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1.
Ann Surg Oncol ; 28(11): 6705-6713, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33683525

RESUMO

BACKGROUND: Ovarian cancer with miliary disease spread is an aggressive phenotype lacking targeted management strategies. We sought to determine whether adjuvant intravenous/intraperitoneal (IV/IP) chemotherapy is beneficial in this disease setting. METHODS: Patient/tumor characteristics and survival data of patients with stage IIIC epithelial ovarian cancer who underwent optimal primary debulking surgery from 01/2010 to 11/2014 were abstracted from records. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous variables. The Kaplan-Meier method was used to estimate survival curves, and outcomes were compared using log-rank tests. Factors significant on univariate analysis were combined into multivariate logistic regression survival models. RESULTS: Among 90 patients with miliary disease spread, 41 (46%) received IV/IP chemotherapy and 49 (54%) received IV chemotherapy. IV/IP chemotherapy, compared with IV chemotherapy, resulted in improved progression-free survival (PFS; 23.0 versus 12.0 months; p = 0.0002) and overall survival (OS; 52 versus 36 months; p = 0.002) in patients with miliary disease. Among 78 patients with nonmiliary disease spread, 23 (29%) underwent IV/IP chemotherapy and 55 (71%) underwent IV chemotherapy. There was no PFS or OS benefit associated with IV/IP chemotherapy over IV chemotherapy in these patients. On multivariate analysis, IV/IP chemotherapy was associated with improved PFS (HR, 0.28; 95% CI 0.15-0.53) and OS (HR, 0.33; 95% CI 0.18-0.61) in patients with miliary disease compared with those with nonmiliary disease (PFS [HR, 1.53; 95% CI 0.74-3.19]; OS [HR, 1.47; 95% CI 0.70-3.09]). CONCLUSIONS: Adjuvant IV/IP chemotherapy was associated with oncologic benefit in miliary disease spread. This survival benefit was not observed in nonmiliary disease.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Ovarianas , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Epitelial do Ovário/tratamento farmacológico , Carcinoma Epitelial do Ovário/patologia , Quimioterapia Adjuvante , Procedimentos Cirúrgicos de Citorredução , Intervalo Livre de Doença , Feminino , Humanos , Infusões Parenterais , Estadiamento de Neoplasias , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/patologia , Estudos Retrospectivos
2.
Gynecol Oncol ; 159(3): 687-691, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32951891

RESUMO

OBJECTIVES: To determine whether neoadjuvant chemotherapy (NACT) disproportionately benefits obese patients. METHODS: Data were collected from stage IIIC-IV ovarian cancer patients treated between 01/2010-07/2015. We performed univariate/multivariate logistic regression analyses with post-operative infection, readmission, any postoperative complication, and time to chemotherapy as outcomes. An interaction term was included in models, to determine if the effect of NACT on post-operative complications was influenced by obesity status. RESULTS: Of 507 patients, 115 (22.6%) were obese and 392 (77.3%) were non-obese (obese defined as BMI ≥30). Among obese patients undergoing primary debulking surgery (PDS) vs. NACT, rates of postoperative infection were 42.9% vs. 30.8% (p = 0.12), 30-day readmission 30.2% vs. 11.5% (p < 0.02), and any post-operative complication were 44.4% vs 30.8% (p = 0.133). Among non-obese patients undergoing PDS vs. NACT, rates of post-operative infection were 20.0% vs. 12.9% (p = 0.057), 30-day readmission 16.9% vs. 9.2% (p = 0.02), and any post-operative complication were 19.4% vs 28% (p = 0.044). Obesity was associated with post-operative infection (OR 2.3; 95%CI 1.22-4.33), 30-day readmission/reoperation (OR 2.27; 95%CI 1.08-3.21) and the development of any post-operative complication (OR 2.1; CI 1.13-3.74). However, there was not a significant interaction between obesity and NACT in any of the models predicting post-operative complications. CONCLUSIONS: The decision to use NACT should not be predicated on obesity alone, as the reduction in post-operative complications in obese patients is similar to non-obese patients.


Assuntos
Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Terapia Neoadjuvante , Obesidade/complicações , Neoplasias Ovarianas/terapia , Complicações Pós-Operatórias/epidemiologia , Idoso , Quimioterapia Adjuvante/estatística & dados numéricos , Tomada de Decisão Clínica , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/complicações , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/patologia , Ovário/patologia , Ovário/cirurgia , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Tempo , Tempo para o Tratamento/estatística & dados numéricos
3.
Gynecol Oncol ; 153(1): 63-67, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30635213

RESUMO

OBJECTIVES: To determine whether perioperative red blood cell transfusion (PRBCT) affects infection, thrombosis, or survival rates in epithelial ovarian cancer (EOC) patients undergoing neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS). METHODS: Demographics, operative characteristics, and outcome data were abstracted from records of stage IIIC-IV EOC patients managed with NACT-IDS from 01/2010-07/2015. Associations of PRBCT with morbidity and oncologic outcomes were evaluated. RESULTS: Of 270 patients, 136 (50.4%) received PRBCT. Patients with preoperative anemia and higher estimated blood loss (EBL) were more likely to undergo PRBCT (OR,95%CI 1.80, 1.02-3.17) and (OR,95%CI 1.00, 1.002-1.004), respectively. There were no significant differences in PRBCT based on patient age, Charlson Comorbidity Index, or stage. When compared to low complexity operations, patients with moderate and high complexity surgeries were more likely to receive PRBCT (OR,95%CI 1.81, 1.05-3.09) and (OR,95%CI 2.25, 1.13-4.50), respectively. On univariate analysis, PRBCT was associated with intraabdominal infection (OR,95%CI 8.31, 1.03-67.41), but not wound complications (OR,95%CI 1.57, 0.76-3.23) or venous thromboembolism/pulmonary embolism (VTE/PE) (OR,95%CI 2.02, 0.49-8.23). After adjusting for surgical complexity and preoperative anemia, PRBCT was not independently associated with intraabdominal infection (OR,95%CI 7.66, 0.92-63.66), wound complications (OR,95%CI 1.70, 0.80-3.64), or VTE/PE (OR,95%CI 2.15, 0.51-9.09). When comparing patients undergoing PRBCT versus those who did not, there were no significant differences in median progression-free survival (PFS) or median overall survival (OS) on univariate analysis after adjusting for age, stage and residual disease. CONCLUSIONS: Among patients undergoing NACT-IDS, intraabdominal infection, wound complication and VTE/PE rates are similar, regardless of PRBCT. PRBCT does not impact PFS or OS.


Assuntos
Carcinoma Epitelial do Ovário/cirurgia , Procedimentos Cirúrgicos de Citorredução/estatística & dados numéricos , Transfusão de Eritrócitos/estatística & dados numéricos , Infecções Intra-Abdominais/epidemiologia , Embolia Pulmonar/epidemiologia , Infecção da Ferida Cirúrgica/epidemiologia , Tromboembolia Venosa/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Epitelial do Ovário/sangue , Carcinoma Epitelial do Ovário/tratamento farmacológico , Quimioterapia Adjuvante , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Humanos , Infecções Intra-Abdominais/etiologia , Pessoa de Meia-Idade , Terapia Neoadjuvante , Assistência Perioperatória/métodos , Assistência Perioperatória/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Intervalo Livre de Progressão , Embolia Pulmonar/genética , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/etiologia , Taxa de Sobrevida , Resultado do Tratamento , Tromboembolia Venosa/etiologia
4.
Am J Obstet Gynecol ; 221(4): 326.e1-326.e7, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31082382

RESUMO

BACKGROUND: Complete surgical resection affords the best prognosis at the time of interval debulking surgery. When complete surgical resection is unachievable, optimal residual disease is considered the next best alternative. Despite contradicting evidence on the survival benefit of interval debulking surgery if macroscopic residual disease remains, the current definition of "optimal" in patients undergoing interval debulking surgery is defined as largest diameter of disease measuring ≤1.0 cm, independent of the total volume of disease. OBJECTIVE: To examine the relationship between volume and anatomic distribution of residual disease and oncologic outcomes among patients with advanced-stage epithelial ovarian/fallopian tube/primary peritoneal carcinoma undergoing neoadjuvant chemotherapy then interval debulking surgery. For patients who did not undergo a complete surgical resection, a surrogate for volume of residual disease was used to assess oncologic outcomes. STUDY DESIGN: Patient demographics, operative characteristics, anatomic site of residual disease, and outcome data were collected from medical records of patients with International Federation of Gynecology and Obstetrics stage IIIC and IV epithelial ovarian cancer undergoing interval debulking surgery from January 2010 to July 2015. Among patients who did not undergo complete surgical resection but had ≤1 cm of residual disease, the number of anatomic sites (single location vs multiple locations) with residual disease was used as a surrogate for volume of residual disease. The effect of residual disease volume on progression-free survival and overall survival was evaluated. RESULTS: Of 270 patients undergoing interval debulking surgery, 173 (64.1%) had complete surgical resection, 34 (12.6%) had ≤1 cm of residual disease in a single anatomic location, 47 (17.4%) had ≤1 cm of residual disease in multiple anatomic locations, and 16 (5.9%) were suboptimally debulked. Median progression-free survival for each group was 14, 12, 10, and 6 months, respectively (P<.001). Median overall survival for each group was: 58, 37, 26, and 33 months, respectively (P<.001). CONCLUSION: Following interval debulking surgery, patients with complete surgical resection have the best prognosis, followed by patients with ≤1 cm single-anatomic location disease. In contrast, despite being considered "optimally debulked," patients with ≤1 cm multiple-anatomic location disease have a survival similar to suboptimally debulked patients.


Assuntos
Carcinoma Epitelial do Ovário/cirurgia , Procedimentos Cirúrgicos de Citorredução/métodos , Neoplasia Residual/classificação , Neoplasias Císticas, Mucinosas e Serosas/cirurgia , Neoplasias Ovarianas/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Carcinoma Epitelial do Ovário/patologia , Neoplasias das Tubas Uterinas/patologia , Neoplasias das Tubas Uterinas/cirurgia , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Estadiamento de Neoplasias , Neoplasias Císticas, Mucinosas e Serosas/patologia , Neoplasias Ovarianas/patologia , Neoplasias Peritoneais/patologia , Neoplasias Peritoneais/cirurgia , Prognóstico , Intervalo Livre de Progressão , Estudos Retrospectivos , Taxa de Sobrevida
5.
Int J Gynecol Cancer ; 29(3): 585-592, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30833444

RESUMO

OBJECTIVE: There are limited data on clinical outcomes of patients with advanced-stage epithelial ovarian cancer who require ostomy formation at the time of either primary cytoreductive surgery or interval cytoreductive surgery. The objective of this study was to evaluate patients undergoing bowel surgery and ostomy formation after primary or interval surgery. METHODS: Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV epithelial ovarian cancer who underwent cytoreductive surgery between January 2010 and December 2014 were identified retrospectively. Patients with non-epithelial histology, low-grade serous histology or incomplete medical records were excluded. Demographic and clinical data were collected and analyzed. Age, stage, co-morbidity index, pre-operative CA125, pre-operative albumin, and Aletti surgical complexity score were included in a multivariable logistic regression model to assess independent associations with ostomy formation. RESULTS: A total of 554 patients were included in the study. Of these, 261 (47%) underwent primary cytoreduction and 293 (53%) underwent interval cytoreduction. Patients undergoing primary surgery were more likely to undergo bowel resection, compared with interval surgery patients (37.2% vs 14%, p<0.001). Of the 139 (25.1%) patients who underwent bowel surgery, 25 (18%) underwent ostomy formation (11 ileostomies and 14 colostomies). Rates of ostomy formation were similar between the groups (6.1% primary vs 3.1% interval, p=0.10). Patients undergoing ostomy formation were more likely to have longer mean operative time (335 vs 229 min, p<0.001) and undergo small and large bowel resections at the time of cytoreductive surgery (44% vs 14%, p<0.001). Multivariate analysis revealed that a high surgical complexity score was associated with ostomy formation. Of the patients who underwent ostomy formation, 13 (43.3%) underwent stoma reversal including 11 ileostomies and two colostomies. Median time to ostomy reversal was 7 months. CONCLUSION: Bowel surgery is more common among patients undergoing primary surgery as compared with interval surgery, but this does not result in an increased risk of ostomy formation.


Assuntos
Carcinoma Epitelial do Ovário/cirurgia , Colectomia/métodos , Procedimentos Cirúrgicos de Citorredução/métodos , Estomia/métodos , Neoplasias Ovarianas/cirurgia , Carcinoma Epitelial do Ovário/patologia , Carcinoma Epitelial do Ovário/fisiopatologia , Feminino , Humanos , Intestinos/fisiopatologia , Intestinos/cirurgia , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/patologia , Neoplasias Ovarianas/fisiopatologia , Intervalo Livre de Progressão , Estudos Retrospectivos , Resultado do Tratamento
6.
Gynecol Oncol ; 150(2): 370-377, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29929923

RESUMO

OBJECTIVES: Thirty-day readmission rate has been proposed as metric of quality and remains an ongoing clinical concern in the primary treatment of patients with advanced-stage ovarian epithelial ovarian cancer. We conducted a review of the literature to identify rates, risk factors, and predictors for 30-day readmission in this population. METHODS: A 10-year period MEDLINE (PubMed) search of English literature studies published between January 01, 2008-January 01, 2018 was performed to identify appropriate studies for review. RESULTS: Thirty -day readmission rates for ovarian cancer patients undergoing primary treatment ranged from 2.5-19.3%. Neoadjuvant chemotherapy and interval cytoreductive surgery (NACT-ICS) surgery was associated with lower readmission rates, when compared to primary debulking surgery (PDS). The most frequently reported adverse events resulting in readmission include inpatient management of ileus/small bowel obstruction, wound-related complications, and thromboembolic events. Readmission predictors included the presence of other medical comorbidities, re-operation, and major complications occurring after initial hospital discharge. Some studies reported lower rates of readmission and survival in patients treated by NACT-ICS. CONCLUSIONS: Policies and programs should be designed to measure short- and long-term outcomes in this patient population to avoid bias in assigning patients to NACT-ICS to maintain low 30-day readmission rates.


Assuntos
Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Neoplasias Ovarianas/cirurgia , Complicações Pós-Operatórias/terapia , Quimioterapia Adjuvante , Procedimentos Cirúrgicos de Citorredução/métodos , Procedimentos Cirúrgicos de Citorredução/estatística & dados numéricos , Feminino , Humanos , Terapia Neoadjuvante , Neoplasias Ovarianas/tratamento farmacológico , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/etiologia
7.
Gynecol Oncol ; 150(3): 406-411, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30017539

RESUMO

OBJECTIVES: To investigate the utility of para-aortic lymph node dissection among women undergoing radical hysterectomy and pelvic lymph adenectomy for FIGO Stage IA2-IB2 cervical cancer using the National Cancer Database (NCDB). METHODS: We identified patients with stage IA2-IB2 squamous cell, adenosquamous, or adenocarcinoma of the cervix diagnosed 2011-2014 in the NCDB. The primary outcome was the negative predictive value of histologically assessed pelvic lymph node status for para-aortic lymph node status among women undergoing pelvic and para-aortic lymph node dissection. We calculated probability of para-aortic lymph node metastasis conditional on pelvic lymph node status. Finally, we compared overall survival between patients undergoing para-aortic lymph node dissection and those in whom this procedure was omitted. RESULTS: A total of 3212 patients met study inclusion criteria, of whom 994 (30.9%) underwent para-aortic lymph node dissection. In this group, the risk of isolated para-aortic metastasis was 0.11%. The negative predictive value of surgically assessed pelvic lymph nodes to predict para-aortic lymph node status was 99.9% (95% CI 99.9-99.9). Among 93 patients with pelvic lymph node metastasis, 18 (19.4%) had concurrent para-aortic lymph node metastasis. There was no difference in overall survival between women undergoing pelvic and para-aortic lymph node dissection compared with those undergoing pelvic lymphadenectomy only (p = 0.69). CONCLUSIONS: In patients undergoing radical hysterectomy and pelvic lymphadenectomy for stage IA2-IB2 cervical cancer, para-aortic lymph node dissection is not warranted based on the low risk of isolated metastatic disease, and lack of survival benefit associated with the procedure.


Assuntos
Carcinoma/secundário , Excisão de Linfonodo , Linfonodos/patologia , Linfonodos/cirurgia , Neoplasias do Colo do Útero/patologia , Aorta , Carcinoma/cirurgia , Feminino , Humanos , Histerectomia , Metástase Linfática , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Pelve , Valor Preditivo dos Testes , Probabilidade , Sistema de Registros , Estudos Retrospectivos , Taxa de Sobrevida , Neoplasias do Colo do Útero/cirurgia
8.
Gynecol Oncol ; 148(3): 521-526, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29395315

RESUMO

BACKGROUND: The American Society of Clinical Oncology recommends that patients with advanced cancer receive dedicated palliative care services early in their disease course. This investigation serves to understand how palliative care services are utilized for ovarian cancer patients in a tertiary referral center. METHODS: We conducted a retrospective review of women treated for ovarian cancer at our institution from 2010 through 2015. Clinical variables included presence and timing of palliative care referral. Data were correlated utilizing univariable and multivariable parametric and non-parametric testing, and survivals were analyzed using the Kaplan-Meier method and cox-proportional hazard models. RESULTS: We identified 391 women treated for ovarian cancer, of whom 68% were diagnosed with stage III or IV disease. Palliative care referral was utilized in 28% in the outpatient (42%) and inpatient (58%) settings. Earlier use of referral was observed in those who never underwent surgical cytoreduction or had interval cytoreductive surgery (p < 0.001). Palliative care referral was independently associated with advanced stage (OR 1.7, p = 0.02), recurrence (OR 2.0, p = 0.002) and hospice referral (OR 6.0, p < 0.001). In 38% of women referral occurred within 30 days of death, and 17% within one week of death. Outpatient initial consultation was associated with an unadjusted 1 year overall survival benefit (p < 0.01) compared to inpatient consultation. CONCLUSIONS: The outcomes in this study suggest a late use of palliative care that is reactionary to patient needs and not a routine component of ovarian cancer care as national guidelines recommend.


Assuntos
Adenocarcinoma/terapia , Carcinossarcoma/terapia , Neoplasias Císticas, Mucinosas e Serosas/terapia , Neoplasias Embrionárias de Células Germinativas/terapia , Neoplasias Ovarianas/terapia , Cuidados Paliativos , Encaminhamento e Consulta/estatística & dados numéricos , Tumores do Estroma Gonadal e dos Cordões Sexuais/terapia , Adenocarcinoma/patologia , Adenocarcinoma de Células Claras/patologia , Adenocarcinoma de Células Claras/terapia , Adenocarcinoma Mucinoso/patologia , Adenocarcinoma Mucinoso/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Carcinoma Endometrioide/patologia , Carcinoma Endometrioide/terapia , Carcinossarcoma/patologia , Procedimentos Cirúrgicos de Citorredução/estatística & dados numéricos , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Análise Multivariada , Estadiamento de Neoplasias , Neoplasias Císticas, Mucinosas e Serosas/patologia , Neoplasias Embrionárias de Células Germinativas/patologia , Razão de Chances , Neoplasias Ovarianas/patologia , Prognóstico , Modelos de Riscos Proporcionais , Qualidade de Vida , Estudos Retrospectivos , Tumores do Estroma Gonadal e dos Cordões Sexuais/patologia , Taxa de Sobrevida , Fatores de Tempo , Adulto Jovem
9.
Gynecol Oncol ; 150(2): 233-238, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29933927

RESUMO

OBJECTIVES: To examine the relationship between volume of residual disease and oncologic outcomes among patients with advanced-stage epithelial ovarian/fallopian tube/primary peritoneal carcinoma undergoing primary debulking surgery (PDS). For patients that did not undergo a complete surgical resection (CSR), a surrogate for volume of residual disease was used to assess oncologic outcomes. METHODS: Medical records of patients with FIGO stage IIIC and IV epithelial ovarian/fallopian tube/primary peritoneal carcinoma undergoing PDS between January 2010 and November 2014 were reviewed. Patient demographics, operative characteristics, residual disease, anatomic site of residual disease and outcome data were collected. Among patients who did not undergo CSR, but had ≤1 cm of residual disease, the number of anatomic sites (single location vs. multiple locations) with residual disease was utilized as a surrogate for volume of residual disease. The effect of residual disease volume on progression-free survival (PFS) and overall survival (OS) was evaluated. RESULTS: Of 240 patients undergoing PDS, 94 (39.2%) had CSR, 41 (17.1%) had ≤1 cm of residual disease confined to a single anatomic location (≤1 cm-SL), 67 (27.9%) had ≤1 cm of residual disease in multiple anatomic locations (≤1 cm-ML) and 38 (15.8%) were sub-optimally (SO) debulked. Median PFS for CSR, ≤1 cm-SL, ≤1 cm-ML and SO-debulked were: 23, 19, 13 and 10 months, respectively (p < 0.001). Median OS for CSR, ≤1 cm-SL, ≤1 cm-ML and SO-debulked were: Not yet reached, 64, 50 and 49 months, respectively (p = 0.001). CONCLUSIONS: Following PDS, CSR and ≤ 1 cm-SL patients have the best prognosis. In contrast, despite being considered "optimally debulked", ≤1 cm-ML patients have survival similar to those SO-debulked.


Assuntos
Neoplasias Epiteliais e Glandulares/cirurgia , Neoplasias Ovarianas/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Epitelial do Ovário , Procedimentos Cirúrgicos de Citorredução/métodos , Neoplasias das Tubas Uterinas/patologia , Neoplasias das Tubas Uterinas/cirurgia , Feminino , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasia Residual , Neoplasias Epiteliais e Glandulares/patologia , Neoplasias Ovarianas/patologia , Neoplasias Peritoneais/patologia , Neoplasias Peritoneais/cirurgia , Resultado do Tratamento
10.
Cancer ; 122(21): 3297-3306, 2016 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-27421044

RESUMO

BACKGROUND: The objective of this phase 1 and 2 trial was to identify the appropriate dose of combined carboplatin and pralatrexate for patients with recurrent, platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer. METHODS: In phase 1, patients received carboplatin (at an area under the curve of 5) and increasing doses of pralatrexate until the maximum-tolerated dose (MTD) of pralatrexate was achieved. The primary endpoint was the response rate. Additional endpoints were safety, response duration, progression-free survival, overall survival, and pharmacokinetics. RESULTS: Thirty patients were enrolled in phase 1, and 20 were enrolled in phase 2. Of all 50 patients, 49 completed the study. The mean patient age was 59 years, and patients completed a median of 6 cycles. The MTD for pralatrexate was 105 mg/m2 . The clinical benefit rate (complete responses plus partial responses plus stable disease) was 86%. Of 26 patients who received the MTD, 12 had a partial response, 11 had stable disease, and 2 had disease progression. The progression-free survival rate at 3 and 6 months was 87% and 79%, respectively; and the overall survival rate was 98% at 6 and 12 months and 66% at 24 months. Of 30 patients, 18 (60%) in phase 1 experienced an adverse event of any grade; and, of those, 4 patients (13%) had a grade 3 or greater adverse event. In phase 2, 12 patients (60%) had an adverse event of any grade, and 4 (20%) had grade 3 or greater toxicity. There was a significant reduction in the total body clearance of pralatrexate when it was received concurrently with carboplatin. CONCLUSIONS: Most patients responded to carboplatin-pralatrexate combination. This regimen is well tolerated and effective in this patient population. Cancer 2016;122:3297-3306. © 2016 American Cancer Society.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias das Tubas Uterinas/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Peritoneais/tratamento farmacológico , Adulto , Idoso , Aminopterina/administração & dosagem , Aminopterina/análogos & derivados , Protocolos de Quimioterapia Combinada Antineoplásica/farmacocinética , Carboplatina/administração & dosagem , Carcinoma de Células de Transição/tratamento farmacológico , Carcinoma de Células de Transição/patologia , Carcinossarcoma/tratamento farmacológico , Carcinossarcoma/patologia , Cistadenocarcinoma Seroso/tratamento farmacológico , Cistadenocarcinoma Seroso/patologia , Neoplasias do Endométrio/tratamento farmacológico , Neoplasias do Endométrio/patologia , Neoplasias das Tubas Uterinas/patologia , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Invasividade Neoplásica , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Neoplasias Ovarianas/patologia , Neoplasias Peritoneais/patologia , Prognóstico , Taxa de Sobrevida , Distribuição Tecidual
11.
Gynecol Oncol ; 142(1): 38-43, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27107722

RESUMO

OBJECTIVE: The aim of this study is to determine if outcomes of patients with ovarian carcinosarcoma (OCS) differ from those of women with high-grade papillary serous ovarian carcinoma (HG-PSOC) when compared by stage and treatment modalities. METHODS: The National Cancer Database was queried to identify patients with OCS and HG-PSOC diagnosed between 2003 and 2011. Demographic and clinical data were compared, and the impact of tumor histology on survival was analyzed using the Kaplan-Meier method. Factors predictive of outcome were compared using the Cox proportional hazards model. RESULTS: The final study group consisted of 45,153 women. 2886 (6.39%) had OCS and 42,267 (93.61%) had HG-PSOC. The mean age at diagnosis was 65.43 (±12.21) years for women with OCS and 61.52 (±12.6) years for HG-PSOC (P<0.001). African-American women had higher rate of OCS relative to white non-hispanic women (7.84% vs. 6.37%; P=0.002). Overall, women with OCS had a worse five-year survival rate, 26.63% [95% Confidence Interval (CI)=24.86%-28.53%] vs. 43.61% (95% CI=43.07%-44.17%). This difference persisted for each FIGO disease stage I-IV, with five-year survival consistently worse for women with OCS compared to those with HG-PSOC. Over the entire study period and after adjusting for histology, age, period of diagnosis, SEER registry, marital status, stage, surgery, radiotherapy, and lymph node dissection, carcinosarcoma histology was associated with decreased survival. CONCLUSION: OCS is associated with a poor prognosis compared to HG-PSOC. This difference was noted across all FIGO stages.


Assuntos
Carcinossarcoma/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Adulto , Idoso , Carcinossarcoma/mortalidade , Carcinossarcoma/patologia , Carcinossarcoma/cirurgia , Cistadenocarcinoma Seroso/tratamento farmacológico , Cistadenocarcinoma Seroso/mortalidade , Cistadenocarcinoma Seroso/patologia , Cistadenocarcinoma Seroso/cirurgia , Bases de Dados Factuais , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Neoplasias Ovarianas/mortalidade , Neoplasias Ovarianas/patologia , Neoplasias Ovarianas/cirurgia , Prognóstico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
Int J Gynecol Cancer ; 26(4): 697-704, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26825834

RESUMO

OBJECTIVE: The aim of the study was to examine the patterns of care and the impact of chemotherapy and radiation on survival in women diagnosed with uterine clear cell carcinoma (UCCC). The primary outcomes of this analysis were receipt of treatment within 6 months of diagnosis and overall survival. METHODS AND MATERIALS: Women diagnosed with UCCC from 2003 to 2011 were identified through the National Cancer Data Base. Standard univariate and multivariable analyses with logistic regression were performed. Kaplan-Meier survival analysis was used to generate overall survival data. Factors predictive of outcome were evaluated using the log-rank test and Cox proportional hazards model. RESULTS: A total of 3212 patients were identified. Chemotherapy, radiation, and combination chemotherapy and radiation were administered in 23.3%, 19.7%, and 11.1% of women, respectively. After adjusting for age, race, socioeconomic status, facility type, stage, surgery, lymph node dissection, comorbidity index, period of diagnosis, and registry location, there was an association between combined chemotherapy and radiation (hazard ratio, 0.74; 95% confidence interval, 0.61-0.90) with improved survival. Adjuvant therapy was not associated with improved survival among patients with early-stage disease (stages I and II). Both chemotherapy and combined chemotherapy and radiation were associated with significantly improved survival among patients with advanced-stage disease (stages III and IV). CONCLUSIONS: In patients with early-stage UCCC, adjuvant therapy was not associated with significantly improved survival. Chemotherapy and combination of chemotherapy and radiation were associated with improved survival in patients with advanced-stage UCCC.


Assuntos
Adenocarcinoma de Células Claras/patologia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Quimiorradioterapia Adjuvante/mortalidade , Excisão de Linfonodo/mortalidade , Padrões de Prática Médica/normas , Neoplasias Uterinas/patologia , Adenocarcinoma de Células Claras/epidemiologia , Adenocarcinoma de Células Claras/terapia , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Invasividade Neoplásica , Estadiamento de Neoplasias , Prognóstico , Taxa de Sobrevida , Estados Unidos/epidemiologia , Neoplasias Uterinas/epidemiologia , Neoplasias Uterinas/terapia
13.
Gynecol Oncol ; 137(3): 401-5, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25839911

RESUMO

OBJECTIVES: The objective of this study was to characterize chemotherapy treatment patterns in elderly patients with epithelial ovarian cancer (EOC) and their impact on overall survival (OS). METHODS: We identified patients age ≥65years with stage II-IV EOC who underwent cytoreduction from 2003 to 2011. Relevant clinical variables were extracted and correlated with OS. Statistical analyses were performed using logistic regression, Kaplan-Meier methods, and multivariable Cox proportional hazard models. RESULTS: One hundred and eighty-four patients were included in the analysis. The average age was 73years with American Society of Anesthesiology Physical Status Class 2 or 3. Approximately 78% underwent primary debulking surgery (PDS). OS for the entire cohort was 3.3years. One hundred and fifty-seven patients received adjuvant chemotherapy, of which 70% received initial platinum-based doublet therapy; 67.5% of patients were able to complete the intended six cycles of chemotherapy; of these, 34% experienced a dose reduction and 45% experienced one or more dose delays. Any dose delay was associated with a decrease in overall survival (p=0.02) and remained significant even after controlling for age, stage, and residual disease and number of chemotherapy cycles received (p=0.029). CONCLUSIONS: Elderly EOC patients frequently required chemotherapy dose reductions and delays in chemotherapy administration. Multivariate analysis confirmed that dose delays are an independent factor associated with decreased OS.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias Epiteliais e Glandulares/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anemia/fisiopatologia , Carcinoma Epitelial do Ovário , Quimioterapia Adjuvante , Intervalo Livre de Doença , Esquema de Medicação , Feminino , Humanos , Neoplasias Epiteliais e Glandulares/sangue , Neoplasias Epiteliais e Glandulares/cirurgia , Neutropenia/fisiopatologia , Compostos Organoplatínicos/administração & dosagem , Neoplasias Ovarianas/sangue , Neoplasias Ovarianas/cirurgia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Taxa de Sobrevida , Tempo para o Tratamento
14.
Gynecol Oncol ; 137(1): 93-7, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25617772

RESUMO

OBJECTIVE: The aim of this study is to explore the previously unexamined role of the Gynecologic Oncologist as an intraoperative consultant during general gynecologic surgery. METHODS: Demographic and clinical data were collected on 98 major gynecologic surgeries that included both a general Gynecologist and a Gynecologic Oncologist between October 2010 and August 2014. Data were analyzed using XLSTAT-Prov2014.2.02. RESULTS: Of 794 major gynecologic surgeries, 98 (12.3%) cases that involved an intraoperative consultation were identified. There were 36 (37%) planned consults and 62 (63%) unplanned consults. Significantly more planned consults were during laparoscopy (100% v 58%; p<0.01) and significantly more unplanned consults were during laparotomy (42% v 0%; p<0.01). The majority of planned consults were for surgical training (86%) and the most common reasons for unplanned consults were adhesions (40%), bowel injury (19%), inability to identify ureter (19%), and cancer (11%). The most common interventions performed during unplanned consults were identification of anatomy (55%), lysis of adhesions (42%), and retroperitoneal dissection (27%). Average surgeon years in practice were significantly lower for unplanned consults (9 v 15; p<0.01). A total of 25 major adverse events occurred in 15 cases with the majority occurring in cases with unplanned consults (23% v 3%; p<0.01). After controlling for laparotomy, unplanned consultation was not significantly associated with major events (OR=6.67, 95%CI 0.69-64.39; p=0.10). CONCLUSIONS: Gynecologic Oncologists play a pivotal role in the support of generalist colleagues during pelvic surgery. In this series, Gynecologic Oncologists were consulted frequently for complex major benign surgeries. It is important to incorporate the skills required of an intraoperative consultant into Gynecologic Oncology fellowship training.


Assuntos
Neoplasias dos Genitais Femininos/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Ginecologia/métodos , Oncologia/métodos , Encaminhamento e Consulta , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Ginecologia/educação , Humanos , Período Intraoperatório , Oncologia/educação , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
15.
Gynecol Oncol ; 136(3): 516-20, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25475542

RESUMO

OBJECTIVE: To validate whether Surgical Apgar Score can predict post-operative morbidity in patients undergoing hysterectomies for malignancies. METHODS: We conducted a retrospective cohort study of consecutive hysterectomies performed for cancer at a single academic institution between 2008 and 2010. The Surgical Apgar Score (SAS) was derived as previously reported. Peri-operative complications were as outlined by the American Board for Obstetrics and Gynecology, and then further subdivided into intra-operative and post-operative events. Univariate and multivariate logistic regressions were utilized. RESULTS: A total of 632 patients were identified. Of our cohort, 64% underwent surgery for cancer arising in the uterus, followed by ovary at 28.6% and cervix at 4%. Median patient age was 60 years old with a mean American Society of Anesthesiologists Physical Status Classification System (ASA) score of 2.5 and a median body mass index of 29. Average Surgical Apgar Score was 7.6. As SAS decreased, the risk of peri-operative complications increased (p<0.01). On univariate analysis SAS could predict for both intra-operative and post-operative complications. However, on multivariate analyses SAS could not independently predict for any post-operative complications (OR 1.02, CI 0.47-2.17). In a multivariable model incorporating age, ASA class, SAS <4, disease site, bowel resection and laparotomy, only ASA class and laparotomy were able to predict for postoperative complication events. CONCLUSIONS: Low Surgical Apgar Score significantly associates with morbidity in women undergoing hysterectomy for malignancy, but is unable to predict which patients will have postoperative complications. This renders the SAS less helpful for the creation of peri-operative metrics to guide post-operative care.


Assuntos
Técnicas de Apoio para a Decisão , Neoplasias dos Genitais Femininos/cirurgia , Indicadores Básicos de Saúde , Histerectomia , Complicações Intraoperatórias/diagnóstico , Complicações Pós-Operatórias/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Perda Sanguínea Cirúrgica , Pressão Sanguínea , Estudos de Coortes , Feminino , Frequência Cardíaca , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Estudos Retrospectivos , Medição de Risco
16.
Int J Gynecol Cancer ; 25(3): 453-8, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25628107

RESUMO

OBJECTIVE: Uterine leiomyosarcoma (LMS) is a relatively rare malignancy that is associated with a poor prognosis. The rarity of LMS has led to a lack of consensus regarding appropriate treatment. The goal of this study was to identify the role that chemotherapy and radiotherapy have played in the treatment of uterine LMS in the United States as well as the effectiveness of adjuvant treatment. MATERIALS/METHODS: We used the SEER (Surveillance, Epidemiology, and End Results)-Medicare database to gather information on uterine LMS patients older than the age of 66 years diagnosed between 1992 and 2009. Basic demographic and clinical characteristics were collected. A logistic regression model analysis was performed to determine predictors of treatment. Cox proportional hazards models were used to identify clinical parameters and treatment strategies associated with survival differences. RESULTS: Our final study group included 230 patients. We found that the rate of use of chemotherapy and radiotherapy in the treatment of patients with uterine LMS increased over the period investigated. However, we identified no significant survival advantage associated with either mode of therapy. The strongest predictor of survival was stage at diagnosis. The logistic regression model analysis revealed that age at diagnosis, treatment year, stage, and underlying health status were all independent predictors of chemotherapy. Age at diagnosis was also a predictor of radiation therapy. CONCLUSIONS: The increasing rates of chemotherapy and radiotherapy use in this population seem to be unfounded given the lack of survival benefit. Further investigation into alternative treatment regimens is merited. The prognostic significance of stage at diagnosis indicates the importance of improving early detection of uterine LMS.


Assuntos
Quimioterapia Adjuvante/tendências , Leiomiossarcoma/terapia , Radioterapia Adjuvante/tendências , Neoplasias Uterinas/terapia , Fatores Etários , Idoso , Antineoplásicos/uso terapêutico , Feminino , Nível de Saúde , Humanos , Leiomiossarcoma/patologia , Medicare/tendências , Estadiamento de Neoplasias , Programa de SEER , Taxa de Sobrevida , Estados Unidos , Neoplasias Uterinas/patologia
17.
Int J Gynecol Cancer ; 25(6): 1023-30, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25914960

RESUMO

OBJECTIVE: The objectives of this study were to evaluate the rates of chemotherapy and radiotherapy delivery in the treatment of uterine serous carcinoma in the Medicare population and to compare clinical outcomes in treated and untreated patients. METHODS: The linked Surveillance, Epidemiology, and End Results and Medicare databases were queried to identify patients with a diagnosis of uterine serous carcinoma between 1992 and 2009. The impact of chemotherapy on survival was analyzed using the Kaplan-Meier method. Factors predictive of outcome were compared using the Cox proportional hazards model. RESULTS: A total of 2188 patients met study eligibility criteria. Stages I, II, III, and IV diseases accounted for 890 (41%), 174 (8%), 470 (21%), and 654 (30%) of the study population, respectively. Chemotherapy, radiotherapy, both, or none, were administered as adjuvant therapy in 635 (29%), 536 (24%), 308 (14%), and 709 (32%) of the study population, respectively. Use of chemotherapy became more frequent over time. Over the study period, and after adjusting for race, time of diagnosis, SEER registry, marital status, stage, age, surgery, lymph node dissection, socioeconomic status, and comorbidity index, there was an association between receipt of radiotherapy alone (hazard ratio [HR], 1.3; 95% CI, 1.04-1.67) and not receiving any treatment (HR, 1.5; 95% CI, 1.2-2.01) and worst survival. Survival was not improved over time. CONCLUSION: Although adjuvant chemotherapy and combination treatment with chemotherapy and radiation were associated with improved survival in our model, there was no significant improvement in survival over time.


Assuntos
Quimiorradioterapia Adjuvante/mortalidade , Cistadenocarcinoma Seroso/terapia , Procedimentos Cirúrgicos de Citorredução/mortalidade , Neoplasias do Endométrio/terapia , Neoplasias Uterinas/terapia , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia Combinada , Cistadenocarcinoma Seroso/epidemiologia , Cistadenocarcinoma Seroso/mortalidade , Cistadenocarcinoma Seroso/patologia , Neoplasias do Endométrio/epidemiologia , Neoplasias do Endométrio/mortalidade , Neoplasias do Endométrio/patologia , Feminino , Seguimentos , Humanos , Medicare , Gradação de Tumores , Estadiamento de Neoplasias , Prognóstico , Programa de SEER , Taxa de Sobrevida , Estados Unidos/epidemiologia , Neoplasias Uterinas/epidemiologia , Neoplasias Uterinas/mortalidade , Neoplasias Uterinas/patologia
18.
J Community Health ; 40(6): 1178-84, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26026277

RESUMO

To evaluate the effect of an educational intervention on four domains of health care utilization and cervical cancer prevention and screening in a Hispanic population. Data collected from a survey were used to design education strategies focused on four domains of interest. A second survey was conducted to measure the impact of the intervention. Following the intervention, respondents were more likely to have any knowledge of human papillomavirus (HPV). Respondents living in the United States (US) for <5 years were more likely to have had a Papanicolaou smear in the preceding 3 years (p = 0.0314), to report knowledge of HPV vaccination (p = 0.0258), and to be willing to vaccinate themselves (p = 0.0124) and their children (p = 0.0341) after the intervention. Educational interventions designed to meet the needs identified by the sample group led to an increase in HPV awareness throughout the entire population surveyed and an increase in health care service utilization and HPV vaccine acceptance for women living in the US for <5 years. These tools should be promoted to reduce the cervical cancer burden on vulnerable populations.


Assuntos
Detecção Precoce de Câncer/estatística & dados numéricos , Educação em Saúde/organização & administração , Conhecimentos, Atitudes e Prática em Saúde , Hispânico ou Latino , Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Neoplasias do Colo do Útero/diagnóstico , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Teste de Papanicolaou , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Estados Unidos , Neoplasias do Colo do Útero/etnologia
19.
Gynecol Oncol ; 135(3): 595-605, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25316177

RESUMO

Nothing stirs the collective soul of primary debulking surgery (PDS) advocates like hard data suggesting equivalent outcomes of neoadjuvant chemotherapy (NAC). These opposing views have even metaphorically come to blows at the highly entertaining "SGO Fight Night" that took place during the 2008 Annual Meeting on Women's Cancer, replete with teams supporting each of the would-be gladiators. Decades of retrospective data supporting the clinical benefit of PDS has recently been challenged by the publication in 2010 of a randomized phase III trial conducted in Europe supporting the clinical efficacy of NAC. Naturally, a firestorm of criticism among believers ensued, yet practice patterns within the United States did slowly change, suggesting an emerging block of dissenters. Another randomized phase III European trial, as presented in abstract form in 2013, showed similar findings. Few other topics within the field of gynecologic oncology have participants so entrenched in the "corners" of their existing practice patterns. This review attempts to consolidate the current evidence supporting both sides so that the patient can be declared the winner.


Assuntos
Neoplasias Ovarianas/cirurgia , Feminino , Humanos , Terapia Neoadjuvante , Neoplasias Ovarianas/tratamento farmacológico
20.
Gynecol Oncol ; 132(3): 649-53, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24462804

RESUMO

OBJECTIVES: The aim of this study is to compare response to chemotherapy and survival between patients with transitional call carcinoma of the ovary (TCCO) and papillary serous ovarian cancer (PSOC). METHODS: We identified women with both pure and mixed TCCO who were treated between 2000 and 2010. Each case was matched to two women with PSOC by age, grade, stage, and year of diagnosis. Correlation between categorical variables was assessed with chi square test. The Kaplan-Meier survival analysis was used to generate overall survival data (OS). Factors predictive of outcome were compared using the log-rank test and Cox proportional hazards model. RESULTS: Eighty-one women diagnosed with TCCO were selected as cases and compared to 162 controls. Women with TCCO had a lower rate of platinum resistance compared to controls (9% vs. 25%; p=0.01). When multivariate logistic regression was used to control for other factors independently associated with platinum resistance, patients with TCCO had a significantly lower risk of platinum resistance compared to PSOC. Median progression-free survival was not significantly different (27 months vs. 22 months; p=0.15) for women with TCCO and PSOC, respectively. Median OS, however, was significantly different at 83 months vs. 52 months for the TCCO and PSOC groups, respectively (p=0.01). A Cox proportional hazards model identified optimal cytoreduction, transitional cell histology, age, stage, and platinum and paclitaxel chemotherapy as independent predictors of OS. CONCLUSIONS: Patients with TCCO are less likely to demonstrate resistance to platinum chemotherapy and have improved overall survival when compared to patients with PSOC.


Assuntos
Carcinoma de Células de Transição/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Carcinoma de Células de Transição/patologia , Estudos de Casos e Controles , Intervalo Livre de Doença , Resistencia a Medicamentos Antineoplásicos , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Compostos Organoplatínicos/farmacologia , Neoplasias Ovarianas/patologia , Estudos Retrospectivos , Taxa de Sobrevida
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