Claudio Martin1, Lorena Lupinacci2, Florencia Perazzo3, Carlos Bas4, Omar Carranza5, Carmen Puparelli6, Rubén Kowalyszyn7, Ignacio Magri8, Mirta Varela9, Eduardo Richardet10, Karina Vera11, Silvia Foglia12, Ignacio Jerez13, Enrique Aman14, Gastón Martinengo15, Emilio Batagelj16, Alejandro Dri17, Norma Pilnik18, Guillermo M Roa19, Pablo Mando3, Florencia Tsou6, Gonzalo Recondo3, Federico Cayol2, Marcos Flores5, Susana Sena4, Claudia Bagnes20, Federico D Waisberg6, José N Minatta2, Manglio Rizzo21. 1. Clinical Oncology Unit, Instituto Alexander Fleming, Buenos Aires, Argentina. Electronic address: cmmartin66@gmail.com. 2. Clinical Oncology Unit, Hospital Italiano, Buenos Aires, Argentina. 3. Clinical Oncology Unit, CEMIC, Buenos Aires, Argentina. 4. Clinical Oncology Unit, Hospital Alemán, Buenos Aires, Argentina. 5. Clinical Oncology Unit, Hospital Privado de La Comunidad, Mar Del Plata, Argentina. 6. Clinical Oncology Unit, Instituto Alexander Fleming, Buenos Aires, Argentina. 7. Clinical Oncology Unit, Clínica Viedma, Viedma, Argentina. 8. Clinical Oncology Unit, Reina Fabiola, Córdoba, Argentina. 9. Clinical Oncology Unit, Centro de Oncología e Investigación de Buenos Aires, Buenos Aires, Argentina. 10. Clinical Oncology Unit, Instituto Oncológico Córdoba, Córdoba, Argentina. 11. Clinical Oncology Unit, Hospital Británico, Buenos Aires, Argentina. 12. Clinical Oncology Unit, Hospital Oncológico Lanús, Lanús, Argentina. 13. Clinical Oncology Unit, Sanatorio Allende, Córdoba, Argentina. 14. Clinical Oncology Unit, Swiss Medical Group, Buenos Aires, Argentina. 15. Clinical Oncology Unit, Sanatorio Parque, Rosario, Argentina. 16. Clinical Oncology Unit, Hospital Militar Central, Buenos Aires, Argentina. 17. Clinical Oncology Unit, Instituto Oncológico de Rosario, Rosario, Argentina. 18. Clinical Oncology Unit, Tránsito Cáceres, Córdoba, Argentina. 19. Clinical Oncology Unit, Hospital Perrando, Resistencia, Argentina. 20. Clinical Oncology Unit, Hospital Tornu, Buenos Aires, Argentina. 21. Clinical Oncology Unit, Hospital Universitario Austral, Argentina.
Abstract
BACKGROUND: Nivolumab was the first anti-programmed cell death 1 drug approved in Argentina for non-small-cell lung cancer treatment in the second-line setting. MATERIALS AND METHODS: The present study was a multicenter, observational, retrospective study of patients with progression to stage IV NSCLC during platinum-based chemotherapy who had received nivolumab monotherapy in a drug-expanded access program in Argentina. RESULTS: The data from 109 patients were assessed retrospectively for safety and clinical outcomes. The follow-up period was 8.83 months (interquartile range, 3.4-12.67); 57.8% were men, 29.4% were current smokers, and 78.0% had a diagnosis of nonsquamous cell cancer. The median number of chemotherapy lines before nivolumab was 2 (range, 1-4). Also, 59.6% had received radiotherapy and 89% had received platinum-based chemotherapy. The drug-related toxicity rate was 78.9%, the grade 2-3 toxicity rate was 28.4%, and 33.9% of patients had required corticosteroids. The treatment response was evaluated in 104 patients. The best response was a complete response in 2 (2%), partial response in 28 (27%), stable disease in 33 (32%), and progressive disease in 41 (39%). Univariate analysis revealed that the absence of corticosteroid use (P = .034), toxicity grade 1-3 (P = .0025), and performance status of ≤ 1 (P = .049) were associated with longer disease-free survival, performance status of ≤ 1 (P < .001), and toxicity grade 1-3 (P = .001) were associated with longer overall survival. On multivariate Cox regression analysis, toxicity grade 1-3 (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.24-0.81; P = .008) and age ≤ 50 years (HR, 0.28; 95% CI, 0.13-0.61; P = .001) were associated with longer progression-free survival and corticosteroid use was associated with shorter progression-free survival (HR, 2.06; 95% CI, 1.22-3.48; P = .007). CONCLUSIONS: The use of nivolumab in the real world setting in patients with heavily pretreated NSCLC was well tolerated and showed promising clinical efficacy. The performance status, use of corticosteroids, and immune-mediated toxicity seem to be the conditions that can affect the clinical outcomes.
BACKGROUND:Nivolumab was the first anti-programmed cell death 1 drug approved in Argentina for non-small-cell lung cancer treatment in the second-line setting. MATERIALS AND METHODS: The present study was a multicenter, observational, retrospective study of patients with progression to stage IV NSCLC during platinum-based chemotherapy who had received nivolumab monotherapy in a drug-expanded access program in Argentina. RESULTS: The data from 109 patients were assessed retrospectively for safety and clinical outcomes. The follow-up period was 8.83 months (interquartile range, 3.4-12.67); 57.8% were men, 29.4% were current smokers, and 78.0% had a diagnosis of nonsquamous cell cancer. The median number of chemotherapy lines before nivolumab was 2 (range, 1-4). Also, 59.6% had received radiotherapy and 89% had received platinum-based chemotherapy. The drug-related toxicity rate was 78.9%, the grade 2-3 toxicity rate was 28.4%, and 33.9% of patients had required corticosteroids. The treatment response was evaluated in 104 patients. The best response was a complete response in 2 (2%), partial response in 28 (27%), stable disease in 33 (32%), and progressive disease in 41 (39%). Univariate analysis revealed that the absence of corticosteroid use (P = .034), toxicity grade 1-3 (P = .0025), and performance status of ≤ 1 (P = .049) were associated with longer disease-free survival, performance status of ≤ 1 (P < .001), and toxicity grade 1-3 (P = .001) were associated with longer overall survival. On multivariate Cox regression analysis, toxicity grade 1-3 (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.24-0.81; P = .008) and age ≤ 50 years (HR, 0.28; 95% CI, 0.13-0.61; P = .001) were associated with longer progression-free survival and corticosteroid use was associated with shorter progression-free survival (HR, 2.06; 95% CI, 1.22-3.48; P = .007). CONCLUSIONS: The use of nivolumab in the real world setting in patients with heavily pretreated NSCLC was well tolerated and showed promising clinical efficacy. The performance status, use of corticosteroids, and immune-mediated toxicity seem to be the conditions that can affect the clinical outcomes.
Authors: Robert Neil Finnegan; Lucia Orlandini; Xiongfei Liao; Jun Yin; Jinyi Lang; Jason Dowling; Davide Fontanarosa Journal: PLoS One Date: 2021-01-14 Impact factor: 3.240
Authors: Christine M Cramer-van der Welle; Marjon V Verschueren; Merel Tonn; Bas J M Peters; Franz M N H Schramel; Olaf H Klungel; Harry J M Groen; Ewoudt M W van de Garde Journal: Sci Rep Date: 2021-03-18 Impact factor: 4.379