Interval design to identify the optimal biological dose for immunotherapy
Immunotherapeutics have revolutionized the treatment of metastatic cancers and are expected to play an increasingly prominent role in the treatment of cancer patients. Recent advances in checkpoint inhibition show promising early results in a number of malignancies, and several treatments have been...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422001223 |
| _version_ | 1811184573968547840 |
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| author | Yeonhee Park |
| author_facet | Yeonhee Park |
| author_sort | Yeonhee Park |
| collection | DOAJ |
| description | Immunotherapeutics have revolutionized the treatment of metastatic cancers and are expected to play an increasingly prominent role in the treatment of cancer patients. Recent advances in checkpoint inhibition show promising early results in a number of malignancies, and several treatments have been approved for use. However, the immunotherapeutic agents have been shown to have different mechanisms of antitumor activity from cytotoxic agents, and many limitations and challenges encountered in the traditional paradigm were recently pointed out for immunotherapy. I propose a desirability-based method to determine the optimal biological dose of immunotherapeutics by effectively using toxicity, immune response, and tumor response. Moreover, a new dose allocation algorithm of interval designs is proposed to incorporate immune response in addition to toxicity and tumor response. Simulation studies show that the proposed design has desirable operating characteristics compared to existing dose-finding designs. It also inherits the strengths of interval designs for dose-finding trials, yielding good performance with ease of implementation. |
| first_indexed | 2024-04-11T13:15:41Z |
| format | Article |
| id | doaj.art-396d9518051f465989f7b68532ba4207 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-11T13:15:41Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-396d9518051f465989f7b68532ba42072022-12-22T04:22:25ZengElsevierContemporary Clinical Trials Communications2451-86542022-12-0130101005Interval design to identify the optimal biological dose for immunotherapyYeonhee Park0Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, United States of AmericaImmunotherapeutics have revolutionized the treatment of metastatic cancers and are expected to play an increasingly prominent role in the treatment of cancer patients. Recent advances in checkpoint inhibition show promising early results in a number of malignancies, and several treatments have been approved for use. However, the immunotherapeutic agents have been shown to have different mechanisms of antitumor activity from cytotoxic agents, and many limitations and challenges encountered in the traditional paradigm were recently pointed out for immunotherapy. I propose a desirability-based method to determine the optimal biological dose of immunotherapeutics by effectively using toxicity, immune response, and tumor response. Moreover, a new dose allocation algorithm of interval designs is proposed to incorporate immune response in addition to toxicity and tumor response. Simulation studies show that the proposed design has desirable operating characteristics compared to existing dose-finding designs. It also inherits the strengths of interval designs for dose-finding trials, yielding good performance with ease of implementation.http://www.sciencedirect.com/science/article/pii/S2451865422001223Dose-findingImmunotherapyInterval designOptimal biological dose |
| spellingShingle | Yeonhee Park Interval design to identify the optimal biological dose for immunotherapy Contemporary Clinical Trials Communications Dose-finding Immunotherapy Interval design Optimal biological dose |
| title | Interval design to identify the optimal biological dose for immunotherapy |
| title_full | Interval design to identify the optimal biological dose for immunotherapy |
| title_fullStr | Interval design to identify the optimal biological dose for immunotherapy |
| title_full_unstemmed | Interval design to identify the optimal biological dose for immunotherapy |
| title_short | Interval design to identify the optimal biological dose for immunotherapy |
| title_sort | interval design to identify the optimal biological dose for immunotherapy |
| topic | Dose-finding Immunotherapy Interval design Optimal biological dose |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422001223 |
| work_keys_str_mv | AT yeonheepark intervaldesigntoidentifytheoptimalbiologicaldoseforimmunotherapy |