SOCRATE-PRODIGE 55 trial: A randomized phase II study to evaluate second-line ramucirumab alone or with paclitaxel in older patients with advanced gastric cancer.

Marie-Pierre Galais, Astrid Lièvre, Côme Lepage, Christophe Louvet, Marie Moreau, Emmanuelle Samalin, Rosine Guimbaud, Louis-Marie Dourthe, David Tougeron, Daniel Lopez-Trabada Ataz, Emeric Boisteau, Elena Paillaud, Boris Guiu, Pierre Laurent-Puig, Thierry Lecomte, Rabia Boulahssass, Karine Le Malicot, Thomas Aparicio, Eric François

Journal: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 2022;54(6):747-754

PMID: 35351371

Full Text on Elsevier Science View on PubMed

Abstract

INTRODUCTION

Patients ≥ 70 years old constitute 40% of patients with advanced gastric cancer (GC). Ramucirumab plus Paclitaxel is a therapeutic option validated in the second-line treatment of advanced GC, but as older patients are at higher risk of severe toxicity, due to comorbidities and/or frailty, we aimed to evaluate second-line Ramucirumab alone or combined with Paclitaxel in terms of overall survival (OS) and quality of life (QoL) in patients ≥ 70 years-old with advanced GC.

METHODS

In this multicenter, randomized, open-label, non-comparative, prospective phase II clinical trial, the main inclusion criteria are: patients ≥ 70 years old, with advanced GC having progressed after first-line chemotherapy or in the six months following the last administration of adjuvant chemotherapy, with WHO performance status <2. They are randomized to receive either ramucirumab alone (arm A) or ramucirumab plus Paclitaxel (arm B). The primary endpoint is 6-month OS and QoL evaluated with the EORTC QLQ-ELD14 questionnaire. The secondary endpoints include other parameters of QoL, time to definitive deterioration (TTDD) in QoL and TTDD in autonomy, treatment toxicities, other parameters of survival and disease control, identification of geriatric and nutritional prognostic scores and predictive factors of treatment safety and efficacy. OS of 60% is expected at 6 months (H0:40%). Using a Simon-minimax design, with one-sided α risk of 2% and 80% power for OS, and considering 5% lost to follow-up, it is necessary to randomize 56 patients in each arm.

PERSPECTIVES

As older patients are at higher risk of chemotherapy toxicity, ramucirumab alone could be an interesting alternative to Paclitaxel plus ramucirumab, as a second-line therapy for patients ≥ 70 years old with advanced GC, and needs to be evaluated.

Address: Service des Maladies de l'Appareil Digestif, INSERM U1242, CHU de Rennes, CHU Pontchaillou, Université de Rennes 1, Rennes Cedex9 35033, France.; Service d'Oncologie, Center Antoine Lacassagne, Nice, France.; Service de Gastroentérologie, Hôpital Saint Louis, APHP, Université de Paris, Paris, France.; FFCD EPICAD INSERM LNC-UMR 1231, Université de Bourgogne Franche-Comté Dijon, France.; Service de Gériatrie, CHU de Nice, Nice, France.; Service d'Hépato-Gastroentérologie, CHU de Tours, Tours, France; INSERM UMR 1069, "Nutrition, Croissance et Cancer", Université de Tours, France.; INSERM U 775 - Faculté des Sciences Fondamentales et Biomédicales, Center Universitaire des Saints-Pères, Université des Saints Pères, Paris Descartes, Paris, France.; Département de Radiologie, CHU St-Eloi, Montpellier, France.; Hôpital Européen Georges Pompidou, Service de Gériatrie, APHP, Paris Cancer Institute CARPEM, Paris 75015, France.; Département d'Oncologie Médiale, Center François Baclesse, Caen, France.; Département d'Oncologie Médiale, Hôpital Saint-Antoine, Paris, France.; Service d'Hépato-gastroentérologie, CHU de Poitiers, La Milétrie, et l'Université de Poitiers, Poitiers, France.; Service d'Oncologie Médicale, Clinique St Anne, Strasbourg, France.; Département d'Oncologie Médicale, Pôle Digestif, CHU Toulouse, Toulouse, France.; Département d'Oncologie Médicale, Institut du Cancer de Montpellier, Université de Montpellier, Montpellier, France.; Fédération Francophone de Cancérologie Digestive (FFCD), Dijon, France.; Service d'Oncologie Médicale, Institut Mutualiste Montsouris, Paris, France.; Service d'Hépato-gastroentérologie, CHU de Dijon, Dijon, France.; Service des Maladies de l'Appareil Digestif, INSERM U1242, CHU de Rennes, CHU Pontchaillou, Université de Rennes 1, Rennes Cedex9 35033, France. Electronic address: [email protected].

DOI: 10.1016/j.dld.2022.03.001

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MeSH Terms: Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Humans, Paclitaxel, Prospective Studies, Quality of Life, Stomach Neoplasms, Ramucirumab