Abstract:
OBJECTIVE:This two-stage Phase II study assessed the activity of single agent alisertib in patients with recurrent/persistent uterine leiomyosarcoma (uLMS). METHODS:Eligibility criteria included histologically-confirmed, recurrent or persistent uLMS, age≥18, 1-2 prior cytotoxic regimens, and RECIST version 1.1 measurable disease. The primary objective of the study was to evaluate the efficacy of alisertib through the frequency of patients with objective tumor responses and the frequency who survived event-free for at least 6months (EFS6). The endpoints for EFS were RECIST progression, death, or beginning a subsequent therapy. The null hypothesis jointly specified the probability of a patient experiencing a tumor response to less than or equal to 5% and the probability of a patient surviving event-free for at least 6months to less than or equal to 20%. A two-stage design was used with a target accrual of 23 patients for stage 1 and 47 pts. cumulative for stage 2. Confidence intervals do not correct for multiplicity. RESULTS:Twenty-three patients were enrolled with two patients excluded on central histology review, yielding 21 eligible patients. Median age was 61years. Prior treatment was either 1 cytotoxic regimen (71.4%) or 2 (28.6%). The most common treatment related AEs (grade 3 or worse) were anemia Hensley et al. (2008a) , leukopenia Hensley et al. (2008b) , neutropenia Maki et al. (2007) , thrombocytopenia Huang et al. (2012) , mucositis Hensley et al. (2008a) , diarrhea Huang et al. (2012) , and palmer-planter syndrome Zivanovic et al. (2012) . There were no objective responses (0%; 90% CI: 0-10.4%). Best response was stable disease (38.1%); 12 patients had progressive disease (57.1%). EFS6 was 0% (90% CI: 0-10.4%). Median PFS and OS were 1.7 (90% CI: 1.4-3.2) and 14.5months (90% CI: 7.6 - NA), respectively. CONCLUSION:Alisertib did not demonstrate clinically meaningful single agent activity in previously treated uLMS.
journal_name
Gynecol Oncoljournal_title
Gynecologic oncologyauthors
Hyman DM,Sill MW,Lankes HA,Piekarz R,Shahin MS,Ridgway MR,Backes F,Tenney ME,Mathews CA,Hoffman JS,Aghajanian C,Hensley MLdoi
10.1016/j.ygyno.2016.10.036subject
Has Abstractpub_date
2017-01-01 00:00:00pages
96-100issue
1eissn
0090-8258issn
1095-6859pii
S0090-8258(16)31513-Xjournal_volume
144pub_type
杂志文章abstract:OBJECTIVE:To evaluate various endometrial pathologies described in association with postmenopausal tamoxifen treatment, as well as the clinical aspects of these endometrial pathologies. METHODS:A search was made in PUB MED for all studies published in English, up to the end of 2003, reporting on endometrial pathologie...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/j.ygyno.2004.03.048
更新日期:2004-08-01 00:00:00
abstract:OBJECTIVE:To prospectively evaluate the feasibility of detecting human papillomavirus (HPV) type 16, 18 and 52 DNA in the peripheral blood of patients with cervical cancer using real-time polymerase chain reaction (PCR) and to determine its prognostic importance. METHODS:Blood and cervical swab specimens from 135 cons...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2005.07.004
更新日期:2005-12-01 00:00:00
abstract:OBJECTIVE:The aberrant expression of hepatocyte growth factor and its receptor c-Met are associated with aggressive disease and poor prognosis in a variety of human malignancies including ovarian cancer (OC). Specificity protein (Sp) transcription factors have high relevance in the signaling cascade associated with c-M...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2011.03.014
更新日期:2011-07-01 00:00:00
abstract:OBJECTIVE:A prospective psychological evaluation study of familial ovarian cancer screening (PsyFOCS) is underway in partnership with the UK Familial Ovarian Cancer Screening Study (UK FOCSS Phase 2). One of the aims of PsyFOCS is to examine factors associated with withdrawal from the UK FOCSS prior to the onset of 4-m...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2011.09.015
更新日期:2012-01-01 00:00:00
abstract:OBJECTIVE:In a previous study using the same cases of squamous cervical neoplasia and microinvasive carcinoma (MICA) we found an association between FHIT gene deletion and infection with high-risk HPV (HR HPV). The purpose of this study was to evaluate Fhit protein expression by immunohistochemistry in order to determi...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2002.6712
更新日期:2002-08-01 00:00:00
abstract:OBJECTIVE:Effective communication improves patient outcomes and is crucial to good patient care. Communication skills training (CST) has been shown to improve communication skills in non-gynecologic oncology specialties. We sought to develop and test CST for gynecologic oncology (GO) providers. METHODS:We developed an...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.03.242
更新日期:2019-06-01 00:00:00
abstract::The patient described synchronous mucinous tumors of the cervix and ovary and concurrent annular tubules, but without the classical stigmata of Peutz-Jeghers syndrome. The cervical tumor was an invasive mucinous adenocarcinoma with mixed components of minimal deviation and less-well-differentiated endometrioid morphol...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(91)90040-c
更新日期:1991-12-01 00:00:00
abstract:OBJECTIVE:The aim of this trial was to investigate the efficacy and toxicity of a relative high-dose of topotecan combined with carboplatin in recurrent or persistent epithelial ovarian cancer (EOC). METHODS:Patients participating in this phase II trial received topotecan at a dose of 1.0 mg/m(2)/day intravenously (IV...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2009.04.016
更新日期:2009-08-01 00:00:00
abstract:OBJECTIVE:Women with persistent, recurrent, and/or metastatic cervical cancer have a poor prognosis. Even with the availability of cisplatin plus paclitaxel and bevacizumab, median overall survival (OS) is only 17.0 months, with median post-progression survival of approximately seven months. We studied the therapeutic ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2020.06.493
更新日期:2020-09-01 00:00:00
abstract:OBJECTIVE:To examine associations between post-diagnosis use of antihypertensive (AH) medications including thiazide diuretics (TDs), angiotensin converting enzyme inhibitors (ACEIs), beta blockers (BBs) [both non-selective (NSBBs) and selective (SBBs)] and calcium channel blockers (CCBs) and ovarian cancer-specific su...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.05.030
更新日期:2019-08-01 00:00:00
abstract:OBJECTIVE:The goal of this work was to evaluate the involvement of gonadotropins in the regulation of adhesion of human epithelial ovarian carcinoma. We studied two pathways that were previously implicated in the metastatic implantation of ovarian carcinoma to the peritoneum, namely hyaluronan-CD44 and RGD-integrin med...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2001.6512
更新日期:2002-02-01 00:00:00
abstract:OBJECTIVE:Cyclin-dependent kinase 7 (CDK7) engages tumor growth by acting as a direct link between the regulation of transcription and the cell cycle. Here, we investigated the clinical significance of CDK7 expression and its potential as a therapeutic target in epithelial ovarian cancer (EOC). METHODS:CDK7 expression...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.11.004
更新日期:2020-01-01 00:00:00
abstract::After standard management of stage III-IV ovarian cancer patients by surgical reduction of tumor mass and subsequent cisplatin-based combination chemotherapy, eradication of residual intraabdominal disease remains a major clinical problem. In an effort to increase response to therapy without adding marrow toxicity, af...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(90)90304-4
更新日期:1990-04-01 00:00:00
abstract:OBJECTIVE:To assess the treatment and outcome of patients with endometrial cancer following isolated pulmonary relapse. METHODS:Between 1984 and 1996, 82 of 1109 patients undergoing surgery for primary endometrial cancer experienced a primary pulmonary recurrence, 28 of which were solitary. Median follow up of censore...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.06.030
更新日期:2007-11-01 00:00:00
abstract:BACKGROUND:Diaphragm involvement by ovarian cancer is often considered to be a major obstacle to successful cytoreductive surgery. Lack of evidence of survival benefit, concerns over safety and lack of experience are common justifications for this belief. In this study, we sought to evaluate the therapeutic value of di...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2005.08.027
更新日期:2006-02-01 00:00:00
abstract:OBJECTIVE:Implicit prejudice and stereotyping may exist in health care providers automatically without their awareness. These biases can correlate with outcomes that are consequential for the patient. This study examined gynecologic oncology care providers' implicit prejudice and stereotyping toward cervical cancer. M...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.01.013
更新日期:2019-04-01 00:00:00
abstract:BACKGROUND:Chemotherapy remains an essential part of the treatment of advanced ovarian cancer. Intraperitoneal (IP) administration has been demonstrated to provide a survival advantage over intravenous chemotherapy in three phase 3 studies. However, IP catheter complications have been a significant factor in aborting I...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.12.029
更新日期:2008-12-01 00:00:00
abstract:OBJECTIVES:While most women with ovarian cancer will achieve complete remission after treatment, the majority will relapse within two years, highlighting the need for novel therapies. Cancer stem cells (CSC) have been identified in ovarian cancer and most other carcinomas as a small population of cells that can self-re...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2013.05.027
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Positron emission tomography (PET) is commonly used to detect occult or recurrent malignancy, including tumors of the female genital tract. Recently, there have been reports of PET scans used in patients with Gestational Trophoblastic Disease (GTD). CASE:A 22-year-old female presented with vaginal bleeding ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2005.01.049
更新日期:2005-05-01 00:00:00
abstract::Human ovarian carcinoma cell lines were genetically engineered to secrete the cytokine interleukin-4 (IL-4) by retroviral-mediated gene transduction. These cells were transduced with the LXSN retroviral vector containing the human IL-4 gene and the neomycin resistance selection marker. Numerous IL-4-secreting clones w...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1995.1216
更新日期:1995-08-01 00:00:00
abstract:OBJECTIVE:This study aims to estimate the activity of docetaxel 60mg/m(2) IV over 1h followed by trabectedin 1.1mg/m(2) over 3h with filgrastim, pegfilgrastim, or sargramostim every 3weeks (one cycle). METHODS:Patients with recurrent and measurable disease, acceptable organ function, PS≤2, and ≤3 prior regimens were e...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2010.11.012
更新日期:2011-03-01 00:00:00
abstract::The incidence of adenocarcinoma of the cervix appears to be increasing. Recent reports have demonstrated an association between adenocarcinoma of the cervix and human papillomavirus (HPV) by Southern blot hybridizations. In situ deoxyribonucleic acid (DNA) hybridization was performed on paraffin-embedded specimens to ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(89)90076-0
更新日期:1989-12-01 00:00:00
abstract:OBJECTIVE:We conducted a case-control study to analyze risk factors for ovarian cancer. METHODS:Cases included 440 women (age range 13-80 years, median 54) with a histologically confirmed diagnosis of epithelial ovarian cancer who were admitted to the Gynecological Oncological Department of Gynecologic Oncology at the...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2000.5909
更新日期:2000-10-01 00:00:00
abstract:OBJECTIVE:Endometrial carcinoma is the most common malignancy of the female reproductive tract. Most cases are diagnosed at an early stage due to the appearance of symptoms such as postmenopausal bleeding. However, endometrial carcinoma carries a poor prognosis when it recurs after previous definitive treatment or when...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/j.ygyno.2010.02.007
更新日期:2010-05-01 00:00:00
abstract:OBJECTIVE:To evaluate the value of the combination of p16 and HPV detection in the screening for cervical cancer. METHODS:186 patients with previous abnormal cervical lesion were studied. After colposcopic examination, two conventional Pap slides were prepared: the first was Papanicolaou-stained and examined by cytolo...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2006.01.033
更新日期:2006-10-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to determine whether there is a link between integrins and components of the plasminogen system, regarding tumor cell invasion to the artificial extracellular matrix. METHODS:Immunocytochemistry was performed with antibodies directed against integrins alpha2beta1, alpha4beta1,...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2001.6410
更新日期:2002-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study is to evaluate the efficacy of intraperitoneal cisplatin as consolidation treatment in epithelian ovarian cancer patients with complete pathologic response following front-line platin-based chemotherapy. PATIENTS AND METHODS:Thirty patients who had no evidence of disease as assessed by ...
journal_title:Gynecologic oncology
pub_type: 临床试验,杂志文章
doi:10.1016/j.ygyno.2003.10.002
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVES:Early detection of ovarian cancer should improve overall survival. Multiple serum markers have been evaluated as possible tests to detect early stage disease, but few urine markers have been studied. Mesothelin has been detected in serum from patients with ovarian cancer, but has not been previously reported...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.04.022
更新日期:2007-09-01 00:00:00
abstract::Relative and population attributable risks for invasive cervical cancer in different age strata relative to screening practices have been estimated using data from a case-control study conducted since 1981 in the greater Milan area, northern Italy. A total of 548 women under 75 years of age with a histologically confi...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(90)90015-d
更新日期:1990-07-01 00:00:00
abstract::Brain metastases from primary cervical carcinoma are uncommon. Only 41 cases have been reported so far in the English literature. We have seen 2 cases over the last 2 years among 481 patients with cervical cancer. Brain metastases developed 7 and 35 months after the primary diagnosis. One patient with solitary metasta...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/0090-8258(92)90239-f
更新日期:1992-09-01 00:00:00