Browsing by Author "Gallardo, Carlos"

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    First-Line Nivolumab Plus Chemotherapy for Advanced Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma: 3-Year Follow-Up of the Phase III CheckMate 649 Trial
    (2024) Janjigian, Yelena Y.; Ajani, Jaffer A.; Moehler, Markus; Shen, Lin; Garrido, Marcelo; Gallardo, Carlos; Wyrwicz, Lucjan; Yamaguchi, Kensei; Cleary, James M.; Elimova, Elena; Karamouzis, Michalis; Bruges, Ricardo; Skoczylas, Tomasz; Bragagnoli, Arinilda; Liu, Tianshi; Tehfe, Mustapha; Zander, Thomas; Kowalyszyn, Ruben; Pazo-Cid, Roberto; Schenker, Michael; Feeny, Kynan; Wang, Rui; Lei, Ming; Chen, Clara; Nathani, Raheel; Shitara, Kohei
    Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We report 3-year efficacy and safety results from the phase III CheckMate 649 trial. Patients with previously untreated advanced or metastatic gastroesophageal adenocarcinoma were randomly assigned to nivolumab plus chemotherapy or chemotherapy. Primary end points were overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors expressed PD-L1 combined positive score (CPS) >= 5. With 36.2-month minimum follow-up, for patients with PD-L1 CPS >= 5, the OS hazard ratio (HR) for nivolumab plus chemotherapy versus chemotherapy was 0.70 (95% CI, 0.61 to 0.81); 21% versus 10% of patients were alive at 36 months, respectively; the PFS HR was 0.70 (95% CI, 0.60 to 0.81); 36-month PFS rates were 13% versus 8%, respectively. The objective response rate (ORR) per BICR was 60% (95% CI, 55 to 65) with nivolumab plus chemotherapy versus 45% (95% CI, 40 to 50) with chemotherapy; median duration of response was 9.6 months (95% CI, 8.2 to 12.4) versus 7.0 months (95% CI, 5.6 to 7.9), respectively. Nivolumab plus chemotherapy also continued to show improvement in OS, PFS, and ORR versus chemotherapy in the overall population. Adding nivolumab to chemotherapy maintained clinically meaningful long-term survival benefit versus chemotherapy alone, with an acceptable safety profile, supporting the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastroesophageal adenocarcinoma.
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    Nivolumab plus chemotherapy or ipilimumab in gastro-oesophageal cancer
    (2022) Shitara, Kohei; Ajani, Jaffer A.; Moehler, Markus; Garrido, Marcelo; Gallardo, Carlos; Shen, Lin; Yamaguchi, Kensei; Wyrwicz, Lucjan; Skoczylas, Tomasz; Bragagnoli, Arinilda Campos; Liu, Tianshu; Tehfe, Mustapha; Elimova, Elena; Bruges, Ricardo; Zander, Thomas; de Azevedo, Sergio; Kowalyszyn, Ruben; Pazo-Cid, Roberto; Schenker, Michael; Cleary, James M.; Yanez, Patricio; Feeney, Kynan; Karamouzis, Michalis, V; Poulart, Valerie; Lei, Ming; Xiao, Hong; Kondo, Kaoru; Li, Mingshun; Janjigian, Yelena Y.
    Standard first-line chemotherapy results in disease progression and death within one year in most patients with human epidermal growth factor receptor 2 (HER2)-negative gastro-oesophageal adenocarcinoma(1-4). Nivolumab plus chemotherapy demonstrated superior overall survival versus chemotherapy at 12-month follow-up in gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in the randomized, global CheckMate 649 phase 3 trial(5) (programmed death ligand-1 (PD-L1) combined positive score >= 5 and all randomized patients). On the basis of these results, nivolumab plus chemotherapy is now approved as a first-line treatment for these patients in many countries(6). Nivolumab and the cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor ipilimumab have distinct but complementary mechanisms of action that contribute to the restoration of anti-tumour T-cell function and induction of de novo anti-tumour T-cell responses, respectively(7-)(11). Treatment combining 1 mg kg(-1) nivolumab with 3 mg kg(-1) ipilimumab demonstrated clinically meaningful anti-tumour activity with a manageable safety profile in heavily pre-treated patients with advanced gastro-oesophageal cancer(12). Here we report both long-term follow-up results comparing nivolumab plus chemotherapyversus chemotherapy alone and the first results comparing nivolumab plus ipilimumab versus chemotherapy alone from CheckMate 649. After the 24.0-month minimum follow-up, nivolumab plus chemotherapy continued to demonstrate improvement in overall survival versus chemotherapy alone in patients with PD-L1 combined positive >= 5 score (hazard ratio 0.70; 95% confidence interval 0.61, 0.81) and all randomized patients (hazard ratio 0.79; 95% confidence interval 0.71, 0.88). Overall survival in patients with PD-L1 combined positive score >= 5 for nivolumab plus ipilimumab versus chemotherapy alone did not meet the prespecified boundary for significance. No new safety signals were identified. Our results support the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastro-oesophageal adenocarcinoma.
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    Uso de cannabis en jóvenes hospitalizados por un primer episodio de psicosis: un estudio caso-control
    (2020) Castañeda, Carmen Paz; Alliende Correa, Luz María; Iruretagoyena, Bárbara; Nachar, Rubén; Mancilla, Felipe; Diaz, Camila; Gallardo, Carlos; Mena, Cristian; Ramírez Mahaluf, Juan Pablo; Undurraga, Juan; González Valderrama, Alfonso; Crossley, Nicolás
    Background: Cannabis use among young people in Chile has increased significantly in the last years. There is a consistent link between cannabis and psychosis. Aim: To compare cannabis use in patients with a first episode of psychosis and healthy controls. Material and Methods: We included 74 patients aged 20 +/- 3 years (78% males) admitted to hospital with a first episode of psychosis and a group of 60 healthy controls aged 23 +/- 4 years (63% males). Cannabis consumption was assessed, including age of first time use and length of regular use. Results: Patients with psychosis reported a non-significantly higher frequency of life-time cannabis use. Patients had longer periods of regular cannabis use compared with healthy subjects (Odds ratio [OR] 2.4; 95% confidence intervals [CI] 1.14-5.05). Patients also used cannabis for the first time at an earlier age (16 compared with 17 years, p < 0.0). The population attributable fraction for regular cannabis use associated with hospital admissions due to psychosis was 17.7% (95% CI 1.2-45.5%). Conclusions: Cannabis use is related to psychosis in this Chilean group of patients. This relationship is stronger in patients with early exposure to the drug and longer the regular use. One of every five admissions due to psychosis is associated with cannabis consumption. These data should influence cannabis legislation and the public policies currently being discussed in Chile.