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1.
Gynecol Oncol ; 184: 168-177, 2024 05.
Artigo em Inglês | MEDLINE | ID: mdl-38325276

RESUMO

OBJECTIVE: To assess patient-reported health-related quality of life (HRQoL) in patients with ovarian cancer (OC) who received niraparib as first-line maintenance therapy. METHODS: PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) enrolled patients with newly diagnosed advanced OC who responded to first-line platinum-based chemotherapy. Patients were randomized (2:1) to niraparib or placebo once daily in 28-day cycles until disease progression, intolerable toxicity, or death. HRQoL was assessed as a prespecified secondary end point using patient-reported responses to the European Organisation for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30), the EORTC QLQ Ovarian Cancer Module (EORTC QLQ-OV28), the Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI), and EQ-5D-5L questionnaires. Assessments were collected at baseline and every 8 weeks (±7 days) for 56 weeks, beginning on cycle 1/day 1, then every 12 weeks (±7 days) thereafter while the patient received study treatment. RESULTS: Among trial participants (niraparib, n = 487; placebo, n = 246), PRO adherence exceeded 80% for all instruments across all cycles. Patients reported no decline over time in HRQoL measured via EORTC QLQ-C30 Global Health Status/QoL and FOSI overall scores. Scores for abdominal/gastrointestinal symptoms (EORTC QLQ-OV28) and nausea and vomiting, appetite loss, and constipation (EORTC QLQ-C30) were higher (worse symptoms) in niraparib-treated patients than placebo-treated patients; except for constipation, these differences resolved over time. Patients did not self-report any worsening from baseline of fatigue, headache, insomnia, or abdominal pain on questionnaires. CONCLUSIONS: Despite some early, largely transient increases in gastrointestinal symptoms, patients with OC treated with niraparib first-line maintenance therapy reported no worsening in overall HRQoL.


Assuntos
Indazóis , Neoplasias Ovarianas , Piperidinas , Qualidade de Vida , Humanos , Feminino , Piperidinas/administração & dosagem , Piperidinas/uso terapêutico , Piperidinas/efeitos adversos , Indazóis/administração & dosagem , Indazóis/efeitos adversos , Indazóis/uso terapêutico , Pessoa de Meia-Idade , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/psicologia , Idoso , Adulto , Método Duplo-Cego , Piperazinas/efeitos adversos , Piperazinas/administração & dosagem , Piperazinas/uso terapêutico , Quimioterapia de Manutenção/métodos , Inibidores de Poli(ADP-Ribose) Polimerases/efeitos adversos , Inibidores de Poli(ADP-Ribose) Polimerases/administração & dosagem , Inibidores de Poli(ADP-Ribose) Polimerases/uso terapêutico , Carcinoma Epitelial do Ovário/tratamento farmacológico , Carcinoma Epitelial do Ovário/psicologia , Idoso de 80 Anos ou mais
2.
Gynecol Oncol ; 164(2): 398-405, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34857397

RESUMO

BACKGROUND: Age and ethnicity are among several factors that influence overall survival (OS) in ovarian cancer. The study objective was to determine whether ethnicity and age were of prognostic significance in women enrolled in a clinical trial evaluating the addition of bevacizumab to front-line therapy. METHODS: Women with advanced stage ovarian, primary peritoneal, or fallopian tube cancer were enrolled in a phase III clinical trial. All women had surgical staging and received adjuvant chemotherapy with one of three regimens. Cox proportional hazards models were used to evaluate the relationship between OS with age and race/ethnicity among the study participants. RESULTS: One-thousand-eight-hundred-seventy-three women were enrolled in the study. There were 280 minority women and 328 women over the age of 70. Women age 70 and older had a 34% increase risk for death when compared to women under 60 (HR = 1.34; 95% CI 1.16-1.54). Non-Hispanic Black women had a 54% decreased risk of death with the addition of maintenance bevacizumab (HR = 0.46, 95% CI:0.26-0.83). Women of Asian descent had more hematologic grade 3 or greater adverse events and a 27% decrease risk of death when compared to non-Hispanic Whites (HR = 0.73; 95% CI: 0.59-0.90). CONCLUSIONS: Non-Hispanic Black women showed a decreased risk of death with the addition of bevacizumab and patients of Asian ancestry had a lower death rate than all other minority groups, but despite these clinically meaningful improvements there was no statistically significant difference in OS among the groups.


Assuntos
Inibidores da Angiogênese/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bevacizumab/uso terapêutico , Carcinoma Epitelial do Ovário/tratamento farmacológico , Quimioterapia Adjuvante/métodos , Etnicidade/estatística & dados numéricos , Neoplasias Císticas, Mucinosas e Serosas/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Adenocarcinoma/tratamento farmacológico , Adenocarcinoma/patologia , Negro ou Afro-Americano/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Asiático/estatística & dados numéricos , Carboplatina/administração & dosagem , Carcinoma Endometrioide/tratamento farmacológico , Carcinoma Endometrioide/patologia , Carcinoma Epitelial do Ovário/patologia , Neoplasias das Tubas Uterinas/tratamento farmacológico , Neoplasias das Tubas Uterinas/patologia , Feminino , Hispânico ou Latino/estatística & dados numéricos , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Císticas, Mucinosas e Serosas/patologia , Neoplasias Ovarianas/patologia , Paclitaxel/administração & dosagem , Neoplasias Peritoneais/tratamento farmacológico , Neoplasias Peritoneais/patologia , Prognóstico , Modelos de Riscos Proporcionais , Taxa de Sobrevida , População Branca/estatística & dados numéricos
3.
Gynecol Oncol ; 161(2): 382-388, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33712274

RESUMO

PURPOSE: Increasing measures of adiposity have been correlated with poor oncologic outcomes and a lack of response to anti-angiogenic therapies. Limited data exists on the impact of subcutaneous fat density (SFD) and visceral fat density (VFD) on oncologic outcomes. This ancillary analysis of GOG-218, evaluates whether imaging markers of adiposity were predictive biomarkers for bevacizumab (bev) use in epithelial ovarian cancer (EOC). PATIENTS AND METHODS: There were 1249 patients (67%) from GOG-218 with imaging measurements. SFD and VFD were calculated utilizing Hounsfield units (HU). Proportional hazards models were used to assess the association between SFD and VFD with overall survival (OS). RESULTS: Increased SFD and VFD showed an increased HR for death (HR per 1-SD increase 1.12, 95% CI:1.05-1.19 p = 0.0009 and 1.13, 95% CI: 1.05-1.20 p = 0.0006 respectively). In the predictive analysis for response to bev, high VFD showed an increased hazard for death in the placebo group (HR per 1-SD increase 1.22, 95% CI: 1.09-1.37; p = 0.025). However, in the bev group there was no effect seen (HR per 1-SD increase: 1.01, 95% CI: 0.90-1.14) Median OS was 45 vs 47 months in the VFD low groups and 36 vs 42 months in the VFD high groups on placebo versus bev, respectively. CONCLUSION: High VFD and SFD have a negative prognostic impact on patients with EOC. High VFD appears to be a predictive marker of bev response and patients with high VFD may be more likely to benefit from initial treatment with bev.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Bevacizumab/uso terapêutico , Biomarcadores Tumorais/sangue , Carcinoma Epitelial do Ovário/tratamento farmacológico , Gordura Intra-Abdominal/diagnóstico por imagem , Neoplasias Ovarianas/tratamento farmacológico , Gordura Subcutânea/diagnóstico por imagem , Adiposidade , Adulto , Idoso , Carcinoma Epitelial do Ovário/sangue , Carcinoma Epitelial do Ovário/diagnóstico por imagem , Carcinoma Epitelial do Ovário/mortalidade , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Neoplasias Ovarianas/sangue , Neoplasias Ovarianas/diagnóstico por imagem , Neoplasias Ovarianas/mortalidade , Análise de Sobrevida , Tomografia Computadorizada por Raios X , Resultado do Tratamento
4.
Gynecol Oncol ; 163(2): 246-253, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34620496

RESUMO

OBJECTIVE: Platinum-resistant, high-grade serous ovarian cancer (HGSOC) has limited treatment options. Preclinical data suggest that poly(ADP-ribose) polymerase inhibitors (PARPi) and ataxia telangiectasia and Rad3-related kinase inhibitors (ATRi) are synergistic. CAPRI (NCT03462342) is an investigator-initiated study of olaparib plus ceralasertib in recurrent HGSOC. Herein, we present results from the platinum-resistant cohort. METHODS: A Simon 2-stage design was utilized. Platinum-resistant HGSOC patients received ceralasertib 160 mg orally daily, days 1-7 and olaparib 300 mg orally twice daily, days 1-28 of a 28-day cycle until toxicity or progression. Primary endpoints were toxicity and efficacy including objective response rate (ORR) by RECIST. Secondary endpoint was progression-free survival (PFS). The null hypothesis (≤5% ORR) would be rejected if there were ≥ 1 responses in 12 patients. RESULTS: Fourteen PARPi-naïve patients were evaluable for toxicity; 12 were evaluable for response. Three had BRCA1 mutations (1 germline, 2 somatic). Adverse events possibly related to treatment were primarily grade (G) 1/2. G3 toxicities included nausea (14.3%), fatigue (7.1%), anorexia (7.1%), and anemia (7.1%). No objective responses occurred. Best response was stable disease in 9 patients and progressive disease in three. Five patients had a ≥ 20% to <30% reduction in disease burden, including 3 with BRCA1 mutations. Three of 11 patients (27%; 2 with BRCA1 mutations) evaluable by Gynecologic Cancer Intergroup criteria had >50% CA-125 decline, including 2 with CA-125 normalization. Median PFS was 4.2 months overall (90% CI:3.5-8.2) and 8.2 months (3.6 months-not determined) for patients with BRCA1 mutations. CONCLUSIONS: Olaparib plus ceralasertib is well-tolerated. No objective responses occurred, though a signal of activity was seen particularly in disease associated with BRCA1. Further evaluation of this combination should include alternate dosing strategies in genomically-selected populations.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Indóis/efeitos adversos , Morfolinas/efeitos adversos , Recidiva Local de Neoplasia/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Ftalazinas/administração & dosagem , Piperazinas/administração & dosagem , Pirimidinas/efeitos adversos , Sulfonamidas/efeitos adversos , Administração Oral , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Proteínas Mutadas de Ataxia Telangiectasia/antagonistas & inibidores , Proteína BRCA1/genética , Esquema de Medicação , Resistencia a Medicamentos Antineoplásicos , Feminino , Humanos , Indóis/administração & dosagem , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Morfolinas/administração & dosagem , Recidiva Local de Neoplasia/mortalidade , Recidiva Local de Neoplasia/patologia , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/genética , Neoplasias Ovarianas/mortalidade , Ovário/diagnóstico por imagem , Ovário/patologia , Ftalazinas/efeitos adversos , Piperazinas/efeitos adversos , Inibidores de Poli(ADP-Ribose) Polimerases/administração & dosagem , Inibidores de Poli(ADP-Ribose) Polimerases/efeitos adversos , Intervalo Livre de Progressão , Inibidores de Proteínas Quinases , Pirimidinas/administração & dosagem , Critérios de Avaliação de Resposta em Tumores Sólidos , Sulfonamidas/administração & dosagem , Tomografia Computadorizada por Raios X
5.
Int J Gynecol Pathol ; 40(2): 175-179, 2021 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-32168063

RESUMO

High-grade serous carcinoma has a variety of different growth patterns, but is typically easily recognizable to pathologists and rarely confused with serous borderline tumors. We report a case of a 71-yr-old woman with a unilateral 5.1 cm ovarian cyst with small papillary projections on contrast-enhanced magnetic resonance imaging of the pelvis. Histologic examination showed a noninvasive papillary neoplasm with hierarchical branching and epithelial proliferation, and thus, at low magnification, bearing a striking resemblance to a serous borderline tumor. However, a more careful examination demonstrated high-grade cytologic features, nuclear pleomorphism, and abundant mitotic activity, suggestive of high-grade serous carcinoma. The morphology and immunohistochemical profile of this lesion is consistent with a rare, purely noninvasive growth pattern of high-grade serous carcinoma. This lesion represents the "far left" of the high-grade ovarian serous carcinoma morphologic spectrum and can mimic a serous borderline tumor.


Assuntos
Cistadenocarcinoma Seroso/diagnóstico por imagem , Neoplasias Epiteliais e Glandulares/diagnóstico por imagem , Cistos Ovarianos/diagnóstico por imagem , Neoplasias Ovarianas/diagnóstico por imagem , Idoso , Cistadenocarcinoma Seroso/patologia , Feminino , Humanos , Histerectomia , Imuno-Histoquímica , Imageamento por Ressonância Magnética , Neoplasias Epiteliais e Glandulares/patologia , Neoplasias Epiteliais e Glandulares/cirurgia , Cistos Ovarianos/patologia , Neoplasias Ovarianas/patologia , Neoplasias Ovarianas/cirurgia
6.
Clin Nephrol ; 96(1): 51-59, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33896447

RESUMO

BACKGROUND: Bevacizumab is a recombinant monoclonal antibody against the vascular endothelial growth factor A (VEGF-A) ligand that is used in the management of various solid malignancies. The adverse effect profiles of angiogenesis inhibitors, such as bevacizumab, have become increasingly well characterized and include renal manifestations such as hypertension, proteinuria, and thrombotic microangiopathy. Eculizumab inhibits terminal-complement activation and is used to treat atypical hemolytic uremic syndrome. There has been growing usage of eculizumab to treat bevacizumab-associated thrombotic microangiopathy. MATERIALS AND METHODS: We performed a systematic review of the literature to identify full-text articles that describe the use of eculizumab for bevacizumab-associated thrombotic microangiopathy. RESULTS: Our systematic review identified 522 unique articles of which 5 were included in the final review. 9 cases, including 2 new cases presented in this review, were identified in which eculizumab was used in the management of bevacizumab-associated thrombotic microangiopathy. Hematologic parameters and kidney function stabilized or improved in all cases, and the 2 patients who required renal replacement therapy were able to discontinue dialysis. CONCLUSIONS: Given the findings of this systematic review, the use of eculizumab in the treatment of bevacizumab-associated thrombotic microangiopathy warrants further study, particularly in severe cases.


Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Bevacizumab/efeitos adversos , Microangiopatias Trombóticas/induzido quimicamente , Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos Imunológicos/uso terapêutico , Bevacizumab/uso terapêutico , Humanos , Neoplasias/tratamento farmacológico
7.
Gynecol Oncol ; 157(3): 613-618, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32359845

RESUMO

OBJECTIVES: To investigate the patterns of use and impact of lymphadenectomy (LND) on overall survival (OS) of patients with apparent early stage malignant ovarian germ cell tumors (MOGCTs). METHODS: Patients with apparent stage I MOGCT diagnosed between 2004 and 2015 were drawn from the National Cancer Database. The performance of LND was assessed from the pathology report. OS was evaluated using Kaplan-Meier curves, and compared with the log-rank test. A multivariate Cox analysis was performed to control for confounders. RESULTS: A total of 2774 patients were identified; 1426 (51.4%) underwent LND. The median number of lymph nodes (LN) removed was 9 (range 1-81); 48.3% of patients had at least 10 lymph nodes removed. The rate of regional lymph node metastasis was 10.3% (147 patients). There was no difference in OS, between patients who did (n = 1287) and did not (n = 1210) undergo LND, p = 0.81; 5-yr OS rates were 96.5% and 97.6% respectively. After controlling for patient age, insurance status, histology, presence of medical comorbidities, and receipt of chemotherapy, the performance of LND was not associated with better survival (HR: 1.33, 95% CI: 0.82, 2.14). CONCLUSIONS: While LN metastasis is common in apparent early stage MOGCTs, the performance of LND was not associated with a survival benefit.


Assuntos
Excisão de Linfonodo/métodos , Neoplasias Embrionárias de Células Germinativas/tratamento farmacológico , Neoplasias Embrionárias de Células Germinativas/cirurgia , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/cirurgia , Platina/uso terapêutico , Adolescente , Adulto , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Platina/farmacologia , Adulto Jovem
8.
Gynecol Oncol ; 157(2): 335-339, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32089334

RESUMO

OBJECTIVE: To evaluate the role of radical hysterectomy in the management of patients with stage II endometrial carcinoma. MATERIALS: Patients diagnosed between 2004 and 2015, with stage II (based on the revised FIGO staging) endometrial carcinoma who had hysterectomy and regional lymph node surgery were identified in the National Cancer Database. Those who had radical or modified radical (RH), or total hysterectomy (TH) were selected. Overall survival (OS) was assessed with Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to evaluate survival after controlling for confounders. RESULTS: A total of 7552 patients who met the inclusion criteria were identified. Rate of RH was 10.5%. Those who underwent RH had longer hospital stay (median 3 vs 2 days, p < 0.001) and a higher 90-day (1.6% vs 0.8%, p = 0.05) mortality. There was no difference in OS between patients who had RH (n = 712) and SH (n = 5955) (p = 0.62); 5-year survival rates were 77.4% and 76.9%, respectively. After controlling for patient age (<65, ≥65 years), race (white, black, other/unknown), insurance status, presence of comorbidities, tumor size (<5, ≥5 cm, unknown), histology (endometrioid, non-endometrioid), performance of adequate lymphadenectomy, and receipt of adjuvant chemotherapy and radiation therapy, performance of radical hysterectomy was not associated with better survival (HR: 1.01, 95% CI: 0.85, 1.21). CONCLUSIONS: Radical hysterectomy was not associated with a survival benefit in a cohort of patients with stage II endometrial carcinoma.


Assuntos
Neoplasias do Endométrio/mortalidade , Neoplasias do Endométrio/cirurgia , Idoso , Neoplasias do Endométrio/patologia , Feminino , Humanos , Histerectomia/estatística & dados numéricos , Estimativa de Kaplan-Meier , Tempo de Internação/estatística & dados numéricos , Excisão de Linfonodo/estatística & dados numéricos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Modelos de Riscos Proporcionais , Estados Unidos/epidemiologia
9.
Arch Gynecol Obstet ; 301(4): 1047-1054, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32185553

RESUMO

OBJECTIVE: To evaluate factors associated with survival of patients with advanced stage mucinous ovarian carcinoma (MOC) using a large multi-institutional database. METHODS: Patients diagnosed between 2004 and 2014 with advanced stage (III-IV) MOC were identified within the National Cancer Database. Those without a personal history of another primary tumor who received cancer-directed surgery with a curative intent were selected for further analysis. Overall survival (OS) was evaluated with Kaplan-Meier curves, and compared with the log-rank test. Multivariate Cox analysis was performed to identify independent predictors of survival. RESULTS: A total of 1509 patients with a median age of 59 years (IQR 20) met the inclusion criteria: stage III (n = 1045, 69.3%) and stage IV disease (n = 464, 30.7%). Patients who received chemotherapy (n = 1065, 70.6%) had better OS compared to those who did not (n = 385, 25.5%), (median OS 15.44 vs 5.06 months, p < 0.001). The type of reporting facility (p = 0.65) and the year of diagnosis (p = 0.27) were not associated with OS. Presence of residual disease was strongly associated with OS (p < 0.001). After controlling for confounders, the administration of chemotherapy (HR 0.63, 95% CI 0.55, 0.72) was associated with better survival. CONCLUSION: Advanced stage MOC has an extremely poor prognosis. Patients who received chemotherapy had a small improvement in survival. Every effort to achieve complete gross resection should be performed. Given no improvement in survival outcomes over time, there is an eminent need for novel treatment options.


Assuntos
Adenocarcinoma Mucinoso/patologia , Neoplasias Ovarianas/patologia , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Prognóstico
10.
Gynecol Oncol ; 154(2): 302-307, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31155308

RESUMO

OBJECTIVE: Primary mucinous ovarian carcinoma (MOC) is a rare histologic subtype of ovarian cancer. The benefit of adjuvant chemotherapy for patients with MOC is unclear. PATIENTS AND METHODS: Patients diagnosed with stage I mucinous ovarian cancer (MOC) between 2004 and 2015 were identified from the U.S National Cancer Database. Those with a history of another primary tumor were excluded. Factors independently associated with the receipt of chemotherapy were identified using logistic regression. Impact of chemotherapy on overall survival (OS) for patients diagnosed between 2004 and 2014 was assessed using was Kaplan-Meier curves, and compared with the log-rank test. A multivariate Cox analysis was performed to control for confounders. RESULTS: We identified 4811 patients with a median age at diagnosis of 51 years (IQR: 21). Chemotherapy was administered to 1488 (30.9%) patients; 20.2% and 60.2% for those with stage IA/IB and IC respectively, p < 0.001. Stage IC, larger tumor size, and high tumor grade, were associated with the receipt of chemotherapy. There was no difference in OS between patients who did (n = 1322) and did not (n = 2920) receive chemotherapy, p = 0.17; 5-year OS rate was 86.8% vs 89.7%, respectively. No difference was noted following stratification by substage (p = 0.46 for IA/IB and p = 0.11 for IC). After controlling for substage, patient age, type of insurance, tumor grade, performance of lymphadenectomy and the presence of co-morbidities, the administration of chemotherapy was not associated with better survival (HR:1.18, 95% CI: 0.85, 1.64). CONCLUSIONS: In a large cohort of patients with stage I MOC, receiving chemotherapy was not associated with a survival benefit.


Assuntos
Adenocarcinoma Mucinoso/tratamento farmacológico , Adenocarcinoma Mucinoso/mortalidade , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/mortalidade , Adulto , Idoso , Estudos de Casos e Controles , Quimioterapia Adjuvante/mortalidade , Bases de Dados Factuais , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Estudos Retrospectivos
11.
Gynecol Oncol ; 154(2): 294-301, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31174889

RESUMO

OBJECTIVES: The WNT pathway is an important oncologic driver of epithelial ovarian cancer (EOC). The first-in-class recombinant fusion protein ipafricept (IPA) blocks Wnt signaling through binding of Wnt ligands. This phase Ib trial was designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RPh2) for IPA in combination with taxane and platinum therapy (C/P). METHODS: Dose escalation started with a standard 3 + 3 design for IPA/C/P with q3w intravenous IPA on Day 1, in cycles 1 to 6 with C (AUC = 5 mg/ml·min) and P (175 mg/m2). For enhanced bone safety the trial was revised to 6-patient cohorts with a q3w regimen of IPA on Day 1 and C/P on Day 3 (IPA → C/P). RESULTS: 37 patients have been treated; 30 of whom were treated following protocol revision to q3w IPA(D1) → C/P(D3) (2 & 4 mg/kg). IPA-related TEAEs that occurred in ≥15% included: fatigue (40%); nausea (35%); diarrhea and decreased appetite (22%) each; dysgeusia (19%); and vomiting (16.2%). 22% reported ≥1 IPA related TEAE Grade ≥3 the most common of which was neutropenia at 16%. There were no DLTs; the MTD was not reached. The maximum administered dose based on bone safety was 6 mg/kg. The overall response rate (ORR) was 75.7%. Median PFS was 10.3 months (95% CI 8.5-14.2) and OS 33 months (95% CI 23.4-NR). CONCLUSIONS: IPA is well tolerated in combination with sequential C/P. ORR, PFS and OS are comparable to historical data but bone toxicity at efficacy doses of this particular Wnt inhibitor limit further development in EOC.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Epitelial do Ovário/tratamento farmacológico , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Neoplasias Ovarianas/tratamento farmacológico , Receptores Acoplados a Proteínas G/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Idoso , Antineoplásicos Fitogênicos , Osso e Ossos/efeitos dos fármacos , Carboplatina/administração & dosagem , Relação Dose-Resposta a Droga , Feminino , Humanos , Fragmentos Fc das Imunoglobulinas/efeitos adversos , Fragmentos Fc das Imunoglobulinas/farmacologia , Dose Máxima Tolerável , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Proteínas Recombinantes de Fusão/efeitos adversos , Proteínas Recombinantes de Fusão/farmacologia , Via de Sinalização Wnt/efeitos dos fármacos
12.
Gynecol Oncol ; 154(2): 420-425, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31229298

RESUMO

PURPOSE: To compare patient/tumor characteristics and outcomes of Asians to Caucasian patients with epithelial ovarian cancer. METHODS: Ancillary data were pooled and analyzed from ten prospective randomized front-line Gynecologic Oncology Group clinical trials from 1996 to 2011. Demographic, clinicopathologic features, disease-specific and all-cause survival were analyzed. RESULTS: Of 7914 patients, 7641 were Caucasian and 273 Asian. When compared to Caucasians, Asians were younger at trial enrollment, had a better performance status, earlier-stage cancers (17.2% vs. 8.1% with stage I; p < 0.001), and were more likely to be of clear cell (15.8% vs. 6.2%, p < 0.001) and mucinous (3.3% vs. 1.9%, p < 0.001) histology. Asians had an improved 5-year disease-specific survival of 54.1% compared to 46.1% for Caucasians, p = 0.001. In multivariate analysis, the Asian race remained a significant prognostic factor for all-cause survival (HR: 0.84; 95% CI: 0.72-0.99; p = 0.04). Other factors predictive of improved survival included younger age, better performance status, optimal cytoreduction, earlier stage, non-clear cell histology, and lower grade tumors. CONCLUSION: Asians enrolled into phase III ovarian cancer clinical trials were younger, with better performance status, earlier-stage of disease, and have a greater number of clear cell and mucinous tumors. After adjusting for these prognostic factors, Asians have a better survival compared to Caucasians.


Assuntos
Povo Asiático/estatística & dados numéricos , Carcinoma Epitelial do Ovário/diagnóstico , Carcinoma Epitelial do Ovário/mortalidade , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/mortalidade , População Branca/estatística & dados numéricos , Idoso , Feminino , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Prognóstico , Modelos de Riscos Proporcionais , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida
13.
Am J Obstet Gynecol ; 221(6): 625.e1-625.e14, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31207237

RESUMO

BACKGROUND: Most women with advanced epithelial ovarian cancer develop recurrent disease, despite maximal surgical cytoreduction and adjuvant platinum-based chemotherapy. In observational studies, secondary cytoreductive surgery has been associated with improved survival; however its use is controversial, because there are concerns that the improved outcomes may reflect selection bias rather than the superiority of secondary surgery. OBJECTIVE: To compare the overall survival of women with platinum-sensitive recurrent ovarian cancer treated at National Cancer Institute-designated cancer centers who receive secondary surgery vs chemotherapy. STUDY DESIGN: This retrospective cohort study included women from 6 National Cancer Institute-designated cancer centers diagnosed with platinum-sensitive recurrent ovarian cancer between January 1, 2004, and December 31, 2011. The primary outcome was overall survival. Propensity score matching was used to compare similar women who received secondary surgery vs chemotherapy. Additional analyses examined how these findings may be influenced by the prevalence of unobserved confounders at the time of recurrence. RESULTS: Among 626 women, 146 (23%) received secondary surgery and 480 (77%) received chemotherapy. In adjusted analyses, patients who received secondary surgery were younger (P = 0.001), had earlier-stage disease at diagnosis (P = 0.002), and had longer disease-free intervals (P < 0.001) compared with those receiving chemotherapy. In the propensity score-matched groups (n = 244 patients), the median overall survival was 54 months in patients who received secondary surgery and 33 months in those treated with chemotherapy (P < 0.001). Among patients who received secondary surgery, 102 (70%) achieved optimal secondary cytoreduction. There were no significant differences in complication rates between the 2 groups. In sensitivity analyses, the survival advantage associated with secondary surgery could be explained by the presence of more multifocal recurrences (if 4.3 times more common), ascites (if 2.7 times more common), or carcinomatosis (if 2.1 times more common) among patients who received chemotherapy instead of secondary surgery. CONCLUSION: Patients with platinum-sensitive recurrent ovarian cancer who received secondary surgery had favorable surgical characteristics and were likely to have minimal residual disease following secondary surgery. These patients had a superior median overall survival compared with patients who received chemotherapy, although unmeasured confounders may explain this observed difference.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma Epitelial do Ovário/terapia , Procedimentos Cirúrgicos de Citorredução/métodos , Recidiva Local de Neoplasia/terapia , Neoplasias Ovarianas/terapia , Compostos de Platina/uso terapêutico , Reoperação/métodos , Adolescente , Adulto , Idoso , Carcinoma Epitelial do Ovário/patologia , Quimioterapia Adjuvante , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/patologia , Pontuação de Propensão , Estudos Retrospectivos , Taxa de Sobrevida , Adulto Jovem
14.
Int J Gynecol Cancer ; 29(7): 1177-1181, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31302627

RESUMO

INTRODUCTION: The National Comprehensive Cancer Network (NCCN) guidelines recommend intraperitoneal chemotherapy in optimally debulked stage III ovarian cancer patients. The objective of this investigation was to determine the rate of intraperitoneal port placement in patients undergoing surgery for ovarian cancer in a national database maintained by the American College of Surgeons. METHOD: We identified ovarian cancer patients in the National Surgical Quality Improvement Program database from 2006 to 2012. Demographics, comorbidities, operative outcomes, and postoperative complications were abstracted. Descriptive analyses were conducted using Wilcoxon rank-sum and Chi square tests, and multivariate regression models were used to analyze pre-operative and post-operative variables associated with intraperitoneal port placement. RESULTS: We identified 2659 ovarian cancer patients who underwent primary surgical management. Of these patients, only 128 (4.8%) had an intraperitoneal port placed at the time of surgery. In multivariable analyses, intraperitoneal ports were associated with body mass index ≤25, disseminated cancer, later portion of the study period (2009-2012), and operative time >200 min. Intraperitoneal port placement was not associated with any difference in surgical site infection, wound disruption, major postoperative complication, readmission within 30 days, or death within 30 days. DISCUSSION: Recent investigation of practice at NCCN institutions between 2003 and 2012 found only 35% of eligible ovarian cancer patients received intraperitoneal chemotherapy. Using intraperitoneal port placement as a surrogate for intraperitoneal chemotherapy administration, our investigation suggests an even lower rate (4.8%) nationally.


Assuntos
Carcinoma Epitelial do Ovário/tratamento farmacológico , Carcinoma Epitelial do Ovário/cirurgia , Cateteres de Demora/estatística & dados numéricos , Sistemas de Liberação de Medicamentos/estatística & dados numéricos , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Ovarianas/cirurgia , Idoso , Carcinoma Epitelial do Ovário/epidemiologia , Carcinoma Epitelial do Ovário/patologia , Estudos de Coortes , Feminino , Humanos , Infusões Parenterais , Pessoa de Meia-Idade , Análise Multivariada , Estadiamento de Neoplasias , Neoplasias Ovarianas/epidemiologia , Neoplasias Ovarianas/patologia , Peritônio/cirurgia , Estados Unidos/epidemiologia
15.
Lancet ; 390(10103): 1654-1663, 2017 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-28756902

RESUMO

BACKGROUND: On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial. In this study, we report the prespecified final analysis of the primary objectives, OS and adverse events. METHODS: In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, persistent, or recurrent cervical carcinoma from 81 centres in the USA, Canada, and Spain. Inclusion criteria included a GOG performance status score of 0 or 1; adequate renal, hepatic, and bone marrow function; adequately anticoagulated thromboembolism; a urine protein to creatinine ratio of less than 1; and measurable disease. Patients who had received chemotherapy for recurrence and those with non-healing wounds or active bleeding conditions were ineligible. We randomly allocated patients 1:1:1:1 (blocking used; block size of four) to intravenous chemotherapy of either cisplatin (50 mg/m2 on day 1 or 2) plus paclitaxel (135 mg/m2 or 175 mg/m2 on day 1) or topotecan (0·75 mg/m2 on days 1-3) plus paclitaxel (175 mg/m2 on day 1) with or without intravenous bevacizumab (15 mg/kg on day 1) in 21 day cycles until disease progression, unacceptable toxic effects, voluntary withdrawal by the patient, or complete response. We stratified randomisation by GOG performance status (0 vs 1), previous radiosensitising platinum-based chemotherapy, and disease status (recurrent or persistent vs metastatic). We gave treatment open label. Primary outcomes were OS (analysed in the intention-to-treat population) and adverse events (analysed in all patients who received treatment and submitted adverse event information), assessed at the second interim and final analysis by the masked Data and Safety Monitoring Board. The cutoff for final analysis was 450 patients with 346 deaths. This trial is registered with ClinicalTrials.gov, number NCT00803062. FINDINGS: Between April 6, 2009, and Jan 3, 2012, we enrolled 452 patients (225 [50%] in the two chemotherapy-alone groups and 227 [50%] in the two chemotherapy plus bevacizumab groups). By March 7, 2014, 348 deaths had occurred, meeting the prespecified cutoff for final analysis. The chemotherapy plus bevacizumab groups continued to show significant improvement in OS compared with the chemotherapy-alone groups: 16·8 months in the chemotherapy plus bevacizumab groups versus 13·3 months in the chemotherapy-alone groups (hazard ratio 0·77 [95% CI 0·62-0·95]; p=0·007). Final OS among patients not receiving previous pelvic radiotherapy was 24·5 months versus 16·8 months (0·64 [0·37-1·10]; p=0·11). Postprogression OS was not significantly different between the chemotherapy plus bevacizumab groups (8·4 months) and chemotherapy-alone groups (7·1 months; 0·83 [0·66-1·05]; p=0·06). Fistula (any grade) occurred in 32 (15%) of 220 patients in the chemotherapy plus bevacizumab groups (all previously irradiated) versus three (1%) of 220 in the chemotherapy-alone groups (all previously irradiated). Grade 3 fistula developed in 13 (6%) versus one (<1%). No fistulas resulted in surgical emergencies, sepsis, or death. INTERPRETATION: The benefit conferred by incorporation of bevacizumab is sustained with extended follow-up as evidenced by the overall survival curves remaining separated. After progression while receiving bevacizumab, we did not observe a negative rebound effect (ie, shorter survival after bevacizumab is stopped than after chemotherapy alone is stopped). These findings represent proof-of-concept of the efficacy and tolerability of antiangiogenesis therapy in advanced cervical cancer. FUNDING: National Cancer Institute.


Assuntos
Bevacizumab/efeitos adversos , Bevacizumab/uso terapêutico , Neoplasias do Colo do Útero/tratamento farmacológico , Neoplasias do Colo do Útero/mortalidade , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Progressão da Doença , Intervalo Livre de Doença , Esquema de Medicação , Feminino , Humanos , Infusões Intravenosas , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Paclitaxel/efeitos adversos , Topotecan/administração & dosagem , Topotecan/efeitos adversos
16.
Oncologist ; 23(12): 1533-1545, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30139839

RESUMO

The treatment of metastatic and recurrent uterine leoimyosarcoma (uLMS) has evolved rapidly in the past several years. Leoimyosarcoma is extremely aggressive and responds poorly to traditional chemotherapeutics. Recent regulatory approval of novel treatment options has significantly expanded the therapeutic armamentarium, and the addition of these therapies has challenged clinicians to select and optimally sequence these new compounds. Additionally, the potential role of immunotherapy is being assessed in current uLMS clinical trials. Given the increasing number of agents available both in the U.S. and globally, a treatment template that addresses optimal sequencing based upon expert consensus would be useful. Current guidelines, although listing various options, lack granularity by line of therapy. Most patients with leiomyosarcoma, even in early stage, are treated with surgery followed by adjuvant chemotherapy despite uLMS being relatively chemoresistant. Adjuvant chemotherapy often includes the combination of gemcitabine and docetaxel with or without doxorubicin in first-line systemic therapy, but these cytotoxic agents only provide patients with advanced disease a 5-year survival <30%. This review will focus on examination of current guidelines and consensus building for optimal sequencing of systemic therapies for advanced or recurrent uLMS. Critical ongoing studies investigating novel approaches including immunotherapeutics and genetic alterations also will be discussed. IMPLICATIONS FOR PRACTICE: Recent regulatory approval of novel treatment options has significantly expanded the therapeutic armamentarium, and the addition of these therapies has challenged clinicians to select and optimally sequence these compounds. This review will focus on examination of current guidelines and consensus building for optimal sequencing of systemic therapies for advanced or recurrent uterine leoimyosarcoma.


Assuntos
Leiomiossarcoma/tratamento farmacológico , Neoplasias Uterinas/tratamento farmacológico , Feminino , Humanos , Leiomiossarcoma/mortalidade , Leiomiossarcoma/patologia , Metástase Neoplásica , Intervalo Livre de Progressão , Neoplasias Uterinas/mortalidade , Neoplasias Uterinas/patologia
17.
Gynecol Oncol ; 148(1): 42-48, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29079037

RESUMO

OBJECTIVE: Improved outcomes realized by patients treated at high-volume institutions have led to a call for centralization of ovarian cancer care. However, it is unknown whether centralization respects patients' preferences regarding treatment location. This study's objective was to determine how patients balance survival benefit against the burdens of travel to a distant treatment center. METHODS: Patients presenting for evaluation of adnexal masses completed two discrete choice experiments (DCEs) assessing 1) the 5-year survival benefit required to justify 50miles of additional travel, and 2) the additional distance patients would travel for a 6% 5-year survival benefit. Demographic data were collected with measures of health numeracy, social support, and comfort with travel. t-Tests were performed to test for significant differences between group means. RESULTS: 81% (50/62) of participants required a 5-year survival benefit of ≤6% to justify 50miles of additional travel (DCE#1). These participants were less likely to be employed (56% vs 83%, p=0.05) and more likely to rate their health as good to excellent (86% vs 50%, p=0.04) than those requiring >6% benefit to travel 50miles. 80% (44/55) of participants would travel ≥50miles for a set 5-year survival benefit of 6% (DCE#2). No association was identified in DCE#2 between willingness to travel and collected sociodemographic covariates. CONCLUSIONS: 1 in 5 patients with ovarian cancer may prefer not to travel to a referral center, even when aware of the survival benefits of doing so. Policymakers should consider patients' travel preferences in designing referral structures for care.


Assuntos
Tomada de Decisões , Acessibilidade aos Serviços de Saúde , Neoplasias Ovarianas/psicologia , Neoplasias Ovarianas/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Preferência do Paciente , Viagem , Adulto Jovem
18.
Gynecol Oncol ; 150(3): 466-470, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30041929

RESUMO

OBJECTIVE: To determine the efficacy of dalantercept, a soluble ALK1 inhibitor receptor fusion protein, in patients with persistent or recurrent ovarian carcinoma and related malignancies. METHODS: Eligibility criteria included measurable disease, 1-2 prior cytotoxic regimens and GOG performance status (PS) ≤2. Dalantercept was administered subcutaneously at 1.2 mg/kg every 3 weeks until disease progression or development of unacceptable toxicity. The primary null hypothesis was the probability of response ≤0.10 and the probability of 6-month progression-free survival without receipt of non-protocol therapy (event-free survival at 6 months, EFS6) ≤0.15, using RECIST 1.1 criteria. RESULTS: The first stage was closed after enrollment of 30 participants with median age of 56.5 years, high-grade serous histology in 76.7%, 2 prior regimens in 46.7%, and platinum-free interval <6 months in 73.3%. All participants discontinued dalantercept, 24 (80.0%), 5 (16.7%) and 1 (3.3%) due to progression, toxicity, and other reason, respectively. The median number of treatment cycles per patient was 2 (range 1-29). There were six treatment-related grade 3 AEs and no grade ≥4 AEs. There were no objective responses. EFS6 was reached in 20% (6 out of 30 participants, 90% CI 9.1% to 35.7%). CONCLUSIONS: Though safe, dalantercept as administered had limited efficacy in this patient population overall.


Assuntos
Receptores de Activinas Tipo II/uso terapêutico , Antineoplásicos/uso terapêutico , Carcinoma/tratamento farmacológico , Neoplasias das Tubas Uterinas/tratamento farmacológico , Fragmentos Fc das Imunoglobulinas/uso terapêutico , Recidiva Local de Neoplasia/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Neoplasias Peritoneais/tratamento farmacológico , Proteínas Recombinantes de Fusão/uso terapêutico , Receptores de Activinas Tipo II/efeitos adversos , Adulto , Idoso , Antineoplásicos/efeitos adversos , Progressão da Doença , Intervalo Livre de Doença , Feminino , Humanos , Fragmentos Fc das Imunoglobulinas/efeitos adversos , Pessoa de Meia-Idade , Neoplasia Residual , Proteínas Recombinantes de Fusão/efeitos adversos , Critérios de Avaliação de Resposta em Tumores Sólidos
19.
Gynecol Oncol ; 149(3): 525-530, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29550184

RESUMO

PURPOSE: We sought to determine the level of concordance among surgeons' assessment of residual disease (RD) and pre-treatment computed tomography (CT) findings among women who underwent optimal surgical cytoreduction for advanced stage ovarian cancer. METHODS: This is a post-trial ad hoc analysis of a phase 3 randomized clinical trial evaluating the impact of bevacizumab in primary and maintenance therapy for patients with advanced stage ovarian cancer following surgical cytoreduction. All subjects underwent imaging of the chest/abdomen/pelvis to establish a post-surgical baseline prior to the initiation of chemotherapy. Information collected on trial was utilized to compare surgeon's operative assessment of RD, to pre-treatment imaging. RESULTS: Of 1873 enrolled patients, surgical outcome was described as optimal (RD≤1cm) in 639 subjects. Twelve patients were excluded as they did not have a baseline, pretreatment imaging, leaving 627 participants for analysis. The average interval from surgery to baseline scan was 26days (range: 1-109). In 251 cases (40%), the post-operative scan was discordant with surgeon assessment, demonstrating RD>1cm in size. RD>1cm was most commonly identified in the right upper quadrant (28.4%), retroperitoneal para-aortic lymph nodes (RD>1.5cm; 28.2%) and the left upper quadrant (10.7%). Patients with RD>1cm on pre-treatment CT (discordant) exhibited a significantly greater risk of disease progression (HR 1.30; 95% CI 1.08-1.56; p=0.0059). CONCLUSIONS: Among patients reported to have undergone optimal cytoreduction, 40% were found to have lesions >1cm on postoperative, pretreatment imaging. Although inflammatory changes and/or rapid tumor regrowth could account for the discordance, the impact on PFS and distribution of RD may suggest underestimation by the operating surgeon.


Assuntos
Neoplasia Residual/diagnóstico , Neoplasias Epiteliais e Glandulares/diagnóstico , Neoplasias Epiteliais e Glandulares/terapia , Neoplasias Ovarianas/diagnóstico , Neoplasias Ovarianas/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Bevacizumab/uso terapêutico , Carboplatina/administração & dosagem , Carcinoma Epitelial do Ovário , Procedimentos Cirúrgicos de Citorredução/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Neoplasia Residual/diagnóstico por imagem , Neoplasia Residual/patologia , Neoplasias Epiteliais e Glandulares/diagnóstico por imagem , Neoplasias Epiteliais e Glandulares/patologia , Neoplasias Ovarianas/diagnóstico por imagem , Neoplasias Ovarianas/patologia , Paclitaxel/administração & dosagem , Adulto Jovem
20.
Gynecol Oncol ; 147(2): 243-249, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28807367

RESUMO

PURPOSE: We examined disparities in prognosis between patients with ovarian clear cell carcinoma (OCCC) and serous epithelial ovarian cancer (SOC). METHODS: We reviewed data from FIGO stage I-IV epithelial ovarian cancer patients who participated in 12 prospective randomized GOG protocols. Proportional hazards models were used to compare progression-free survival (PFS) and overall survival (OS) by cell type (clear cell versus serous). RESULTS: There were 10,803 patients enrolled, 9531 were eligible, evaluable and treated with platinum, of whom 544 (6%) had OCCC, 7054 (74%) had SOC, and 1933 (20%) had other histologies and are not included further. In early stage (I-II) patients, PFS was significantly better in OCCC than in SOC patients. For late stage (III, IV) patients, OCCC had worse PFS and OS compared to SOC, OS HR=1.66 (1.43, 1.91; p<0.001). After adjusting for age and stratifying by protocol and treatment arm, stage, performance status, and race, OCCC had a significantly decreased OS, HR=1.53 (1.33, 1.76; p<0.001). In early stage cases, there was a significantly decreased treatment effect on PFS for consolidative therapy with weekly Paclitaxel versus observation in OCCC compared to SOC (p=0.048). CONCLUSIONS: This is one of the largest analyses to date of OCCC treated on multiple cooperative group trials. OCCC histology is more common than SOC in early stage disease. When adjusted for prognostic factors, in early stage patients, PFS was better for OCCC than for SOC; however, in late-stage patients, OCCC was significantly associated with decreased OS. Finally, treatment effect was influenced by histology.


Assuntos
Adenocarcinoma de Células Claras/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cistadenocarcinoma Seroso/tratamento farmacológico , Neoplasias Ovarianas/tratamento farmacológico , Adenocarcinoma de Células Claras/mortalidade , Adenocarcinoma de Células Claras/patologia , Adulto , Idoso , Carboplatina/administração & dosagem , Cistadenocarcinoma Seroso/mortalidade , Cistadenocarcinoma Seroso/patologia , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Ovarianas/mortalidade , Neoplasias Ovarianas/patologia , Paclitaxel/administração & dosagem , Prognóstico , Modelos de Riscos Proporcionais , Ensaios Clínicos Controlados Aleatórios como Assunto , Taxa de Sobrevida
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