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Articles 1 - 30 of 44
Full-Text Articles in Hematology
Mutations Associated With A 17-Gene Leukemia Stem Cell Score And The Score’S Prognostic Relevance In The Context Of The European Leukemianet Classification Of Acute Myeloid Leukemia, M. Bill, D. Nicolet, J. Kohlschmidt, C. J. Walker, K. Mrózek, A. K. Eisfeld, D. Papaioannou, X. Rong-Mullins, J. E. Kolitz, C. D. Bloomfield, +8 Additional Authors
Mutations Associated With A 17-Gene Leukemia Stem Cell Score And The Score’S Prognostic Relevance In The Context Of The European Leukemianet Classification Of Acute Myeloid Leukemia, M. Bill, D. Nicolet, J. Kohlschmidt, C. J. Walker, K. Mrózek, A. K. Eisfeld, D. Papaioannou, X. Rong-Mullins, J. E. Kolitz, C. D. Bloomfield, +8 Additional Authors
Journal Articles
© 2020 Ferrata Storti Foundation. Leukemia stem cells (LSC) are more resistant to standard chemotherapy and their persistence during remission can cause relapse, which is still one of the major clinical challenges in the treatment of acute myeloid leukemia (AML). A better understanding of the mutational patterns and the prognostic impact of molecular markers associated with stemness could lead to better clinical management and improve patients’ outcomes. We applied a previously described 17-gene expression score comprising genes differently expressed between LSC and leukemic bulk blasts, for 934 adult patients with de novo AML, and studied associations of the 17-gene LSC …
A Case Of Vancomycin-Induced Immune Thrombocytopenia., K. N. Macdougall, S. Parylo, A. Sokoloff
A Case Of Vancomycin-Induced Immune Thrombocytopenia., K. N. Macdougall, S. Parylo, A. Sokoloff
Journal Articles
Vancomycin-induced immune thrombocytopenia (ITP) is a rare, potentially life-threatening complication from an antibiotic frequently used in medical practice. We report a case of an 81-year-old male with recent removal of an infected right knee prosthesis and insertion of an articulating antibiotic spacer, presenting from rehabilitation for severe thrombocytopenia (1 X 103/µL). The patient's thrombocytopenia was initially falsely attributed to rifampin-induced ITP, a much more common cause of drug-induced thrombocytopenia. Only later, after a second precipitous drop in platelet count, vancomycin was correctly identified as the culprit. The patient's serum was tested for drug-dependent platelet antibodies with and without vancomycin. A …
Relationship Between Obesity And Clinical Outcome In Adults With Acute Myeloid Leukemia: A Pooled Analysis From Four Calgb (Alliance) Clinical Trials, J. J. Castillo, F. Mulkey, S. Geyer, J. E. Kolitz, W. Blum, B. L. Powell, S. L. George, R. A. Larson, R. M. Stone
Relationship Between Obesity And Clinical Outcome In Adults With Acute Myeloid Leukemia: A Pooled Analysis From Four Calgb (Alliance) Clinical Trials, J. J. Castillo, F. Mulkey, S. Geyer, J. E. Kolitz, W. Blum, B. L. Powell, S. L. George, R. A. Larson, R. M. Stone
Journal Articles
Obesity has been previously suggested as an adverse prognostic marker in patients with acute leukemia. To evaluate the relationship between obesity and clinical outcome, disease-free survival (DFS) and overall survival (OS), in patients with acute myelogenous leukemia (AML), including acute promyelocytic leukemia (APL), we performed a pooled analysis of four CALGB (Alliance) clinical trials. Our study included 446 patients with APL from CALGB 9710, and 1,648 patients between 18 and 60 years of age with non-APL AML from CALGB 9621, 10503, and 19808. Obesity was defined as BMI >/=30 kg/m(2) . Multivariate Cox proportional-hazard regression models were fitted for DFS …
Sotatercept (Ace-011) For The Treatment Of Chemotherapy-Induced Anemia In Patients With Metastatic Breast Cancer Or Advanced Or Metastatic Solid Tumors Treated With Platinum-Based Chemotherapeutic Regimens: Results From Two Phase 2 Studies, H. Raftopoulos, A. Laadem, P. J. Hesketh, J. Goldschmidt, N. Gabrail, C. Osborne, M. Ali, M. L. Sherman, D. Wang, J. Crawford, +3 Additional Authors
Sotatercept (Ace-011) For The Treatment Of Chemotherapy-Induced Anemia In Patients With Metastatic Breast Cancer Or Advanced Or Metastatic Solid Tumors Treated With Platinum-Based Chemotherapeutic Regimens: Results From Two Phase 2 Studies, H. Raftopoulos, A. Laadem, P. J. Hesketh, J. Goldschmidt, N. Gabrail, C. Osborne, M. Ali, M. L. Sherman, D. Wang, J. Crawford, +3 Additional Authors
Journal Articles
PURPOSE: Sotatercept may represent a novel approach to the treatment of chemotherapy-induced anemia (CIA). We report the results from two phase 2 randomized studies examining the use of sotatercept for the treatment of CIA in patients with metastatic cancer. METHODS: In study A011-08, patients with metastatic breast cancer were randomized to 2:2:2:1 to receive sotatercept 0.1, 0.3, or 0.5 mg/kg, or placebo, respectively, every 28 days. In study ACE-011-NSCL-001, patients with solid tumors treated with platinum-based chemotherapy received sotatercept 15 or 30 mg every 42 days. The primary endpoint for both studies was hematopoietic response, defined as a hemoglobin (Hb) …
A Phase Ii Randomized Trial Comparing Standard And Low Dose Rituximab Combined With Alemtuzumab As Initial Treatment Of Progressive Chronic Lymphocytic Leukemia In Older Patients: A Trial Of The Ecog-Acrin Cancer Research Group (E1908), C. S. Zent, X. V. Wang, R. P. Ketterling, C. A. Hanson, E. N. Libby, J. C. Barrientos, T. G. Call, J. E. Chang, J. J. Liu, M. S. Tallman, +5 Additional Authors
A Phase Ii Randomized Trial Comparing Standard And Low Dose Rituximab Combined With Alemtuzumab As Initial Treatment Of Progressive Chronic Lymphocytic Leukemia In Older Patients: A Trial Of The Ecog-Acrin Cancer Research Group (E1908), C. S. Zent, X. V. Wang, R. P. Ketterling, C. A. Hanson, E. N. Libby, J. C. Barrientos, T. G. Call, J. E. Chang, J. J. Liu, M. S. Tallman, +5 Additional Authors
Journal Articles
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL) patients requiring initial therapy are often older and frailer and unsuitable candidates for standard chemoimmunotherapy regimens. Shorter duration combination monoclonal antibody (mAb) therapy using alemtuzumab and rituximab has been shown to be effective and tolerable treatment for CLL. Standard dose anti-CD20 mAb therapy causes loss of CD20 expression by surviving CLL cells, which can be minimized by decreasing the mAb dose. We report a randomized phase II clinical trial enrolling older (>/= 65 years) patients (median age 76 years, n=31) with treatment naive progressive CLL. Patients received 8-12 weeks of standard subcutaneous alemtuzumab …
Acalabrutinib (Acp-196) In Relapsed Chronic Lymphocytic Leukemia, J. C. Byrd, B. Harrington, S. O'Brien, J. A. Jones, A. Schuh, S. Devereux, J. Chaves, W. G. Wierda, J. C. Barrientos, R. R. Furman, +20 Additional Authors
Acalabrutinib (Acp-196) In Relapsed Chronic Lymphocytic Leukemia, J. C. Byrd, B. Harrington, S. O'Brien, J. A. Jones, A. Schuh, S. Devereux, J. Chaves, W. G. Wierda, J. C. Barrientos, R. R. Furman, +20 Additional Authors
Journal Articles
Background Irreversible inhibition of Bruton's tyrosine kinase (BTK) by ibrutinib represents an important therapeutic advance for the treatment of chronic lymphocytic leukemia (CLL). However, ibrutinib also irreversibly inhibits alternative kinase targets, which potentially compromises its therapeutic index. Acalabrutinib (ACP-196) is a more selective, irreversible BTK inhibitor that is specifically designed to improve on the safety and efficacy of first-generation BTK inhibitors. Methods In this uncontrolled, phase 1-2, multicenter study, we administered oral acalabrutinib to 61 patients who had relapsed CLL to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of acalabrutinib. Patients were treated with acalabrutinib at a dose of 100 …
Romidepsin In Peripheral And Cutaneous T-Cell Lymphoma: Mechanistic Implications From Clinical And Correlative Data, S. E. Bates, R. Eisch, A. Ling, D. Rosing, M. Turner, S. Pittaluga, H. M. Prince, M. H. Kirschbaum, S. L. Allen, R. L. Piekarz, +15 Additional Authors
Romidepsin In Peripheral And Cutaneous T-Cell Lymphoma: Mechanistic Implications From Clinical And Correlative Data, S. E. Bates, R. Eisch, A. Ling, D. Rosing, M. Turner, S. Pittaluga, H. M. Prince, M. H. Kirschbaum, S. L. Allen, R. L. Piekarz, +15 Additional Authors
Journal Articles
Romidepsin is an epigenetic agent approved for the treatment of patients with cutaneous or peripheral T-cell lymphoma (CTCL and PTCL). Here we report data in all patients treated on the National Cancer Institute 1312 trial, demonstrating long-term disease control and the ability to retreat patients relapsing off-therapy. In all, 84 patients with CTCL and 47 with PTCL were enrolled. Responses occurred early, were clinically meaningful and of very long duration in some cases. Notably, patients with PTCL receiving romidepsin as third-line therapy or later had a comparable response rate (32%) of similar duration as the total population (38%). Eight patients …
Therapeutic Potential Of New B Cell-Targeted Agents In The Treatment Of Elderly And Unfit Patients With Chronic Lymphocytic Leukemia, K. R. Rai
Journal Articles
Chronic lymphocytic leukemia (CLL), the most common adult leukemia in the Western world, is primarily a disease of the elderly, with most patients >= 65 years of age and having at least one major comorbidity. Aggressive chemoimmunotherapy regimens recommended to achieve remission and improve survival in young, fit patients are often poorly tolerated in elderly and/or less physiologically fit ("unfit") patients, necessitating alternative treatment options. Although patient age, fitness, and comorbidities are key considerations in the selection of a treatment regimen, historically, clinical trials have been limited to young, fit patients by virtue of the ethical concerns associated with potential …
Tamibarotene In Patients With Acute Promyelocytic Leukaemia Relapsing After Treatment With All-Trans Retinoic Acid And Arsenic Trioxide, D. Sanford, F. Lo-Coco, M. A. Sanz, E. Di Bona, S. Coutre, J. K. Altman, M. Wetzler, S. L. Allen, F. Ravandi, H. Kantarjian, J. E. Cortes
Tamibarotene In Patients With Acute Promyelocytic Leukaemia Relapsing After Treatment With All-Trans Retinoic Acid And Arsenic Trioxide, D. Sanford, F. Lo-Coco, M. A. Sanz, E. Di Bona, S. Coutre, J. K. Altman, M. Wetzler, S. L. Allen, F. Ravandi, H. Kantarjian, J. E. Cortes
Journal Articles
Treatment of acute promyelocytic leukaemia (APL) with arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) is highly effective first-line therapy, although approximately 5-10% of patients relapse. Tamibarotene is a synthetic retinoid with activity in APL patients who relapse after chemotherapy and ATRA, but has not been studied in relapse after treatment with ATO and ATRA. We report on a phase II study of tamibarotene in adult patients with relapsed or refractory APL after treatment with ATRA and ATO (n = 14). Participants were treated with tamibarotene (6 mg/m2 /d) during induction and for up to six cycles of consolidation. The …
Management Of Chronic Lymphocytic Leukemia In The Elderly, J. C. Barrientos
Management Of Chronic Lymphocytic Leukemia In The Elderly, J. C. Barrientos
Journal Articles
No abstract provided.
Phase Ii, Multicenter, Randomized Trial Of Cpx-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adults With First Relapse Aml, J. E. Cortes, S. L. Goldberg, E. J. Feldman, D. A. Rizzeri, D. E. Hogge, M. Larson, A. Pigneux, C. Recher, G. Schiller, J. E. Kolitz, +3 Additional Authors
Phase Ii, Multicenter, Randomized Trial Of Cpx-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adults With First Relapse Aml, J. E. Cortes, S. L. Goldberg, E. J. Feldman, D. A. Rizzeri, D. E. Hogge, M. Larson, A. Pigneux, C. Recher, G. Schiller, J. E. Kolitz, +3 Additional Authors
Journal Articles
BACKGROUNDCPX-351 is a liposome-encapsulated fixed-molar-ratio formulation of cytarabine and daunorubicin that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy. METHODSThis phase II study randomized 125 patients 2:1 to CPX-351 or investigators' choice of first salvage chemotherapy. Patients with acute myeloid leukemia (AML) in first relapse after initial Complete Remission (CR) lasting 1 month were stratified per the European Prognostic Index (EPI) into favorable, intermediate, and poor-risk groups based on duration of first CR, cytogenetics, age, and transplant history. Control salvage treatment was usually based on cytarabine and anthracycline, often with 1 or more additional agents. Survival at 1 year …
Feasibility And Cardiac Safety Of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (Neo) Adjuvant Therapy For Human Epidermal Growth Factor Receptor 2-Positive Early-Stage Breast Cancer, I. E. Krop, T. M. Suter, C. T. Dang, L. Dirix, G. Romieu, C. Zamagni, M. L. Citron, M. Campone, N. Xu, M. Smitt, L. Gianni
Feasibility And Cardiac Safety Of Trastuzumab Emtansine After Anthracycline-Based Chemotherapy As (Neo) Adjuvant Therapy For Human Epidermal Growth Factor Receptor 2-Positive Early-Stage Breast Cancer, I. E. Krop, T. M. Suter, C. T. Dang, L. Dirix, G. Romieu, C. Zamagni, M. L. Citron, M. Campone, N. Xu, M. Smitt, L. Gianni
Journal Articles
Purpose Trastuzumab emtansine (T-DM1), an antibody-drug conjugate comprising the cytotoxic agent DM1, a stable linker, and trastuzumab, has demonstrated substantial activity in human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer, raising interest in evaluating the feasibility and cardiac safety of T-DM1 in early-stage breast cancer (EBC). Patients and Methods Patients (N = 153) with HER2-positive EBC and prechemotherapy left ventricular ejection fraction (LVEF) >= 55% received (neo) adjuvant doxorubicin plus cyclophosphamide or fluorouracil plus epirubicin plus cyclophosphamide followed by T-DM1 for four cycles. Patients could then receive three to four cycles of optional docetaxel with or without …
Identification And Characterization Of Distinct Il-17f Expression Patterns And Signaling Pathways In Chronic Lymphocytic Leukemia And Normal B Lymphocytes, B. Sherry, P. Jain, P. Y. Chiu, L. Leung, S. L. Allen, J. E. Kolitz, K. R. Rai, J. Barrientos, S. Liang, R. Hawtin, N. Chiorazzi
Identification And Characterization Of Distinct Il-17f Expression Patterns And Signaling Pathways In Chronic Lymphocytic Leukemia And Normal B Lymphocytes, B. Sherry, P. Jain, P. Y. Chiu, L. Leung, S. L. Allen, J. E. Kolitz, K. R. Rai, J. Barrientos, S. Liang, R. Hawtin, N. Chiorazzi
Journal Articles
Chronic lymphocytic leukemia (CLL) is characterized by a progressive accumulation of B lymphocytes. T cell abnormalities are a common feature of CLL and contribute to impaired immune function in these patients. T cells are ineffective in eliminating the leukemic clone and may actually promote tumor growth and survival. Previous work from our laboratory documented elevated circulating levels of IL-17A-producing Th17 cells in CLL patients as compared to healthy age-matched control subjects. These high circulating Th17 levels associated with better prognostic markers and significantly longer overall survival, even among patients whose clones used unmutated IGHVs (U-CLL). Recent studies suggest that Th17 …
Integrating Targeted Drugs With Taxanes And Platinums: Opportunities And Challenges, D. Kudlowitz, E. Teplinsky, F. Muggia
Integrating Targeted Drugs With Taxanes And Platinums: Opportunities And Challenges, D. Kudlowitz, E. Teplinsky, F. Muggia
Journal Articles
In ovarian cancer, multiple attempts to adjust the standard taxane/platinum doublet by adding cytotoxic therapy or varying scheduling, dosage, and delivery have been met with limited success. Alternative methods to improve the grim prognosis of ovarian cancer, including molecular therapies, are currently under investigation. Efforts have been made to study tyrosine kinase inhibitors (including imatinib and pazopanib), Src kinase inhibitors and histone deacetylase inhibitors (HDACi) in combination with taxanes/platinums in order to improve efficacy. Unfortunately, while many pre-clinical and early phase clinical trials argue that the utilization of these molecular targets may enhance survival, only modest benefit has been seen …
Introduction: Moving Beyond Chemotherapy, F. Muggia, E. Teplinsky
Introduction: Moving Beyond Chemotherapy, F. Muggia, E. Teplinsky
Journal Articles
Epithelial ovarian cancer and related cancers arising in extrauterine Mullerian epithelium are generally chemosensitive—particularly to the platinum drugs, cisplatin and carboplatin, that form the backbone of first-line treatments upon diagnosis even at early stages. Doublets of platinums with paclitaxel have represented the standard-of-care since the late 1990s, with further notable advances taking place by intraperitoneal administration (in Gynecologic Oncology Group studies) after optimal surgical cytoreduction is achieved, and by divided doses of paclitaxel (in a Japanese GOG study). Adding another agent to improve on these results has otherwise proven to be quite challenging. Nevertheless, continued forays into introducing ‘targeted therapies’ …
Long-Term Follow-Up Of Mcl Patients Treated With Single-Agent Ibrutinib: Updated Safety And Efficacy Results, M. L. Wang, K. A. Blum, P. Martin, A. Goy, R. Auer, B. S. Kahl, W. Jurczak, R. H. Advani, J. C. Barrientos, S. Rule, +14 Additional Authors
Long-Term Follow-Up Of Mcl Patients Treated With Single-Agent Ibrutinib: Updated Safety And Efficacy Results, M. L. Wang, K. A. Blum, P. Martin, A. Goy, R. Auer, B. S. Kahl, W. Jurczak, R. H. Advani, J. C. Barrientos, S. Rule, +14 Additional Authors
Journal Articles
Ibrutinib, an oral inhibitor of Bruton tyrosine kinase, is approved for patients with mantle cell lymphoma (MCL) who have received one prior therapy. We report the updated safety and efficacy results from the multicenter, open-label phase 2 registration trial of Ibrutinib (median 26.7-month follow-up). Patients (N = 111) received oral ibrutinib 560 mg once daily, and those with stable disease or better could enter a long-term extension study. The primary end point was overall response rate (ORR). The median patient age was 68 years (range, 40-84), with a median of 3 prior therapies (range, 1-5). The median treatment duration was …
Acute Myeloid Leukemia Ontogeny Is Defined By Distinct Somatic Mutations, R. C. Lindsley, B. G. Mar, E. Mazzola, P. V. Grauman, S. Shareef, S. L. Allen, A. Pigneux, M. Wetzler, R. K. Stuart, B. L. Ebert, +9 Additional Authors
Acute Myeloid Leukemia Ontogeny Is Defined By Distinct Somatic Mutations, R. C. Lindsley, B. G. Mar, E. Mazzola, P. V. Grauman, S. Shareef, S. L. Allen, A. Pigneux, M. Wetzler, R. K. Stuart, B. L. Ebert, +9 Additional Authors
Journal Articles
Acute myeloid leukemia (AML) can develop after an antecedent myeloid malignancy (secondary AML [s-AML]), after leukemogenic therapy (therapy-related AML [t-AML]), or without an identifiable prodrome or known exposure (de novo AML). The genetic basis of these distinct pathways of AML development has not been determined. We performed targeted mutational analysis of 194 patients with rigorously defined s-AML or t-AML and 105 unselected AML patients. The presence of a mutation in SRSF2, SF3B1, U2AF1, ZRSR2, ASXL1, EZH2, BCOR, or STAG2 was >95% specific for the diagnosis of s-AML. Analysis of serial samples from individual patients revealed that these mutations occur early …
Body Mass Index, Pam50 Subtype, And Outcomes In Node-Positive Breast Cancer: Calgb 9741 (Alliance), J. A. Ligibel, C. T. Cirrincione, M. Liu, M. Citron, J. N. Ingle, W. Gradishar, S. Martino, W. Sikov, R. Michaelson, W. T. Barry, +6 Additional Authors
Body Mass Index, Pam50 Subtype, And Outcomes In Node-Positive Breast Cancer: Calgb 9741 (Alliance), J. A. Ligibel, C. T. Cirrincione, M. Liu, M. Citron, J. N. Ingle, W. Gradishar, S. Martino, W. Sikov, R. Michaelson, W. T. Barry, +6 Additional Authors
Journal Articles
BACKGROUND: Obesity at diagnosis is associated with poor prognosis in women with breast cancer, but few reports have been adjusted for treatment factors. METHODS: CALGB 9741 was a randomized trial of dose density and sequence of chemotherapy for node-positive breast cancer. All patients received doxorubicin, cyclophosphamide, and paclitaxel, dosed by actual body weight. Height and weight at diagnosis were abstracted from patient records, and the PAM50 assay was performed from archived specimens using the NanoString platform. Relationships between body mass index (BMI), PAM50, and recurrence-free and overall survival (RFS and OS) were evaluated using proportional hazards regression, adjusting for number …
Successful Pregnancy Outcome In Paroxysmal Nocturnal Hemoglobinuria (Pnh) Following Escalated Eculizumab Dosing To Control Breakthrough Hemolysis, R. Sharma, A. Keyzner, J. Liu, T. Bradley, S. L. Allen
Successful Pregnancy Outcome In Paroxysmal Nocturnal Hemoglobinuria (Pnh) Following Escalated Eculizumab Dosing To Control Breakthrough Hemolysis, R. Sharma, A. Keyzner, J. Liu, T. Bradley, S. L. Allen
Journal Articles
Pregnancy in women with paroxysmal nocturnal hemoglobinuria (PNH) is associated with increased maternal and fetal morbidity and mortality. There is limited published experience regarding therapy of PNH during pregnancy. We describe a case of a 30 year old female with hypoplastic myelodysplastic syndrome and PNH. After two years of treatment with eculizumab, she became pregnant. She developed breakthrough hemolysis at 20 weeks gestation. Pharmacokinetic and pharmacodynamic studies demonstrated a subtherapeutic eculizumab level with absence of complement blockade. Escalation of her eculizumab dose successfully controlled hemolysis and restored therapeutic eculizumab level and activity. She delivered a healthy baby at 36 weeks.
Targeting Mutant Braf In Relapsed Or Refractory Hairy-Cell Leukemia, E. Tiacci, J. H. Park, L. De Carolis, S. S. Chung, A. Broccoli, S. Scott, F. Zaja, S. Devlin, K. R. Rai, M. S. Tallman, +31 Additional Authors
Targeting Mutant Braf In Relapsed Or Refractory Hairy-Cell Leukemia, E. Tiacci, J. H. Park, L. De Carolis, S. S. Chung, A. Broccoli, S. Scott, F. Zaja, S. Devlin, K. R. Rai, M. S. Tallman, +31 Additional Authors
Journal Articles
Background BRAF V600E is the genetic lesion underlying hairy-cell leukemia. We assessed the safety and activity of the oral BRAF inhibitor vemurafenib in patients with hairy-cell leukemia that had relapsed after treatment with a purine analogue or who had disease that was refractory to purine analogues. Methods We conducted two phase 2, single-group, multicenter studies of vemurafenib (at a dose of 960 mg twice daily) - one in Italy and one in the United States. The therapy was administered for a median of 16 weeks in the Italian study and 18 weeks in the U.S. STUDY: Primary end points were …
Management Of Adverse Events Associated With Idelalisib Treatment: Expert Panel Opinion, S. E. Coutre, J. C. Barrientos, J. R. Brown, S. De Vos, R. R. Furman, M. J. Keating, D. Li, S. M. O'Brien, J. M. Pagel, A. D. Zelenetz, +3 Additional Authors
Management Of Adverse Events Associated With Idelalisib Treatment: Expert Panel Opinion, S. E. Coutre, J. C. Barrientos, J. R. Brown, S. De Vos, R. R. Furman, M. J. Keating, D. Li, S. M. O'Brien, J. M. Pagel, A. D. Zelenetz, +3 Additional Authors
Journal Articles
Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kdelta) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe diarrhea or colitis, hepatotoxicity, pneumonitis and intestinal perforation. An expert panel was convened to review the pathology of these treatment-emergent adverse events (TEAEs) to propose key management tools for patients receiving idelalisib therapy. This article provides an overview of idelalisib TEAEs reported in clinical trials, and a summary of the panel's recommendations …
Phase Ii Double-Blind Placebo-Controlled Randomized Study Of Armodafinil For Brain Radiation-Induced Fatigue, B. R. Page, E. G. Shaw, L. Lu, D. Bryant, D. Grisell, G. J. Lesser, D. C. Monitto, M. J. Naughton, S. R. Savona, M. D. Chan, +3 Additional Authors
Phase Ii Double-Blind Placebo-Controlled Randomized Study Of Armodafinil For Brain Radiation-Induced Fatigue, B. R. Page, E. G. Shaw, L. Lu, D. Bryant, D. Grisell, G. J. Lesser, D. C. Monitto, M. J. Naughton, S. R. Savona, M. D. Chan, +3 Additional Authors
Journal Articles
BACKGROUND: Common acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT. METHODS: A phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect. RESULTS: From September 20, 2010, to October 20, 2012, 54 participants …
Egfr And Her2: Is There A Role In Ovarian Cancer?, E. Teplinsky, F. Muggia
Egfr And Her2: Is There A Role In Ovarian Cancer?, E. Teplinsky, F. Muggia
Journal Articles
Advanced ovarian cancer carries a grim prognosis and development of targeted therapies to improve outcomes has become an active area of research in this disease. The epidermal growth factor receptor (EGFR) and HER2/neu have shown to be overexpressed in ovarian cancer and there have been several clinical trials evaluating anti-EGFR and HER2 therapies in ovarian cancer. Unfortunately, the drugs have shown minimal efficacy and more recent work has now focused on identifying mechanisms of resistance and alternative ways of targeting these pathways. This review will discuss the currently published trials with anti-EGFR and HER2 agents in ovarian cancer and the …
In Support Of A Patient-Driven Initiative And Petition To Lower The High Price Of Cancer Drugs, A. Tefferi, K. Rai, A. I. Schafer, C. Schiffer, M. A. Sekeres, L. L. Siu, F. M. Stewart, M. Thompson, J. M. Vose, P. H. Wiernik, +109 Additional Authors
In Support Of A Patient-Driven Initiative And Petition To Lower The High Price Of Cancer Drugs, A. Tefferi, K. Rai, A. I. Schafer, C. Schiffer, M. A. Sekeres, L. L. Siu, F. M. Stewart, M. Thompson, J. M. Vose, P. H. Wiernik, +109 Additional Authors
Journal Articles
No abstract provided.
Augmenting Nf-Kappab In Poor-Risk Cll: A General Paradigm For Other Cancers?, D. Tuveson, K. R. Rai
Augmenting Nf-Kappab In Poor-Risk Cll: A General Paradigm For Other Cancers?, D. Tuveson, K. R. Rai
Journal Articles
No abstract provided.
The Bruton Tyrosine Kinase Inhibitor Ibrutinib With Chemoimmunotherapy In Patients With Chronic Lymphocytic Leukemia, J. R. Brown, J. C. Barrientos, P. M. Barr, I. W. Flinn, J. A. Burger, A. Tran, F. Clow, D. F. James, K. Rai, S. O'Brien, +2 Additional Authors
The Bruton Tyrosine Kinase Inhibitor Ibrutinib With Chemoimmunotherapy In Patients With Chronic Lymphocytic Leukemia, J. R. Brown, J. C. Barrientos, P. M. Barr, I. W. Flinn, J. A. Burger, A. Tran, F. Clow, D. F. James, K. Rai, S. O'Brien, +2 Additional Authors
Journal Articles
The safety and efficacy of ibrutinib, an oral inhibitor of Bruton tyrosine kinase, were evaluated with chemoimmunotherapy (CIT) in a multicenter phase 1b study. Patients with relapsed/refractory chronic lymphocytic leukemia received bendamustine and rituximab (BR) or fludarabine, cyclophosphamide, and rituximab (FCR) for up to 6 cycles with daily ibrutinib (420 mg) until progressive disease or unacceptable toxicity. Enrollment to FCR-ibrutinib closed early due to a lack of fludarabine-naive previously treated patients. No patients treated with BR-ibrutinib (n = 30) or FCR-ibrutinib (n = 3) experienced prolonged hematologic toxicity in cycle 1 (primary end point). Tolerability was as expected with either …
More Than 9 Years Of Continuous Trastuzumab Treatment In Metastatic Breast Cancer Without Cardiac Toxicity: A Case Report And Literature Review, F. Badulescu, A. Badulescu, D. Paul, C. F. Popescu, C. Florescu
More Than 9 Years Of Continuous Trastuzumab Treatment In Metastatic Breast Cancer Without Cardiac Toxicity: A Case Report And Literature Review, F. Badulescu, A. Badulescu, D. Paul, C. F. Popescu, C. Florescu
Journal Articles
The main concern of long-term use of trastuzumab remains its association with potential cardiac side effects. Although these side effects are real, they are probably overemphasized. We report the case of a woman with metastatic breast cancer, who is currently in complete remission, and who received trastuzumab continuously for more than 9 years, without any significant cardiac toxicity.
Outcomes Of Temporary Interruption Of Rivaroxaban Compared With Warfarin In Patients With Nonvalvular Atrial Fibrillation, M. W. Sherwood, J. D. Douketis, M. R. Patel, J. P. Piccini, A. S. Hellkamp, Y. Lokhnygina, A. C. Spyropoulos, G. J. Hankey, D. E. Singer, R. C. Becker, +4 Additional Authors
Outcomes Of Temporary Interruption Of Rivaroxaban Compared With Warfarin In Patients With Nonvalvular Atrial Fibrillation, M. W. Sherwood, J. D. Douketis, M. R. Patel, J. P. Piccini, A. S. Hellkamp, Y. Lokhnygina, A. C. Spyropoulos, G. J. Hankey, D. E. Singer, R. C. Becker, +4 Additional Authors
Journal Articles
Background During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI. Methods and Results In the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including …
Phase 2 Trial Of Cpx-351, A Fixed 5:1 Molar Ratio Of Cytarabine/Daunorubicin, Vs Cytarabine/Daunorubicin In Older Adults With Untreated Aml, J. E. Lancet, J. E. Cortes, D. E. Hogge, M. S. Tallman, T. J. Kovacsovics, L. E. Damon, R. Komrokji, S. R. Solomon, J. E. Kolitz, E. J. Feldman, +3 Additional Authors
Phase 2 Trial Of Cpx-351, A Fixed 5:1 Molar Ratio Of Cytarabine/Daunorubicin, Vs Cytarabine/Daunorubicin In Older Adults With Untreated Aml, J. E. Lancet, J. E. Cortes, D. E. Hogge, M. S. Tallman, T. J. Kovacsovics, L. E. Damon, R. Komrokji, S. R. Solomon, J. E. Kolitz, E. J. Feldman, +3 Additional Authors
Journal Articles
CPX-351 is a liposomal formulation of cytarabine: daunorubicin designed to deliver synergistic drug ratios to leukemia cells. In this phase 2 study, newly diagnosed older acute myeloid leukemia (AML) patients were randomized 2: 1 to first-line CPX-351 or 713 treatment. The goal was to determine efficacy and identify patient subgroups that may benefit from CPX-351 treatment. Response rate (complete remission 1 incomplete remission) was the primary end point, with event-free survival (EFS) and overall survival (OS) as secondary end points. The 126 patients entered were balanced for disease and patient-specific risk factors. Overall, CPX-351 produced higher response rates (66.7% vs …
Prognostic And Biologic Significance Of Dnmt3b Expression In Older Patients With Cytogenetically Normal Primary Acute Myeloid Leukemia, C. Niederwieser, J. Kohlschmidt, S. Volinia, S. P. Whitman, K. H. Metzeler, A. K. Eisfeld, K. Maharry, P. Yan, J. E. Kolitz, C. D. Bloomfield, +17 Additional Authors
Prognostic And Biologic Significance Of Dnmt3b Expression In Older Patients With Cytogenetically Normal Primary Acute Myeloid Leukemia, C. Niederwieser, J. Kohlschmidt, S. Volinia, S. P. Whitman, K. H. Metzeler, A. K. Eisfeld, K. Maharry, P. Yan, J. E. Kolitz, C. D. Bloomfield, +17 Additional Authors
Journal Articles
DNMT3B encodes a DNA methyltransferase implicated in aberrant epigenetic changes contributing to leukemogenesis. We tested whether DNMT3B expression, measured by NanoString nCounter assay, associates with outcome, gene and microRNA expression and DNA methylation profiles in 210 older (60 years) adults with primary, cytogenetically normal acute myeloid leukemia (CN-AML). Patients were dichotomized into high versus low expressers using median cut. Outcomes were assessed in the context of known CN-AML prognosticators. Gene and microRNA expression, and DNA methylation profiles were analyzed using microarrays and MethylCap-sequencing, respectively. High DNMT3B expressers had fewer complete remissions (CR; P=0.002) and shorter disease-free (DFS; P=0.02) and overall …