, discusses overall survival results after a 7-year follow-up of the SOLO1/GOG-3004 trial for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation who received maintenance olaparib. Dr. DiSilvestro details the increasing role of such PARP inhibitors in ovarian cancer treatment and their benefit to patients (Abstract 517O).
The ASCO Post Staff
Marleen Kok, MD, PhD, of The Netherlands Cancer Institute in Amsterdam, discusses the initial results from the BELLINI trial, which tested whether short-term preoperative nivolumab, either as monotherapy or in combination with low-dose doxorubicin or novel immunotherapy combinations, can induce immune activation in patients with early-stage triple-negative breast cancer with tumor-infiltrating lymphocytes (Abstract LBA13).
