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Article ; Online: An overview of the BOIN design and its current extensions for novel early-phase oncology trials.

Ananthakrishnan, Revathi / Lin, Ruitao / He, Chunsheng / Chen, Yanping / Li, Daniel / LaValley, Michael

Contemporary clinical trials communications

2022 Volume 28, Page(s) 100943

Abstract: Bayesian Optimal Interval (BOIN) designs are a class of model-assisted dose-finding designs that can be used in oncology trials to determine the maximum tolerated dose (MTD) of a study drug based on safety or the optimal biological dose (OBD) based on ... ...

Abstract	Bayesian Optimal Interval (BOIN) designs are a class of model-assisted dose-finding designs that can be used in oncology trials to determine the maximum tolerated dose (MTD) of a study drug based on safety or the optimal biological dose (OBD) based on safety and efficacy. BOIN designs provide a complete suite for dose finding in early phase trials, as well as a consistent way to explore different scenarios such as toxicity, efficacy, continuous outcomes, delayed toxicity or efficacy and drug combinations in a unified manner with easy access to software to implement most of these designs. Although built upon Bayesian probability models, BOIN designs are operationally simple in general and have good statistical operating characteristics compared to other dose-finding designs. This review paper describes the original BOIN design and its many extensions, their advantages and limitations, the software used to implement them, and the most suitable situation for use of each of these designs. Published examples of the implementation of BOIN designs are provided in the Appendix.
Language	English
Publishing date	2022-06-13
Publishing country	Netherlands
Document type	Journal Article ; Review
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2022.100943
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: An overview of the BOIN design and its current extensions for novel early-phase oncology trials

Revathi Ananthakrishnan / Ruitao Lin / Chunsheng He / Yanping Chen / Daniel Li / Michael LaValley

Contemporary Clinical Trials Communications, Vol 28, Iss , Pp 100943- (2022)

2022

Abstract	Bayesian Optimal Interval (BOIN) designs are a class of model-assisted dose-finding designs that can be used in oncology trials to determine the maximum tolerated dose (MTD) of a study drug based on safety or the optimal biological dose (OBD) based on safety and efficacy. BOIN designs provide a complete suite for dose finding in early phase trials, as well as a consistent way to explore different scenarios such as toxicity, efficacy, continuous outcomes, delayed toxicity or efficacy and drug combinations in a unified manner with easy access to software to implement most of these designs. Although built upon Bayesian probability models, BOIN designs are operationally simple in general and have good statistical operating characteristics compared to other dose-finding designs. This review paper describes the original BOIN design and its many extensions, their advantages and limitations, the software used to implement them, and the most suitable situation for use of each of these designs. Published examples of the implementation of BOIN designs are provided in the Appendix.
Keywords	Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Critical review of oncology clinical trial design under non-proportional hazards.

Ananthakrishnan, Revathi / Green, Stephanie / Previtali, Alessandro / Liu, Rong / Li, Daniel / LaValley, Michael

Critical reviews in oncology/hematology

2021 Volume 162, Page(s) 103350

Abstract: In trials of novel immuno-oncology drugs, the proportional hazards (PH) assumption often does not hold for the primary time-to-event (TTE) efficacy endpoint, likely due to the unique mechanism of action of these drugs. In practice, when it is anticipated ...

Abstract	In trials of novel immuno-oncology drugs, the proportional hazards (PH) assumption often does not hold for the primary time-to-event (TTE) efficacy endpoint, likely due to the unique mechanism of action of these drugs. In practice, when it is anticipated that PH may not hold for the TTE endpoint with respect to treatment, the sample size is often still calculated under the PH assumption, and the hazard ratio (HR) from the Cox model is still reported as the primary measure of the treatment effect. Sensitivity analyses of the TTE data using methods that are suitable under non-proportional hazards (non-PH) are commonly pre-planned. In cases where a substantial deviation from the PH assumption is likely, we suggest designing the trial, calculating the sample size and analyzing the data, using a suitable method that accounts for non-PH, after gaining alignment with regulatory authorities. In this comprehensive review article, we describe methods to design a randomized oncology trial, calculate the sample size, analyze the trial data and obtain summary measures of the treatment effect in the presence of non-PH. For each method, we provide examples of its use from the recent oncology trials literature. We also summarize in the Appendix some methods to conduct sensitivity analyses for overall survival (OS) when patients in a randomized trial switch or cross-over to the other treatment arm after disease progression on the initial treatment arm, and obtain an adjusted or weighted HR for OS in the presence of cross-over. This is an example of the treatment itself changing at a specific point in time - this cross-over may lead to a non-PH pattern of diminishing treatment effect.
MeSH term(s)	Clinical Trials as Topic ; Humans ; Neoplasms/drug therapy ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Research Design ; Sample Size
Language	English
Publishing date	2021-05-12
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2021.103350
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Article ; Online: Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.

Minakata, Daisuke / Ishida, Tadao / Ando, Kiyoshi / Suzuki, Rikio / Tanaka, Junji / Hagiwara, Shotaro / Ananthakrishnan, Revathi / Kuwayama, Shigeki / Nishio, Mitsufumi / Kanda, Yoshinobu / Suzuki, Kenshi

International journal of hematology

2023 Volume 117, Issue 5, Page(s) 729–737

Abstract: Background: In the phase 2 KarMMa trial, patients with relapsed/refractory multiple myeloma (RRMM) achieved deep and durable responses with idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell ... ...

Abstract	Background: In the phase 2 KarMMa trial, patients with relapsed/refractory multiple myeloma (RRMM) achieved deep and durable responses with idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy. Here we report a sub-analysis of the Japanese cohort of KarMMa. Methods: Adult patients with RRMM who had received ≥ 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and had disease refractory to last treatment received ide-cel at a target dose of 450 × 10 Results: Nine patients were treated with ide-cel. The overall response rate was 89% (median follow-up, 12.9 months). The best overall response was stringent complete response in 5 patients (56%), very good partial response in 3 (33%), and stable disease in 1. Median duration of response was not reached. All patients experienced grade ≤ 2 cytokine release syndrome and one patient experienced grade 2 neurotoxicity, but all resolved. Two patients died, one each from plasma cell myeloma and general health deterioration. Conclusion: Ide-cel yielded deep, durable responses with a tolerable and predictable safety profile in Japanese patients with RRMM. These results are similar to those of the non-Japanese population in KarMMa.
MeSH term(s)	Adult ; Humans ; Multiple Myeloma/therapy ; Receptors, Chimeric Antigen ; Neoplasms, Plasma Cell ; Immunotherapy, Adoptive/adverse effects ; Cytokine Release Syndrome
Chemical Substances	idecabtagene vicleucel (8PX1X7UG4D) ; Receptors, Chimeric Antigen
Language	English
Publishing date	2023-01-24
Publishing country	Japan
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	1076875-0
ISSN	1865-3774 ; 0917-1258 ; 0925-5710
ISSN (online)	1865-3774
ISSN	0917-1258 ; 0925-5710
DOI	10.1007/s12185-023-03538-6
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Article ; Online: 2D (2 Dimensional) TEQR design for Determining the optimal Dose for safety and efficacy.

Ananthakrishnan, Revathi / Green, Stephanie / Li, Daniel / LaValley, Michael

Contemporary clinical trials communications

2019 Volume 16, Page(s) 100461

Abstract: Designs, such as the Eff-Tox, OBD (optimal biological dose), STEIN (simple efficacy toxicity interval), and TEPI (toxicity efficacy probability interval) designs, have been proposed to determine the optimal dose of a new oncology drug using both efficacy ...

Abstract	Designs, such as the Eff-Tox, OBD (optimal biological dose), STEIN (simple efficacy toxicity interval), and TEPI (toxicity efficacy probability interval) designs, have been proposed to determine the optimal dose of a new oncology drug using both efficacy and toxicity. The goal of these designs is to select the optimal drug dose for further phase trials more accurately than dose finding designs that only consider toxicity, such as the 3 + 3, TEQR (toxicity equivalence range), mTPI (modified toxicity probability interval), and EWOC (escalation with overdose control) designs. We propose a new frequentist design for optimal dose selection, the 2D TEQR design, that is easier to understand and simpler to implement than the TEPI, Eff-Tox, STEIN and OBD designs, as it is based on the empirical or observed toxicity and efficacy rates and does not require specialized computations. We compare the performance of this new design with those of the TEPI, STEIN, Eff-Tox and OBD Isotonic designs. Although for the same sample size and cohort size, the frequentist 2D TEQR design is less accurate than the Bayesian TEPI design and also the STEIN design in selecting the optimal dose, the accuracy of optimal dose selection of the 2D TEQR design can be increased, in many cases, with a moderate increase in cohort size. The 2D TEQR design is as accurate as or more accurate than the Eff-Tox design in optimal dose selection, and better than the OBD Isotonic design, unless there is a clear peak in the true response rates, in which case the OBD Isotonic design performs better than the other designs.
Language	English
Publishing date	2019-10-12
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2019.100461
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Article ; Online: Phase 2 results of lisocabtagene maraleucel in Japanese patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.

Makita, Shinichi / Yamamoto, Go / Maruyama, Dai / Asano-Mori, Yuki / Kaji, Daisuke / Ananthakrishnan, Revathi / Ogasawara, Ken / Stepan, Lara / Schusterbauer, Claudia / Rettby, Nils / Hasskarl, Jens / Izutsu, Koji

Cancer medicine

2022 Volume 11, Issue 24, Page(s) 4889–4899

Abstract: The autologous anti-CD19 chimeric antigen receptor (CAR) T-cell product, lisocabtagene maraleucel (liso-cel), is administered at equal target doses of ... ...

Abstract	The autologous anti-CD19 chimeric antigen receptor (CAR) T-cell product, lisocabtagene maraleucel (liso-cel), is administered at equal target doses of CD8
MeSH term(s)	Humans ; Antigens, CD19 ; Cytokine Release Syndrome/chemically induced ; Cytokine Release Syndrome/epidemiology ; Immunotherapy, Adoptive/adverse effects ; Lymphoma, Large B-Cell, Diffuse/drug therapy ; Receptors, Chimeric Antigen ; Thrombocytopenia/chemically induced ; Thrombocytopenia/epidemiology ; Japan
Chemical Substances	Antigens, CD19 ; Receptors, Chimeric Antigen
Language	English
Publishing date	2022-05-26
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2659751-2
ISSN	2045-7634 ; 2045-7634
ISSN (online)	2045-7634
ISSN	2045-7634
DOI	10.1002/cam4.4820
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Article ; Online: 2D (2 Dimensional) TEQR design for Determining the optimal Dose for safety and efficacy

Revathi Ananthakrishnan / Stephanie Green / Daniel Li / Michael LaValley

Contemporary Clinical Trials Communications, Vol 16, Iss , Pp - (2019)

2019

Abstract	Designs, such as the Eff-Tox, OBD (optimal biological dose), STEIN (simple efficacy toxicity interval), and TEPI (toxicity efficacy probability interval) designs, have been proposed to determine the optimal dose of a new oncology drug using both efficacy and toxicity. The goal of these designs is to select the optimal drug dose for further phase trials more accurately than dose finding designs that only consider toxicity, such as the 3 + 3, TEQR (toxicity equivalence range), mTPI (modified toxicity probability interval), and EWOC (escalation with overdose control) designs. We propose a new frequentist design for optimal dose selection, the 2D TEQR design, that is easier to understand and simpler to implement than the TEPI, Eff-Tox, STEIN and OBD designs, as it is based on the empirical or observed toxicity and efficacy rates and does not require specialized computations. We compare the performance of this new design with those of the TEPI, STEIN, Eff-Tox and OBD Isotonic designs. Although for the same sample size and cohort size, the frequentist 2D TEQR design is less accurate than the Bayesian TEPI design and also the STEIN design in selecting the optimal dose, the accuracy of optimal dose selection of the 2D TEQR design can be increased, in many cases, with a moderate increase in cohort size. The 2D TEQR design is as accurate as or more accurate than the Eff-Tox design in optimal dose selection, and better than the OBD Isotonic design, unless there is a clear peak in the true response rates, in which case the OBD Isotonic design performs better than the other designs. Keywords: Early phase oncology design, 2D TEQR design, OBD isotonic and eff-tox designs, Optimal dose for safety and efficacy
Keywords	Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2019-12-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Extensions of the mTPI and TEQR designs to include non-monotone efficacy in addition to toxicity for optimal dose determination for early phase immunotherapy oncology trials.

Ananthakrishnan, Revathi / Green, Stephanie / Li, Daniel / LaValley, Michael

Contemporary clinical trials communications

2018 Volume 10, Page(s) 62–76

Abstract: With the emergence of immunotherapy and other novel therapies, the traditional assumption that the efficacy of the study drug increases monotonically with dose levels is not always true. Therefore, dose-finding methods evaluating only toxicity data may ... ...

Abstract	With the emergence of immunotherapy and other novel therapies, the traditional assumption that the efficacy of the study drug increases monotonically with dose levels is not always true. Therefore, dose-finding methods evaluating only toxicity data may not be adequate. In this paper, we have first compared the Modified Toxicity Probability Interval (mTPI) and Toxicity Equivalence Range (TEQR) dose-finding oncology designs for safety with identical stopping rules; we have then extended both designs to include efficacy in addition to safety - we determine the optimal dose for safety and efficacy using these designs by applying isotonic regression to the observed toxicity and efficacy rates, once the early phase trial is completed. We consider multiple types of underlying dose response curves, i.e., monotonically increasing, plateau, or umbrella-shaped. We conduct simulation studies to investigate the operating characteristics of the two proposed designs and compare them to existing designs. We found that the extended mTPI design selects the optimal dose for safety and efficacy more accurately than the other designs for most of the scenarios considered.
Language	English
Publishing date	2018-01-31
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2018.01.006
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Design of oncology clinical trials: a review.

Ananthakrishnan, Revathi / Menon, Sandeep

Critical reviews in oncology/hematology

2013 Volume 88, Issue 1, Page(s) 144–153

Abstract: Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the ... ...

Abstract	Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This review focuses on statistical considerations in the design and analysis of oncology clinical trials.
MeSH term(s)	Clinical Trials as Topic/standards ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Neoplasms/drug therapy ; Research Design/standards
Language	English
Publishing date	2013-10
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2013.03.007
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Article ; Online: Extensions of the mTPI and TEQR designs to include non-monotone efficacy in addition to toxicity for optimal dose determination for early phase immunotherapy oncology trials

Revathi Ananthakrishnan / Stephanie Green / Daniel Li / Michael LaValley

Contemporary Clinical Trials Communications, Vol 10, Iss , Pp 62-

2018 Volume 76

Abstract	With the emergence of immunotherapy and other novel therapies, the traditional assumption that the efficacy of the study drug increases monotonically with dose levels is not always true. Therefore, dose-finding methods evaluating only toxicity data may not be adequate. In this paper, we have first compared the Modified Toxicity Probability Interval (mTPI) and Toxicity Equivalence Range (TEQR) dose-finding oncology designs for safety with identical stopping rules; we have then extended both designs to include efficacy in addition to safety – we determine the optimal dose for safety and efficacy using these designs by applying isotonic regression to the observed toxicity and efficacy rates, once the early phase trial is completed. We consider multiple types of underlying dose response curves, i.e., monotonically increasing, plateau, or umbrella-shaped. We conduct simulation studies to investigate the operating characteristics of the two proposed designs and compare them to existing designs. We found that the extended mTPI design selects the optimal dose for safety and efficacy more accurately than the other designs for most of the scenarios considered. Keywords: Early phase immunooncology design considering efficacy and safety, Extended mTPI design, Extended TEQR design, Optimal biological dose isotonic design, Eff-Tox design, Umbrella-shaped dose-response curve
Keywords	Medicine (General) ; R5-920
Subject code	310
Language	English
Publishing date	2018-06-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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