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  • 1
    Online Resource
    Online Resource
    Management of Mantle Cell Lymphoma in the Era of Novel Oral Agents
    SAGE Publications ; 2020
    In:  Annals of Pharmacotherapy Vol. 54, No. 9 ( 2020-09), p. 879-898
    Details
    In: Annals of Pharmacotherapy, SAGE Publications, Vol. 54, No. 9 ( 2020-09), p. 879-898
    Abstract: Objectives: To discuss (1) recent and emerging data for pharmacological management of untreated and relapsed/refractory (R/R) mantle cell lymphoma (MCL) with agents approved in the United States, (2) important considerations for toxicity monitoring and management, and (3) preliminary data and ongoing studies for agents in MCL-specific clinical trials. Data Sources: PubMed/MEDLINE, EMBASE, Google Scholar, product labeling, National Comprehensive Cancer Network, American Cancer Society, and ClinicalTrials.gov were searched for studies published between January 1, 2017, and January 31, 2020, and key historical trials. Study Selection and Data Extraction: Relevant studies conducted in humans and selected supporting preclinical data were reviewed. Data Synthesis: MCL is a rare but usually aggressive non-Hodgkin lymphoma that most commonly affects the older population. Traditionally, the treatment of MCL has been determined based on transplant eligibility. Newer data suggest that more tolerable frontline therapy may produce outcomes similar to intensive historical induction regimens, possibly precluding fewer patients from autologous stem cell transplant and producing better long-term outcomes in transplant-ineligible patients. In the R/R setting, novel regimens are improving outcomes and changing the landscape of treatment. Relevance to Patient Care and Clinical Practice: This review summarizes and discusses recent and emerging data for management of newly diagnosed and R/R MCL; key supportive care considerations for agents are also discussed. Conclusions: Recent study results are changing management of MCL. Although these data have complicated the picture of regimen selection, increasingly effective and tolerable therapy and additional anticipated data point to a brighter future for patients with MCL.
    Type of Medium: Online Resource
    ISSN: 1060-0280 , 1542-6270
    URL: Article
    DOI: 10.1177/1060028020909117
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2053518-1
    SSG: 15,3
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  • 2
    Online Resource
    Online Resource
    Selinexor: A First-in-Class Nuclear Export Inhibitor for Management of Multiply Relapsed Multiple Myeloma
    SAGE Publications ; 2020
    In:  Annals of Pharmacotherapy Vol. 54, No. 6 ( 2020-06), p. 577-582
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    In: Annals of Pharmacotherapy, SAGE Publications, Vol. 54, No. 6 ( 2020-06), p. 577-582
    Abstract: Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of selinexor for management of relapsed multiple myeloma (MM). Data Sources: A literature search was performed of PubMed and MEDLINE databases (January 1, 2000, to November 14, 2019), abstracts from the American Society of Hematology and the American Society of Clinical Oncology, and ongoing studies from US National Institutes of Health ClinicalTrials.gov. Queries were performed using key words selinexor, SINE, XPO1, and Xpovio. Study Selection/Data Extraction: Human and animal studies related to the pharmacology, pharmacokinetics, efficacy, and safety of selinexor were identified. Data Synthesis: Although numerous advances have been made in MM management, there remains an unmet need for treatment of heavily relapsed/refractory disease. Selinexor is a first-in-class selective inhibitor of nuclear export, which, through inhibition of exportin-1, causes accumulation of tumor suppressor proteins, reduction in oncoproteins, and apoptosis of plasma cells. Selinexor exhibited an overall response in 26% of patients with multiply relapsed MM. Median progression-free survival was 3.7 months, and overall survival was 8.6 months. Common adverse effects include thrombocytopenia, neutropenia, fatigue, and nausea. Ongoing studies are investigating combination therapies utilizing selinexor. Relevance to Patient Care and Clinical Practice: This review describes the efficacy, safety, and clinical applicability of selinexor, a novel agent with potential to meet an unmet need in refractory MM. Conclusion: Selinexor has demonstrated activity in a heavily refractory patient population. Given the adverse effect profile and associated costs, additional studies are needed to further elucidate the appropriate clinical scenario and combinations for selinexor use.
    Type of Medium: Online Resource
    ISSN: 1060-0280 , 1542-6270
    URL: Article
    DOI: 10.1177/1060028019892643
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2053518-1
    SSG: 15,3
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  • 3
    Online Resource
    Online Resource
    Venetoclax: A First-in-Class Oral BCL-2 Inhibitor for the Management of Lymphoid Malignancies
    SAGE Publications ; 2017
    In:  Annals of Pharmacotherapy Vol. 51, No. 5 ( 2017-05), p. 410-416
    Details
    In: Annals of Pharmacotherapy, SAGE Publications, Vol. 51, No. 5 ( 2017-05), p. 410-416
    Abstract: Objective: To review the pharmacology, efficacy, and safety of venetoclax for treatment of lymphoid malignancies. Data Sources: A literature search was performed of PubMed and MEDLINE databases (2005 to September 2016), abstracts from the American Society of Hematology and the American Society of Clinical Oncology, and ongoing studies from clinicaltrials.gov. Searches were performed utilizing the following key terms: venetoclax, ABT-199, GDC-199, obatoclax, GX15-070, BCL-2 inhibitor, navitoclax, ABT-263, and Venclexta. Study Selection/Data Extraction: Studies of pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of venetoclax in lymphoid malignancies were identified. Data Synthesis: Recently, treatment of B-cell lymphoproliferative disorders has shifted from conventional cytotoxic chemotherapy to novel small-molecule inhibitors. The advent of recently Food and Drug Administration–approved oral agents ibrutinib and idelalisib has shifted the paradigm of chronic lymphocytic leukemia (CLL) treatment; however, complete remission is uncommon, and the outcome for patients progressing on these treatments remains poor. Attention has been focused on a novel target, the B-cell lymphoma-2 protein (BCL-2), which serves an essential role in regulation of apoptosis. Venetoclax has demonstrated efficacy in multiple subtypes of lymphoid malignancies, including patients with relapsed/refractory CLL harboring deletion 17p, with an overall response rate of nearly 80%. Venetoclax is generally well tolerated, with the significant adverse effect being tumor lysis syndrome, for which there are formal management recommendations. Conclusion: Venetoclax has demonstrated promising results in relapsed/refractory lymphoid malignancies, with an acceptable adverse effect profile. As the role of BCL-2 inhibition in various malignancies becomes further elucidated, venetoclax may offer benefit to a myriad other patient populations.
    Type of Medium: Online Resource
    ISSN: 1060-0280 , 1542-6270
    URL: Article
    DOI: 10.1177/1060028016685803
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 2053518-1
    SSG: 15,3
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  • 4
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    Online Resource
    Lateral Extra-Articular Tenodesis Reduces Failure of Hamstring Tendon Autograft ACL Reconstruction -Two Year Outcomes from the STABILITY Study Randomized Clinical Trial
    SAGE Publications ; 2019
    In:  Orthopaedic Journal of Sports Medicine Vol. 7, No. 7_suppl5 ( 2019-07), p. 2325967119S0028-
    Details
    In: Orthopaedic Journal of Sports Medicine, SAGE Publications, Vol. 7, No. 7_suppl5 ( 2019-07), p. 2325967119S0028-
    Abstract: Persistent anterolateral rotatory laxity following anterior cruciate ligament reconstruction (ACLR) has been correlated with poor outcome and graft failure. We hypothesized that anterolateral complex reconstruction by way of a Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. Methods: This is a pragmatic, multicenter, randomized clinical trial comparing standard hamstring tendon ACLR with combined ACLR and LET, utilizing a strip of iliotibial band (Modified Lemaire). Patients aged 25 years or less with an ACL deficient knee were included. They also had to have two of the following three criteria: 1) Grade 2 pivot shift or greater; 2) Returning to high risk/pivoting sports; 3) Generalized ligamentous laxity. The primary outcome was graft failure defined as either the need for revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift, indicating persistent rotational laxity. Secondary outcome measures included the P4 pain scale, KOOS, IKDC. Patients were followed for two years with visits at 3, 6, 12 and 24 months postoperatively. A sample size of 300 per group was calculated based on a relative reduction in graft failure by 40%, with type 1 error of 5%, 80% power and 15% loss to follow-up rate. Results: 624 patients were randomized with a mean age of 18.9 (range: 14-25), 293 male. 436 (87.9%) patients presented pre-operatively with high-grade rotatory laxity (grade 2 pivot or greater) and 215 (42.1%) were diagnosed as having generalized ligamentous laxity (Beighton Score of 4 or greater). 523 of the 624 patients are at least 2 years postoperative; 29 lost to follow-up (˜5%). In the ACLR group 104/252 (41%) of patients suffered the primary outcome compared to 61/242 (25%) of the ACLR+LET patients (RR=0.61, 95%CI 0.47 to 0.79), p 〈 0.0001. 39 patients suffered graft rupture, 28/252 (11%) in the ACLR group compared to 11/242 (4.5%) in the ACL+LET group (RR=0.41, 95%CI 0.21 to 0.80, p 〈 0.001). At 3 months postoperative, patients in the ACLR group had less pain (p=0.004); at 3 and 6 months all KOOS subdomains, the IKDC favored the ACLR alone group (p=0.03). At 12 and 24 months, no important between-group differences were observed in any patient reported outcome. Conclusion: The addition of LET to a hamstring autograft ACLR in young active patients significantly reduces graft failure and persistent anterolateral rotatory laxity at 2 years post operatively.
    Type of Medium: Online Resource
    ISSN: 2325-9671 , 2325-9671
    URL: Article
    DOI: 10.1177/2325967119S00280
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2706251-X
    SSG: 31
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