A phase 2 study of alisertib (MLN8237) in recurrent or persistent uterine leiomyosarcoma: An NRG Oncology/Gynecologic Oncology Group study 0231D.


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.


Gynecol Oncol


Gynecologic oncology


Hyman DM,Sill MW,Lankes HA,Piekarz R,Shahin MS,Ridgway MR,Backes F,Tenney ME,Mathews CA,Hoffman JS,Aghajanian C,Hensley ML




Has Abstract


2017-01-01 00:00:00














  • Epithelial ovarian carcinoma in patients with intersex disorders: the role of pituitary gonadotropins in ovarian tumorigenesis.

    abstract::The common epithelial tumors of the human ovary have rarely been found in the gonads of intersex patients with gonadal dysgenesis or true hermaphroditism. This report describes a patient with ovarian serous cystadenocarcinoma and mixed gonadal dysgenesis (45,X/46,XY) and reviews other reported cases. Intersex patients...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Miller DS,Teng NN,Ballon SC

    更新日期:1986-07-01 00:00:00

  • DNA aneuploidy is associated with increased mortality for stage I endometrial cancer.

    abstract:OBJECTIVE:The current study was undertaken to determine if DNA ploidy is a useful prognostic variable for predicting recurrence in stage I endometrial cancer. For cancer of the endometrium, survival following recurrence may depend on a number of factors, including the pattern of recurrence and the response to second li...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Terada K,Mattson D,Goo D,Shimizu D

    更新日期:2004-12-01 00:00:00

  • Proliferating cell nuclear antigen in endometrial carcinoma: pretreatment identification of high-risk patients.

    abstract:OBJECTIVE:The aim of our study was to retrospectively examine the proliferating cell nuclear antigen (PCNA) immunoreactivity of tumor cells in curettage specimens containing endometrioid adenocarcinoma and obtained immediately before definitive surgical staging. This PCNA index was compared with the one subsequently de...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Garzetti GG,Ciavattini A,Goteri G,De Nictolis M,Romanini C

    更新日期:1996-04-01 00:00:00

  • DNA flow cytometry and morphometry as prognostic indicators in advanced ovarian cancer: a step forward in predicting the clinical outcome.

    abstract::In 74 patients with advanced ovarian cancer, the value of DNA flow cytometry and morphometry was evaluated and compared with histological grading and clinical outcome. By means of both DNA flow cytometry and morphometry a clear distinction was found between a favorable group of 15 patients, with a median survival of m...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Rodenburg CJ,Cornelisse CJ,Hermans J,Fleuren GJ

    更新日期:1988-02-01 00:00:00

  • The prognostic significance of peritoneal seeding and size of postsurgical residual in patients with stage III epithelial ovarian cancer treated with surgery, chemotherapy, and high-dose radiotherapy.

    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


    authors: Kapp KS,Kapp DS,Poschauko J,Stücklschweiger GF,Hackl A,Pickel H,Petru E,Winter R

    更新日期:1999-09-01 00:00:00

  • CYP1A1, GSTM1, and GSTT1 polymorphisms and the risk of cervical squamous intraepithelial lesions in a multiethnic population.

    abstract:OBJECTIVE:In this investigation, we explored the hypothesis that genetic polymorphisms in the cytochrome P4501A1 (T3801C) and glutathione S-transferase classes mu and theta (GSTM1 and GSTT1) gene deletions promote the development of cervical dysplasia by moderating the activation and detoxification of polycyclic hydroc...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章,多中心研究


    authors: Goodman MT,McDuffie K,Hernandez B,Bertram CC,Wilkens LR,Guo C,Seifried A,Killeen J,Le Marchand L

    更新日期:2001-05-01 00:00:00

  • "MECCA": a developmental, dose-intensive, non-cross-resistant platinum-based chemotherapy for advanced ovarian cancer.

    abstract::Twenty-nine women, ages 30-58 years, with advanced ovarian carcinoma were treated with a developmental combination chemotherapy regimen consisting of mitomycin C, etoposide, cisplatin, and carboplatin (MECCA). This protocol utilized the concepts of dose intensity, front-end loading, non-cross-resistance, and synergy. ...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Hoskins PJ,Swenerton KD,Pike JA,McMurtrie EM,Lee N

    更新日期:1996-12-01 00:00:00

  • PTEN expression in clear cell adenocarcinoma of the ovary.

    abstract:OBJECTIVES:In this study, we analyzed the PTEN expression in a large collection of clear cell adenocarcinomas of the ovary. Furthermore, we analyzed the expression of cyclin D1 and p27, and investigated the correlation among all these variables. METHODS:Totally, 40 clear cell adenocarcinomas were included in this stud...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Hashiguchi Y,Tsuda H,Inoue T,Berkowitz RS,Mok SC

    更新日期:2006-04-01 00:00:00

  • Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial.

    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


    authors: Lorusso D,Ferrandina G,Colombo N,Pignata S,Pietragalla A,Sonetto C,Pisano C,Lapresa MT,Savarese A,Tagliaferri P,Lombardi D,Cinieri S,Breda E,Sabatucci I,Sabbatini R,Conte C,Cecere SC,Maltese G,Scambia G

    更新日期:2019-12-01 00:00:00

  • The benefits of low anterior en bloc resection as part of cytoreductive surgery for advanced primary and recurrent epithelial ovarian cancer patients outweigh morbidity concerns.

    abstract:OBJECTIVES:The aim of this study was to assess the safety, efficacy and impact on survival of low anterior resection and primary anastomosis at the time of en bloc resection for primary and recurrent epithelial ovarian carcinoma. METHODS:We performed a retrospective review of 46 primary and 14 recurrent epithelial ova...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Park JY,Seo SS,Kang S,Lee KB,Lim SY,Choi HS,Park SY

    更新日期:2006-12-01 00:00:00

  • Vulval Keratoacanthoma: a case report.

    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


    authors: Nascimento MC,Cominos D,Davies NJ,Obermair A

    更新日期:2005-05-01 00:00:00

  • The prognostic value of semiquantitative nuclear grading in endometrial carcinomas.

    abstract::The objective of this study was to evaluate the prognostic value of a convenient nuclear grading system based on only the proportion of nuclei measuring more than 10 microm in length at the shortest axis in endometrial carcinomas. Of the 235 cases reviewed, 9 serous and 5 clear cell adenocarcinomas and 2 small cell ca...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Hachisuga T,Kawarabayashi T,Iwasaka T,Sugimori H,Kamura T,Tsuneyoshi M

    更新日期:1997-04-01 00:00:00

  • Intraperitoneal cytosine arabinoside administered in sequence with systemic cisplatin, doxorubicin, and cyclophosphamide in advanced ovarian cancer.

    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


    authors: Campora E,Bruzzone M,Chiara S,Alama A,Iskra L,Carnino F,Parodi S,Foglia G,Ragni N,Rosso R

    更新日期:1990-04-01 00:00:00

  • Matrix metalloproteinase 2 immunoreactive protein appears early in cervical epithelial dedifferentiation.

    abstract:OBJECTIVE:Expression of the immunoreactive protein of matrix metalloproteinase 2 (MMP-2) was studied in cervical tumors representing various stages of cell atypia and differentiation. In this study, we evaluated whether the expression of MMP-2 is an early or late event in the process of dedifferentiation and cancer pro...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Talvensaari A,Apaja-Sarkkinen M,Höyhtyä M,Westerlund A,Puistola U,Turpeenniemi T

    更新日期:1999-03-01 00:00:00

  • Bolus mitomycin C and 5-FU with sequential radiation for poor-prognosis locally advanced cervical cancer.

    abstract::Forty patients with locally advanced cervical carcinoma were entered into a protocol utilizing the bolus administration of both mitomycin C (10 or 15 mg) on Day 1 and 5-fluorouracil (400 mg) on Day 1-5 followed by sequential pelvic irradiation on Day 6 between September 1980 and October 1985. All patients had poor-pro...

    journal_title:Gynecologic oncology

    pub_type: 临床试验,杂志文章,评审


    authors: Denehy TR,Eastman R,SanFilippo L,Gregori CA,Breen JL

    更新日期:1996-01-01 00:00:00

  • Inverse expression of Cdk4 and p16 in epithelial ovarian tumors.

    abstract:OBJECTIVES:The aim of this study was to elucidate the expression and the correlation of two cell cycle regulators, cdk4 and its inhibitor p16, in a series of benign, borderline, and malignant ovarian tumors and to evaluate whether their alterations correlate with clinicopathologial parameters and patients' prognosis in...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Sui L,Dong Y,Ohno M,Goto M,Inohara T,Sugimoto K,Tai Y,Hando T,Tokuda M

    更新日期:2000-11-01 00:00:00

  • Granulosa cell tumor of ovary: a clinicopathologic and flow cytometric DNA analysis.

    abstract::Flow cytometric DNA ploidy and S-phase fraction (SPF) analysis was performed on 18 granulosa cell tumors of the ovary. Clinical and pathologic data from patients followed for an average of 10 years were compared to flow cytometry ploidy to determine its prognostic usefulness. Eleven (62%) tumors were diploid and seven...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Roush GR,el-Naggar AK,Abdul-Karim FW

    更新日期:1995-03-01 00:00:00

  • Cervical dysplasia in women infected with the human immunodeficiency virus (HIV): a correlation with HIV viral load and CD4+ count.

    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


    authors: Davis AT,Chakraborty H,Flowers L,Mosunjac MB

    更新日期:2001-03-01 00:00:00

  • Prognostic significance of c-erB-2 mRNA in ovarian carcinoma.

    abstract::The oncogene specific mRNA of c-erbB-2 was detected by the S1 nuclease protection assay in 95 ovarian cancer specimens. In 79 primary carcinomas, we found 16 (20%) with strong expression, 13 (17%) with weak expression, 4 (5%) with very weak expression, and 46 (58%) with no expression. In 3 of 16 recurrencies (19%) a s...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Tanner B,Kreutz E,Weikel W,Meinert R,Oesch F,Knapstein PG,Becker R

    更新日期:1996-08-01 00:00:00

  • The results of treatment of epithelial ovarian cancer after centralisation of primary surgery. Results from North Jutland, Denmark.

    abstract:OBJECTIVE:The study was performed to evaluate the results of treatment of ovarian carcinoma after the introduction of centralised primary surgery in the County of North Jutland, Denmark. METHOD:Prospective study of consecutive cases of ovarian cancer undergoing primary surgical treatment at the Gynecologic Oncologic C...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Soegaard Andersen E,Knudsen A,Svarrer T,Lund B,Nielsen K,Grove A,Tetsche M

    更新日期:2005-12-01 00:00:00

  • HLA-DQB1 and cervical cancer in Venezuelan women.

    abstract:BACKGROUND:Cervical cancer represents a major health problem in Venezuela as well as in other Latin American countries. High-risk human papillomavirus (HR-HPV) infection is known as the major risk factor of cervical cancer. However, whether or not a HR-HPV-infected woman progresses to cervical cancer may depend on the ...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Dao DD,Sierra-Torres CH,Robazetti SC,de Gomez MN,König R,Lema C,Lester LJ,Au WW,Tyring SK

    更新日期:2005-02-01 00:00:00

  • The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study.

    abstract:OBJECTIVE:To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom e...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Raphaelis S,Mayer H,Ott S,Mueller MD,Steiner E,Joura E,Senn B

    更新日期:2017-07-01 00:00:00

  • Second primary malignancy in endometrial carcinoma patients.

    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


    authors: Schwartz Z,Ohel G,Birkenfeld A,Anteby SO,Schenker JG

    更新日期:1985-09-01 00:00:00

  • Phase II study of neoadjuvant chemotherapy with mitomycin-c, vincristine and cisplatin (MVC) in patients with stages IB2-IIB cervical carcinoma.

    abstract:OBJECTIVE:The efficacy and toxicity of neoadjuvant chemotherapy (NAC) with mitomycin-C, vincristine and cisplatin (MVC) were assessed in bulky cervical carcinoma patients. METHODS:Forty-six patients with stage IB2 to IIB cervical cancer were treated with intravenous combination of mitomycin-C 10 mg/m(2), vincristine 1...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Choi CH,Kim TJ,Lee JW,Kim BG,Lee JH,Bae DS

    更新日期:2007-01-01 00:00:00

  • Detection of a small molecular species of human chorionic gonadotropin in the urine of patients with carcinoma of the cervix and cervical intraepithelial neoplasia: comparison with other assays for human chorionic gonadotropin and its fragments.

    abstract::A low-molecular-weight glycoprotein containing sequences of the beta subunit of human chorionic gonadotropin (hCG) has been found in the urine of patients with carcinoma of the cervix using an immunoradiometric assay. This fragment has chromatographic and immunological identity with hCG beta core. This molecule was pr...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Norman RJ,Buck RH,Aktar B,Mayet N,Moodley J

    更新日期:1990-05-01 00:00:00

  • Uterine tumors in ataxia-telangiectasia.

    abstract::Roughly one-third of patients with ataxia-telangiectasia (AT) develop malignant tumors, usually of lymphoid origin. AT patients also exhibit progeric changes. We describe three patients, between the ages of 27 and 32 years, with uterine tumors: one with a frank leiomyosarcoma and chronic T-cell leukemia, one with a mu...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Gatti RA,Nieberg R,Boder E

    更新日期:1989-02-01 00:00:00

  • A phase II trial of carboplatin for recurrent or metastatic squamous carcinoma of the uterine cervix: a Southwest Oncology Group study.

    abstract::Forty-one eligible patients with metastatic or recurrent carcinoma of the uterine cervix received 149 courses of carboplatin. The drug was administered at a starting dosage of 400 mg/m2 IV every 28 days. The overall response rate was 15% (two complete responses, four partial responses; 95% confidence interval 6-29%) a...

    journal_title:Gynecologic oncology

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Weiss GR,Green S,Hannigan EV,Boutselis JG,Surwit EA,Wallace DL,Alberts DS

    更新日期:1990-12-01 00:00:00

  • Endometrial cancer surgery in Arizona: a statewide analysis of access to care.

    abstract:OBJECTIVES:To investigate access to surgical care for endometrial cancer in Arizona. METHODS:The Arizona HealthQuery (AZHQ) data warehouse with claims information on over 7 million patients in Arizona was searched using the International Classification of Disease (ICD-9) codes and Current Procedural Terminology (CPT) ...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Benjamin I,Dalton H,Qiu Y,Cayco L,Johnson WG,Balducci J

    更新日期:2011-04-01 00:00:00

  • Anti-diabetic doses of metformin decrease proliferation markers in tumors of patients with endometrial cancer.

    abstract:BACKGROUND:Metformin has been associated with reduced cancer risk. The mechanisms underlying this cancer protective effect remain unknown. METHODS:"Window of opportunity" study of metformin in women with operable endometrial cancer (EC). Eleven newly diagnosed, untreated, non-diabetic patients with EC received metform...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章


    authors: Laskov I,Drudi L,Beauchamp MC,Yasmeen A,Ferenczy A,Pollak M,Gotlieb WH

    更新日期:2014-09-01 00:00:00

  • Prognostic factors for complete debulking in advanced ovarian cancer and its impact on survival. An exploratory analysis of a prospectively randomized phase III study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVA

    abstract:BACKGROUND:No residual tumor as result of primary surgery in advanced ovarian cancer is known as one of the most important prognostic factors. PURPOSE:To evaluate the impact of different prognostic factors for surgical outcome and to evaluate the impact of surgical outcome on survival. METHODS:Surgical data as well a...

    journal_title:Gynecologic oncology

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Wimberger P,Lehmann N,Kimmig R,Burges A,Meier W,Du Bois A,Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group.

    更新日期:2007-07-01 00:00:00