Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial
Abstract Objectives To examine the presence of the time-dependent effect of metronomic chemotherapy for the treatment of older patients with acute myeloid leukemia (AML) who were unfit for standard chemotherapy and to reanalyze the data using an appropriate statistical approach in the presence of no...
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| Format: | Article |
| Language: | English |
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BMC
2021-01-01
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| Series: | BMC Research Notes |
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| Online Access: | https://doi.org/10.1186/s13104-020-05423-5 |
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| author | Phichayut Phinyo Jayanton Patumanond Saranya Pongudom |
| author_facet | Phichayut Phinyo Jayanton Patumanond Saranya Pongudom |
| author_sort | Phichayut Phinyo |
| collection | DOAJ |
| description | Abstract Objectives To examine the presence of the time-dependent effect of metronomic chemotherapy for the treatment of older patients with acute myeloid leukemia (AML) who were unfit for standard chemotherapy and to reanalyze the data using an appropriate statistical approach in the presence of non-proportional hazards, the restricted mean survival time (RMST). Results This was a secondary analysis of a multi-center, open-label, randomized controlled trial, which was conducted in seven tertiary care hospitals across Thailand. A total of 81 unfit AML patients were randomized into two treatment groups, metronomic chemotherapy and palliative treatment. The hazard ratio of metronomic chemotherapy over palliative treatment was time-dependent. At three landmark time points of 90, 180, 365 days, the restricted mean survival time differences were 13.3 (95% CI 1.9–24.7) days, 28.9 (95% CI 3.3–54.4) days, and 40.4 (95% CI − 1.3 to 82.0) days, respectively. With non-proportional hazards modeling and RMST analysis, we were able to conclude that metronomic chemotherapy is a potentially effective alternative treatment for elderly AML patients who were medically unfit for intensive chemotherapy. In the future clinical trials, non-proportional hazards should be carefully inspected and properly handled with appropriate statistical methods. Trial registration Randomized clinical trial TCTR20150918001; registration date: 15/09/2015. Retrospectively registered |
| first_indexed | 2024-12-20T12:58:25Z |
| format | Article |
| id | doaj.art-629d146d1ad04929914ad4cbf0f9524c |
| institution | Directory Open Access Journal |
| issn | 1756-0500 |
| language | English |
| last_indexed | 2024-12-20T12:58:25Z |
| publishDate | 2021-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Research Notes |
| spelling | doaj.art-629d146d1ad04929914ad4cbf0f9524c2022-12-21T19:39:59ZengBMCBMC Research Notes1756-05002021-01-011411610.1186/s13104-020-05423-5Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trialPhichayut Phinyo0Jayanton Patumanond1Saranya Pongudom2Department of Family Medicine and Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai UniversityFaculty of Medicine, Center for Clinical Epidemiology and Clinical Statistics, Chiang Mai UniversityDepartment of Medicine, Udon Thani Medical Education Center, Udon Thani HospitalAbstract Objectives To examine the presence of the time-dependent effect of metronomic chemotherapy for the treatment of older patients with acute myeloid leukemia (AML) who were unfit for standard chemotherapy and to reanalyze the data using an appropriate statistical approach in the presence of non-proportional hazards, the restricted mean survival time (RMST). Results This was a secondary analysis of a multi-center, open-label, randomized controlled trial, which was conducted in seven tertiary care hospitals across Thailand. A total of 81 unfit AML patients were randomized into two treatment groups, metronomic chemotherapy and palliative treatment. The hazard ratio of metronomic chemotherapy over palliative treatment was time-dependent. At three landmark time points of 90, 180, 365 days, the restricted mean survival time differences were 13.3 (95% CI 1.9–24.7) days, 28.9 (95% CI 3.3–54.4) days, and 40.4 (95% CI − 1.3 to 82.0) days, respectively. With non-proportional hazards modeling and RMST analysis, we were able to conclude that metronomic chemotherapy is a potentially effective alternative treatment for elderly AML patients who were medically unfit for intensive chemotherapy. In the future clinical trials, non-proportional hazards should be carefully inspected and properly handled with appropriate statistical methods. Trial registration Randomized clinical trial TCTR20150918001; registration date: 15/09/2015. Retrospectively registeredhttps://doi.org/10.1186/s13104-020-05423-5LeukemiasMaintenance chemotherapySurvivalProportional hazard model |
| spellingShingle | Phichayut Phinyo Jayanton Patumanond Saranya Pongudom Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial BMC Research Notes Leukemias Maintenance chemotherapy Survival Proportional hazard model |
| title | Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial |
| title_full | Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial |
| title_fullStr | Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial |
| title_full_unstemmed | Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial |
| title_short | Time-dependent treatment effects of metronomic chemotherapy in unfit AML patients: a secondary analysis of a randomised controlled trial |
| title_sort | time dependent treatment effects of metronomic chemotherapy in unfit aml patients a secondary analysis of a randomised controlled trial |
| topic | Leukemias Maintenance chemotherapy Survival Proportional hazard model |
| url | https://doi.org/10.1186/s13104-020-05423-5 |
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