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  1. Article ; Online: A phase I/II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202).

    Voorhees, Peter M / Suman, Vera J / Tuchman, Sascha A / Laubach, Jacob P / Hassoun, Hani / Efebera, Yvonne A / Mulkey, Flora / Bova-Solem, Misty / Santo, Katelyn / Carlisle, Destin / McCarthy, Philip L / Richardson, Paul G

    American journal of hematology

    2021  Volume 96, Issue 12, Page(s) 1595–1603

    Abstract: Preclinical studies have demonstrated activity of the oral proteasome inhibitor (PI) ixazomib (IXA) in bortezomib-resistant multiple myeloma (MM) and synergy with immunomodulatory drugs. We therefore conducted a phase I/II study to establish the safety ... ...

    Abstract Preclinical studies have demonstrated activity of the oral proteasome inhibitor (PI) ixazomib (IXA) in bortezomib-resistant multiple myeloma (MM) and synergy with immunomodulatory drugs. We therefore conducted a phase I/II study to establish the safety and preliminary efficacy of IXA with pomalidomide (POM) and dexamethasone (DEX) in lenalidomide (LEN)/PI-refractory MM. Dose escalation established a 4 mg dose of POM and IXA and 20/40 mg dose of DEX as the maximum tolerated dose. The phase II portion of the trial was redesigned and started anew after six patients had been randomized to IXA-POM-DEX due to a rapidly changing treatment landscape. Among the 29 evaluable LEN/PI-refractory patients treated with IXA-POM-DEX in phase I/II, the overall response rate (partial response or better) was 51.7% with a median duration of response of 16.8 months (range 56 days to 4.1 years), median progression-free survival of 4.4 months (95% confidence interval [CI]: 3.0-18.4), and median overall survival of 34.3 months (95% CI: 19.2 to not reached). Hematologic, gastrointestinal, and constitutional adverse events were common and consistent with the side-effect profiles of the individual agents. Our results support further evaluation of this all-oral regimen in relapsed/refractory MM.
    MeSH term(s) Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Boron Compounds/administration & dosage ; Boron Compounds/adverse effects ; Boron Compounds/therapeutic use ; Dexamethasone/administration & dosage ; Dexamethasone/adverse effects ; Dexamethasone/therapeutic use ; Drug Resistance, Neoplasm/drug effects ; Female ; Glycine/administration & dosage ; Glycine/adverse effects ; Glycine/analogs & derivatives ; Glycine/therapeutic use ; Humans ; Lenalidomide/administration & dosage ; Lenalidomide/adverse effects ; Lenalidomide/therapeutic use ; Male ; Maximum Tolerated Dose ; Middle Aged ; Multiple Myeloma/drug therapy ; Proteasome Inhibitors/administration & dosage ; Proteasome Inhibitors/adverse effects ; Proteasome Inhibitors/therapeutic use ; Thalidomide/administration & dosage ; Thalidomide/adverse effects ; Thalidomide/analogs & derivatives ; Thalidomide/therapeutic use
    Chemical Substances Boron Compounds ; Proteasome Inhibitors ; Thalidomide (4Z8R6ORS6L) ; ixazomib (71050168A2) ; Dexamethasone (7S5I7G3JQL) ; pomalidomide (D2UX06XLB5) ; Lenalidomide (F0P408N6V4) ; Glycine (TE7660XO1C)
    Language English
    Publishing date 2021-10-06
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 196767-8
    ISSN 1096-8652 ; 0361-8609
    ISSN (online) 1096-8652
    ISSN 0361-8609
    DOI 10.1002/ajh.26361
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1251: Show issues Location:
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  2. Article ; Online: Evaluation of Alisertib Alone or Combined With Fulvestrant in Patients With Endocrine-Resistant Advanced Breast Cancer: The Phase 2 TBCRC041 Randomized Clinical Trial.

    Haddad, Tufia C / Suman, Vera J / D'Assoro, Antonino B / Carter, Jodi M / Giridhar, Karthik V / McMenomy, Brendan P / Santo, Katelyn / Mayer, Erica L / Karuturi, Meghan S / Morikawa, Aki / Marcom, P Kelly / Isaacs, Claudine J / Oh, Sun Young / Clark, Amy S / Mayer, Ingrid A / Keyomarsi, Khandan / Hobday, Timothy J / Peethambaram, Prema P / O'Sullivan, Ciara C /
    Leon-Ferre, Roberto A / Liu, Minetta C / Ingle, James N / Goetz, Matthew P

    JAMA oncology

    2023  Volume 9, Issue 6, Page(s) 815–824

    Abstract: Importance: Aurora A kinase (AURKA) activation, related in part to AURKA amplification and variants, is associated with downregulation of estrogen receptor (ER) α expression, endocrine resistance, and implicated in cyclin-dependent kinase 4/6 inhibitor ( ...

    Abstract Importance: Aurora A kinase (AURKA) activation, related in part to AURKA amplification and variants, is associated with downregulation of estrogen receptor (ER) α expression, endocrine resistance, and implicated in cyclin-dependent kinase 4/6 inhibitor (CDK 4/6i) resistance. Alisertib, a selective AURKA inhibitor, upregulates ERα and restores endocrine sensitivity in preclinical metastatic breast cancer (MBC) models. The safety and preliminary efficacy of alisertib was demonstrated in early-phase trials; however, its activity in CDK 4/6i-resistant MBC is unknown.
    Objective: To assess the effect of adding fulvestrant to alisertib on objective tumor response rates (ORRs) in endocrine-resistant MBC.
    Design, setting, and participants: This phase 2 randomized clinical trial was conducted through the Translational Breast Cancer Research Consortium, which enrolled participants from July 2017 to November 2019. Postmenopausal women with endocrine-resistant, ERBB2 (formerly HER2)-negative MBC who were previously treated with fulvestrant were eligible. Stratification factors included prior treatment with CDK 4/6i, baseline metastatic tumor ERα level measurement (<10%, ≥10%), and primary or secondary endocrine resistance. Among 114 preregistered patients, 96 (84.2%) registered and 91 (79.8%) were evaluable for the primary end point. Data analysis began after January 10, 2022.
    Interventions: Alisertib, 50 mg, oral, daily on days 1 to 3, 8 to 10, and 15 to 17 of a 28-day cycle (arm 1) or alisertib same dose/schedule with standard-dose fulvestrant (arm 2).
    Main outcomes and measures: Improvement in ORR in arm 2 of at least 20% greater than arm 1 when the expected ORR for arm 1 was 20%.
    Results: All 91 evaluable patients (mean [SD] age, 58.5 [11.3] years; 1 American Indian/Alaskan Native [1.1%], 2 Asian [2.2%], 6 Black/African American [6.6%], 5 Hispanic [5.5%], and 79 [86.8%] White individuals; arm 1, 46 [50.5%]; arm 2, 45 [49.5%]) had received prior treatment with CDK 4/6i. The ORR was 19.6%; (90% CI, 10.6%-31.7%) for arm 1 and 20.0% (90% CI, 10.9%-32.3%) for arm 2. In arm 1, the 24-week clinical benefit rate and median progression-free survival time were 41.3% (90% CI, 29.0%-54.5%) and 5.6 months (95% CI, 3.9-10.0), respectively, and in arm 2 they were 28.9% (90% CI, 18.0%-42.0%) and 5.4 months (95% CI, 3.9-7.8), respectively. The most common grade 3 or higher adverse events attributed to alisertib were neutropenia (41.8%) and anemia (13.2%). Reasons for discontinuing treatment were disease progression (arm 1, 38 [82.6%]; arm 2, 31 [68.9%]) and toxic effects or refusal (arm 1, 5 [10.9%]; arm 2, 12 [26.7%]).
    Conclusions and relevance: This randomized clinical trial found that adding fulvestrant to treatment with alisertib did not increase ORR or PFS; however, promising clinical activity was observed with alisertib monotherapy among patients with endocrine-resistant and CDK 4/6i-resistant MBC. The overall safety profile was tolerable.
    Trial registration: ClinicalTrials.gov Identifier: NCT02860000.
    MeSH term(s) Humans ; Female ; Middle Aged ; Fulvestrant ; Breast Neoplasms/pathology ; Estrogen Receptor alpha ; Aurora Kinase A/therapeutic use ; Receptor, ErbB-2/metabolism ; Receptors, Estrogen/metabolism ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
    Chemical Substances Fulvestrant (22X328QOC4) ; Estrogen Receptor alpha ; MLN 8237 ; Aurora Kinase A (EC 2.7.11.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Receptors, Estrogen
    Language English
    Publishing date 2023-03-06
    Publishing country United States
    Document type Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2022.7949
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Long-Term Follow-up of CALGB (Alliance) 100001: Autologous Followed by Nonmyeloablative Allogeneic Transplant for Multiple Myeloma.

    Holstein, Sarah A / Suman, Vera J / Owzar, Kouros / Santo, Katelyn / Benson, Don M / Shea, Thomas C / Martin, Thomas / Silverman, Margarida / Isola, Luis / Vij, Ravi / Cheson, Bruce D / Linker, Charles / Anderson, Kenneth C / Richardson, Paul G / McCarthy, Philip L

    Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

    2020  Volume 26, Issue 8, Page(s) 1414–1424

    Abstract: CALGB (Alliance) 100001 was a phase II study evaluating autologous stem cell transplant (ASCT) followed by nonmyeloablative allogeneic stem cell transplant (alloSCT) in patients with multiple myeloma who had received no more than 18 months of prior ... ...

    Abstract CALGB (Alliance) 100001 was a phase II study evaluating autologous stem cell transplant (ASCT) followed by nonmyeloablative allogeneic stem cell transplant (alloSCT) in patients with multiple myeloma who had received no more than 18 months of prior therapy and had experienced no more than 1 prior progression event. Conditioning for ASCT was with high-dose melphalan (200 mg/m
    MeSH term(s) Allografts ; Follow-Up Studies ; Graft vs Host Disease/etiology ; Hematopoietic Stem Cell Transplantation ; Humans ; Multiple Myeloma/therapy ; Transplantation Conditioning ; Transplantation, Autologous ; Transplantation, Homologous ; Treatment Outcome
    Language English
    Publishing date 2020-04-20
    Publishing country United States
    Document type Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 1474865-4
    ISSN 1523-6536 ; 1083-8791
    ISSN (online) 1523-6536
    ISSN 1083-8791
    DOI 10.1016/j.bbmt.2020.03.028
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5082: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 462: Show issues

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  4. Article ; Online: Patient-Derived Xenograft Engraftment and Breast Cancer Outcomes in a Prospective Neoadjuvant Study (BEAUTY).

    Boughey, Judy C / Suman, Vera J / Yu, Jia / Santo, Katelyn / Sinnwell, Jason P / Carter, Jodi M / Kalari, Krishna R / Tang, Xiaojia / McLaughlin, Sarah A / Moreno-Aspitia, Alvaro / Northfelt, Donald W / Gray, Richard J / Hunt, Katie N / Conners, Amy Lynn / Ingle, James N / Moyer, Ann / Weinshilboum, Richard / Copland, John A / Wang, Liewei /
    Goetz, Matthew P

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2021  Volume 27, Issue 17, Page(s) 4696–4699

    Abstract: Purpose: Patient-derived xenografts (PDX) are a research tool for studying cancer biology and drug response phenotypes. While engraftment rates are higher for tumors with more aggressive characteristics, it is uncertain whether engraftment is prognostic ...

    Abstract Purpose: Patient-derived xenografts (PDX) are a research tool for studying cancer biology and drug response phenotypes. While engraftment rates are higher for tumors with more aggressive characteristics, it is uncertain whether engraftment is prognostic for cancer recurrence.
    Patients and methods: In a prospective study of patients with breast cancer treated with neoadjuvant chemotherapy (NAC) with taxane ± trastuzumab followed by anthracycline-based chemotherapy, we report the association between breast cancer events and PDX engraftment using tumors derived from treatment naïve (pre-NAC biopsies from 113 patients) and treatment resistant (post-NAC at surgery from 34 patients). Gray test was used to assess whether the cumulative incidence of a breast cancer event differs with respect to either pre-NAC PDX engraftment or post-NAC PDX engraftment.
    Results: With a median follow-up of 5.7 years, the cumulative incidence of breast cancer relapse did not differ significantly according to pre-NAC PDX engraftment (5-year rate: 13.6% vs. 13.4%;
    Conclusions: In treatment-naïve breast cancer receiving standard NAC, PDX engraftment was not prognostic for breast cancer recurrence. Further study is needed to establish whether PDX engraftment in the treatment-resistant setting is prognostic for cancer recurrence.
    MeSH term(s) Animals ; Breast Neoplasms/drug therapy ; Breast Neoplasms/surgery ; Female ; Humans ; Mice ; Neoadjuvant Therapy ; Prospective Studies ; Transplantation, Heterologous ; Treatment Outcome ; Xenograft Model Antitumor Assays
    Language English
    Publishing date 2021-06-02
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-21-0641
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 4223: Show issues Location:
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