Abstract:
OBJECTIVE:The purpose of this multicenter, open label, randomized phase III study was to determine whether ixabepilone resulted in improved overall survival (OS) compared with commonly used single-agent chemotherapy (doxorubicin or paclitaxel) in women with locally advanced, recurrent, or metastatic endometrial cancer with at least one failed prior platinum-based chemotherapeutic regimen. METHODS:Patients were randomized 1:1 to ixabepilone (40mg/m(2)), or either paclitaxel (175mg/m(2)) or doxorubicin (60mg/m(2)), every 21days. Patients that had previously received an anthracycline were randomized to ixabepilone or paclitaxel; all other patients were randomized to ixabepilone or doxorubicin. An interim analysis of futility for OS was planned. RESULTS:At the time of database lock, 496 patients were randomized to receive ixabepilone (n=248) or control (n=248); nine patients in the control arm were not treated. The interim analysis of futility for OS (219 events) favored the control chemotherapy arm (hazard ratio=1.3 [95% confidence interval: 1.0-1.7], stratified log rank test P=0.0397), indicating that the study would not meet its primary objective. The study was discontinued based on the interim OS results. The frequency of adverse events was comparable between the treatment arms. CONCLUSIONS:The study did not meet its primary objective of improving OS in the ixabepilone arm compared to the control chemotherapy arm. A favorable risk/benefit ratio was not observed for ixabepilone versus control at the time of the interim analysis. The safety results were consistent with the known safety profiles of ixabepilone and control.
journal_name
Gynecol Oncoljournal_title
Gynecologic oncologyauthors
McMeekin S,Dizon D,Barter J,Scambia G,Manzyuk L,Lisyanskaya A,Oaknin A,Ringuette S,Mukhopadhyay P,Rosenberg J,Vergote Idoi
10.1016/j.ygyno.2015.04.026subject
Has Abstractpub_date
2015-07-01 00:00:00pages
18-23issue
1eissn
0090-8258issn
1095-6859pii
S0090-8258(15)00855-0journal_volume
138pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVES:To determine the incidence and prognostic implications of positive mesorectal lymph nodes in patients undergoing total pelvic exenteration for recurrent gynecologic malignancies. METHODS:We performed a retrospective chart review of all patients who had undergone total pelvic exenteration for a gynecologic m...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2005.08.039
更新日期:2006-03-01 00:00:00
abstract::Stains for mucosubstances were performed on endometrial curetting material of normal and pathological endometrium. The study included normal proliferative and secretory endometrium, cystic and adenomatous hyperplasia, and endometrial adenocarcinoma. It was attempted to characterize the epithelial mucin in each of thes...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(88)90033-9
更新日期:1988-06-01 00:00:00
abstract:OBJECTIVE:Human leukocyte antigens (HLA) play an important role in presenting virus antigens to immune cells that are responsible for the clearance of virus-infected cells and tumor cells. Herein, we evaluated whether genetic variants of HLA-DP and HLA-DQ are associated with cervical cancer risk. METHODS:We genotyped ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2013.02.017
更新日期:2013-05-01 00:00:00
abstract::The distribution of colon--ovarian tumor antigen (COTA) and colon-specific antigen (CSA) was studied immunohistochemically in gynecologic tumors. The antigens were absent in the serous benign tumors of the ovary and in the normal ovarian tissues, whereas they were detected in some of the mucinous benign tumors. COTA a...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(89)90019-x
更新日期:1989-10-01 00:00:00
abstract::For over forty years, the Gynecologic Oncology Group drove progress in treating endometrial cancer. The first decades of investigation began with a meticulous prospective, surgicopathologic staging study that was the platform for development of all subsequent trials. The resultant statistical model of low risk, interm...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2020.01.012
更新日期:2020-05-01 00:00:00
abstract:OBJECTIVE:Most women with ovarian cancer relapse and undergo further chemotherapy however evidence regarding the benefits of this for women with platinum-resistant disease is limited. Our objective was to determine whether there was a quality of life improvement or treatment response among women treated for platinum-re...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2013.10.004
更新日期:2014-01-01 00:00:00
abstract:OBJECTIVE:To estimate the survival benefit and cost-effectiveness of performing hysterectomy during risk-reducing salpingo-oophorectomy (RRSO) for BRCA1 mutation carriers. METHODS:Based on a recent prospective cohort study indicating an elevated incidence of serous/serous-like uterine cancers among BRCA1 mutation carr...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2017.03.025
更新日期:2017-06-01 00:00:00
abstract:OBJECTIVE(S):To determine whether antibiotic treatment (ABX) during platinum chemotherapy (PC) for epithelial ovarian cancer (EOC) impacts progression-free survival (PFS) and overall survival (OS). STUDY DESIGN:Retrospective single institution cohort study in women with newly diagnosed stage III/IV EOC (n = 424) who u...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2020.09.010
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:To test if TP53 hot spot mutations (HSMs) confer differential chemotherapy resistance or survival outcomes, the effects of microtubule stabilizers on human ovarian carcinoma cells (OCCs) expressing TP53 HSMs were studied in vitro. Survival outcomes of patients with high grade serous epithelial ovarian carcino...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2015.04.039
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVES:To identify angiogenic biomarkers associated with tumor angiogenesis and clinical outcome in high-grade serous ovarian cancer (HGSC). METHODS:51 HGSC samples were analyzed using Affymetrix HG-U133A microarray. Microvessel density (MVD) counts were determined using CD31 and CD105. Associations between mRNA e...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2015.08.001
更新日期:2015-10-01 00:00:00
abstract:OBJECTIVE:To determine the relationship between history of cervical dysplasia or carcinoma and the development of cervical dysplasia or adenocarcinoma in women who have a diagnosis of atypical glandular cells of undetermined significance (AGUS), favor endocervical origin, or AGUS, not otherwise specified. METHODS:A 6-...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1999.5512
更新日期:1999-09-01 00:00:00
abstract:OBJECTIVE:Vulvar reconstruction following oncologic resection is challenging. Some flaps used for reconstruction can show adverse characteristics such as excessive tissue bulk or increased distance to the defect. Region of the sulcus genitofemoralis is of thin and pliable tissue proximate to the vulva. Vasculature and ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2010.08.033
更新日期:2010-12-01 00:00:00
abstract:OBJECTIVE:Describe clinical characteristics and risk reducing strategies utilized among women with a BRCA mutation who lived to age 75 and above. METHODS:A retrospective study of women with BRCA mutations identified from 1995 to 2015 in a California health care system. From a database of 1189 women, 69 participants we...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.05.017
更新日期:2019-08-01 00:00:00
abstract:OBJECTIVE:To compare outcomes of patients undergoing continent or incontinent urinary diversion after pelvic exenteration for gynecologic malignancies. METHODS:Data on patients who underwent pelvic exenteration for gynecologic malignancies at The University of Texas MD Anderson Cancer Center between January 1993 and D...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2013.02.024
更新日期:2013-06-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to retrospectively analyze the prognostic importance of age, histologic type and grade, ascites, lymph node status, size and type of postoperative residual disease, and radiation dose on disease-specific (DSS) and progression-free survival (PFS) in stage III epithelial ovarian cancer...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1999.5477
更新日期:1999-09-01 00:00:00
abstract:OBJECTIVE:Since 1999, patients with low risk endometrial cancer (EC) as defined by the Mayo criteria have preferably not undergone lymphadenectomy (LND) at our institution. Here we prospectively assess survival, sites of recurrence, morbidity, and cost in this low risk cohort. METHODS:Cause-specific survival (CSS) was...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2012.06.035
更新日期:2012-10-01 00:00:00
abstract:OBJECTIVE:To determine whether single agent chemotherapy with intramuscular methotrexate 50mg administered on days 1, 3, 5, and 7 and oral folinic acid 15mg administered on days 2, 4, 6, and 8 in 2 weekly cycles (IM MTX/FA) is an effective treatment regimen for patients with low risk gestational choriocarcinoma. METHO...
journal_title:Gynecologic oncology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.ygyno.2014.12.024
更新日期:2015-02-01 00:00:00
abstract:OBJECTIVES:Although the reported incidence of carboplatin hypersensitivity is low, its occurrence is important to characterize because of potential fatal complications. The purpose of this study was to determine the current incidence of carboplatin hypersensitivity in the ovarian cancer patients compared to other oncol...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2006.04.002
更新日期:2006-11-01 00:00:00
abstract:OBJECTIVE:To analyze the expression of Heparanase, an enzyme involved in cancer metastasis and angiogenesis, in ovarian and breast carcinoma cells in effusions. METHODS:Heparanase protein expression was analyzed in malignant effusions from ovarian (=200) and breast (=41) carcinoma patients using immunocytochemistry. T...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2006.08.045
更新日期:2007-02-01 00:00:00
abstract:OBJECTIVE:Heredity is a major cause of ovarian cancer and during recent years the contribution from germline mismatch repair (MMR) gene mutations linked to Lynch syndrome has gradually been recognized. METHODS:We characterized clinical features, tumor morphology and mismatch repair defects in all ovarian cancers ident...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2011.02.010
更新日期:2011-06-01 00:00:00
abstract:OBJECTIVES:Based on our previous report showing that orobol, a potent phosphatidylinositol 4-kinase (PI4K) inhibitor, produced cisplatin (DDP) sensitivity, we have determined the mechanism of orobol-sensitization effect. METHODS AND RESULTS:Orobol produced >2-fold DDP sensitivity in human ovarian carcinoma 2008 cells ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/s0090-8258(03)00316-0
更新日期:2003-08-01 00:00:00
abstract::Breast cancer is the leading cause of cancer death in women. Ovarian cancer, although less frequent, is detected very late, and survival is correlated to early detection. Therefore, better methods for early detection would help to increase the number of survivors. The incidence of young women diagnosed with breast can...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/j.ygyno.2009.10.079
更新日期:2010-05-01 00:00:00
abstract:OBJECTIVES:Differentiation between grade-1 endometrial cancer (EC) and atypical endometrial hyperplasia (AEH) is crucial to determine optimal surgical management. However, discrepancies exist between preoperative diagnosis of AEH and final histology. Our aim was to establish clusters of immunohistochemical markers to d...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2014.02.018
更新日期:2014-05-01 00:00:00
abstract:OBJECTIVES:This phase II study conducted to investigate the efficacy and toxicity of the combination of gemcitabine (GEM) and pegylated liposomal doxorubicin (LDOX) alternating with cisplatin (CDDP) and cyclophosphamide (CTX) in platinum-resistant/refractory, paclitaxel pretreated epithelial ovarian cancer (EOC). PATI...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.08.061
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To define a prognostic score based on pretreatment values of leucocyte, platelet and hemoglobin in locally advanced cervical cancer (LACC). MATERIAL AND METHODS:We conducted a prospective study of 238 patients for LACC with negative PET imaging in the para-aortic (PA) area and who were undergoing laparoscopi...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2020.08.002
更新日期:2020-11-01 00:00:00
abstract::A histopathologic review of synchronous primary neoplasms of the female reproductive tract is presented. During a 30-year period, 3863 patients with female genital malignancies were accessioned to the UCLA Tumor Registry: 958 had ovarian cancer, 776 endometrial cancer, 1556 cervical cancer, and 573 other gynecologic m...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(89)90523-4
更新日期:1989-06-01 00:00:00
abstract:OBJECTIVES:The incidence of cervical dysplasia and carcinoma is known to be increased in HIV-infected women. In addition, there is a positive correlation between HIV viral load (VL), CD4+ count, and opportunistic infections, as well as the incidence of various malignancies. This study compares HIV VL and CD4+ count wit...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2000.6104
更新日期:2001-03-01 00:00:00
abstract:OBJECTIVE:To determine the feasibility of docetaxel-cisplatin combination therapy compared with docetaxel-carboplatin combination therapy as first-line chemotherapy for patients with ovarian cancer. METHODS:Fifty patients with International Federation of Gynecology and Obstetrics stage Ic-IV ovarian cancer who underwe...
journal_title:Gynecologic oncology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/j.ygyno.2005.11.020
更新日期:2006-06-01 00:00:00
abstract:OBJECTIVE:This study was undertaken to determine the incidence and distribution of the location of benign müllerian inclusions in pelvic and paraaortic lymph nodes. METHODS:A total of 114 patients operated on for gynecologic malignancy between 1995 and 1998 underwent surgery including systematic pelvic (n = 114) or pe...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2000.5867
更新日期:2000-08-01 00:00:00
abstract:OBJECTIVE:The incidence of anemia in the cervical cancer patients treated with concurrent chemoradiotherapy is estimated to be more than 50%. Transfusion has been the mainstay of hematologic support with its inherent hazards including infection and transfusion reaction. The aim of this study was to examine the impact o...
journal_title:Gynecologic oncology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/j.ygyno.2006.11.014
更新日期:2007-04-01 00:00:00