MARIA DEL PILAR ESTEVEZ DIZ

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

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Assunto: Obstetrics & Gynecology ×

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  • article 21 Citação(ões) na Scopus
    A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma
    (2015) SMALETZ, Oren; DIZ, Maria D. P. E.; CARMO, Claudio C. do; SABBAGA, Jorge; CUNHA-JUNIOR, Geraldo F.; AZEVEDO, Sergio J.; MALUF, Fernando C.; BARRIOS, Carlos H.; COSTA, Ronaldo L.; FONTANA, Ana G.; MADRIGAL, Vivian; WAINSTEIN, Alberto J.; YEDA, Fernanda P.; ALVES, Venancio A.; MORO, Ana M.; BLASBALG, Roberto; SCOTT, Andrew M.; HOFFMAN, Eric W.
    Objectives. The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in patients with platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and patient characteristics. Methods. This two-stage, multicenter, single arm, phase II trial enrolled eligible patients to receive hu3S193 weekly at a dose of 20 mg/m(2) intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks). Results. 26 of 31 patients were eligible for efficacy analysis. No complete/partial responses were observed. Six patients had stable disease for 24+ weeks [clinical benefit rate 23% (95% CI = 9.77%-46.71%)]. Median PFS was 8.4 weeks (95% CI = 6.0 to 16.1). Median PFS differed between patients with no ascites and no visceral disease and patients with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p = 0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 patients (5 with Grade 1/2; 1 with Grade 3). Conclusions. Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in patients with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested. (C) 2015 Elsevier Inc. All rights resenied.
  • article 12 Citação(ões) na Scopus
    Carboplatin-based chemoradiotherapy in advanced cervical cancer: an alternative to cisplatin-based regimen?
    (2016) SEBASTIAO, Ana Morais; ROCHA, Lucila Soares da Silva; GIMENEZ, Rodrigo Darouche; BARROS, Laryssa Almeida Borges de; FUKUSHIMA, Julia Tizuko; SILVA, Samantha Cabral Severino da; MIRANDA, Vanessa da Costa; CAIRES, Inacelli Queiros de Souza; FREITAS, Daniela de; ABDO FILHO, Elias; DIZ, Maria Del Pilar Estevez
    Objective: To evaluate the results of treatment with cisplatin or carboplatin concomitant with radiotherapy (RT) in cases of locally advanced cervical cancer (CC). Methods: This study is a retrospective analysis of medical records of 184 patients with cervical cancer stage IIB-IVA who were treated at Instituto do Cancer do Estado de Sao Paulo from May 2008 to December 2012. All patients received complete pelvic region external-beam RT with weekly cisplatin (cis-RT, 40 mg/m(2); n = 159) or carboplatin (carbo-RT, AUC 2; n = 25), followed by high-dose-rate intracavitary brachytherapy (HDR-ICBT). Primary endpoint was progression free survival; secondary endpoints were overall survival and overall response rate, which includes complete and partial responses. Results: Five or more chemotherapy cycles were administered to 87.3% and 84% of the cis-RT- and carbo-RT- treated patients, respectively (p = 0.749). Estimated 3-years progression free survival was 59% in the cis-RT group vs 40% in the carbo-RT group (p = 0.249). Estimated 3-years overall survival was 70% in the cis-RT group vs 68% in the carbo-RT group (p = 0.298). Overall response rate (95.3% cis-RT vs 95.4% carbo-RT; p = 0.911) and grade >= 3 toxic effects (8.5% cis-RT vs 11.8% carbo-RT; p = 0.757) were similar. In multivariate analysis, only the overall response rate was a significant predictor of survival. Conclusions: Patients with advanced cervical cancer who are treated with carbo-RT have similar 3-years overall survival, progression free survival, overall response rate, and toxic effects when compared to cis-RT-treated patients. Carbo-RT may be an alternative treatment in patients that cannot receive cisplatin.
  • article 3 Citação(ões) na Scopus
    Everolimus plus anastrozole for female adnexal tumor of probable Wolffian origin (FATWO) with STK11 mutation
    (2021) ESTEVEZ-DIZ, Maria De Pilar; BONADIO, Renata Colombo; CARVALHO, Filomena Marino; CARVALHO, Jesus Paula
    Female adnexal tumor of probable Wolffian origin (FATWO) are a rare type of cancer that originates from Wolffian duct remnants. Due to its rarity, no standard systemic treatment is established for cases of recurrent or metastatic disease. Previous literature reported the use of platinum-based chemotherapy and c-Kit tyrosine kinase inhibitors for FATWO cases with c-Kit positive expression. Currently, however, the broader availability of next-generation sequencing (NGS) tests allows a better molecular characterization of rare cancer such as FATWO and a possibility for the use of personalized, targeted therapy. Previous case series that performed NGS for FATWO patients described the presence of STK11 mutations in a considerable number of cases, representing a potential target in this population. To our knowledge, we describe here the first case report of a patient with FATWO and STK11 mutation exhibiting a considerable and durable response after treatment with an mTOR inhibitor plus endocrine therapy.
  • article 58 Citação(ões) na Scopus
    Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab in patients with recurrent and/or metastatic cervical cancer
    (2021) O'MALLEY, David M.; OAKNIN, Ana; MONK, Bradley J.; SELLE, Frederic; ROJAS, Carlos; GLADIEFF, Laurence; BERTON, Dominique; LEARY, Alexandra; MOORE, Kathleen N.; ESTEVEZ-DIZ, Maria D. P.; HARDY-BESSARD, Anne-Claire; ALEXANDRE, Jerome; OPPERMAN, Christina P.; AZEVEDO, Carla Rameri A. S. de; RANDALL, Leslie M.; FELIU, Waldo Ortuzar; ANCUKIEWICZ, Marek; RAY-COQUARD, Isabelle
    Objective. This phase II clinical trial evaluated the safety and antitumor activity of balstilimab, an anti-PD-1 antibody, in patients with previously-treated, recurrent/metastatic cervical cancer. Methods. Eligible patients were 18 years or older with recurrent and/or metastatic cervical cancer and who had relapsed after a prior platinum-based treatment regimen for advanced disease. Balstilimab was administered intravenously at 3 mg/kg once every two weeks, for up to 24 months. The primary endpoint was objective response rate (ORR, RECIST v1.1) as assessed by an independent review committee. Results. At data cutoff, 161 women (median age, 53 years [range 25-81]) were enrolled and treated with balstilimab. Of these, 140 had measurable disease at baseline and one prior line of platinum-based therapy in the metastatic, persistent, or recurrent setting; these patients were included in the efficacy analyses. The ORR was 15% (95% CI, 10.0%-21.8%) and included 5 patients with a complete response and 16 with a partial response. The median duration of response was 15.4 months. In patients with PD-L1-positive tumors the ORR was 20%, however patients with PD-L1-negative tumors also responded to balstilimab (ORR, 7.9%). Responses were not re-stricted to tumors of squamous cell histology, and an ORR of 12.5% was seen in the subset of patients with cervical adenocarcinoma. The disease control rate was 49.3% (95% CI, 41.1%-57.5%). Immune-mediated enterocolitis (3.1%) and diarrhea (1.9%) were the most common grade 3 or higher treatment-related adverse events. Conclusion. Balstilimab demonstrated meaningful and durable clinical activity, with manageable safety, in pa-tients with previously-treated, recurrent/metastatic cervical cancer. (c) 2021 The Authors.
  • article 11 Citação(ões) na Scopus
    Quality of life of locally advanced cervical cancer patients after neoadjuvant chemotherapy followed by chemoradiation versus chemoradiation alone (CIRCE trial): a randomized phase II trial
    (2020) ARRUDA, Fernanda Nunes de; COSTA, Samantha da; BONADIO, Renata; DORNELLAS, Abraao; PEREIRA, Daniela; BOCK, Geertruida H. de; DIZ, Maria Del Pilar Estevez
    Objective The CIRCE trial (NCT 01973101) investigated the efficacy, safety, and quality of life of the addition of neoadjuvant chemotherapy with cisplatin and gemcitabine to standard chemoradiation for locally advanced cervical cancer (stages IIB-IVA). The impact of both treatment arms on quality of life is reported in the present study. Methods Patients completed the European Organization of Research and Treatment of Cancer questionnaire QLQ-C30 and CX24 before treatment and at 3, 6, 9, and 12 months after treatment. Linear mixed models were fitted to analyze differences in quality of life over time and between groups. Differences in mean quality of life scales >10 points and p<0.05 were considered clinically relevant and statistically significant, respectively. Inclusion criteria were: (1) histological diagnosis of locally advanced invasive carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics stages IIB-IVA; (2) signed informed consent to participate in the CIRCE trial; and (3) answered at least one quality of life questionnaire. Excluded were patients who did not complete any quality of life questionnaire. Relevant exclusion criteria for the CIRCE trial included Eastern Cooperative Oncology Group performance status >2 and peripheral neuropathy >2. Mann-Whitney U tests were performed to assess differences between groups in quality of life at baseline. To evaluate differences between treatment arms, linear mixed models were fitted using the transformed quality of life scores as a dependent variable and time of follow-up and study arm as factors. Results A total of 107 patients were enrolled (n=55 neoadjuvant chemotherapy arm; n=52 chemoradiation arm). Quality of life compliance rates were higher for the chemoradiation group at every assessment time (ranging from 75-86.5% in the chemoradiation arm vs 55-81.8% in the neoadjuvant chemotherapy arm). For quality of life results at baseline, no statistically significant difference between the groups was seen. For both groups, most scales showed improvements over time, except for worsening of the summary score, sexual enjoyment, peripheral neuropathy, and menopausal symptoms. For chemoradiation, body image was lower (p<0.001) and patients presented more lymphedema (p<0.001) and sexual worry (p<0.001) at 12 months compared with baseline. Comparing study arms, neoadjuvant chemotherapy showed significantly lower scores in the menopausal symptoms scale (p=0.03) and higher scores for sexual/vaginal functioning (p=0.01). At 12 months, clinical differences were seen only for body image and menopausal symptoms scale, with neoadjuvant chemotherapy presenting better body image scores and a lower burden of menopausal symptoms. Conclusion After treatment for locally advanced cervical cancer, patients improved in most quality of life aspects. However, worsening was observed in sexual enjoyment, peripheral neuropathy, and menopausal symptoms. To improve patients' quality of life, efforts should be made to prevent and treat these long term effects of locally advanced cervical cancer treatment.
  • article 5 Citação(ões) na Scopus
    Management of Para-aortic Lymph Node Disease in Patients With Cervical Cancer What Is the Best Approach?
    (2017) NEGRAO, Marcelo Vailati; LIMA, Julianne Maria da Silva; SILVA, Samantha Cabral Severino; DIZ, Maria Del Pilar Estevez; MIRANDA, Vanessa da Costa
    Cervical cancer remains a prevalent and deadly disease in low-income countries, especially among young and otherwise healthy women. Multimodality treatment has led to a significant improvement in outcomes for patients with locally advanced disease, and this is mainly because of the incorporation of platinum-based chemoradiotherapy in current treatment protocols. However, locally advanced tumors are associated with a greater risk for para-aortic lymph node (PALN) involvement, which is an important adverse prognostic factor. Most staging techniques have low accuracy for detection of disease in this area, which could lead to understaging and undertreatment. Meanwhile, patients with PALN disease are underrepresented in trials addressing the treatment of advanced cervical cancer and a few studies have been directed at this population. The aim of this review is to analyze the current data regarding staging and treatment of cervical cancer with PALN disease to determine which strategy is best when managing these patients.
  • article 0 Citação(ões) na Scopus
    A matched case-control study of the prognosis of early breast cancer in patients with Li-Fraumeni syndrome (BREAST TP53)
    (2023) PETRY, Vanessa; BONADIO, Renata Colombo; TESTA, Laura; COHN, Daniela JBH.; CAGNACCI, Allyne; CAMPOS, Roberta G.; FRAGOSO, Maria Candida Bv; ESTEVEZ-DIZ, Maria del Pilar
    Introduction: Breast cancer (BC) is the most common type of cancer in premenopausal women with germline TP53 pathogenic variants (mTP53) (Li Fraumeni syndrome -LFS). However, little is known about the BC prognosis in these patients. This study analyzed the BC-related oncologic outcomes of patients with LFS.Methods: We evaluated a cohort of LFS patients with BC in comparison with a control cohort of BC patients with no pathogenic variant in a hereditary cancer panel. The primary endpoint was recurrence-free survival (RFS). Due to the risk of second malignancies in LFS, only locoregional and distant recurrences were considered events for RFS. Secondary endpoints included rates of contralateral BC, overall survival (OS), and breast cancer-specific survival (BCSS).Results: Forty-one patients were evaluated in the mTP53 group and 82 in the control group. Median age at BC diagnosis was 40 and 41 years, respectively. The mTP53 group received less adjuvant radiotherapy than the control group (63.4% vs 93.9%, P < 0.001). Other relevant baseline characteristics and treatment received were similar between groups. 5y-RFS rates were 79.4% in the mTP53 versus 93.6% in the control group (HR 2.43, 95% CI 0.74-8.01, P = 0.143); and were not impacted by the use of adjuvant radiotherapy. 5y-BCSS rates were 92.2% and 98.6%, respectively (HR 1.87, IC95% 0.25-13.48, P = 0.534).Conclusions: Our results showed no statistically significant difference in BC-related RFS and BCSS between pa-tients with mTP53 and a control group with no pathogenic variant. Larger multicentric studies are warranted to confirm these results.
  • conferenceObject
    NEOADJUVANT CHEMOTHERAPY FOLLOWED BY RADICAL SURGERY VERSUS CHEMORADIATION FOR STAGE IB2, IIA2 AND IIB CERVICAL CANCER: AN OPEN-LABEL, PHASE III, RANDOMIZED CONTROLLED TRIAL
    (2019) REIS FILHO, P. T. F.; BATISTA, M. P.; SOUSA, C. B.; OLIVIERA, T. H. G. F.; ARRUDA, G. V.; ANDRADE, J. M.; DIZ, M. Del Pilar Estevez; REIS, F. J. C. D.
  • article 2 Citação(ões) na Scopus
    Role of systematic pelvic and para-aortic lymphadenectomy in delayed debulking surgery after six neoadjuvant chemotherapy cycles for high-grade serous ovarian carcinoma
    (2021) LOPES, Andre; GENTA, Maria L. N. D.; MIRANDA, Vanessa da Costa; ARANHA, Andrea; LOPEZ, Rossana V. M.; PIATO, Dariane S. A. M.; ANTON, Cristina; CARVALHO, Filomena M.; DIZ, Maria del Pilar Esteves; CARVALHO, Jesus P.
    Introduction We analyzed the role of systematic pelvic and para-aortic lymphadenectomy in delayed debulking surgery after six neoadjuvant chemotherapy (NACT) cycles for advanced high-grade serous ovarian carcinoma. Materials and Methods We retrospectively reviewed patients with advanced ovarian carcinoma who underwent NACT with carboplatin-paclitaxel between 2008 and 2016. Patients were included only if they had FIGO IIIC-IVB high-grade serous carcinoma with clinically negative lymph nodes after six NACT cycles (carboplatin-paclitaxel) and underwent complete or near complete cytoreduction. Patients with partial lymphadenectomy or bulky nodes were excluded. Patients who underwent systematic pelvic and aortic lymphadenectomy and those who did not undergo lymph node dissection were compared. Progression-free and overall survivals were analyzed using the Kaplan-Meier method. Results Totally, 132 patients with FIGO IIIC-IVB epithelial ovarian carcinoma were surgically treated after NACT. Sixty patients were included (39 and 21 in the lymphadenectomy and nonlymphadenectomy group, respectively); 40% had suspicious lymph nodes before NACT. Patient characteristics, blood transfusion numbers, and complication incidence were similar between the groups. In the lymphadenectomy group, 12 patients (30.8%) had histologically positive lymph nodes and the surgical time was longer (229 vs. 164 min). The median overall survival in the lymphadenectomy and nonlymphadenectomy groups, respectively, was 56.7 (95% CI 43.4-70.1) and 61.2 (21.4-101.0) months (p = 0.934); the corresponding disease-free survival was 8.1 (6.2-10.1) and 8.3 (5.1-11.6) months (p = 0.878). Six patients exclusively presented with lymph node recurrence. Conclusions Systematic lymphadenectomy after six NACT cycles may have no influence on survival.
  • article 24 Citação(ões) na Scopus
    Primary results from CECILIA, a global single-arm phase II study evaluating bevacizumab, carboplatin and paclitaxel for advanced cervical cancer
    (2020) REDONDO, Andres; COLOMBO, Nicoletta; MCCORMACK, Mary; DREOSTI, Lydia; NOGUEIRA-RODRIGUES, Angelica; SCAMBIA, Giovanni; LORUSSO, Domenica; JOLY, Florence; SCHENKER, Michael; RUFF, Paul; ESTEVEZ-DIZ, Maria; IRAHARA, Natsumi; DONICA, Margarita; GONZALEZ-MARTIN, Antonio
    Objective. Adding bevacizumab to cisplatin-paclitaxel for advanced cervical cancer significantly improves overall and progression-free survival. We evaluated bevacizumab with a widely used carboplatin-paclitaxel backbone. Methods. Patients with metastatic/recurrent/persistent cervical cancer not amenable to curative surgery and/ or radiotherapy received 3-weekly bevacizumab 15 mg/kg, paditaxel 175 mg/m(2), and carboplatin AUC 5 until progression or unacceptable toxicity. Maintenance bevacizumab was allowed. Patients with ongoing bladder/rectal involvement, prior cobalt radiotherapy, a history of fistula/gastrointestinal perforation, or recent bowel resection/chemoradiation were excluded. The primary objective was to determine incidences of gastrointestinal perforation/fistula, gastrointestinal-vaginal fistula, and genitourinary fistula. Results. Among 150 treated patients, disease at study entry was persistent in 21%, recurrent in 56%, and newly diagnosed metastatic in 23%. After 27.8 months median follow-up, median bevadzumab duration was 6.7 months; 57% received maintenance bevacizumab. Seventeen patients (11.3%; 95% CI: 6.7-17.5%) experienced >= 1 perforation/fistula event: gastrointestinal perforation/fistula in 4.7% (1.9-9.4%), gastrointestinal-vaginal fistula in 4.0% (1.5-8.5%), and genitourinary fistula in 4.7% (1.9-9.4%). Of these, 16 were previously irradiated, several with ongoing radiation effects. The most common grade 3/4 adverse events were neutropenia (25%), anemia (19%), and hypertension (14%). Five patients (3%) had fatal adverse events. Objective response rate was 61% (95% CI: 52-69%), median progression-free survival was 10.9 (10.1-13.7) months, and median overall survival was 25.0 (20.9-30.4) months. Conclusions. Bevadzumab can be combined with carboplatin-paclitaxel in the CECILIA study population. The fistula/gastrointestinal perforation incidence is in line with GOG-0240: efficacy results are encouraging.