ROBERTO HEGG

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Departamento de Obstetrícia e Ginecologia, Faculdade de Medicina - Docente
LIM/58 - Laboratório de Ginecologia Estrutural e Molecular, Hospital das Clínicas, Faculdade de Medicina

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Autor: CORTES, Javier ×

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  • conferenceObject
    Genomic markers of response to monotherapy abemaciclib in the nextMONARCH 1 study
    (2020) HAMILTON, Erika P.; CORTES, Javier; JERUSALEM, Guy; KAUFMAN, Peter A.; OZYILKAN, Ozgur; HEGG, Roberto; LITCHFIELD, Lacey M.; WANG, Hong; GRAHAM, Hillary T.; WIJAYAWARDANA, Sameera R.; JANSEN, Valerie M.; MARTIN, Miguel
  • article 2065 Citação(ões) na Scopus
    Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer
    (2012) BASELGA, Jose; CORTES, Javier; KIM, Sung-Bae; IM, Seock-Ah; HEGG, Roberto; IM, Young-Hyuck; ROMAN, Laslo; PEDRINI, Jose Luiz; PIENKOWSKI, Tadeusz; KNOTT, Adam; CLARK, Emma; BENYUNES, Mark C.; ROSS, Graham; SWAIN, Sandra M.
    BACKGROUND The anti-human epidermal growth factor receptor 2 (HER2) humanized monoclonal antibody trastuzumab improves the outcome in patients with HER2-positive metastatic breast cancer. However, most cases of advanced disease eventually progress. Pertuzumab, an anti-HER2 humanized monoclonal antibody that inhibits receptor dimerization, has a mechanism of action that is complementary to that of trastuzumab, and combination therapy with the two antibodies has shown promising activity and an acceptable safety profile in phase 2 studies involving patients with HER2-positive breast cancer. METHODS We randomly assigned 808 patients with HER2-positive metastatic breast cancer to receive placebo plus trastuzumab plus docetaxel (control group) or pertuzumab plus trastuzumab plus docetaxel (pertuzumab group) as first-line treatment until the time of disease progression or the development of toxic effects that could not be effectively managed. The primary end point was independently assessed progression-free survival. Secondary end points included overall survival, progression-free survival as assessed by the investigator, the objective response rate, and safety. RESULTS The median progression-free survival was 12.4 months in the control group, as compared with 18.5 months in the pertuzumab group (hazard ratio for progression or death, 0.62; 95% confidence interval, 0.51 to 0.75; P<0.001). The interim analysis of overall survival showed a strong trend in favor of pertuzumab plus trastuzumab plus docetaxel. The safety profile was generally similar in the two groups, with no increase in left ventricular systolic dysfunction; the rates of febrile neutropenia and diarrhea of grade 3 or above were higher in the pertuzumab group than in the control group. CONCLUSIONS The combination of pertuzumab plus trastuzumab plus docetaxel, as compared with placebo plus trastuzumab plus docetaxel, when used as first-line treatment for HER2-positive metastatic breast cancer, significantly prolonged progression-free survival, with no increase in cardiac toxic effects. (Funded by F. Hoffmann-La Roche/Genentech; ClinicalTrials.gov number, NCT00567190.)
  • article 75 Citação(ões) na Scopus
    Preliminary safety and efficacy of first-line pertuzumab combined with trastuzumab and taxane therapy for HER2-positive locally recurrent or metastatic breast cancer (PERUSE)
    (2019) BACHELOT, T.; CIRUELOS, E.; SCHNEEWEISS, A.; PUGLISI, F.; PERETZ-YABLONSKI, T.; BONDARENKO, I.; PALUCH-SHIMON, S.; WARDLEY, A.; MEROT, J. -L.; TOIT, Y. du; EASTON, V.; LINDEGGER, N.; MILES, D.; BOUZID, Kamel; CAMPONE, Mario; COUDERT, Bruno; NOWECKI, Zbigniew; ERRIHANI, Hassan; DALENC, Florence; FERREIRA, Ana; MANO, Max; RICCI, Francesco; KALOFONOS, Haralabos; ANDREETTA, Claudia; MONTEMURRO, Filippo; BARRETT, Sophie; ZHANG, Qingyuan; MAVROUDIS, Dimitris; MATUS, Juan; BEATO, Carlos; HU, Xichun; GAAFAR, Rabab; AZEEM, Hamdy Abdel; PERRIN, Christophe; ETTL, Johannes; LANG, Istvan; VERMA, Sunil; LI, Huiping; BRAIN, Etienne; HOFFMANN, Oliver; CARIELLO, Anna; TONDINI, Carlo; ALTWEGEIRI, Taher; LOMAN, Niklas; LUX, Michael; FRASSOLDATI, Antonio; AZIZ, Zeba; SALAS, Fernando; STREB, Joanna; WRONSKI, Andrzej; BELTRAN, Salomon Menjon; CICIN, Irfan; SCHMID, Peter; LAING, Robert; TONG, Zhongsheng; BOER, Katalin; JUHASZ, Balazs; GIANNI, Luca; CURIGLIANO, Giuseppe; JUAREZ, Alejandro; MATOS, Erika; USLU, Ruchan; WILDIERS, Hans; CRUZ, Marcelo; BOURGEOIS, Hugues; SCHUMANN, Raquel von; STEMMER, Salomon; VASQUEZ, Flavia Morales; DOMINGUEZ, Adriana; WOJTUKIEWICZ, Marek; TRIFUNOVIC, Jasna; ILLARRAMENDI, Jose Juan; GARCIA, Laura; PERON, Yann Izarzugaza; ECHARRI, Maria Jose; VOITKO, Natliia; WHEATLEY, Duncan; WATERS, Simon; BOER, Richard De; JERUSALEM, Guy; COCQUYT, Veronique; BARRIOS, Carlos; PANASCI, Lawrence; MATTSON, Johanna; TANNER, Minna; GOZY, Michel; VASILOPOULOS, Georgios; REVESZ, Janos; LATINI, Luciano; GRIDELLI, Cesare; LAZARO, Jesus; GONZALEZ, Antonio; MOLINS, Agusti Barnadas; MARTINEZ, Eduardo; ALARCON, Jesus; ARANCE, Ana; KLINT, Leif; KOVALYOV, Oleksiy; BAIRD, Richard; YEO, Belinda; MCCARTHY, Nicole; GREIL, Richard; WANG, Shusen; ARTIGNAN, Xavier; AUGEREAU, Paule; JUHASZ-BOESS, Ingolf; NGAN, Roger; GOLDBERG, Hadassah; COSTANZO, Francesco Di; FERRAU, Francesco; ALEKNAVICIUS, Eduardas; RASHID, Kamran; COSTA, Luis; GARCIA, Jose Angel; CRUZ, Luis Ruiz de la; LOPEZ, Rafael Lopez; VAL, Olga Del; OZYILKAN, Ozgur; AZRIBI, Fathi; VERRILL, Mark; TURNER, Nicholas; BEITH, Jane; PETZER, Andreas; ANDRADE, Jurandyr; BERNSTEIN, Vanessa; RAYSON, Daniel; ELDIN, Ibtessam Saad; ACHILLE, Mihaela; MUELLER, Volkmar; GENNARI, Alessandra; CASCINU, Stefano; GHOSN, Marwan; EL-SAGHIR, Nagi; BOSCH, Joan Van den; OOSTERKAMP, Rianne; KUKULSKA, Monika; PELAEZ, Ignacio; HERNANDEZ, Carolina; GORDON, Maria del Mar; DALMAU, Elsa; ALONSO, Jose Luis; AKSOY, Sercan; COSKUN, Hasan Senol; SHPARYK, Yaroslav; VARUGHESE, Mohini; PANWAR, Udaiveer; BARRACLOUGH, Lisa; LEVITT, Nicola; HICKS, Jonathan; RIGG, Anna; ALLEN, Mark; CASTILLO, Cecila; FEIN, Luis Enrique; STUART-HARRIS, Robin; SINGER, Christian; STOEGER, Herbert; SMILJANIC, Sasha; FENG, Jifeng; CEDENO, Miguel; BERDAH, Jean Francois; ORFEUVRE, Hubert; GONCALVES, Anthony; GRISCHKE, Eva-Maria; SIMON, Eike; WAGNER, Steffen; EFREMIDOU, Anna; PAPAZISIS, Konstantinos; EVRON, Ella; INBAR, Moshe; BARUCH, Noa Ben; GEFFEN, David; KARMINSKY, Natalya; RUGGERI, Enzo Maria; LUIGI, Cavanna; GRASSO, Donatella; JUOZAITYTE, Elona; CID, Jeronimo Rafael Rodriguez; ROERDINK, Henk; SIDDIQI, Neelum; COELHO, Jose Luis Passos; GARRE, Elisa Garcia; GARCIA, Andres; JANEZ, Noelia Martinez; CEBALLOS, Maria Helena Lopez; MELE, Mireia; GARCIA, Maria; ARCEDIANO, Alberto; MCADAM, Karen; PERREN, Timothy; HICKS, Jonathan; TAYLOR, Wendy; HUMPHREYS, Alison; VERA, Raul; STEGER, Guenther; ANDEL, Johannes; GREVE, Jacques de; HUIZING, Manon; HEGG, Roberto; JOY, Anil; SEHDEV, Sandeep; KUTNER, Riina; RUOHOLA, Johanna; DOHOLLOU, Nadine; GROSJEAN, Jessica; LAPLAIGE, Philippe; LARGILLIER, Remy; MARTIN, Philippe; POTTIER, Virginie; ALEXANDRE, Jerome; CHRISTENSEN, Bernd; ZAHM, Dirk-Michael; KHANDAN, Fariba; LUECK, Hans-Joachim; FOUNTZILAS, Georgios; FRIED, Georgeta; GIACOBINO, Alice; BONETTI, Andrea; GUERRA, Yanin Chavarri; WARMERDAM, Laurens Van; VELDEN, Annette Van der; VRIJALDENHOVEN, Suzan; JONGH, Felix de; CAVERO, Milagros; CONEJERO, Raquel Andres; MURIAS, Adolfo; SAURA, Salvador; OLTRA, Amparo; REDONDO, Andres; RIBELLES, Nuria; BACHMEIER, Kilian; JOFFE, Johnathan; CHAKRABORTI, Prabir; BERESFORD, Mark; BUTT, Mohammad; POOLE, Christopher; YORDI, Gassan; WOODWARD, Natasha; AMORIM, Gilberto; CALIFARETTI, Nadia; FOX, Susan; ROBIDOUX, Andre; LI, NanLi; LI, Nenxiao; JIANG, Jun; SORIA, Tannia; PADRIK, Peeter; SAARNI, Outi; GENET, Dominique; CATALA, Stephanie; BARLETTA, Hugues; TEIXEIRA, Luis; FACCHINI, Thomas; HESSE, Tobias; KUEHN, Thorsten; OBER, Angelika; REPP, Roland; SCHROEDER, Willibald; PECTASIDES, Dimitrios; BODOKY, Gyorgy; KAHAN, Zsuzsanna; JIVELIOUK, Irina; ROSENGARTEN, Ora; ALABISO, Oscar; PEREZ, Mario; WOUW, Yes Van de; SMOK-KALWAT, Jolanta; DAMASCENO, Margarida; SOUSA, Gabriela; ABULKHAIR, Omalkhair; TORRES, Antonio Anton; MARTINEZ, Maria Purificacion; MATA, Jesus Garcia; JERICO, Marta Santisteban Jesus Florian; LLOMBART, Antonio; SANCHEZ, Rosa; TORREGO, Juan Carlos; GARATE, Clara Olier; RODRIGUEZ, Cesar; LLORENTE, Rosa; PRADO, Diego Soto de; CORTES, Javier; LLORCA, Cristina; GALAN, Antonio; VILLARO, Gemma Vinas; NARBE, Ulrik; BJOMEKLETT, Helena Granstam; WESTWELL, Sarah; NEWBY, Jackie; JAFRI, Mariam; RODRIGUEZ, Robinson; ALONSO, Isabel
    Background: Pertuzumab combined with trastuzumab and docetaxel is the standard first-line therapy for HER2-positive metastatic breast cancer, based on results from the phase III CLEOPATRA trial. PERUSE was designed to assess the safety and efficacy of investigator-selected taxane with pertuzumab and trastuzumab in this setting. Patients and methods: In the ongoing multicentre single-arm phase IIIb PERUSE study, patients with inoperable HER2-positive advanced breast cancer (locally recurrent/metastatic) (LR/MBC) and no prior systemic therapy for LR/MBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab [8 mg/kg loading dose, then 6 mg/kg every 3 weeks (q3w)] and pertuzumab (840 mg loading dose, then 420 mg q3w) until disease progression or unacceptable toxicity. The primary end point was safety. Secondary end points included overall response rate (ORR) and progression-free survival (PFS). Results: Overall, 1436 patients received at least one treatment dose (initially docetaxel in 775 patients, paclitaxel in 589, nab-paclitaxel in 65; 7 discontinued before starting taxane). Median age was 54 years; 29% had received prior trastuzumab. Median treatment duration was 16 months for pertuzumab and trastuzumab and 4 months for taxane. Compared with docetaxel-containing therapy, paclitaxel-containing therapy was associated with more neuropathy (all-grade peripheral neuropathy 31% versus 16%) but less febrile neutropenia (1% versus 11%) and mucositis (14% versus 25%). At this preliminary analysis (52 months' median follow-up), median PFS was 20.6 [95% confidence interval (CI) 18.9-22.7] months overall (19.6, 23.0 and 18.1 months with docetaxel, paclitaxel and nab-paclitaxel, respectively). ORR was 80% (95% CI 78%-82%) overall (docetaxel 79%, paclitaxel 83%, nab-paclitaxel 77%). Conclusions: Preliminary findings from PERUSE suggest that the safety and efficacy of first-line pertuzumab, trastuzumab and taxane for HER2-positive LR/MBC are consistent with results from CLEOPATRA. Paclitaxel appears to be a valid alternative taxane backbone to docetaxel, offering similar PFS and ORR with a predictable safety profile.
  • conferenceObject
    Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated survival results of the randomized, phase 3 study DESTINY-Breast03
    (2023) HURVITZ, Sara; HEGG, Roberto; CHUNG, Wei-Pang; IM, Seock-Ah; JACOT, William; GANJU, Vinod; CHIU, Joanne Win Yang; XU, Binghe; HAMILTON, Erika; MADHUSUDAN, Srinivasan; IWATA, Hiroji; ALTINTAS, Sevilay; HENNING, Jan-Willem; CURIGLIANO, Giuseppe; PEREZ-GARCIA, Jose Manuel; EGOROV, Anton; LIU, Yali; CATHCART, Jillian; ASHFAQUE, Shahid; CORTES, Javier
  • article 22 Citação(ões) na Scopus
    nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer
    (2021) HAMILTON, Erika; CORTES, Javier; OZYILKAN, Ozgur; CHEN, Shin-Cheh; PETRAKOVA, Katarina; MANIKHAS, Aleksey; JERUSALEM, Guy; HEGG, Roberto; HUOBER, Jens; CHAPMAN, Sonya C.; LU, Yi; HARDEBECK, Molly C.; BEAR, Melissa M.; JOHNSTON, Erica L.; MARTIN, Miguel
    nextMONARCH investigated abemaciclib monotherapy and abemaciclib combined with tamoxifen. Patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) were treated with abemaciclib (with or without prophylactic loperamide) and combined with tamoxifen for endocrine refractory MBC after chemotherapy. The results confirmed the single-agent activity of abemaciclib in heavily pretreated hormone receptor-positive, human epidermal growth factor receptor 2-negative MBC. Background: Abemaciclib is a selective cyclin-dependent kinase 4 and 6 inhibitor administered continuously for hormone receptor-positive (HR*), human epidermal growth factor receptor 2-negative (HER2(-)) advanced breast cancer. Abemaciclib is associated with dose-dependent early-onset diarrhea. nextMONARCH evaluated abemaciclib monotherapy (with or without prophylactic loperamide) and combined with tamoxifen for endocrine refractory metastatic breast cancer (MBC) after chemotherapy. Patients and Methods: nextMONARCH is an open-label, controlled, randomized, phase II study of women with endocrine-refractory HR+, HER2(-) MBC previously treated with chemoherapy. Patients received abemaciclib 150 mg plus tamoxifen 20 mg (A+T), abemaciclib 150 mg every 12 hours (A-150), or abemaciclib 200 mg plus prophylactic loperamide (A-200). The primary objective was progression-free survival (PFS). PFS analyses tested superiority of A+T to A-200 and informal noninferiority of A-150 to A-200. The secondary objectives included the objective response rate (ORR), safety, and pharmacokinetics. Results: The median PFS was 9.1 months for A+T versus 7.4 months for A-200 (hazard ratio, 0.815; 95% confidence interval, 0.556-1.193; P = .293). The A-200 PFS was comparable to that with A-150 at 6.5 months (hazard ratio, 1.045; 95% confidence nterval, 0.711-1.535; P = .811). The ORR was 34.6%, 24.1%, and 32.5% for A+T, A-150, and A-200, respectively. No new safety signals were identified. The incidence and severity of diarrhea (62.3%; grade 3, 7.8%) with A-200 was similar to that with A-150 (67.1%; grade 3, 3.8%). The pharmacokinetics were comparable to previous observations. Conclusions: The addition of tamoxifen to abemaciclib did not significantly improve PFS or ORR compared with abemaciclib monotherapy but confirmed the single-agent activity of abemaciclib in heavily pretreated HR+, HER2(-) MBC. Dose reductions and antidiarrheal medication generally managed diarrhea while maintaining efficacy. (C) 2020 Published by Elsevier Inc.
  • article 4 Citação(ões) na Scopus
    nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR +, HER2-metastatic breast cancer
    (2022) HAMILTON, Erika; CORTES, Javier; OZYILKAN, Ozgur; CHEN, Shin-Cheh; PETRAKOVA, Katarina; MANIKHAS, Aleksey; JERUSALEM, Guy; HEGG, Roberto; HUOBER, Jens; ZHANG, Wei; CHEN, Yanyun; MARTIN, Miguel
    Purpose Resistance to endocrine therapy poses a major clinical challenge for patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). We present the preplanned 24-month final overall survival (OS) results, alongside updated progression-free survival (PFS), and objective response rate (ORR) results. Methods nextMONARCH is an open-label, controlled, randomized, Phase 2 study of abemaciclib alone or in combination with tamoxifen in women with endocrine-refractory HR + , HER2- MBC previously treated with chemotherapy. Patients were randomized 1:1:1 to: abemaciclib 150 mg and tamoxifen 20 mg (A + T), abemaciclib 150 mg (A-150), or abemaciclib 200 mg and prophylactic loperamide (A-200). OS was the main prespecified secondary endpoint. PFS, ORR, and safety at 24 months were compared to previously reported primary analysis results. Results Of the 234 patients enrolled, 12 were receiving study treatment at data cutoff (28Jun2019). Median follow-up was 27.2 months. Median OS was 24.2 months in the A + T arm, 20.8 months in A-150, and 17.0 months in A-200 (A + T versus A-200: HR 0.62; 95%CI [0.40, 0.97], P = 0.03 and A-150 versus A-200: HR 0.96; 95%CI [0.64, 1.44], P = 0.83). PFS and ORR results at 24 months were consistent with the primary analysis. The safety profile corresponded with previous reports. Conclusion The addition of tamoxifen to abemaciclib demonstrated greater OS benefit than monotherapy. This study confirmed the single-agent activity of abemaciclib in heavily pretreated women with endocrine-refractory HR + , HER2- MBC, as well as the previously reported primary PFS and ORR results, with no new safety signals observed.