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Phase II trial of humanized anti-Lewis Y monoclonal antibody for advanced hormone receptor-positive breast cancer that progressed following endocrine therapy
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Testa, Laura

; Mano, Max

; Arai, Roberto Jun

; Bonadio, Renata Colombo

; Serrano, Sergio V.

; Zorzetto, Marina M Costa

; Crocamo, Susanne

; Smaletz, Oren

; Freitas-Junior, Ruffo

; Hoff, Paulo M.

Clinics

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2021, Volume 76 elocation e3146

Resumo: En | Texto: En | PDF: En

OBJECTIVES: The Lewis-Y antigen is expressed in 44%-90% of breast cancers (BCs). The expression of the antigen in carcinoma tissue differs from that in normal tissues. This study aimed to evaluate the clinical benefit of the humanized anti-Lewis Y monoclonal antibody, hu3S193, in advanced hormone receptor-positive and Lewis Y-positive BC after administration of endocrine therapy (ET). METHODS: A single-arm phase II study was conducted in seven centers. Patients with advanced hormone receptor-positive BC who failed first-line ET were included. The inclusion criterion was the observation of tumoral expression of the Lewis Y antigen during immunohistochemistry. The treatment comprised hu3S193 antibody administration at weekly intravenous doses of 20 mg/m2 for 8-week cycles. The primary endpoint was the clinical benefit rate. ClinicalTrials.gov NCT01370239. RESULTS: The study stopped accrual following an unplanned interim analysis as the hu3S193 antibody lacked sufficient activity to justify continuation of the study. Twenty-two patients were enrolled, of whom 21 were included in the efficacy analysis. The clinical benefit rate was 19%, with four patients presenting with stable disease after 24 weeks. One patient with prolonged stable disease received medication for over 2 years. No partial or complete responses were observed. The median time to progression and overall survival was 5.4 and 37.5 months, respectively. CONCLUSIONS: The humanized anti-Lewis Y monoclonal antibody, hu3S193, exhibited insufficient activity in this cohort. However, the possibility of activity in a more strictly selected subgroup of patients with higher levels of Lewis Y tumoral expression cannot be overlooked.

https://doi.org/10.6061/clinics/2021/e3146 110 downloads

Second brazilian consensus on the treatment of advanced prostate cancer: a SBOC-SBU-SBRT panel review
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Sasse, Andre Deeke

; Reis, Rodolfo Borges dos

; Nogueira, Lucas Mendes

; Maluf, Fernando Cotait

; Herchenhorn, Daniel

; Smaletz, Oren

; Lima, Volney Soares

; Schutz, Fábio

; Bastos, Diogo

; Wiermann, Evanius Garcia

; Morbeck, Igor Alexandre Protzner

; Jardim, Leonardo Fontes

; Souza, Vinicius Carrera

; Carvalho, Icaro Thiago

; Leite, Elton Trigo Teixeira

; Nardozza Jr., Archimedes

; Pompeo, Antonio Carlos Lima

; Bretas, Francisco

; Leal, Marcos Lima de Oliveira

; Sadi, Marcus Vinicius

; Ponte, José Ricardo Tuma da

; Carvalhal, Gustavo F.

International braz j urol

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Jun 2019, Volume 45 Nº 3 Páginas 449 - 458

Resumo: En | Texto: En | PDF: En

ABSTRACT Prostate cancer is the second most common cancer and the fifth leading cause of cancer deaths. In Brazil, it is likewise the second most common cancer among men, second only to non-melanoma skin cancers. The aim of this consensus is to align different opinions and interpretations of the medical literature in a practical and patient-oriented approach. The first Brazilian Consensus on the Treatment of Advanced Prostate Cancer was published in 2017, with the goal of reducing the heterogeneity of therapeutic conduct in Brazilian patients with metastatic prostate cancer. We acknowledge that in Brazil the incorporation of different technologies is a big challenge, especially in the Sistema Único de Saúde (SUS), which allows for the disparity in the options available to patients treated in different institutions. In order to update the recommendations and to make them objective and easily accessible, once more a panel of specialists was formed in order to discuss and elaborate a new Brazilian Consensus on Advanced Prostate Cancer. This Consensus was written through a joint initiative of the Brazilian Society of Clinical Oncology (SBOC) and the Brazilian Society of Urology (SBU) to support the clinical decisions of physicians and other health professionals involved in the care of patients with prostate cancer.

https://doi.org/10.1590/s1677-5538.ibju.2018.0798 885 downloads

Comparison of Gleason upgrading rates in transrectal ultrasound systematic random biopsies versus US-MRI fusion biopsies for prostate cancer
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Kayano, Paulo Priante

; Carneiro, Arie

; Castilho, Tiago Mendonça Lopez

; Sivaraman, Arjun

; Claros, Oliver Rojas

; Baroni, Ronaldo Hueb

; Garcia, Rodrigo Gobbo

; Mariotti, Guilherme Cayres

; Smaletz, Oren

; Filippi, Renne Zon

; Lemos, Gustavo Caserta

International braz j urol

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Dez 2018, Volume 44 Nº 6 Páginas 1106 - 1113

Resumo: En | Texto: En | PDF: En

ABSTRACT Purpose: Ultrasound-magnetic resonance imaging (US-MRI) fusion biopsy (FB) improves the detection of clinically significant prostate cancer (PCa). We aimed to compare the Gleason upgrading (GU) rates and the concordance of the Gleason scores in the biopsy versus final pathology after surgery in patients who underwent transrectal ultrasound (TRUS) systematic random biopsies (SRB) versus US-MRI FB for PCa. Materials and Methods: A retrospective analysis of data that were collected prospectively from January 2011 to June 2016 from patients who underwent prostate biopsy and subsequent radical prostatectomy. The study cohort was divided into two groups: US-MRI FB (Group A) and TRUS SRB (Group B). US-MRI FB was performed in patients with a previous MRI with a focal lesion with a Likert score ≥3; otherwise, a TRUS SRB was performed. Results: In total, 73 men underwent US-MRI FB, and 89 underwent TRUS SRB. The GU rate was higher in Group B (31.5% vs. 16.4%; p=0.027). According to the Gleason grade pattern, GU was higher in Group B than in Group A (40.4% vs. 23.3%; p=0.020). Analyses of the Gleason grading patterns showed that Gleason scores 3+4 presented less GU in Group A (24.1% vs. 52.6%; p=0.043). The Bland-Altman plot analysis showed a higher bias in Group B than in Group A (-0.27 [-1.40 to 0.86] vs. −0.01 [-1.42 to 1.39]). In the multivariable logistic regression analysis, the only independent predictor of GU was the use of TRUS SRB (2.64 [1.11 – 6.28]; p=0.024). Conclusions: US-MRI FB appears to be related to a decrease in GU rate and an increase in concordance between biopsy and final pathology compared to TRUS SRB, suggesting that performing US-MRI FB leads to greater accuracy of diagnosis and better treatment decisions.

https://doi.org/10.1590/s1677-5538.ibju.2017.0552 665 downloads

Prostate cancer recurrence in vas deferens – fusion image guide as an important tool in dignosis
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Valle, Leonardo Guedes Moreira

; Rahal Jr., Antônio

; Falsarella, Priscila Mina

; Andrade, Juliano Ribeiro de

; Smaletz, Oren

; Osawa, Akemi

; Garcia, Rodrigo Gobbo

International braz j urol

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Fev 2018, Volume 44 Nº 1 Páginas 192 - 195

Resumo: En | Texto: En | PDF: En

ABSTRACT The biochemical recurrence after local treatment for prostate cancer is an often challenging condition of clinical management. The aim of this report is to demonstrate the importance of the association of various imaging methods in the identification and subsequent accurate percutaneous biopsy in patients with recurrence of prostate cancer, especially in unusual sites. An 86 years old male with biochemical recurrence, during radiological investigation a PET-MRI was noted the presence of an asymmetry of the vas deferens with PSMA-68Ga uptaken, suggesting the recurrence. A percutaneous fusion biopsy with PET-MRI and ultrasound was performed using transrectal access using ultrasound confirming infiltrating adenocarcinoma of the wall of the vas deferens, compatible with neoplastic prostate recurrence. The fusion image technique combines the real–time view of the US to the possibility of higher definition and higher specificity, methods more anatomical detail as tomography and magnetic resonance imaging, simultaneously. High resolution acquired in PET / MR associated with image fusion allows orientation procedures, even in areas of difficult access, with greater accuracy than conventional techniques.

https://doi.org/10.1590/s1677-5538.ibju.2017.0071 570 downloads

Impact of local treatment on overall survival of patients with metastatic prostate cancer: systematic review and meta-analysis
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Carneiro, Arie

; Baccaglini, Willy

; Glina, Felipe P.A.

; Kayano, Paulo P.

; Nunes, Victor M.

; Smaletz, Oren

; Bernardo, Wanderley Marques

; Carvalho, Icaro Thiago de

; Lemos, Gustavo Caserta

International braz j urol

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Ago 2017, Volume 43 Nº 4 Páginas 588 - 599

Resumo: En | Texto: En | PDF: En

ABSTRACT Context Currently, standard treatment of metastatic prostatic cancer (MPCa) is androgen-deprivation therapy (ADT). Recent studies suggested that local treatment of MPCa is related to increase of survival of those patients, as observed in other tumors. Objective To evaluate the impact of local treatment on overall survival and cancer specific survival in 3 and 5 years in patients with MPCa. Materials and Methods Systematic review and meta-analysis of population studies published at PubMed, Scielo, Lilacs, Cochrane and EMBASE databases until June 2016. Several large cohorts and Post-Roc studies were included, that evaluated patients with MPCa submitted to local treatment (LT) using radiotherapy (RDT), surgery (RP) or brachytherapy (BCT) or not submitted to local treatment (NLT). Results 34.338 patients were analyzed in six included papers, 31.653 submitted to NLT and 2.685 to LT. Overall survival in three years was significantly higher in patients submitted to LT versus NLT (64.2% vs. 44.5%; RD 0.19, 95% CI, 0.17-0.21; p<0.00001; I2=0%), as well as in five years (51.9% vs. 23.6%; RD 0.30, 95% CI, 0.11-0.49; p<0.00001; I2=97%). Sensitive analysis according to type of local treatment showed that surgery (78.2% and 45.0%; RD 0.31, 95% CI, 0.26-0.35; p<0.00001; I2=50%) and radiotherapy (60.4% and 44.5%; RD 0.17, 95% CI, 0.12-0.22; p<0.00001; I2=67%) presented better outcomes. Conclusion LT using RDT, RP or BCT seems to significantly improve overall survival and cancer-specific survival of patients with metastatic prostatic cancer. Prospective and randomized studies must be performed in order to confirm our results.

https://doi.org/10.1590/s1677-5538.ibju.2016.0483 1507 downloads

First brazilian consensus of advanced prostate cancer: recommendations for clinical practice
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Sasse, Andre Deeke

; Wiermann, Evanius Garcia

; Herchenhorn, Daniel

; Bastos, Diogo Assed

; Schutz, Fabio A.

; Maluf, Fernando Cotait

; Coura Filho, George

; Morbeck, Igor Alexandre Protzner

; Cerci, Juliano J.

; Smaletz, Oren

; Lima, Volney Soares

; Adamy Jr., Ari

; Campos, Franz Santos de

; Carvalhal, Gustavo Franco

; Cezar, Leandro Casemiro

; Dall´Oglio, Marcos Francisco

; Sadi, Marcus Vinicius

; Reis, Rodolfo Borges dos

; Nogueira, Lucas

International braz j urol

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Jun 2017, Volume 43 Nº 3 Páginas 407 - 415

Resumo: En | Texto: En | PDF: En

ABSTRACT Introduction Prostate cancer still represents a major cause of morbidity, and still about 20% of men with the disease are diagnosed or will progress to the advanced stage without the possibility of curative treatment. Despite the recent advances in scientific and technological knowledge and the availability of new therapies, there is still considerable heterogeneity in the therapeutic approaches for metastatic prostate cancer. Objectives This article presents a summary of the I Brazilian Consensus on Advanced Prostate Cancer, conducted by the Brazilian Society of Urology and Brazilian Society of Clinical Oncology. Materials and Methods Experts were selected by the medical societies involved. Forty issues regarding controversial issues in advanced disease were previously elaborated. The panel met for consensus, with a threshold established for 2/3 of the participants. Results and Conclusions The treatment of advanced prostate cancer is complex, due to the existence of a large number of therapies, with different response profiles and toxicities. The panel addressed recommendations on preferred choice of therapies, indicators that would justify their change, and indicated some strategies for better sequencing of treatment in order to maximize the potential for disease control with the available therapeutic arsenal. The lack of consensus on some topics clearly indicates the absence of strong evidence for some decisions.

https://doi.org/10.1590/s1677-5538.ibju.2016.0490 1303 downloads

Current management and future directions in the treatment of advanced renal cell carcinoma-a latin american perspective: 10 years in review
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Smaletz, Oren

International braz j urol

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Out 2015, Volume 41 Nº 5 Páginas 835 - 843

Resumo: En | Texto: En | PDF: En

ABSTRACT The worldwide incidence of kidney cancer is estimated at 337,860 new cases per year in the International Agency for Research on Cancer's GLOBOCAN 2012 update, with an estimated 143,369 deaths annually. Over the past 10 years, there have been significant advances in the treatment of advanced/metastatic renal cell carcinoma, including the development of targeted therapies. Currently recommended first-line treatments include sunitinib, temsirolimus, bevacizumab plus interferon, and pazopanib, or high-dose interleukin-2 or sorafenib for selected patients. Recommended second-line treatments include all of the above agents, as well as everolimus and axitinib. Unfortunately, combination therapies have generally resulted in increased toxicity and little improvement in efficacy. Recent studies focused on identification of predictive biomarkers for responses to specific targeted therapies and have not been successful to date. Despite recent advances in targeted treatment for metastatic renal cell carcinoma, important questions regarding biomarkers of efficacy, and optimal combination and sequencing of agents remain to be answered. This paper reviews literature concerned with first-and second-line treatment of metastatic renal cell carcinoma and will discuss key issues in Latin America.

https://doi.org/10.1590/S1677-5538.IBJU.2014.0651 2099 downloads

Higher overall survival in metastatic pancreatic cancer: the impact of where and how treatment is delivered
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Usón Junior, Pedro Luiz Serrano

; França, Monique Sedlmaier

; Rodrigues, Heloisa Veasey

; Macedo, Antônio Luiz de Vasconcellos

; Goldenberg, Alberto

; Smaletz, Oren

; Armentano, Daniela Pezzutti Domingues

; Simon, Sergio Daniel

; Gansl, Rene Claudio

einstein (São Paulo)

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Set 2015, Volume 13 Nº 3 Páginas 347 - 351

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

Objetivo Determinar a sobrevida global dos pacientes com câncer pancreático avançado e avaliar fatores com impacto prognóstico em um centro de câncer privado.Métodos Foram coletados retrospectivamente os dados do Registro de Câncer do Hospital Israelita Albert Einstein. Os pacientes incluídos apresentaram câncer metastático ao diagnóstico ou em estádio mais precoce com recorrência subsequente. Os casos de tumores neuroendócrinos foram excluídos.Resultados Foram avaliados 65 pacientes, incluindo 63 com adenocarcinoma. A sobrevida global mediana dos pacientes em todos os estádios foi 20,7 meses (IC95%: 15,6-25,7), enquanto a sobrevida global de doença metastática foi de 13,3 meses. Entre os 33 casos com câncer em estádio IV, não houve evidência de associação estatisticamente significativa entre a sobrevida mediana e CA19-9 ao diagnóstico (p=0,212), localização do tumor (p=0,482), primeiro tratamento realizado (p=0,337), invasão vasculo-linfática (p=0,286) e idade (p=0,152). No entanto, o número de linhas de quimioterapia foi significativamente associado com a sobrevida (log-rankp=0,013), com uma sobrevida mediana estimada de 10,2 meses para os pacientes que receberam até duas linhas de tratamento e de 23,5 meses para os que receberam mais de duas linhas.Conclusão A sobrevida dos pacientes tratados foi maior do que o relatado na literatura. O único fator estatisticamente significativo relacionado à maior sobrevida foi maior número de linhas de quimioterapia recebidas. Acreditamos que o nível socioeconômico dos pacientes pesquisados neste estudo, assim como seu maior acesso a opções de tratamento, pode ter influenciado em sua sobrevivência global.

Objective To determine the overall survival of patients with advanced pancreatic cancer and evaluate factors that impact prognosis in a private cancer center.Methods Data from the Hospital Cancer Registry at Hospital Israelita Albert Einstein were retrospectively collected. The patients enrolled had metastatic cancer at diagnosis or earlier staging and subsequent recurrence. Cases of neuroendocrine tumors were excluded.Results A total of 65 patients were evaluated, including 63 with adenocarcinoma. The median overall survival for patients in all stages was 20.7 months (95%CI: 15.6-25.7), while the overall survival of metastatic disease was 13.3 months. Among the 33 cases with stage IV cancer, there was no evidence of a statistically significant association between median survival and CA19-9 dosage (p=0.212), tumor location (p=0.482), first treatment performed (p=0.337), lymphovascular invasion (p=0.286), and age (p=0.152). However, the number of lines of chemotherapy was significantly associated with survival (log-rank p=0.013), with an estimated median survival of 10.2 months for patients who received up to two lines of treatment and 23.5 months for those receiving more than two lines of chemotherapy.Conclusion The survival of patients treated was longer than that reported in the literature. The only statistically significant factor related to increased survival was higher number of lines of chemotherapy received. We believe that the higher socioeconomic status of patients surveyed in this study, as well as their greater access to treatment options, may have influenced their overall survival.

https://doi.org/10.1590/S1679-45082015AO3303 3698 downloads

The impact of erlotinib use in non-small-cell lung cancer patients treated in a private reference general hospital and in a private cancer clinic from 2005 to 2011
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Bognar, Cinthia Leite Frizzera Borges

; Simon, Sergio Daniel

; Gansl, Rene Claudio

; Abramoff, Roberto

; Aisen, Marcelo

; Lopes Junior, Gilberto de Lima

; Smaletz, Oren

; Peres, Stela Verzinhasse

; Tabacof, Jacques

einstein (São Paulo)

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Jun 2015, Volume 13 Nº 2 Páginas 215 - 220

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

RESUMO Objetivo: Relatar as características demográficas e a evolução de pacientes com neoplasia de pulmão de não pequenas células que receberam erlotinibe em qualquer linha de tratamento. Métodos: Coletamos retrospectivamente dados de pacientes portadores de neoplasia de pulmão de não pequenas células que receberam erlotinibe em qualquer linha de tratamento em um hospital geral de referência e em uma clínica particular de oncologia em São Paulo, no período de 2005 a 2011. Foi realizada a análise estatística e foram avaliados aspectos demográficos e resposta ao tratamento estabelecido, correlacionando os resultados dessa primeira coorte publicada no Brasil com resultados da literatura vigente. Resultados: Foram avaliados 44 pacientes, dos quais 65,9% eram portadores de adenocarcinoma e 63,6% tinham doença metastática. A média de idade foi de 63,3 anos. O seguimento mediano foi de 47,9 meses. A pesquisa de mutação do receptor do fator de crescimento epidérmico foi realizada em 22,7% dos pacientes (n=10), resultando positiva em 30% dos avaliados. A sobrevida global mediana foi de 46,3 meses, e observou-se uma probabilidade maior de sobrevida em 60 meses para o grupo feminino, quando comparado ao grupo masculino (29,4% versus 15,8%; p=0,042). As demais variáveis não apresentaram diferença estatística significativa. Conclusão: Coletamos a maior sequência de pacientes com neoplasia de pulmão de não pequenas células que fizeram uso de erlotinibe no Brasil até a data vigente e demonstramos que a evolução dos pacientes tratados no período avaliado teve resultados concordantes com os da literatura vigente em pacientes semelhantes.

ABSTRACT Objective: To report the demographic data and clinical outcomes of non-small-cell lung cancer patients exposed to erlotinib in any line of treatment. Methods: This was a retrospective cohort study of nonsmall-cell lung cancer patients from a reference general hospital and a private oncology clinic, who received erlotinib from 2005 to 2011. Statistical analysis was performed and we evaluated demographic data and response to treatment, by correlating the results of this first cohort published in Brazil with results of current literature. Results: A total of 44 patients were included; 65.9% were diagnosed with adenocarcinoma, and 63.6% had metastatic disease. The mean age was 63.3 years. The median follow-up was 47.9 months. Epidermal growth factor receptor mutation screening was performed in 22.7% of patients (n=10), with mutation present in 30% of patients. The median overall survival was 46.3 months, and there was a higher probability of survival at 60 months for females compared to males (29.4% versus 15.8%; p=0.042). The other variables did not present significant statistical difference. Conclusion: We collected the largest cohort of patients with non-small-cell lung cancer who have used erlotinib in Brazil to date, and demonstrated that outcomes of patients treated at our clinic during the study period were consistent with the results of current literature in similar patients.

https://doi.org/10.1590/S1679-45082015AO3326 3497 downloads

10.

Castration-resistant prostate cancer: systemic therapy in 2012
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Maluf, Fernando C.

; Smaletz, Oren

; Herchenhorn, Daniel

Clinics

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2012, Volume 67 Nº 4 Páginas 389 - 394

Resumo: En | Texto: En | PDF: En

Prostate cancer is the most common non-cutaneous neoplasm in the male population worldwide. It is typically diagnosed in its early stages, and the disease exhibits a relatively indolent course in most patients. Despite the curability of localized disease with prostatectomy and radiation therapy, some patients develop metastatic disease and die. Although androgen deprivation is present in the majority of patients with metastatic prostate cancer, a state of androgen resistance eventually develops. Castration-resistant prostate cancer, defined when there is progression of disease despite low levels of testosterone, requires specialized care, and improved communication between medical and urologic oncologists has been identified as a key component in delivering effective therapy. Despite being considered a chemoresistant tumor in the past, the use of a prostate-specific antigen has paved the way for a new generation of trials for castration-resistant prostate cancer. Docetaxel is a life-prolonging chemotherapy that has been established as the standard first-line agent in two phase III clinical trials. Cabazitaxel, a novel taxane with activity in cancer models resistant to paclitaxel and docetaxel, is the only agent that has been compared to a chemotherapy control in a phase III clinical trial as a second-line therapy; it was found to prolong the overall survival of patients with castration-resistant prostate cancer previously treated with docetaxel when compared to mitoxantrone. Other agents used in this setting include abiraterone and sipuleucel-T, and novel therapies are continually being investigated in an attempt to improve the outcome for patients with castration-resistant prostate cancer.

https://doi.org/10.6061/clinics/2012(04)13 3943 downloads

11.

A oncopsiquiatria no câncer de mama: considerações a respeito de questões do feminino
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Cantinelli, Fábio Scaramboni

; Camacho, Renata Sciorilli

; Smaletz, Oren

; Gonsales, Bárbara Karina

; Braguittoni, Érika

; Rennó Jr., Joel

Archives of Clinical Psychiatry (São Paulo)

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2006, Volume 33 Nº 3 Páginas 124 - 133

Resumo: Pt En | Texto: Pt En | PDF: Pt | PDF: En

Os autores revisaram amplamente a literatura em relação aos fatores psiquiátricos envolvendo o câncer de mama. Dentro da linha de raciocínio mestra dos tratamentos cirúrgico e oncológico dessas pacientes, ressalta-se seu impacto sobre a saúde mental. Aspectos como possibilidades cirúrgicas, imagem corporal e impacto sobre auto-estima e sexualidade, tratamentos sistêmicos e conseqüências físicas, tais como fadiga, náuseas e vômitos, foram discutidos. As diferenças entre os grupos etários submetidos ao tratamento também foram relevadas, separando-se suas questões. Tópicos sobre a qualidade de vida sempre foram ressaltados. Questões sobre intervenções farmacológicas e psicoterapêuticas foram igualmente levantadas, incluindo medicina alternativa.

The authors performed a broad literature review about psychiatric factors in breast cancer. Inside the master reasoning of the surgical and oncological treatments, an emphasis was made on heir impact over the mental health. Aspects like surgical possibilities and body image and its impact over the self-estime and sexuality and systemic treatments and their physical consequences, like fatigue, nausea and vomiting were discussed. The differences between the aged groups treated also were considered, separating their issues. Topics about Quality of Life was always considered. Questions about pharmacological and psychotherapeutical approach were considered too, including alternative medicine.

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