Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study
Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Leal, Ticiana B. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2011 |
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| Schlagwörter: |
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| Anmerkung: |
© Springer-Verlag 2011 |
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| Übergeordnetes Werk: |
Enthalten in: Cancer chemotherapy and pharmacology - Berlin : Springer, 1978, 68(2011), 6 vom: 09. Apr., Seite 1439-1447 |
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| Übergeordnetes Werk: |
volume:68 ; year:2011 ; number:6 ; day:09 ; month:04 ; pages:1439-1447 |
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| DOI / URN: |
10.1007/s00280-011-1637-5 |
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| Katalog-ID: |
SPR003599922 |
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| 100 | 1 | |a Leal, Ticiana B. |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study |
| 264 | 1 | |c 2011 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a © Springer-Verlag 2011 | ||
| 520 | |a Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. | ||
| 650 | 4 | |a Renal function |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Bortezomib |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Toxicity |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Pharmacokinetics |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Pharmacodynamics |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Remick, Scot C. |4 aut | |
| 700 | 1 | |a Takimoto, Chris H. |4 aut | |
| 700 | 1 | |a Ramanathan, Ramesh K. |4 aut | |
| 700 | 1 | |a Davies, Angela |4 aut | |
| 700 | 1 | |a Egorin, Merrill J. |4 aut | |
| 700 | 1 | |a Hamilton, Anne |4 aut | |
| 700 | 1 | |a LoRusso, Patricia A. |4 aut | |
| 700 | 1 | |a Shibata, Stephen |4 aut | |
| 700 | 1 | |a Lenz, Heinz-Josef |4 aut | |
| 700 | 1 | |a Mier, James |4 aut | |
| 700 | 1 | |a Sarantopoulos, John |4 aut | |
| 700 | 1 | |a Mani, Sridhar |4 aut | |
| 700 | 1 | |a Wright, John J. |4 aut | |
| 700 | 1 | |a Ivy, S. Percy |4 aut | |
| 700 | 1 | |a Neuwirth, Rachel |4 aut | |
| 700 | 1 | |a von Moltke, Lisa |4 aut | |
| 700 | 1 | |a Venkatakrishnan, Karthik |4 aut | |
| 700 | 1 | |a Mulkerin, Daniel |4 aut | |
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10.1007/s00280-011-1637-5 doi (DE-627)SPR003599922 (SPR)s00280-011-1637-5-e DE-627 ger DE-627 rakwb eng Leal, Ticiana B. verfasserin aut Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2011 Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. Renal function (dpeaa)DE-He213 Bortezomib (dpeaa)DE-He213 Toxicity (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Pharmacodynamics (dpeaa)DE-He213 Remick, Scot C. aut Takimoto, Chris H. aut Ramanathan, Ramesh K. aut Davies, Angela aut Egorin, Merrill J. aut Hamilton, Anne aut LoRusso, Patricia A. aut Shibata, Stephen aut Lenz, Heinz-Josef aut Mier, James aut Sarantopoulos, John aut Mani, Sridhar aut Wright, John J. aut Ivy, S. Percy aut Neuwirth, Rachel aut von Moltke, Lisa aut Venkatakrishnan, Karthik aut Mulkerin, Daniel aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 68(2011), 6 vom: 09. Apr., Seite 1439-1447 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:68 year:2011 number:6 day:09 month:04 pages:1439-1447 https://dx.doi.org/10.1007/s00280-011-1637-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 68 2011 6 09 04 1439-1447 |
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10.1007/s00280-011-1637-5 doi (DE-627)SPR003599922 (SPR)s00280-011-1637-5-e DE-627 ger DE-627 rakwb eng Leal, Ticiana B. verfasserin aut Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2011 Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. Renal function (dpeaa)DE-He213 Bortezomib (dpeaa)DE-He213 Toxicity (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Pharmacodynamics (dpeaa)DE-He213 Remick, Scot C. aut Takimoto, Chris H. aut Ramanathan, Ramesh K. aut Davies, Angela aut Egorin, Merrill J. aut Hamilton, Anne aut LoRusso, Patricia A. aut Shibata, Stephen aut Lenz, Heinz-Josef aut Mier, James aut Sarantopoulos, John aut Mani, Sridhar aut Wright, John J. aut Ivy, S. Percy aut Neuwirth, Rachel aut von Moltke, Lisa aut Venkatakrishnan, Karthik aut Mulkerin, Daniel aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 68(2011), 6 vom: 09. Apr., Seite 1439-1447 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:68 year:2011 number:6 day:09 month:04 pages:1439-1447 https://dx.doi.org/10.1007/s00280-011-1637-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 68 2011 6 09 04 1439-1447 |
| allfields_unstemmed |
10.1007/s00280-011-1637-5 doi (DE-627)SPR003599922 (SPR)s00280-011-1637-5-e DE-627 ger DE-627 rakwb eng Leal, Ticiana B. verfasserin aut Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2011 Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. Renal function (dpeaa)DE-He213 Bortezomib (dpeaa)DE-He213 Toxicity (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Pharmacodynamics (dpeaa)DE-He213 Remick, Scot C. aut Takimoto, Chris H. aut Ramanathan, Ramesh K. aut Davies, Angela aut Egorin, Merrill J. aut Hamilton, Anne aut LoRusso, Patricia A. aut Shibata, Stephen aut Lenz, Heinz-Josef aut Mier, James aut Sarantopoulos, John aut Mani, Sridhar aut Wright, John J. aut Ivy, S. Percy aut Neuwirth, Rachel aut von Moltke, Lisa aut Venkatakrishnan, Karthik aut Mulkerin, Daniel aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 68(2011), 6 vom: 09. Apr., Seite 1439-1447 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:68 year:2011 number:6 day:09 month:04 pages:1439-1447 https://dx.doi.org/10.1007/s00280-011-1637-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 68 2011 6 09 04 1439-1447 |
| allfieldsGer |
10.1007/s00280-011-1637-5 doi (DE-627)SPR003599922 (SPR)s00280-011-1637-5-e DE-627 ger DE-627 rakwb eng Leal, Ticiana B. verfasserin aut Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2011 Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. Renal function (dpeaa)DE-He213 Bortezomib (dpeaa)DE-He213 Toxicity (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Pharmacodynamics (dpeaa)DE-He213 Remick, Scot C. aut Takimoto, Chris H. aut Ramanathan, Ramesh K. aut Davies, Angela aut Egorin, Merrill J. aut Hamilton, Anne aut LoRusso, Patricia A. aut Shibata, Stephen aut Lenz, Heinz-Josef aut Mier, James aut Sarantopoulos, John aut Mani, Sridhar aut Wright, John J. aut Ivy, S. Percy aut Neuwirth, Rachel aut von Moltke, Lisa aut Venkatakrishnan, Karthik aut Mulkerin, Daniel aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 68(2011), 6 vom: 09. Apr., Seite 1439-1447 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:68 year:2011 number:6 day:09 month:04 pages:1439-1447 https://dx.doi.org/10.1007/s00280-011-1637-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 68 2011 6 09 04 1439-1447 |
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10.1007/s00280-011-1637-5 doi (DE-627)SPR003599922 (SPR)s00280-011-1637-5-e DE-627 ger DE-627 rakwb eng Leal, Ticiana B. verfasserin aut Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer-Verlag 2011 Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. Renal function (dpeaa)DE-He213 Bortezomib (dpeaa)DE-He213 Toxicity (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Pharmacodynamics (dpeaa)DE-He213 Remick, Scot C. aut Takimoto, Chris H. aut Ramanathan, Ramesh K. aut Davies, Angela aut Egorin, Merrill J. aut Hamilton, Anne aut LoRusso, Patricia A. aut Shibata, Stephen aut Lenz, Heinz-Josef aut Mier, James aut Sarantopoulos, John aut Mani, Sridhar aut Wright, John J. aut Ivy, S. Percy aut Neuwirth, Rachel aut von Moltke, Lisa aut Venkatakrishnan, Karthik aut Mulkerin, Daniel aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 68(2011), 6 vom: 09. Apr., Seite 1439-1447 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:68 year:2011 number:6 day:09 month:04 pages:1439-1447 https://dx.doi.org/10.1007/s00280-011-1637-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 68 2011 6 09 04 1439-1447 |
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Enthalten in Cancer chemotherapy and pharmacology 68(2011), 6 vom: 09. Apr., Seite 1439-1447 volume:68 year:2011 number:6 day:09 month:04 pages:1439-1447 |
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Leal, Ticiana B. @@aut@@ Remick, Scot C. @@aut@@ Takimoto, Chris H. @@aut@@ Ramanathan, Ramesh K. @@aut@@ Davies, Angela @@aut@@ Egorin, Merrill J. @@aut@@ Hamilton, Anne @@aut@@ LoRusso, Patricia A. @@aut@@ Shibata, Stephen @@aut@@ Lenz, Heinz-Josef @@aut@@ Mier, James @@aut@@ Sarantopoulos, John @@aut@@ Mani, Sridhar @@aut@@ Wright, John J. @@aut@@ Ivy, S. Percy @@aut@@ Neuwirth, Rachel @@aut@@ von Moltke, Lisa @@aut@@ Venkatakrishnan, Karthik @@aut@@ Mulkerin, Daniel @@aut@@ |
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Leal, Ticiana B. |
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Leal, Ticiana B. misc Renal function misc Bortezomib misc Toxicity misc Pharmacokinetics misc Pharmacodynamics Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study |
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Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study Renal function (dpeaa)DE-He213 Bortezomib (dpeaa)DE-He213 Toxicity (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Pharmacodynamics (dpeaa)DE-He213 |
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misc Renal function misc Bortezomib misc Toxicity misc Pharmacokinetics misc Pharmacodynamics |
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Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study |
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Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study |
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Leal, Ticiana B. |
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Cancer chemotherapy and pharmacology |
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2011 |
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Leal, Ticiana B. Remick, Scot C. Takimoto, Chris H. Ramanathan, Ramesh K. Davies, Angela Egorin, Merrill J. Hamilton, Anne LoRusso, Patricia A. Shibata, Stephen Lenz, Heinz-Josef Mier, James Sarantopoulos, John Mani, Sridhar Wright, John J. Ivy, S. Percy Neuwirth, Rachel von Moltke, Lisa Venkatakrishnan, Karthik Mulkerin, Daniel |
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68 |
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Elektronische Aufsätze |
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Leal, Ticiana B. |
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10.1007/s00280-011-1637-5 |
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dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a national cancer institute organ dysfunction working group study |
| title_auth |
Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study |
| abstract |
Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. © Springer-Verlag 2011 |
| abstractGer |
Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. © Springer-Verlag 2011 |
| abstract_unstemmed |
Purpose To determine the toxicities, pharmacokinetics, pharmacodynamics, and maximum tolerated dose of bortezomib in patients with renal impairment and to develop dosing guidelines for such a patient population. Patients and Methods Sixty-two adult cancer patients received intravenous bortezomib at 0.7–1.5 mg/$ m^{2} $ on days 1, 4, 8, and 11 every 3 weeks. Patients were stratified by 24-h creatinine clearance (CrCl) normalized to body surface area (BSA) 1.73 $ m^{2} $ into five cohorts: normal renal function (≥60 ml/min/1.73 $ m^{2} $); mild dysfunction (40–59 ml/min/1.73 $ m^{2} $); moderate dysfunction (20–39 ml/min/1.73 $ m^{2} $); severe dysfunction (<20 ml/min/1.73 $ m^{2} $); and dialysis. Dose escalation was planned for the four cohorts with renal dysfunction. Plasma bortezomib concentrations and blood 20S proteasome inhibition were assayed. Results Bortezomib escalation to the standard 1.3 mg/$ m^{2} $ dose was well tolerated in all patients with CrCl ≥20 ml/min/1.73 $ m^{2} $; 0.7 mg/$ m^{2} $ was tolerated in three patients with severe renal dysfunction (<20 ml/min/1.73 $ m^{2} $). Bortezomib dose escalation was well tolerated in nine dialysis patients, including to 1.3 mg/$ m^{2} $ in four patients. Decreased CrCl did not affect bortezomib pharmacokinetics or pharmacodynamics. Bortezomib-related side-effects were neither more common nor severe in patients with renal dysfunction versus those with normal renal function. Conclusion Bortezomib 1.3 mg/$ m^{2} $ is well tolerated, and dose reductions are not necessary in patients with renal dysfunction. Extrapolation from clinical and pharmacologic data suggests patients with severe renal dysfunction, including dialysis patients, can receive bortezomib at the full dose established to be clinically effective in the general patient population. © Springer-Verlag 2011 |
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Dose-escalating and pharmacological study of bortezomib in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study |
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Remick, Scot C. Takimoto, Chris H. Ramanathan, Ramesh K. Davies, Angela Egorin, Merrill J. Hamilton, Anne LoRusso, Patricia A. Shibata, Stephen Lenz, Heinz-Josef Mier, James Sarantopoulos, John Mani, Sridhar Wright, John J. Ivy, S. Percy Neuwirth, Rachel von Moltke, Lisa Venkatakrishnan, Karthik Mulkerin, Daniel |
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Remick, Scot C. Takimoto, Chris H. Ramanathan, Ramesh K. Davies, Angela Egorin, Merrill J. Hamilton, Anne LoRusso, Patricia A. Shibata, Stephen Lenz, Heinz-Josef Mier, James Sarantopoulos, John Mani, Sridhar Wright, John J. Ivy, S. Percy Neuwirth, Rachel von Moltke, Lisa Venkatakrishnan, Karthik Mulkerin, Daniel |
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2024-07-03T20:32:34.348Z |
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| score |
7.398361 |