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Войти в исследования European journal of cancer (Oxford, England : 1990) · 2026
Perioperative treatment in resectable gastric cancer with spartalizumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT): Results from the GASPAR phase 2 study.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Dos Santos Mélanie, Lequesne Justine, Piessen Guillaume, Leconte Alexandra, Guimbaud Rosine, Pernot Simon, Bouche Olivier, Hiret Sandrine, Soularue Emilie, Tougeron David, Dahan Laetitia, Le Sourd Samuel, Borg Christophe, Samalin Emmanuelle, Corbinais Stéphane, Parzy Aurélie, Guilloit Jean-Marc, Varatharajah Sharmini, Brachet Pierre-Emmanuel, Dorbeau Marine, Galais Marie-Pierre, Desgrippes Romain, Clarisse Bénédicte
Аннотация
PURPOSE: Perioperative chemotherapy with FLOT is a standard of care for patients with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. This trial evaluated the anti-PD-1 monoclonal antibody spartalizumab combined with FLOT as perioperative treatment for resectable patients.
PATIENTS AND METHODS: GASPAR is a multicenter, single-arm, Simon two-stage phase 2 trial. Patients with untreated localized gastric or GEJ adenocarcinoma considered resectable (≥ cT2 or cN+) received 4 pre- and post-operative cycles of FLOT and 2 pre- and post-operative cycles of spartalizumab. The main endpoint was the rate of pathological complete regression (pCR) according to the Becker criteria, requiring 67 patients (H0/H1 =10/23 %, α=5 %, β=20 %).
RESULTS: Overall, 68 patients were included: men (78 %), median age 63 years [range 31-79], cT3 51 %, GEJ 60 %, cN+ 58 %. Treatment was started in 67 patients. Delayed FLOT administration for toxicity and dose reduction concerned 14 (21 %) and 28 (42 %) patients, respectively. Surgery was R0 in 62 (95 %) of the patients operated on. Among 64 patients assessable for efficacy, pCR was observed in 20 patients (31 %), and major pathological response in 12 patients (19 %), meaning a major response rate of 50 %. Five patients developed grade 3 immune-mediated adverse events. One death related to pneumocystis occurred. Severe post-surgery complications occurred in 15 patients (23 %). After a median follow-up of 30 months [range 4-42], OS and DFS at 2 years were 86 % [77.8-94.9] and 77.5 % [68.1-88.2], respectively.
CONCLUSIONS: Spartalizumab combined with FLOT shows high efficacy as perioperative treatment in patients with resectable gastric cancer, and an acceptable safety profile.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04736485.
PATIENTS AND METHODS: GASPAR is a multicenter, single-arm, Simon two-stage phase 2 trial. Patients with untreated localized gastric or GEJ adenocarcinoma considered resectable (≥ cT2 or cN+) received 4 pre- and post-operative cycles of FLOT and 2 pre- and post-operative cycles of spartalizumab. The main endpoint was the rate of pathological complete regression (pCR) according to the Becker criteria, requiring 67 patients (H0/H1 =10/23 %, α=5 %, β=20 %).
RESULTS: Overall, 68 patients were included: men (78 %), median age 63 years [range 31-79], cT3 51 %, GEJ 60 %, cN+ 58 %. Treatment was started in 67 patients. Delayed FLOT administration for toxicity and dose reduction concerned 14 (21 %) and 28 (42 %) patients, respectively. Surgery was R0 in 62 (95 %) of the patients operated on. Among 64 patients assessable for efficacy, pCR was observed in 20 patients (31 %), and major pathological response in 12 patients (19 %), meaning a major response rate of 50 %. Five patients developed grade 3 immune-mediated adverse events. One death related to pneumocystis occurred. Severe post-surgery complications occurred in 15 patients (23 %). After a median follow-up of 30 months [range 4-42], OS and DFS at 2 years were 86 % [77.8-94.9] and 77.5 % [68.1-88.2], respectively.
CONCLUSIONS: Spartalizumab combined with FLOT shows high efficacy as perioperative treatment in patients with resectable gastric cancer, and an acceptable safety profile.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04736485.