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https://www.readbyqxmd.com/read/27769273/communicating-brca-research-results-to-patients-enrolled-in-international-clinical-trials-lessons-learnt-from-the-ago-ovar-16-study
#1
David J Pulford, Philipp Harter, Anne Floquet, Catherine Barrett, Dong Hoon Suh, Michael Friedlander, José Angel Arranz, Kosei Hasegawa, Hiroomi Tada, Peter Vuylsteke, Mansoor R Mirza, Nicoletta Donadello, Giovanni Scambia, Toby Johnson, Charles Cox, John K Chan, Martin Imhof, Thomas J Herzog, Paula Calvert, Pauline Wimberger, Dominique Berton-Rigaud, Myong Cheol Lim, Gabriele Elser, Chun-Fang Xu, Andreas du Bois
BACKGROUND: The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. METHODS: An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis...
October 21, 2016: BMC Medical Ethics
https://www.readbyqxmd.com/read/27561452/prognostic-factors-in-young-ovarian-cancer-patients-an-analysis-of-four-prospective-phase-iii-intergroup-trials-of-the-ago-study-group-gineco-and-nsgo
#2
M Klar, A Hasenburg, M Hasanov, F Hilpert, W Meier, J Pfisterer, E Pujade-Lauraine, J Herrstedt, A Reuss, A du Bois
OBJECTIVES: We evaluated in a large study meta-database of prospectively randomised phase III trials the prognostic factors for progression-free survival (PFS) and overall survival (OS) in patients < and >40 years of age with advanced epithelial ovarian cancer. METHODS: A total of 5055 patients of the AGO, GINECO, NSGO intergroup studies AGO-OVAR 3, 5, 7 and 9 were merged to identify 294 patients <40 years and 4761 patients ≥40 years. We conducted survival analyses and Cox proportional hazard regression models and additionally analysed a very homogeneous subcohort of 405 patients with serous epithelial ovarian cancer, excellent performance status, who had received complete macroscopic upfront cytoreduction and ≥5 chemotherapy cycles...
October 2016: European Journal of Cancer
https://www.readbyqxmd.com/read/27269942/double-blind-placebo-controlled-randomized-phase-iii-trial-evaluating-pertuzumab-combined-with-chemotherapy-for-low-tumor-human-epidermal-growth-factor-receptor-3-mrna-expressing-platinum-resistant-ovarian-cancer-penelope
#3
Christian Kurzeder, Isabel Bover, Frederik Marmé, Joern Rau, Patricia Pautier, Nicoletta Colombo, Domenica Lorusso, Petronella Ottevanger, Maria Bjurberg, Christian Marth, Pilar Barretina-Ginesta, Ignace Vergote, Anne Floquet, Josep M Del Campo, Sven Mahner, Lydie Bastière-Truchot, Nicolas Martin, Mikkel Z Oestergaard, Astrid Kiermaier, Carmen Schade-Brittinger, Sandra Polleis, Andreas du Bois, Antonio Gonzalez-Martin
PURPOSE: The AGO-OVAR 2.29/ENGOT-ov14/PENELOPE prospectively randomized phase III trial evaluated the addition of pertuzumab to chemotherapy in patients with platinum-resistant ovarian carcinoma with low tumor human epidermal growth factor receptor 3 (HER3) mRNA expression. We report the results of the primary efficacy analysis. PATIENTS AND METHODS: Eligible patients had ovarian carcinoma that progressed during or within 6 months of completing four or more platinum cycles, centrally tested low tumor HER3 mRNA expression (concentration ratio ≤ 2...
July 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/26941446/statement-of-the-ago-kommission-ovar-ago-study-group-noggo-ago-austria-and-ago-switzerland-regarding-the-use-of-hyperthermic-intraperitoneal-chemotherapy-hipec-in-ovarian-cancer
#4
P Harter, A du Bois, S Mahner, J Pfisterer, O Ortmann, C Marth, D Fink, F Hilpert, U Wagner, J Sehouli
The AGO Kommission Ovar already published a statement in 2013, warning about the uncritical use of hyperthermic intraperitoneal chemotherapy (HIPEC) outside controlled studies. This statement has now been updated after the most recent literature was reviewed by AGO Kommission Ovar, the AGO Study Group, NOGGO, AGO Austria and AGO Switzerland. The authors conclude that HIPEC remains experimental. Its use is not recommended and should be rejected outside of prospective controlled trials.
February 2016: Geburtshilfe und Frauenheilkunde
https://www.readbyqxmd.com/read/26590673/standard-first-line-chemotherapy-with-or-without-nintedanib-for-advanced-ovarian-cancer-ago-ovar-12-a-randomised-double-blind-placebo-controlled-phase-3-trial
#5
RANDOMIZED CONTROLLED TRIAL
Andreas du Bois, Gunnar Kristensen, Isabelle Ray-Coquard, Alexander Reuss, Sandro Pignata, Nicoletta Colombo, Ursula Denison, Ignace Vergote, Jose M Del Campo, Petronella Ottevanger, Martin Heubner, Thomas Minarik, Emmanuel Sevin, Nikolaus de Gregorio, Mariusz Bidziński, Jacobus Pfisterer, Susanne Malander, Felix Hilpert, Mansoor R Mirza, Giovanni Scambia, Werner Meier, Maria O Nicoletto, Line Bjørge, Alain Lortholary, Martin Oliver Sailer, Michael Merger, Philipp Harter
BACKGROUND: Angiogenesis is a target in the treatment of ovarian cancer. Nintedanib, an oral triple angiokinase inhibitor of VEGF receptor, platelet-derived growth factor receptor, and fibroblast growth factor receptor, has shown activity in phase 2 trials in this setting. We investigated the combination of nintedanib with standard carboplatin and paclitaxel chemotherapy in patients with newly diagnosed advanced ovarian cancer. METHODS: In this double-blind phase 3 trial, chemotherapy-naive patients (aged 18 years or older) with International Federation of Gynecology and Obstetrics (FIGO) IIB-IV ovarian cancer and upfront debulking surgery were stratified by postoperative resection status, FIGO stage, and planned carboplatin dose...
January 2016: Lancet Oncology
https://www.readbyqxmd.com/read/26556905/statement-by-the-kommission-ovar-of-the-ago-the-new-figo-and-who-classifications-of-ovarian-fallopian-tube-and-primary-peritoneal-cancer
#6
I Meinhold-Heerlein, C Fotopoulou, P Harter, C Kurzeder, A Mustea, P Wimberger, S Hauptmann, J Sehouli
More than 25 years after the last revision, in 2012 the FIGO Oncology Committee began revising the FIGO classification for staging ovarian, Fallopian tube and primary peritoneal cancers. The new classification has become effective with its publication at the beginning of 2014. Following recent findings on the pathogenesis of ovarian, Fallopian tube and primary peritoneal cancer and reflecting standard clinical practice, the three entities have now been classified uniformly. The histological subtype is included (high-grade serous - HGSC; low-grade serous - LGSC; mucinous - MC; clear cell - CCC; endometrioid - EC)...
October 2015: Geburtshilfe und Frauenheilkunde
https://www.readbyqxmd.com/read/26033044/the-fntb-promoter-polymorphism-rs11623866-as-a-potential-predictive-biomarker-for-lonafarnib-treatment-of-ovarian-cancer-patients
#7
MULTICENTER STUDY
Hagen Sjard Bachmann, Werner Meier, Andreas du Bois, Rainer Kimmig, Jan Dominik Kuhlmann, Winfried Siffert, Jalid Sehouli, Kerstin Wollschlaeger, Jens Huober, Peter Hillemanns, Alexander Burges, Barbara Schmalfeldt, Behnaz Aminossadati, Pauline Wimberger
AIM: Despite promising preclinical findings regarding clinical utility of farnesyltransferase inhibitors (FTI), such as lonafarnib, success of clinical trials is limited. A multicentre AGO-OVAR-15 phase II trial reported an unfavourable effect of lonafarnib on the outcome of patients with advanced ovarian cancer. This study was performed as a genetic subgroup analysis of the AGO-OVAR-15 trial, and investigated the utility of the promoter polymorphism rs11623866 of the farnesyltransferase ß-subunit gene (FNTB) in predicting the clinical effectiveness of lonafarnib...
November 2015: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/25914073/opportunistic-salpingectomies-for-the-prevention-of-a-high-grade-serous-carcinoma-a-statement-by-the-kommission-ovar-of-the-ago
#8
REVIEW
Martin Pölcher, Steffen Hauptmann, Christina Fotopoulou, Barbara Schmalfeldt, Ivo Meinhold-Heerlein, Alexander Mustea, Ingo Runnebaum, Jalid Sehouli
The detection of premalignant cells in the epithelium of the fallopian tube has resulted in revolutionary theories regarding the origin of epithelial ovarian cancer (EOC). Serous tubal intra-epithelial carcinomas (STIC) have been detected in patients with BRCA 1 or 2 mutations and are considered as the most likely precursors of the high-grade serous ovarian cancer (HGSOC), which is the most common histological subtype in patients with EOC. A bilateral salpingo-oophorectomy is associated with a significant reduction in risk of developing EOC...
July 2015: Archives of Gynecology and Obstetrics
https://www.readbyqxmd.com/read/25739827/the-prognostic-relevance-of-node-metastases-in-optimally-cytoreduced-advanced-ovarian-cancer
#9
Cornelia Bachmann, Sara Y Brucker, Bernhard Kraemer, Ralf Rothmund, Anette Staebler, Falko Fend, Diethelm Wallwiener, Eva-Maria Grischke
PURPOSE: To delineate the relevance of pelvic and para-aortic node involvement in optimally cytoreduced (residual tumour <1 cm) stage IIIC ovarian cancer patients. METHODS: Ninety-five consecutive optimally cytoreduced (R ≤ 1 cm) patients with primary stage IIIc ovarian cancer underwent stage-related surgery and got adjuvant platinum-based chemotherapy. Median follow-up: 53.5 months. All patients got systematic lymphadenectomy. On average, 24.7 pelvic and para-aortic lymph nodes were removed per patient (range 1-60 nodes)...
August 2015: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/25174293/isolated-splenic-metastasis-of-ovaric-cancer-case-report-and-literature-review
#10
REVIEW
G Resta, L Vedana, Silvia Marino, L Scagliarini, M Bandi, G Anania
Splenic metastasis is extremely rare and are usually found in conjunction with metastasis of other organs. In addition, late recurrence even after 10 years of operation is very unusual. The most common sources of splenic metastasis are lung, colonrectal, melanoma, breast and ovarian carcinoma. We present a case of 67 year old woman who was admitted to our department with a solitary splenic metastases after hysterectomy with bilateral salpingo-oophorectomy for ovaric carcinoma 10 years ago. In conclusion, solitary splenic metastasis are very rare and the incidence of the reported cases in the medical literature is increasing...
July 2014: Il Giornale di Chirurgia
https://www.readbyqxmd.com/read/25082124/two-new-unusual-monoterpene-acid-glycosides-from-acacia-cyclops-with-potential-cytotoxic-activity
#11
Amira Jelassi, Afifa Zardi-Bergaoui, Aymen Ben Nejma, Meriam Belaiba, Jalloul Bouajila, Hichem Ben Jannet
A phytochemical investigation of the Tunisian plant Acacia cyclops pods led to the isolation of two new monoterpenoid glycosides, which have been designated Cyclopside 1 and Cyclopside 2. Their structures were elucidated on the basis of extensive spectroscopic procedures including IR, MS and 2D-NMR. The cytotoxic effect of the isolates was also evaluated in vitro against the human breast cancer (MCF-7) and ovarian cancer (OVAR) cell lines. Results showed that the highest cytotoxic activity (90.88%) was against MCF-7 cell line and was exhibited by the Cyclopside 1 at the concentration of 50 μg/mL...
August 15, 2014: Bioorganic & Medicinal Chemistry Letters
https://www.readbyqxmd.com/read/24947930/acquired-resistance-to-endocrine-treatments-is-associated-with-tumor-specific-molecular-changes-in-patient-derived-luminal-breast-cancer-xenografts
#12
Paul Cottu, Ivan Bièche, Franck Assayag, Rania El Botty, Sophie Chateau-Joubert, Aurélie Thuleau, Thomas Bagarre, Benoit Albaud, Audrey Rapinat, David Gentien, Pierre de la Grange, Vonick Sibut, Sophie Vacher, Rana Hatem, Jean-Luc Servely, Jean-Jacques Fontaine, Didier Decaudin, Jean-Yves Pierga, Sergio Roman-Roman, Elisabetta Marangoni
PURPOSE: Patients with luminal breast cancer (LBC) often become endocrine resistant over time. We investigated the molecular changes associated with acquired hormonoresistances in patient-derived xenografts of LBC. EXPERIMENTAL DESIGN: Two LBC xenografts (HBCx22 and HBCx34) were treated with different endocrine treatments (ET) to obtain xenografts with acquired resistances to tamoxifen (TamR) and ovariectomy (OvaR). PI3K pathway activation was analyzed by Western blot analysis and IHC and responses to ET combined to everolimus were investigated in vivo...
August 15, 2014: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/24920435/use-of-iota-simple-rules-for-diagnosis-of-ovarian-cancer-meta-analysis
#13
REVIEW
N Nunes, G Ambler, X Foo, J Naftalin, M Widschwendter, D Jurkovic
OBJECTIVES: To present data on prospective evaluation of the International Ovarian Tumor Analysis (IOTA) 'simple-rules' tool for the diagnosis of ovarian cancer and to perform a meta-analysis of studies that utilized the same diagnostic method. METHODS: In the present study a level-II ultrasound operator systematically assessed the tumors of women with an ultrasound diagnosis of adnexal tumor(s) according to the IOTA simple-rules protocol to determine the risk of the tumor being malignant...
November 2014: Ultrasound in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/24771913/statement-by-the-kommission-ovar-of-the-ago-study-group-on-the-use-of-hipec-hyperthermic-intraperitoneal-chemotherapy-to-treat-primary-and-recurrent-ovarian-cancer
#14
P Harter, S Mahner, F Hilpert, I Runnebaum, O Ortmann, A Mustea, J Sehouli, A du Bois, U Wagner
HIPEC is offered to patients with ovarian, fallopian tube or primary peritoneal cancer at some hospitals. Altogether, there is still no evidence that HIPEC leads to an improvement of prognosis in any gynecologic tumor, neither in primary therapy nor in treatment of relapse. The available data indicate an increased complication rate which might negatively impact the benefit-risk balance of this procedure. In addition, standard treatment with proven efficacy might be withheld due to application of unproven methods...
March 2013: Geburtshilfe und Frauenheilkunde
https://www.readbyqxmd.com/read/24457552/secondary-complete-cytoreduction-in-recurrent-ovarian-cancer-benefit-of-optimal-patient-selection-using-scoring-system
#15
MULTICENTER STUDY
Enora Laas, Mathieu Luyckx, Marjolein De Cuypere, Frederic Selle, Emile Daraï, Denis Querleu, Roman Rouzier, Elisabeth Chéreau
OBJECTIVE: Complete tumor cytoreduction seems to be beneficial for patients with recurrent epithelial ovarian cancer (REOC). The challenge is to identify patients eligible for such surgery. Several scores based on simple clinical parameters have attempted to predict resectability and help in patient selection for surgery in REOC.The aims of this study were to assess the performance of these models in an independent population and to evaluate the impact of complete resection. MATERIALS AND METHODS: A total of 194 patients with REOC between January 2000 and December 2010 were included in 2 French centers...
February 2014: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/24005613/addition-of-vandetanib-to-pegylated-liposomal-doxorubicin-pld-in-patients-with-recurrent-ovarian-cancer-a-randomized-phase-i-ii-study-of-the-ago-study-group-ago-ovar-2-13
#16
RANDOMIZED CONTROLLED TRIAL
Philipp Harter, Jalid Sehouli, Rainer Kimmig, Jörn Rau, Felix Hilpert, Christian Kurzeder, Gabriele Elser, Andreas du Bois
BACKGROUND: PLD is a standard treatment in patients with recurrent platinum-resistant or refractory ovarian cancer. Vandetanib is an oral once daily administered inhibitor of VEGFR-, EGFR- and RET-signaling with activity in combination with chemotherapy in some solid tumours. We aimed to establish a feasible combination therapy of PLD and vandetanib in ovarian cancer. METHODS: Eligible patients were treated with PLD 50 mg/m(2) q28 and vandetanib 100 mg/d po. It was planned to recruit at least 10 patients evaluable for toxicity over 2 treatment cycles...
December 2013: Investigational New Drugs
https://www.readbyqxmd.com/read/23500609/impact-of-beta-blocker-medication-in-patients-with-platinum-sensitive-recurrent-ovarian-cancer-a-combined-analysis-of-2-prospective-multicenter-trials-by-the-ago-study-group-ncic-ctg-and-eortc-gcg
#17
RANDOMIZED CONTROLLED TRIAL
Florian Heitz, Andreas du Bois, Philipp Harter, Dirk Lubbe, Christian Kurzeder, Ignace Vergote, Marie Plante, Jacobus Pfisterer
OBJECTIVE: Retrospective analyses suggest that the treatment with beta blocker improves survival in patients with breast cancer and melanoma. The aim of this study was to investigate the impact of medication with beta blocker in patients with recurrent ovarian cancer. METHODS: Included patients received treatment within two prospective clinical trials: AGO-OVAR 2.4 phase I trial (carboplatin/gemcitabine; N=25, protocol AGO-OVAR 2.4) and AGO led intergroup phase III trial (carboplatin vs carboplatin/gemcitabine; N=356, protocol AGO-OVAR 2...
June 2013: Gynecologic Oncology
https://www.readbyqxmd.com/read/23478059/abagovomab-as-maintenance-therapy-in-patients-with-epithelial-ovarian-cancer-a-phase-iii-trial-of-the-ago-ovar-cogi-gineco-and-geico-the-mimosa-study
#18
RANDOMIZED CONTROLLED TRIAL
Paul Sabbatini, Philipp Harter, Giovanni Scambia, Jalid Sehouli, Werner Meier, Pauline Wimberger, Klaus H Baumann, Christian Kurzeder, Barbara Schmalfeldt, David Cibula, Mariusz Bidzinski, Antonio Casado, Andrea Martoni, Nicoletta Colombo, Robert W Holloway, Luigi Selvaggi, Andrew Li, Jose del Campo, Karel Cwiertka, Tamas Pinter, Jan B Vermorken, Eric Pujade-Lauraine, Simona Scartoni, Monica Bertolotti, Cecilia Simonelli, Angela Capriati, Carlo Alberto Maggi, Jonathan S Berek, Jacobus Pfisterer
PURPOSE: To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission. PATIENTS AND METHODS: Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum- and taxane-based chemotherapy were randomly assigned at a ratio of 2:1 in a phase III, double-blind, placebo-controlled, multicenter study...
April 20, 2013: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/23234805/a-phase-ii-randomized-double-blind-study-of-zibotentan-zd4054-in-combination-with-carboplatin-paclitaxel-versus-placebo-in-combination-with-carboplatin-paclitaxel-in-patients-with-advanced-ovarian-cancer-sensitive-to-platinum-based-chemotherapy-ago-ovar-2-14
#19
RANDOMIZED CONTROLLED TRIAL
F Cognetti, A Bagnato, N Colombo, A Savarese, G Scambia, J Sehouli, P Wimberger, R Sorio, P Harter, E Mari, S McIntosh, F Nathan, K Pemberton, K Baumann
BACKGROUND: In platinum-sensitive relapsed ovarian cancer, paclitaxel plus carboplatin is a standard second-line treatment. Zibotentan (ZD4054) is an oral, specific ETA-receptor antagonist with demonstrated antitumour activity in xenograft models of human ovarian cancer. METHODS: In this Phase II, randomized, placebo-controlled study, patients with relapsed ovarian cancer sensitive to platinum-based chemotherapy received zibotentan 10mg or placebo once-daily, plus paclitaxel 175 mg/m(2) iv followed by carboplatin iv (AUC 5) on day 1 of every 3-week cycle for a maximum of eight cycles...
July 2013: Gynecologic Oncology
https://www.readbyqxmd.com/read/23104722/a-prognostic-nomogram-to-predict-overall-survival-in-patients-with-platinum-sensitive-recurrent-ovarian-cancer
#20
C K Lee, R J Simes, C Brown, V Gebski, J Pfisterer, A-M Swart, D Berton-Rigaud, M Plante, T Skeie-Jensen, I Vergote, C Schauer, C Pisano, G Parma, K Baumann, J A Ledermann, E Pujade-Lauraine, J Bentley, G Kristensen, A Belau, M Nankivell, U Canzler, S J Lord, C Kurzeder, M Friedlander
BACKGROUND: Patients with platinum-sensitive recurrent ovarian cancer have variable prognosis and survival. We extend previous work on prediction of progression-free survival by developing a nomogram to predict overall survival (OS) in these patients treated with platinum-based chemotherapy. PATIENTS AND METHODS: The nomogram was developed using data from the CAELYX in Platinum-Sensitive Ovarian Patients (CALYPSO) trial. Multivariate proportional hazards models were generated based on pre-treatment characteristics to develop a nomogram that classifies patient prognosis based on OS outcome...
April 2013: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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