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https://www.readbyqxmd.com/read/27717299/niraparib-maintenance-therapy-in-platinum-sensitive-recurrent-ovarian-cancer
#1
Mansoor R Mirza, Bradley J Monk, Jørn Herrstedt, Amit M Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A Ledermann, Domenica Lorusso, Ignace Vergote, Noa E Ben-Baruch, Christian Marth, Radosław Mądry, René D Christensen, Jonathan S Berek, Anne Dørum, Anna V Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert, Bobbie J Rimel, Joseph Buscema, John P Balser, Shefali Agarwal, Ursula A Matulonis
Background Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. Methods In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2:1 ratio to receive niraparib (300 mg) or placebo once daily...
October 7, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27663600/sequence-specific-pharmacokinetic-and-pharmacodynamic-phase-i-ib-study-of-olaparib-tablets-and-carboplatin-in-women-s-cancer
#2
Jung-Min Lee, Cody J Peer, Minshu Yu, Lauren Amable, Nicolas Gordon, Christina M Annunziata, Nicole Houston, Andrew K L Goey, Tristan M Sissung, Bernard Parker, Lori Minasian, Victoria Chiou, Robert F Murphy, Brigitte C Widemann, William D Figg, Elise C Kohn
PURPOSE: Our preclinical studies showed the PARP inhibitor, olaparib prior to carboplatin attenuated carboplatin cytotoxicity. We evaluated sequence-specific pharmacokinetic/pharmacodynamic (PK/PD) effects, safety and activity of the combination. PATIENTS AND METHODS: Eligible patients had metastatic or recurrent women's cancer. Olaparib tablets were introduced (100 or 200mg bid, days1-7) in a 3+3 dose escalation with carboplatin AUC4 or 5 q21 days, up to eight cycles, followed by olaparib maintenance...
September 23, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/26801247/phase-i-study-of-veliparib-abt-888-combined-with-cisplatin-and-vinorelbine-in-advanced-triple-negative-breast-cancer-and-or-brca-mutation-associated-breast-cancer
#3
Eve T Rodler, Brenda F Kurland, Melissa Griffin, Julie R Gralow, Peggy Porter, Rosa F Yeh, Vijayakrishna K Gadi, Jamie Guenthoer, Jan H Beumer, Larissa Korde, Sandra Strychor, Brian F Kiesel, Hannah M Linden, John A Thompson, Elizabeth Swisher, Xiaoyu Chai, Stacie Shepherd, Vincent Giranda, Jennifer M Specht
PURPOSE: Cisplatin is synergistic with vinorelbine and the PARP inhibitor veliparib, and has antineoplastic activity in triple-negative breast cancer (TNBC) and BRCA mutation-associated breast cancer. This phase I study assessed veliparib with cisplatin and vinorelbine. EXPERIMENTAL DESIGN: A 3+3 dose-escalation design evaluated veliparib administered twice daily for 14 days with cisplatin (75 mg/m(2) day 1) and vinorelbine (25 mg/m(2) days 1, 8) every 21 days, for 6 to 10 cycles, followed by veliparib monotherapy...
June 15, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/25899311/olaparib-a-review-of-its-use-as-maintenance-therapy-in-patients-with-ovarian-cancer
#4
REVIEW
James E Frampton
Olaparib (Lynparza™) is a first-in-class, orally-active, small molecule, poly (ADP-ribose) polymerase inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. In the EU, the capsule formulation of olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive, relapsed, BRCA-mutated (germline and/or somatic), high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy...
April 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/25818403/a-phase-ii-evaluation-of-the-potent-highly-selective-parp-inhibitor-veliparib-in-the-treatment-of-persistent-or-recurrent-epithelial-ovarian-fallopian-tube-or-primary-peritoneal-cancer-in-patients-who-carry-a-germline-brca1-or-brca2-mutation-an-nrg-oncology
#5
MULTICENTER STUDY
Robert L Coleman, Michael W Sill, Katherine Bell-McGuinn, Carol Aghajanian, Heidi J Gray, Krishnansu S Tewari, Steven C Rubin, Thomas J Rutherford, John K Chan, Alice Chen, Elizabeth M Swisher
BACKGROUND: Veliparib is a potent small molecule inhibitor of PARP-1/2, which is cytotoxic in tumor cells with deficiencies in BRCA1 or BRCA2. We studied the clinical activity and toxicity of veliparib in ovarian cancer patients carrying a germline BRCA1 or BRCA2 mutation (gBRCA). METHODS: Eligibility included three or fewer prior chemotherapy regimens, measurable disease and no prior use of a PARP inhibitor. Veliparib was administered at 400mg orally BID with one cycle being 28days...
June 2015: Gynecologic Oncology
https://www.readbyqxmd.com/read/25481791/olaparib-combined-with-chemotherapy-for-recurrent-platinum-sensitive-ovarian-cancer-a-randomised-phase-2-trial
#6
RANDOMIZED CONTROLLED TRIAL
Amit M Oza, David Cibula, Ana Oaknin Benzaquen, Christopher Poole, Ron H J Mathijssen, Gabe S Sonke, Nicoletta Colombo, Jiří Špaček, Peter Vuylsteke, Holger Hirte, Sven Mahner, Marie Plante, Barbara Schmalfeldt, Helen Mackay, Jacqui Rowbottom, Elizabeth S Lowe, Brian Dougherty, J Carl Barrett, Michael Friedlander
BACKGROUND: The poly(ADP-ribose) polymerase inhibitor olaparib has shown antitumour activity in patients with platinum-sensitive, recurrent, high-grade serous ovarian cancer with or without BRCA1 or BRCA2 mutations. The aim of this study was to assess the efficacy and tolerability of olaparib in combination with chemotherapy, followed by olaparib maintenance monotherapy, versus chemotherapy alone in patients with platinum-sensitive, recurrent, high-grade serous ovarian cancer. METHODS: In this randomised, open-label, phase 2 study, adult patients with platinum-sensitive, recurrent, high-grade serous ovarian cancer who had received up to three previous courses of platinum-based chemotherapy and who were progression free for at least 6 months before randomisation received either olaparib (200 mg capsules twice daily, administered orally on days 1-10 of each 21-day cycle) plus paclitaxel (175 mg/m(2), administered intravenously on day 1) and carboplatin (area under the curve [AUC] 4 mg/mL per min, according to the Calvert formula, administered intravenously on day 1), then olaparib monotherapy (400 mg capsules twice daily, given continuously) until progression (the olaparib plus chemotherapy group), or paclitaxel (175 mg/m(2) on day 1) and carboplatin (AUC 6 mg/mL per min on day 1) then no further treatment (the chemotherapy alone group)...
January 2015: Lancet Oncology
https://www.readbyqxmd.com/read/25001612/tbcrc-018-phase-ii-study-of-iniparib-in-combination-with-irinotecan-to-treat-progressive-triple-negative-breast-cancer-brain-metastases
#7
Carey Anders, Allison M Deal, Vandana Abramson, Minetta C Liu, Anna M Storniolo, John T Carpenter, Shannon Puhalla, Rita Nanda, Amal Melhem-Bertrandt, Nancy U Lin, P Kelly Marcom, Catherine Van Poznak, Vered Stearns, Michelle Melisko, J Keith Smith, Olga Karginova, Joel Parker, Jonathan Berg, Eric P Winer, Amy Peterman, Aleix Prat, Charles M Perou, Antonio C Wolff, Lisa A Carey
Nearly half of patients with advanced triple negative breast cancer (TNBC) develop brain metastases (BM) and most will also have uncontrolled extracranial disease. This study evaluated the safety and efficacy of iniparib, a small molecule anti-cancer agent that alters reactive oxygen species tumor metabolism and penetrates the blood brain barrier, with the topoisomerase I inhibitor irinotecan in patients with TNBC-BM. Eligible patients had TNBC with new or progressive BM and received irinotecan and iniparib every 3 weeks...
August 2014: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/24842883/phase-i-ib-study-of-olaparib-and-carboplatin-in-brca1-or-brca2-mutation-associated-breast-or-ovarian-cancer-with-biomarker-analyses
#8
Jung-Min Lee, John L Hays, Christina M Annunziata, Anne M Noonan, Lori Minasian, Jo Anne Zujewski, Minshu Yu, Nicolas Gordon, Jiuping Ji, Tristan M Sissung, William D Figg, Nilofer Azad, Bradford J Wood, James Doroshow, Elise C Kohn
BACKGROUND: Olaparib has single-agent activity against breast/ovarian cancer (BrCa/OvCa) in germline BRCA1 or BRCA2 mutation carriers (gBRCAm). We hypothesized addition of olaparib to carboplatin can be administered safely and yield preliminary clinical activity. METHODS: Eligible patients had measurable or evaluable disease, gBRCAm, and good end-organ function. A 3 + 3 dose escalation tested daily oral capsule olaparib (100 or 200mg every 12 hours; dose level1 or 2) with carboplatin area under the curve (AUC) on day 8 (AUC3 day 8), then every 21 days...
June 2014: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/24692579/activity-of-trabectedin-in-germline-brca1-2-mutated-metastatic-breast-cancer-results-of-an-international-first-in-class-phase-ii-study
#9
S Delaloge, R Wolp-Diniz, T Byrski, J L Blum, A Gonçalves, M Campone, P Lardelli, C Kahatt, A Nieto, M Cullell-Young, J Lubinski
BACKGROUND: Breast cancer is a heterogeneous disease defined by both germline and somatic abnormalities. In preclinical models, tumors carrying homologous recombination defects are highly sensitive to trabectedin. This phase II trial evaluated the efficacy and safety of trabectedin in BRCA1/2 germline mutation carriers with pretreated metastatic breast cancer (MBC). PATIENTS AND METHODS: Trabectedin 1.3 mg/m(2) as a 3-h i.v. infusion was administered every 3 weeks until progression or intolerance...
June 2014: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/24217135/the-influence-of-brca1-brca2-mutations-on-toxicity-related-to-chemotherapy-and-radiotherapy-in-early-breast-cancer-patients
#10
COMPARATIVE STUDY
Joanna Huszno, Magdalena Budryk, Zofia Kołosza, Elżbieta Nowara
OBJECTIVE: The presence of BRCA gene mutation and low expressions of BRCA proteins are associated with a greater sensitivity of tumor cells to ionizing radiation and to cytostatics damaging the DNA of the cells. The purpose of this study was to estimate the rate of adverse events in BRCA1/2-associated breast cancer patients receiving anthracycline-based chemotherapy compared to patients without mutation. The authors also compared radiotherapy toxicity in these 2 groups. METHODS: The analysis included 270 early-stage breast cancer patients treated between 2006 and 2012...
2013: Oncology
https://www.readbyqxmd.com/read/23810788/the-poly-adp-ribose-polymerase-inhibitor-niraparib-mk4827-in-brca-mutation-carriers-and-patients-with-sporadic-cancer-a-phase-1-dose-escalation-trial
#11
MULTICENTER STUDY
Shahneen K Sandhu, William R Schelman, George Wilding, Victor Moreno, Richard D Baird, Susana Miranda, Lucy Hylands, Ruth Riisnaes, Martin Forster, Aurelius Omlin, Nathan Kreischer, Khin Thway, Heidrun Gevensleben, Linda Sun, John Loughney, Manash Chatterjee, Carlo Toniatti, Christopher L Carpenter, Robert Iannone, Stan B Kaye, Johann S de Bono, Robert M Wenham
BACKGROUND: Poly(ADP-ribose) polymerase (PARP) is implicated in DNA repair and transcription regulation. Niraparib (MK4827) is an oral potent, selective PARP-1 and PARP-2 inhibitor that induces synthetic lethality in preclinical tumour models with loss of BRCA and PTEN function. We investigated the safety, tolerability, maximum tolerated dose, pharmacokinetic and pharmacodynamic profiles, and preliminary antitumour activity of niraparib. METHODS: In a phase 1 dose-escalation study, we enrolled patients with advanced solid tumours at one site in the UK and two sites in the USA...
August 2013: Lancet Oncology
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