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
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
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, discusses results from the CheckMate 915 trial, an analysis of the pretreatment circulating tumor DNA, along with other clinical and translational baseline factors, and their association with disease recurrence in patients with stage IIIB–D/IV melanoma treated with adjuvant immunotherapy (Abstract 788O).
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
Bernd Kasper, MD, PhD, of Germany’s Mannheim Cancer Center, discusses phase III data from the DeFi trial, the largest study conducted to date for patients with desmoid tumors. The trial showed that the gamma secretase inhibitor nirogacestat demonstrated improvements in all primary and secondary efficacy endpoints. Although considered benign because of their inability to metastasize, desmoid tumors can cause significant morbidity and, occasionally, mortality in patients (Abstract LBA2).
The ASCO Post Staff
Marinde J.G. Bond, PhD Candidate, of the University Medical Center, Utrecht, discusses phase III findings from the CAIRO5 study of the Dutch Colorectal Cancer Group, the first such trial in defined subgroups of patients with initially unresectable colorectal cancer liver metastases and left-sided and RAS/BRAF V600E wild-type tumor. The study compared FOLFOX/FOLFIRI plus either bevacizumab or panitumumab (Abstract LBA21).
