Assessing Delayed Treatment Benefits of Immunotherapy Using Long-Term Average Hazard: A Novel Test/Estimation Approach
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arXiv
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| Autori principali: | , , , |
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| Natura: | Preprint |
| Pubblicazione: |
2024
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| _version_ | 1866911799161389056 |
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| author | Horiguchi, Miki Tian, Lu Kehl, Kenneth L. Uno, Hajime |
| author_facet | Horiguchi, Miki Tian, Lu Kehl, Kenneth L. Uno, Hajime |
| contents | Delayed treatment effects on time-to-event outcomes have often been observed in randomized controlled studies of cancer immunotherapies. In the case of delayed onset of treatment effect, the conventional test/estimation approach using the log-rank test for between-group comparison and Cox's hazard ratio to estimate the magnitude of treatment effect is not optimal, because the log-rank test is not the most powerful option, and the interpretation of the resulting hazard ratio is not obvious. Recently, alternative test/estimation approaches were proposed to address both the power issue and the interpretation problems of the conventional approach. One is a test/estimation approach based on long-term restricted mean survival time, and the other approach is based on average hazard with survival weight. This paper integrates these two ideas and proposes a novel test/estimation approach based on long-term average hazard (LT-AH) with survival weight. Numerical studies reveal specific scenarios where the proposed LT-AH method provides a higher power than the two alternative approaches. The proposed approach has test/estimation coherency and can provide robust estimates of the magnitude of treatment effect not dependent on study-specific censoring time distribution. Also, the proposed LT-AH approach can summarize the magnitude of the treatment effect in both absolute difference and relative terms using ``hazard'' (i.e., difference in LT-AH and ratio of LT-AH), meeting guideline recommendations and practical needs. This proposed approach can be a useful alternative to the traditional hazard-based test/estimation approach when delayed onset of survival benefit is expected. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2403_10742 |
| institution | arXiv |
| publishDate | 2024 |
| record_format | arxiv |
| spellingShingle | Assessing Delayed Treatment Benefits of Immunotherapy Using Long-Term Average Hazard: A Novel Test/Estimation Approach Horiguchi, Miki Tian, Lu Kehl, Kenneth L. Uno, Hajime Methodology Delayed treatment effects on time-to-event outcomes have often been observed in randomized controlled studies of cancer immunotherapies. In the case of delayed onset of treatment effect, the conventional test/estimation approach using the log-rank test for between-group comparison and Cox's hazard ratio to estimate the magnitude of treatment effect is not optimal, because the log-rank test is not the most powerful option, and the interpretation of the resulting hazard ratio is not obvious. Recently, alternative test/estimation approaches were proposed to address both the power issue and the interpretation problems of the conventional approach. One is a test/estimation approach based on long-term restricted mean survival time, and the other approach is based on average hazard with survival weight. This paper integrates these two ideas and proposes a novel test/estimation approach based on long-term average hazard (LT-AH) with survival weight. Numerical studies reveal specific scenarios where the proposed LT-AH method provides a higher power than the two alternative approaches. The proposed approach has test/estimation coherency and can provide robust estimates of the magnitude of treatment effect not dependent on study-specific censoring time distribution. Also, the proposed LT-AH approach can summarize the magnitude of the treatment effect in both absolute difference and relative terms using ``hazard'' (i.e., difference in LT-AH and ratio of LT-AH), meeting guideline recommendations and practical needs. This proposed approach can be a useful alternative to the traditional hazard-based test/estimation approach when delayed onset of survival benefit is expected. |
| title | Assessing Delayed Treatment Benefits of Immunotherapy Using Long-Term Average Hazard: A Novel Test/Estimation Approach |
| topic | Methodology |
| url | https://arxiv.org/abs/2403.10742 |