Phase 1 Study to Evaluate the Safety of Reducing the Prophylactic Dose of Dexamethasone around Docetaxel Infusion in Patients with Prostate and Breast Cancer
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Patient
2.3. Endpoint
2.4. Quality of Life
2.5. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Toxicity
3.3. Quality of Life
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Breast Cancer (Docetaxel Dosage 75–100 mg/m2) | ||||||
---|---|---|---|---|---|---|
Day −1 | Day 0 | Day 1 | ||||
Cohort 1 | 8 mg | 4 mg | 8 mg | 4 mg | 8 mg | 4 mg |
Cohort 2 | 8 mg | 8 mg | 8 mg | |||
Cohort 3 | 4 mg | 8 mg | 4 mg | |||
Prostate cancer (Docetaxel dosage 75 mg/m2) | ||||||
Day −1 | Day 0 | |||||
Cohort 1 | 8 mg | 8 mg | ||||
Cohort 2 | - | 8 mg | ||||
Cohort 3A | - | 4 mg, with 2dd 5 mg prednisone continuously | ||||
Cohort 3B | - | 4 mg, without 2dd 5 mg prednisone continuously |
Prostate Cancer (N = 28) | Breast Cancer (N = 18) | |
---|---|---|
Median Age (range), Years | 69.5 (55–80) | 54 (34–67) |
Median Body Mass Index (range), kg/m2 | 26.9 (21.3–32.7) | 26.4 (18.6–40.4) |
WHO Status | ||
Grade 0 | 15 (54%) | 12 (67%) |
Grade 1 | 6 (21%) | 3 (17%) |
Grade 2 | 1 (4%) | 0 (0%) |
Missing | 6 (21%) | 3 (17%) |
Stage | ||
I | 0 (0%) | 3 (17%) |
II | 0 (0%) | 12 (67%) |
III | 0 (0%) | 1 (6%) |
IV | 28 (100%) | 2 (11%) |
Chemotherapy Regimen | ||
(Neo)adjuvant | 0 (0%) | 16 (89%) |
Palliative | 28 (100%) | 2 (11%) |
Docetaxel Dosage | ||
75 mg/m2 | 28 (100%) | 2 (11%) |
100 mg/m2 | 0 (0%) | 16 (89%) |
Treatment | ||
Monotherapy Docetaxel | 28 (100%) | 14 (78%) |
Combination Chemotherapy | 0 (0%) | 4 (22%) |
Breast Cancer | Number of Patients Evaluated | Median Cycles of Docetaxel (Range) | Mean Cumulative Dose of Docetaxel (Range) | HSR (Any Grade) | HSR (Grade III/IV) | Fluid Retention * (Any Grade) | Fluid Retention (Grade III/IV) |
Cohort 1 | 6 | 4 (4) | 351 mg/m2 (325–400) | 0 | 0 | 1/6 (grade I) | 0 |
Cohort 2 | 6 | 4 (1–4) | 307 mg/m2 (100–400) | 0 | 0 | 1/6 (grade II) | 0 |
Cohort 3 | 2 | 6 (6) | 525 mg/m2 (450–600) | 0 | 0 | 0 | 0 |
Prostate Cancer | Number of Patients Evaluated | Median Cycles of Docetaxel (Range) | Mean Cumulative Dose of Docetaxel (Range) | HSR (Any Grade) | HSR (Grade III/IV) | Fluid Retention * (Any Grade) | Fluid Retention (Grade III/IV) |
Cohort 1 | 6 | 6 (1–9) | 445 mg/m2 (75–645) | 0 | 0 | 1/6 (grade II) | 0 |
Cohort 2 | 7 | 6 (5–6) | 407 mg/m2 (225–450) | 1/6 (grade I) ** | 0 | 0 | 0 |
Cohort 3A | 6 | 6 (2–6) | 372 mg/m2 (150–450) | 0 | 0 | 1/6 (grade I/II) | 0 |
Cohort 3B | 6 | 6 (5–6) | 434 mg/m2 (356–450) | 0 | 0 | 2/6 (grade I/II) | 0 |
Febrile Neutropenia | Nausea | Hyperglycaemia | |
---|---|---|---|
Cohorts 1 | 3/12 (grade IV) * | 5/12 (grade I–II) | 4/12 (grade I–II) |
Cohorts 2 | 1/13 (grade IV) * | 5/13 (grade I) | 3/13 (grade I) |
Cohorts 3 | 0/14 | 2/14 (grade I–II) | 1/14 (grade I) |
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Lugtenberg, R.T.; de Groot, S.; Houtsma, D.; Dezentjé, V.O.; Vulink, A.J.E.; Fischer, M.J.; Portielje, J.E.A.; van der Hoeven, J.J.M.; Gelderblom, H.; Pijl, H.; et al. Phase 1 Study to Evaluate the Safety of Reducing the Prophylactic Dose of Dexamethasone around Docetaxel Infusion in Patients with Prostate and Breast Cancer. Cancers 2023, 15, 1691. https://doi.org/10.3390/cancers15061691
Lugtenberg RT, de Groot S, Houtsma D, Dezentjé VO, Vulink AJE, Fischer MJ, Portielje JEA, van der Hoeven JJM, Gelderblom H, Pijl H, et al. Phase 1 Study to Evaluate the Safety of Reducing the Prophylactic Dose of Dexamethasone around Docetaxel Infusion in Patients with Prostate and Breast Cancer. Cancers. 2023; 15(6):1691. https://doi.org/10.3390/cancers15061691
Chicago/Turabian StyleLugtenberg, Rieneke T., Stefanie de Groot, Danny Houtsma, Vincent O. Dezentjé, Annelie J. E. Vulink, Maarten J. Fischer, Johanneke E. A. Portielje, Jacobus J. M. van der Hoeven, Hans Gelderblom, Hanno Pijl, and et al. 2023. "Phase 1 Study to Evaluate the Safety of Reducing the Prophylactic Dose of Dexamethasone around Docetaxel Infusion in Patients with Prostate and Breast Cancer" Cancers 15, no. 6: 1691. https://doi.org/10.3390/cancers15061691
APA StyleLugtenberg, R. T., de Groot, S., Houtsma, D., Dezentjé, V. O., Vulink, A. J. E., Fischer, M. J., Portielje, J. E. A., van der Hoeven, J. J. M., Gelderblom, H., Pijl, H., & Kroep, J. R. (2023). Phase 1 Study to Evaluate the Safety of Reducing the Prophylactic Dose of Dexamethasone around Docetaxel Infusion in Patients with Prostate and Breast Cancer. Cancers, 15(6), 1691. https://doi.org/10.3390/cancers15061691