Abstract:
OBJECTIVE:Early-phase data have demonstrated induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821. We sought to determine if this combination decreases the hazard of progression or death compared to OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. Secondary and translational objectives were overall survival (OS), safety, and immunogenicity. METHODS:From 2010-2013, patients were randomized (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for pre-defined dose-limiting toxicity. RESULTS:Of 171 patients randomized, 170 were treated. Most had disease of serous histology (85%), stage 3 disease at diagnosis (77%), and had received 2 prior regimens (68%). 32% received >6 treatment cycles [median 6, each arm (p = 0.33)]. 77% discontinued due to progression, 4% due to toxicity, and 1 due to myeloid dysplastic syndrome (MDS). Maximum toxicities included grade 4 MDS and depression/personality change (1 each, unlikely related), as well as grade 3 gastrointestinal disorders and others (n = 21, 4 related). Lesser adverse events were injection site reactions (82%) and fever (11%). Estimated HR for progression-free survival (PFS) of the vaccine + OPT-821 to OPT-821 arm was 0.98 (95% CI: 0.71-1.36). At a median follow-up of 60 months, median OS was 47 and 46 months, respectively. CONCLUSIONS:Vaccine + OPT-821 compared to OPT-821 alone was modestly immunogenic and did not prolong PFS or OS. Multi-remission patients are a viable, well-defined population for exploring innovative consolidation and maintenance approaches. TRIAL REGISTRATION:NCT00857545.
journal_name
Gynecol Oncoljournal_title
Gynecologic oncologyauthors
O'Cearbhaill RE,Deng W,Chen LM,Lucci JA 3rd,Behbakht K,Spirtos NM,Muller CY,Benigno BB,Powell MA,Berry E,Tewari KS,Hanjani P,Lankes HA,Aghajanian C,Sabbatini PJdoi
10.1016/j.ygyno.2019.09.015subject
Has Abstractpub_date
2019-12-01 00:00:00pages
393-399issue
3eissn
0090-8258issn
1095-6859pii
S0090-8258(19)31536-7journal_volume
155pub_type
杂志文章,随机对照试验abstract:OBJECTIVE:BRCA1 mutation carriers have a high rate of both breast and ovarian cancer. Tamoxifen is a selective estrogen receptor modulator (SERM), which is used for the treatment of primary breast cancer and for the prevention of contralateral breast cancer. Our objective is to assess if tamoxifen treatment is associat...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2009.06.012
更新日期:2009-10-01 00:00:00
abstract::From January 1, 1946, through January 1, 1986, at the University of Michigan, 60 patients were treated with Stage IB (FIGO) carcinoma of the cervix with lymph node metastases. Clinical variables were examined with regard to long-term survival. Prognostically significant variables were (1) highest level of lymph node i...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/s0090-8258(88)80022-2
更新日期:1988-11-01 00:00:00
abstract::A case of high-grade endometrioid adenosquamous carcinoma of the ovary showing pilomatricoma-like areas and neuroendocrine differentiation is presented. The pilomatricoma-like areas were strongly positive for cytokeratin and vimentin, whereas the poorly differentiated areas of the tumor were positive for cytokeratin, ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1996.0142
更新日期:1996-05-01 00:00:00
abstract::A number of chemical agents have been found to influence the proliferation, morphology, enzymatic activity, and antigen expression of neoplastic cells toward a more differentiated phenotype. We studied the effects of differentiating agents retinoic acid, sodium butyrate, and dibutyryl cyclic AMP on the expression of t...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(91)90356-a
更新日期:1991-09-01 00:00:00
abstract:BACKGROUND:Vulval Keratoacanthoma (KA) is very rare and its differential diagnosis from the commonly occurring Vulval Squamous Cell Carcinoma (SCC) is important to avoid overtreatment. CASE:A case of Vulval KA in a 79-year-old lady is reported. She presented with a 9-mm firm raised lesion on the antero-lateral left si...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2004.12.033
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVE:Links between obesity, with its attendant estrogen abnormalities, and the endometrial carcinoma (EC) DNA Mismatch Repair Protein (MMR) system have recently been proposed. We investigated relationships between body mass index (BMI) and clinicopathological correlates including MMR expression in a large single i...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2014.01.017
更新日期:2014-04-01 00:00:00
abstract:OBJECTIVE:The goal of this study was to evaluate the effects of single fractions of 10 Gy pelvic irradiation for palliation and life prolongation in patients with cancer of the uterine cervix or corpus. METHODS:A retrospective analysis was performed on 37 cervical cancer and 27 corpus cancer patients treated in the pe...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.2001.6233
更新日期:2001-07-01 00:00:00
abstract:OBJECTIVE:To assess the safety and efficacy of pegylated liposomal doxorubicin (PLD), carboplatin, plus bevacizumab in patients with ovarian, fallopian tube, or primary peritoneal cancer. METHODS:Patients with platinum-sensitive, recurrent disease received PLD 30 mg/m(2) and carboplatin area under the curve (AUC) 5 on...
journal_title:Gynecologic oncology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.ygyno.2012.05.028
更新日期:2012-09-01 00:00:00
abstract:OBJECTIVES:Ovarian cancer remains a leading cause of death in women and development of new therapies is essential. Second mitochondria derived activator of caspase (Smac) has been described to sensitize for apoptosis. We have explored the proapoptotic activity of a small molecule mimic of Smac/DIABLO on ovarian cancer ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2007.01.011
更新日期:2007-05-01 00:00:00
abstract::Colposcopic cervical/vaginal examinations were performed on 10 healthy adult baboons. Five of the ten baboons had a "satisfactory" colposcopic cervical examination with columnar epithelium visible on the exocervix. However, only three of five with "satisfactory" colposcopic exams had large visible transformation zones...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(84)90216-6
更新日期:1984-03-01 00:00:00
abstract:OBJECTIVE:Small cell carcinoma (SmCC) of the female genital tract constitutes a diagnostic and clinical challenge given its rarity and the lack of standardized therapeutic approaches. Here we review the morphological, clinical and molecular features of gynecologic SmCCs and discuss potential areas for future research. ...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/j.ygyno.2014.05.017
更新日期:2014-08-01 00:00:00
abstract:PURPOSE:Efflux transporters of the ATP-binding cassette (ABC) family are major determinants of chemoresistance in tumor cells. This study examined associations between functional variants in ABCB1, ABCC2 and ABCG2 genes and clinical outcomes in patients with epithelial ovarian/primary peritoneal cancer (EOC/PPC) follow...
journal_title:Gynecologic oncology
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.ygyno.2011.11.022
更新日期:2012-03-01 00:00:00
abstract::Didemnin B was administered to 24 women with recurrent squamous cell cervical carcinoma. The initial dose was 4.2 mg/m2, intravenously, repeated every 28 days. Twenty-three patients were evaluable for toxicity and twenty-one for response. Toxicity was mild, consisting mainly of nausea and vomiting. There were no objec...
journal_title:Gynecologic oncology
pub_type: 临床试验,杂志文章
doi:10.1016/0090-8258(92)90055-n
更新日期:1992-03-01 00:00:00
abstract:OBJECTIVE:Incorporating topotecan into standard platinum/taxane chemotherapy for advanced ovarian cancer has been complicated by myelosuppression. This study evaluated sequential doublets of topotecan and carboplatin, followed by paclitaxel and carboplatin, in newly diagnosed advanced ovarian cancer patients. METHODS:...
journal_title:Gynecologic oncology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.ygyno.2004.05.021
更新日期:2004-08-01 00:00:00
abstract::An epidemiologic study of multiple primary malignant neoplasms in endometrial cancer patients in Israel is presented. During the 7-year period of the study, 104 patients (10.3%) out of 1007 patients diagnosed as having endometrial cancer had another primary cancer. There was a significant difference in the incidence o...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(85)90005-8
更新日期:1985-09-01 00:00:00
abstract:OBJECTIVE:Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. METHODS:In a phase II trial, patients with adva...
journal_title:Gynecologic oncology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.ygyno.2019.10.013
更新日期:2019-12-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to determine the rate of occult metastasis, including isolated tumor cells, in para-aortic lymph nodes of patients with stage IIIC1 endometrial cancer who underwent pelvic and para-aortic lymphadenectomy. METHODS:A series of 15 patients who had undergone combined pelvic and para-aor...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2012.08.026
更新日期:2012-12-01 00:00:00
abstract:BACKGROUND:According to current treatment guidelines, comprehensive surgical staging procedures in endometrial cancer confined to the uterus depend on uterine risk factors: a systematic lymph node dissection (LND) is recommended in high risk patients and should be omitted in low risk patients. Its role in intermediate ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2019.04.002
更新日期:2019-07-01 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::This study evaluated the effect ovarian weight has on the accuracy of frozen sections in serous and mucinous ovarian tumors. The study group included 294 patients who had an initial frozen section (189 serous and 105 mucinous tumors) at surgery. The pathology reports were separated into subgroups (benign, borderline, ...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1997.4836
更新日期:1997-10-01 00:00:00
abstract:BACKGROUND:Improvements in surgical technique of pelvic exenteration have mainly occurred in the reconstructive phase of the procedure. Quality of life seems to be improved when performing continent rather than non-continent urinary diversion [1]. Unfortunately, Miami continent urinary pouch is a surgical technique not...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2018.06.010
更新日期:2018-08-01 00:00:00
abstract::A case of Stage IIIC primary ovarian leiomyosarcoma in a premenopausal woman with multiple recurrences alive and well 7 years after diagnosis is presented. In addition to the typical light microscopic, immunohistochemical, and electron microscopic features of ovarian leiomyosarcoma, the tumor was progesterone receptor...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1006/gyno.1997.4824
更新日期:1997-09-01 00:00:00
abstract::A case of Stage IV endometrial squamous cell carcinoma occurring 8 years after a low anterior resection and whole pelvic radiation therapy for a Dukes D colon carcinoma is presented. Koilocytosis was present in the tumor. There was no evidence of human papillomavirus antigen or DNA in the tumor. The patient was treate...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1006/gyno.1995.1167
更新日期:1995-06-01 00:00:00
abstract::Symptomatic uterine lymphangioleiomyomatosis (LAM) simulating high-stage uterine sarcoma in a patient with tuberous sclerosis complex is reported. A 49-year-old female presented with abdominal pain and anemia. Preoperative workup revealed a uterine mass and a large amount of peritoneal free fluid and possible metastat...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1006/gyno.1996.0344
更新日期:1996-12-01 00:00:00
abstract:OBJECTIVE:To conduct a systematic review of the literature regarding the systemic treatment of advanced uterine sarcoma and provide an evidence-based summary of the available literature. METHODS:MEDLINE, EMBASE, and the Cochrane Library databases were searched. "Uterine sarcoma," "leiomyosarcoma," "mixed mesodermal tu...
journal_title:Gynecologic oncology
pub_type: 杂志文章,评审
doi:10.1016/j.ygyno.2005.01.041
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVE:Nuclear lamina plays important roles in nuclear shape and mechanical stability. Many studies demonstrated that defects of lamin-A were associated with several diseases, but little research was found on its potential roles in ovarian cancer. METHODS:GEPIA and GEO database were used to analyze lamin-A in ovari...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2018.10.030
更新日期:2019-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the association between lymphopenia and survival in women with cervical cancer treated with primary chemoradiation. METHODS:A single institution, retrospective analysis of patients with stage IB2-IVA cervical cancer who received upfront chemoradiation from 1998 to 2013 was performed. Complete blo...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2015.11.013
更新日期:2016-01-01 00:00:00
abstract::Previous herpes simplex virus type 2 (HSV-2) infections are known to predispose women for the development of cervical cancer, but causal relationship between the virus and the cancer has never been proven. Forty-six patients with cervical carcinoma (13 with preinvasive lesions and 33 with various stages of invasive di...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/0090-8258(84)90047-7
更新日期:1984-07-01 00:00:00
abstract:OBJECTIVES:The aim of this study is to determine the impact of obesity on surgical and oncologic outcomes after primary debulking surgery (PDS) in advanced epithelial ovarian cancer (EOC). METHODS:Women with stage IIIC/IV EOC who underwent PDS with curative intent between 1/2/2003 and 12/30/2011 were included. Patient...
journal_title:Gynecologic oncology
pub_type: 杂志文章
doi:10.1016/j.ygyno.2014.07.103
更新日期:2014-10-01 00:00:00
abstract:OBJECTIVE:Currently available epidemiologic evidences concerning the chemopreventive effect of aspirin on ovarian cancer are inconsistent. Therefore, we aimed to further explore the association by synthesizing evidence from population-based studies. METHODS:We searched PubMed, EMBASE, Web of Science, and Scopus using ...
journal_title:Gynecologic oncology
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.ygyno.2016.04.543
更新日期:2016-08-01 00:00:00