GILBERTO DE CASTRO JUNIOR

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Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/24 - Laboratório de Oncologia Experimental, Hospital das Clínicas, Faculdade de Medicina - Líder

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  • article 32 Citação(ões) na Scopus
    Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial(aEuro)
    (2016) CLEMENT, P. M.; GAULER, T.; MACHIELS, J. P.; HADDAD, R. I.; FAYETTE, J.; LICITRA, L. F.; TAHARA, M.; COHEN, E. E. W.; CUPISSOL, D.; GRAU, J. J.; GUIGAY, J.; CAPONIGRO, F.; CASTRO JR., G. de; VIANA, L. de Souza; KEILHOLZ, U.; CAMPO, J. M. del; CONG, X. J.; EHRNROOTH, E.; VERMORKEN, J. B.
    In the LUX-Head & Neck 1 study, older age (a parts per thousand yen65 years) did not adversely affect the benefit in patient-reported outcomes and antitumor activity observed with afatinib over methotrexate, which was consistent with findings from the overall population. Safety in older patients was also consistent with the overall population, favoring afatinib in terms of fewer dose reductions and discontinuations.In the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in prespecified subgroups of patients aged a parts per thousand yen65 and < 65 years. Patients were randomized (2:1) to 40 mg/day oral afatinib or 40 mg/m(2)/week intravenous methotrexate. PFS was the primary end point; overall survival (OS) was the key secondary end point. Other end points included: objective response rate (ORR), patient-reported outcomes, tumor shrinkage, and safety. Disease control rate (DCR) was also assessed. Of 483 randomized patients, 27% (83 afatinib; 45 methotrexate) were aged a parts per thousand yen65 years (older) and 73% (239 afatinib; 116 methotrexate) < 65 years (younger) at study entry. Similar PFS benefit with afatinib versus methotrexate was observed in older {median 2.8 versus 2.3 months, hazard ratio (HR) = 0.68 [95% confidence interval (CI) 0.45-1.03], P = 0.061} and younger patients [2.6 versus 1.6 months, HR = 0.79 (0.62-1.01), P = 0.052]. In older and younger patients, the median OS with afatinib versus methotrexate was 7.3 versus 6.4 months [HR = 0.84 (0.54-1.31)] and 6.7 versus 6.2 months [HR = 0.98 (0.76-1.28)]. ORRs with afatinib versus methotrexate were 10.8% versus 6.7% and 10.0% versus 5.2%; DCRs were 53.0% versus 37.8% and 47.7% versus 38.8% in older and younger patients, respectively. In both subgroups, the most frequent treatment-related adverse events were rash/acne (73%-77%) and diarrhea (70%-80%) with afatinib, and stomatitis (43%) and fatigue (31%-34%) with methotrexate. Fewer treatment-related discontinuations were observed with afatinib (each subgroup 7% versus 16%). A trend toward improved time to deterioration of global health status, pain, and swallowing with afatinib was observed in both subgroups. Advancing age (a parts per thousand yen65 years) did not adversely affect clinical outcomes or safety with afatinib versus methotrexate in second-line R/M HNSCC patients. NCT01345682 (ClinicalTrials.gov).
  • conferenceObject
    PROs With Ceritinib Versus Chemotherapy in Patients With Previously Untreated ALK-rearranged Nonsquamous NSCLC (ASCEND-4)
    (2017) TAN, Daniel Shao-Weng; SORIA, Jean-Charles; CASTRO JR., Gilberto De; WU, Yi Long; PAZ-ARES, Luis; WOLF, Juergen; GEATER, Sarayut; ORLOV, Sergey; CORTINOVIS, Diego; YU, Chong-Jen; HOCHMAIR, Maximilian; CORTOT, Alexis; TSAI, Chun-Ming; MORO-SIBILOT, Denis; CAMPELO, Rosario Garcia; BRANLE, Fabrice; SEN, Paramita; STRUEBBE, Gero; MCCULLOCH, Tracey; CRINO, Lucio
  • conferenceObject
    Pembrolizumab (pembro) vs docetaxel (doce) for previously treated, PD-L1-expressing NSCLC: Updated outcomes of KEYNOTE-010
    (2016) HERBST, R. S.; BAAS, P.; KIM, D-W.; FELIP, E.; PEREZ-GRACIA, J. L.; HAN, J-Y.; MOLINA, J.; KIM, J-H.; ARVIS, C. Dubos; AHN, M-J. A.; MAJEM, M.; FIDLER, M. J.; CASTRO JR., G. De; GARRIDO, M.; SHENTU, Y.; LUBINIECKI, G. M.; GARON, E. B.
  • article 946 Citação(ões) na Scopus
    First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study
    (2017) SORIA, Jean-Charles; TAN, Daniel S. W.; CHIARI, Rita; WU, Yi-Long; PAZ-ARES, Luis; WOLF, Juergen; GEATER, Sarayut L.; ORLOV, Sergey; CORTINOVIS, Diego; YU, Chong-Jen; HOCHMAIR, Maximillian; CORTOT, Alexis B.; TSAI, Chun-Ming; MORO-SIBILOT, Denis; CAMPELO, Rosario G.; MCCULLOCH, Tracey; SEN, Paramita; DUGAN, Margaret; PANTANO, Serafino; BRANLE, Fabrice; MASSACESI, Cristian; CASTRO JR., Gilberto de
    Background The efficacy of ceritinib in patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC) is not known. We assessed the efficacy and safety of ceritinib versus platinum-based chemotherapy in these patients. Methods This randomised, open-label, phase 3 study in untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC was done in 134 centres across 28 countries. Eligible patients were assigned via interactive response technology to oral ceritinib 750 mg/day or platinum-based chemotherapy ([cisplatin 75 mg/m(2) or carboplatin AUC 5-6 plus pemetrexed 500 mg/m(2)] every 3 weeks for four cycles followed by maintenance pemetrexed); randomisation was stratified by World Health Organization performance status (0 vs 1-2), previous neoadjuvant or adjuvant chemotherapy, and presence of brain metastases as per investigator's assessment at screening. Investigators and patients were not masked to treatment assignment. The primary endpoint was blinded independent review committee assessed progression-free survival, based on all randomly assigned patients (the full analysis set). Efficacy analyses were done based on the full analysis set. All safety analyses were done based on the safety set, which included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT01828099. Findings Between Aug 19, 2013, and May 11, 2015, 376 patients were randomly assigned to ceritinib (n=189) or chemotherapy (n=187). Median progression-free survival (as assessed by blinded independent review committee) was 16.6 months (95% CI 12.6-27.2) in the ceritinib group and 8.1 months (5.8-11.1) in the chemotherapy group (hazard ratio 0.55 [95% CI 0.42-0.73]; p<0.00001). The most common adverse events were diarrhoea (in 160 [85%] of 189 patients), nausea (130 [69%]), vomiting (125 [66%]), and an increase in alanine aminotransferase (114 [60%]) in the ceritinib group and nausea (in 97 [55%] of 175 patients), vomiting (63 [36%]), and anaemia (62 [35%]) in the chemotherapy group. Interpretation First-line ceritinib showed a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy in patients with advanced ALK-rearranged NSCLC.
  • conferenceObject
    Canopy-1: Phase 3 Study of Canakinumab/Placebo
    (2020) FELIP, E.; JR, G. Castro; GREYSTOKE, A.; SOLOMON, B.; TAN, D. S. W.; GROHE, C.; PASSOS, V. Q.; DEUDON, S.; LOUVEAU, A. L.; ARTICUS, K.; JOHNSON, B.
  • conferenceObject
    First-line (1L) maintenance therapy with niraparib (nira) plus pembrolizumab (pembro) vs placebo plus pembro in advanced/metastatic non-small cell lung cancer (NSCLC): Phase 3 ZEAL-1L study
    (2021) NAGRIAL, Adnan; RAMALINGAM, Suresh S.; CASTRO JR., Gilberto de; GARASSINO, Marina Chiara; MAZIERES, Julien; SANBORN, Rachel; SMIT, Egbert; SPIGEL, David R.; THOMAS, Michael; VELCHETI, Vamsidhar; SHI, Lei; NEIBAUER, Melissa Whipple; STOJADINOVIC, Alexander; PETERS, Solange
  • conferenceObject
    Safety run-in results from phase 3 study of canakinumab (CAN) or placebo in combination with pembrolizumab (PEM) plus platinum based doublet chemotherapy (Ctx) as 1st line therapy in patients (pts) with advanced or metastatic NSCLC (CANOPY-1)
    (2019) JOHNSON, Bruce E.; KIM, Tae Min; HILTERMANN, T. Jeroen N.; BARLESI, Fabrice; GROHE, Christian; GOTO, Yasushi; GUNNARSSON, Orvar; OVERBECK, Tobias; REGUART, Noemi; WERMKE, Martin; CASTRO, Gilberto; FELIP, Enriqueta; GREYSTOKE, Alastair; SOLOMON, Benjamin J.; NEBOT, Noelia; DEUDON, Stephanie; LOUVEAU, Anne-Laure; PASSOS, Vanessa Q.; TAN, Daniel S. W.
  • conferenceObject
    Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC
    (2016) BARLESI, F.; GARON, E.; KIM, D-W.; FELIP, E.; HAN, J-Y.; KIM, J-H.; AHN, M-J. A.; FIDLER, M. J.; GUBENS, M. A.; CASTRO, G.; SURMONT, V.; LI, Q.; DEITZ, A. C.; LUBINIECKI, G.; HERBST, R. S.
  • conferenceObject
    KEYNOTE-010: Phase 2/3 study of pembrolizumab (MK-3475) vs docetaxel for PD-L1-positive NSCLC after platinum-based therapy
    (2015) HERBST, R. S.; KIM, D-W.; FELIP, E.; PEREZ-GRACIA, J. L.; GARON, E. B.; HAN, J-Y.; MOLINA, J.; KIM, J-H.; GERVAIS, R.; AHN, M-J.; MAJEM, M.; FIDLER, M. J.; CASTRO JR., G. De; GARRIDO, M.; LUBINIECKI, G. M.; SHENTU, Y.; IM, E.; BAAS, P.
  • article 30 Citação(ões) na Scopus
    Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial
    (2019) BURTNESS, Barbara; HADDAD, Robert; DINIS, Jose; TRIGO, Jose; YOKOTA, Tomoya; VIANA, Luciano de Souza; ROMANOV, Ilya; VERMORKEN, Jan; BOURHIS, Jean; TAHARA, Makoto; SEGALLA, Jose Getulio Martins; ESCOBAR, Yolanda; SORIA, Ainara; CHAVES, Mauel; JOHANSSON, Gun Wickart; FRIESLAND, Signe; TELL, Roger; NYMAN, Jan; ROTHSCHILD, Sacha; ZIPPELIUS, Alfred; ASARAWALA, Nirav; KARAVASILIS, Vasilios; RAUCH, Daniel; USLUOGLU, Nurguel; GOGUNSKA, Inna; ZABOLOTNIY, Dmytro; VINNYK, Yuriy; BURIAN, Oleksandr; HARRINGTON, Kevin; SYKES, Andrew; PEEL, David; LESTER, James; FOUNTZILAS, Georgios; NICOLAU, Ulisses Ribaldo; ROBINSON, Martin; SRINIVASAN, Devraj; FRAGKANDREA-NIXON, Ioanna; JUNOR, Elizabeth; GOLLINS, Simon; EVANS, Mererid; NEWBOLD, Kate; HWANG, David; SCHIPANI, Stefano; PSYRRI, Diamanto; RIZWANULLAH, Mohammed; RAUCH, Daniel; ATIQ, Omar; ARNAOUTAKIS, Konstantinos; BAUMAN, Jessica; BURTNESS, Barbara; MEHRA, Ranee; KANG, Hyunseok; CHUNG, Christine; DAVIS, Thomas; LANG, Istvan; HADDAD, Robert; JIMENO, Antonio; EVEN, Caroline; KERESZTES, Roger; NANGIA, Chaitali; IGNATIUS, Sai-Hong; SU, Yungpo Bernard; OVERTON, Lindsay Carol; GARRISON, Mitchell A.; JEONG, Woondong; BOER, Andras; WEHBE, Ahmad; ARGIRIS, Athanassios; CHIANG, Anne; WANG, Bushi; MORGENSZTERN, Daniel; HAIGENTZ JR., Missak; MARTINCIC, Danko; POROSNICU, Mercedes; GIBSON, Neil; EHRNROOTH, Eva; KOCSIS, Judit; HARRINGTON, Kevin; COHEN, Ezra E. W.; GIGLIO, Raul Eduardo; BLAJMAN, Cesar Raul; FREUE, Jose Mario; PILNIK, Norma Graciela; PALAZZO, Felipe Salvador; MCGRATH, Margaret; FUREDER, Thorsten; KORNEK, Gabriela; PAJKOS, Gabor; PICHLER, Angelika; BAUERNHOFER, Thomas; TINCHON, Christoph; GREIL, Richard; BURIAN, Martin; KIENZER, Heinz; SPECENIER, Pol; SAUTOIS, Brieuc; DEBRUYNE, Philip; GRAAS, Marie-Pascale; TAMAS, Laszlo; MAES, Annelies; LONCHAY, Christophe; DAISNE, Jean-Francois; FONTAINE, Christel; CASTRO JUNIOR, Gilberto; OLIVEIRA, Frias de; PEREIRA, Rodrigo Perez; MARCHI, Pedro Rafael Martins De; VIANA, Luciano de Souza; SEGALLA, Jose Getulio Martins; ANAND, A. L.; NICOLAU, Ulisses Ribaldo; LAZARETTI, Nicolas Silva; KULKARNI, Swati; ALAM, Yasmin; HO, Cheryl; SHENOUDA, George; SOULIERES, Denis; SULTANEM, Khalil; SINGH, Simron; MELLA, Pablo Gonzalez; SHARMA, Ajay; CAMPOS, Jose Antonio Solis; HOLECKOVA, Petra; PRAUSOVA, Jana; OBERMANNOVA, Radka; FRIBORG, Jeppe; SPECHT, Lena; ELSAID, Amr Abdelaziz; MINN, Heikki; MARTIN, Laurent; ROLLAND, Frederic; PSYRRI, Amanda; CERUSE, Philippe; CALAIS, Gilles; EVEN, Caroline; GUIGAY, Joe; FERTE, Charles; PEYRADE, Frederic; DUFFAUD, Florence; CHAMPEAUX-ORANGE, Elise; COUTTE, Alexandre; CLATOT, Florian; Sharma; FOURNEL, Pierre; MOAL, Laurence Bozec Le; DIETZ, Andreas; GRUENWALD, Viktor; GAULER, Thomas; GUNTINAS-LICHIUS, Orlando; HILDEBRANDT, Guido; KUHNT, Thomas; SCHMIDT, Horst-Juergen; HENKE, Michael; VOONA, Murali; RUECKERT, Anja; BRUGGER, Wolfram; ROTTER, Nicole; MAHLBERG, Rolf; PANDY, Ananda Selvakumar; KUMAR, Kirushna; NATHAN, Raj Kumar Poovna; SRINIVASAN, Venkatesan; ZADE, Bhooshan; JAIN, Minish; SRINIVASA, B. J.; NAIK, Radheshyam; VASILEVSKAYA, Irina; MOHANTY, B. K.; ASARAWALA, Nirav; CHARAS, Tomer; BILLAN, Salem; POPOVTZER, Aron; LICITRA, Lisa; FERRARI, Daris; FAO, Paolo; MERLANO, Marco; ROCCA, Maria Cossu; NANGIA, Chaitali Singh; HOMMA, Akihiro; FUJII, Hirofumi; TAHARA, Makoto; MINAMI, Syujiro; FUJII, Masato; YOKOTA, Tomoya; KADOWAKI, Shigenori; MURO, Kei; KIYOTA, Naomi; OKAMI, Kenji; CHAVES-CONDE, Manuel; YAGI, Toshinari; YOSHINO, Kunitoshi; MATSUMOTO, Koji; TAKAHASHI, Shunji; MATSUURA, Kazuto; AVITIA, Miguel Angel Alvarez; RIESTRA, Hector Jorge Gonzalez; MEERTEN, E. van; BUTER, J.; GELDERBLOM, A. J.; KIYOTA, Naomi; KAWECKI, Andrzej; GOLUSINSKI, Wojciech; DINIS, Jose; DINIS, Rui; RIBEIRO, Leonor; SILVA, Regina; MANSINHO, Helder; SELEZNEVA, Irina; BIAKHOV, Mikhail; GALIULIN, Rinat; HOMMA, Akihiro; IZMAILOV, Adel; ROMANOV, Ilya; VLADIMIROV, Vladimir; VINOGRADOV, Valery; MUFAZALOV, Fagim; VASILEVSKAYA, Irina; BASTE, Neus; CAMPO, Josep Ma del; NIN, Ricard Mesia; POUSA, Antonio Lopez; HOLECKOVA, Petra; CASTRO, Juan Jose Grau de; REIG, Oscar; VERA, Ruth; TRIGO, JoseManuel; IGLESIAS, Lara; TRUFERO, Javier Martinez; VAZQUEZ, Sergio; RUBIO, Belen; ALES, Jose Enrique; VILLAR, Esther; CAMPO, Josep Maria Del; RUBIO, Jordi
    ImportanceLocoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC. ObjectiveTo assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC. Design, Setting, and ParticipantsThis multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population. InterventionsPatients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal. Main Outcomes and MeasuresThe primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life. ResultsA total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P=.48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group). Conclusions and RelevanceThis study's findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended. Trial RegistrationClinicalTrials.gov identifier: NCT01345669