MAX SENNA MANO
Projetos de Pesquisa
Unidades Organizacionais
LIM/24 - Laboratório de Oncologia Experimental, Hospital das Clínicas, Faculdade de Medicina
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article BRAZILIAN DIRECTOR OF CARDIO-ONCOLOGY OF THE BRAZILIAN CARDIOLOGY SOCIETY ACHIEVEMENT(2011) KALIL FILHO, Roberto; HAJJAR, Ludhmila Abrahao; BACAL, Fernando; HOFF, Paulo Marcelo Gehm; DIZ, Maria Del Pilar Estevez; GALAS, Filomena Regina Barbosa Gomes; FUKUSHIMA, Julia Tizue; ALMEIDA, Juliano Pinheiro de; NAKAMURA, Rosana Ely; TRIELLI, Thalia Rodrigues; BITTAR, Cristina Salvadori; SANTOS, Marilia Harumi dos; GALDEANO, Flavia Gomes; AULER JUNIOR, Jose Otavio da Costa; SILVESTRINI, Anderson Arantes; ALENCAR, Aristoteles; MOTA, Augusto Cesar de Andrade; GUSMAO, Cid Abreu Buarque de; ALMEIDA, Dirceu Rodrigues; SIMOES, Claudia Marques; BOCCHI, Edimar Alcides; LIMA, Enaldo Melo de; FERNANDES, Fabio; SILVEIRA, Fabio Serra; VILAS-BOAS, Fabio; SILVA NETO, Luis Beck da; ROHDE, Luis Eduardo Paim; MONTERA, Marcelo Westerlund; BARBOSA, Marcia; MANO, Max Senna; RIECHELMANN, Rachel Simoes; ARAI, Roberto Jun; MARTINS, Silvia M.; FERREIRA, Silvia Moreira Ayub; SANTOS, Veronica- Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial(2011) GIANNI, Luca; DAFNI, Urania; GELBER, Richard D.; AZAMBUJA, Evandro; MUEHLBAUER, Susanne; GOLDHIRSCH, Aron; UNTCH, Michael; SMITH, Ian; BASELGA, Jose; JACKISCH, Christian; CAMERON, David; MANO, Max; PEDRINI, Jose Luiz; VERONESI, Andrea; MENDIOLA, Cesar; PLUZANSKA, Anna; SEMIGLAZOV, Vladimir; VRDOLJAK, Eduard; ECKART, Michael J.; SHEN, Zhenzhou; SKIADOPOULOS, George; PROCTER, Marion; PRITCHARD, Kathleen I.; PICCART-GEBHART, Martine J.; BELL, RichardBackground Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial. Methods The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48.4 months (IQR 42.0-56.5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11. Findings The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78.6%) compared with the observation group (4-year disease-free survival 72.2%; hazard ratio [HR] 0.76; 95% CI 0.66-0.87; p<0.0001). Intention-to-treat analysis of overall survival showed no significant difference in the risk of death (4-year overall survival 89.3% vs 87.7%, respectively; HR 0.85; 95% CI 0.70-1.04; p=0.11). Overall, 885 patients (52%) of the 1698 patients in the observation group crossed over to receive trastuzumab, and began treatment at median 22.8 months (range 4.5-52.7) from randomisation. In a non-randomised comparison, patients in the selective-crossover cohort had fewer disease-free survival events than patients remaining in the observation group (adjusted HR 0.68; 95% CI 0.51-0.90; p=0.0077). Higher incidences of grade 3-4 and fatal adverse events were noted on 1-year trastuzumab than in the observation group. The most common grade 3 or 4 adverse events, each in less than 1% of patients, were congestive cardiac failure, hypertension, arthralgia, back pain, central-line infection, hot flush, headache, and diarrhoea. Interpretation Treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up. The substantial selective crossover of patients in the observation group to trastuzumab was associated with improved outcomes for this cohort.
- NEW DRUGS IN MEDICAL ONCOLOGY: NEW DIFFICULTIES TO DISTINGUISH DRUG-INDUCED SIDE EFFECTS FROM CANCER COMPLICATIONS: A CASE-REPORT(2011) SERONT, E.; MAZZEO, F.; MANO, M.; STERCKX, M.; HUMBLET, Y.; MACHIELS, J. P.; BAURAIN, J. F.We report the case of a woman with a metastatic breast cancer, who started a third-line treatment with dasatinib, a new oral tyrosine kinase inhibitor, and who developed, one week later, a progressive breathless sensation. Workup demonstrated pleuropericardial effusion that turned out to be a side effect of this new investigational drug. Although this dasatinib-induced side effect is well known, this case clearly illustrates the importance of an accurate diagnosis and adequate treatment of complications of new agents which are easy to use since most of them are orally taken, and the difficulty to clearly separate drug origin and cancer morbidities. The patient recovered completely one month after discontinuation of dasatinib. In this report, we will review the differential diagnosis and management of pleuropericardial effusion.