MARCOS FRANCISCO DALL'OGLIO
Projetos de Pesquisa
Unidades Organizacionais
Departamento de Cirurgia, Faculdade de Medicina - Docente
LIM/55 - Laboratório de Urologia, Hospital das Clínicas, Faculdade de Medicina - Líder
LIM/55 - Laboratório de Urologia, Hospital das Clínicas, Faculdade de Medicina - Líder
4 resultados
Resultados de Busca
Agora exibindo 1 - 4 de 4
- Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial(2018) PARKER, Christopher C.; COLEMAN, Robert E.; SARTOR, Oliver; VOGELZANG, Nicholas J.; BOTTOMLEY, David; HEINRICH, Daniel; HELLE, Svein I.; O'SULLIVAN, Joe M.; FOSSA, Sophie D.; CHODACKI, Ales; WIECHNO, Pawel; LOGUE, John; SEKE, Mihalj; WIDMARK, Anders; JOHANNESSEN, Dag Clement; HOSKIN, Peter; JAMES, Nicholas D.; SOLBERG, Arne; SYNDIKUS, Isabel; KLIMENT, Jan; WEDEL, Steffen; BOEHMER, Sibylle; DALL'OGLIO, Marcos; FRANZEN, Lars; BRULAND, Oyvind S.; PETRENCIUC, Oana; STAUDACHER, Karin; LI, Rui; NILSSON, StenBackground: In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment. Objective: To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection. Design, setting, and participants: Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving >= 1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr. Outcome measurements and statistical analysis: All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics. Results and limitations: During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non-treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up. Conclusions: Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns. (C) 2017 European Association of Urology.
conferenceObject Hematologic safety of radium-223 dichloride (Ra-223) in the phase 3 ALSYMPCA trial in castration-resistant prostate cancer (CRPC) patients with bone metastases: Baseline prognostic factor subgroup analysis(2013) O'SULLIVAN, J.; JOHANNESSEN, D. C.; WIDMARK, A.; SYNDIKUS, I.; JAMES, N.; DALL'OGLIO, M.; HAUGEN, I.; CROSS, A.; GARCIA-VARGAS, J.; VOGELZANG, N.- Transfusion Requirements in Surgical Oncology Patients A Prospective, Randomized Controlled Trial(2015) ALMEIDA, Juliano Pinheiro de; VINCENT, Jean-Louis; GALAS, Filomena Regina Barbosa Gomes; ALMEIDA, Elisangela Pinto Marinho de; FUKUSHIMA, Julia T.; OSAWA, Eduardo A.; BERGAMIN, Fabricio; PARK, Clarice Lee; NAKAMURA, Rosana Ely; FONSECA, Silvia M. R.; CUTAIT, Guilherme; ALVES, Joseane Inacio; BAZAN, Mellik; VIEIRA, Silvia; SANDRINI, Ana C. Vieira; PALOMBA, Henrique; RIBEIRO JR., Ulysses; CRIPPA, Alexandre; DALLOGLIO, Marcos; DIZ, Maria del Pilar Estevez; KALIL FILHO, Roberto; AULER JR., Jose Otavio Costa; RHODES, Andrew; HAJJAR, Ludhmila AbrahaoBackground: Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients, but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer. Methods: In a randomized, controlled, parallel-group, double-blind (patients and outcome assessors) superiority trial in the intensive care unit of a tertiary oncology hospital, the authors evaluated whether a restrictive strategy of erythrocyte transfusion (transfusion when hemoglobin concentration <7 g/dl) was superior to a liberal one (transfusion when hemoglobin concentration <9 g/dl) for reducing mortality and severe clinical complications among patients having major cancer surgery. All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and randomly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy. The primary outcome was a composite endpoint of mortality and morbidity. Results: A total of 198 patients were included as follows: 101 in the restrictive group and 97 in the liberal group. The primary composite endpoint occurred in 19.6% (95% CI, 12.9 to 28.6%) of patients in the liberal-strategy group and in 35.6% (27.0 to 45.4%) of patients in the restrictive-strategy group (P = 0.012). Compared with the restrictive strategy, the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16% (3.8 to 28.2%) and a number needed to treat of 6.2 (3.5 to 26.5). Conclusion: A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy.
- Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer(2013) PARKER, C.; NILSSON, S.; HEINRICH, D.; HELLE, S. I.; O'SULLIVAN, J. M.; FOSSA, S. D.; CHODACKI, A.; WIECHNO, P.; LOGUE, J.; SEKE, M.; WIDMARK, A.; JOHANNESSEN, D. C.; HOSKIN, P.; BOTTOMLEY, D.; JAMES, N. D.; SOLBERG, A.; SYNDIKUS, I.; KLIMENT, J.; WEDEL, S.; BOEHMER, S.; DALL'OGLIO, M.; FRANZEN, L.; COLEMAN, R.; VOGELZANG, N. J.; O'BRYAN-TEAR, C. G.; STAUDACHER, K.; GARCIA-VARGAS, J.; SHAN, M.; BRULAND, O. S.; SARTOR, O.Background Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. Methods In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. Results At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P=0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. Conclusions In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. (Funded by Algeta and Bayer HealthCare Pharmaceuticals; ALSYMPCA ClinicalTrials.gov number, NCT00699751.)