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Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients
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| Zeitschriftentitel: | Clinical Cancer Research |
|---|---|
| Personen und Körperschaften: | , , , , |
| In: | Clinical Cancer Research, 15, 2009, 1, S. 346-354 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
American Association for Cancer Research (AACR)
|
| Schlagwörter: |
| author_facet |
Latz, Jane E. Schneck, Karen Lee Nakagawa, Kazuhiko Miller, Mary Alice Takimoto, Chris H. Latz, Jane E. Schneck, Karen Lee Nakagawa, Kazuhiko Miller, Mary Alice Takimoto, Chris H. |
|---|---|
| author |
Latz, Jane E. Schneck, Karen Lee Nakagawa, Kazuhiko Miller, Mary Alice Takimoto, Chris H. |
| spellingShingle |
Latz, Jane E. Schneck, Karen Lee Nakagawa, Kazuhiko Miller, Mary Alice Takimoto, Chris H. Clinical Cancer Research Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients Cancer Research Oncology |
| author_sort |
latz, jane e. |
| spelling |
Latz, Jane E. Schneck, Karen Lee Nakagawa, Kazuhiko Miller, Mary Alice Takimoto, Chris H. 1078-0432 1557-3265 American Association for Cancer Research (AACR) Cancer Research Oncology http://dx.doi.org/10.1158/1078-0432.ccr-08-0791 <jats:title>Abstract</jats:title> <jats:p>Purpose: The objectives of the analysis were to characterize the time course of neutropenia after pemetrexed administration using an established semimechanistic-physiologic model, characterize the relationship between pemetrexed exposure and neutropenia, and describe differences in neutropenic response by vitamin supplementation status and between Japanese and Western patients.</jats:p> <jats:p>Experimental Design: An eight-compartment population pharmacokinetic/pharmacodynamic model was used to describe the absolute neutrophil count (ANC)-time profile (neutropenic response) following pemetrexed doses of 300 to 1,400 mg/m2 administered every 21 days. The analyses pooled data from 13 studies including 279 patients (161 supplemented with oral folic acid and intramuscular vitamin B12, and 118 unsupplemented; 248 Western and 31 Japanese) who received 857 treatment cycles.</jats:p> <jats:p>Results: Vitamin supplementation status, ethnic origin, and drug exposure were the dominant predictors of neutropenic response. Vitamin supplementation diminishes neutropenic response to pemetrexed. Model-predicted ANC nadirs for the “typical” Western patient receiving 500 mg/m2 pemetrexed ± vitamin supplementation were 2.74 × 109/L and 1.70 × 109/L, respectively. Japanese patients had a less pronounced neutropenic response to pemetrexed relative to Western patients. The model-predicted ANC nadir for Japanese patients receiving 500 mg/m2 pemetrexed with vitamin supplementation was 2.66 × 109/L. Values for the 1,000 mg/m2 dose with vitamin supplementation were 1.91 × 109/L and 1.34 × 109/L for Japanese and Western patients, respectively. Increased albumin, decreased cystathionine, and decreased body surface area were also associated with increased neutropenic response.</jats:p> <jats:p>Conclusions: The neutropenic response to higher pemetrexed doses administered with vitamin supplementation is tolerable. All other factors equal, Japanese patients have a lesser neutropenic response to pemetrexed relative to Western patients.</jats:p> Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients Clinical Cancer Research |
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10.1158/1078-0432.ccr-08-0791 |
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American Association for Cancer Research (AACR), 2009 |
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American Association for Cancer Research (AACR), 2009 |
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1078-0432 1557-3265 |
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| title |
Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_unstemmed |
Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_full |
Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_fullStr |
Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_full_unstemmed |
Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_short |
Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_sort |
population pharmacokinetic/pharmacodynamic analyses of pemetrexed and neutropenia: effect of vitamin supplementation and differences between japanese and western patients |
| topic |
Cancer Research Oncology |
| url |
http://dx.doi.org/10.1158/1078-0432.ccr-08-0791 |
| publishDate |
2009 |
| physical |
346-354 |
| description |
<jats:title>Abstract</jats:title>
<jats:p>Purpose: The objectives of the analysis were to characterize the time course of neutropenia after pemetrexed administration using an established semimechanistic-physiologic model, characterize the relationship between pemetrexed exposure and neutropenia, and describe differences in neutropenic response by vitamin supplementation status and between Japanese and Western patients.</jats:p>
<jats:p>Experimental Design: An eight-compartment population pharmacokinetic/pharmacodynamic model was used to describe the absolute neutrophil count (ANC)-time profile (neutropenic response) following pemetrexed doses of 300 to 1,400 mg/m2 administered every 21 days. The analyses pooled data from 13 studies including 279 patients (161 supplemented with oral folic acid and intramuscular vitamin B12, and 118 unsupplemented; 248 Western and 31 Japanese) who received 857 treatment cycles.</jats:p>
<jats:p>Results: Vitamin supplementation status, ethnic origin, and drug exposure were the dominant predictors of neutropenic response. Vitamin supplementation diminishes neutropenic response to pemetrexed. Model-predicted ANC nadirs for the “typical” Western patient receiving 500 mg/m2 pemetrexed ± vitamin supplementation were 2.74 × 109/L and 1.70 × 109/L, respectively. Japanese patients had a less pronounced neutropenic response to pemetrexed relative to Western patients. The model-predicted ANC nadir for Japanese patients receiving 500 mg/m2 pemetrexed with vitamin supplementation was 2.66 × 109/L. Values for the 1,000 mg/m2 dose with vitamin supplementation were 1.91 × 109/L and 1.34 × 109/L for Japanese and Western patients, respectively. Increased albumin, decreased cystathionine, and decreased body surface area were also associated with increased neutropenic response.</jats:p>
<jats:p>Conclusions: The neutropenic response to higher pemetrexed doses administered with vitamin supplementation is tolerable. All other factors equal, Japanese patients have a lesser neutropenic response to pemetrexed relative to Western patients.</jats:p> |
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| author | Latz, Jane E., Schneck, Karen Lee, Nakagawa, Kazuhiko, Miller, Mary Alice, Takimoto, Chris H. |
| author_facet | Latz, Jane E., Schneck, Karen Lee, Nakagawa, Kazuhiko, Miller, Mary Alice, Takimoto, Chris H., Latz, Jane E., Schneck, Karen Lee, Nakagawa, Kazuhiko, Miller, Mary Alice, Takimoto, Chris H. |
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| description | <jats:title>Abstract</jats:title> <jats:p>Purpose: The objectives of the analysis were to characterize the time course of neutropenia after pemetrexed administration using an established semimechanistic-physiologic model, characterize the relationship between pemetrexed exposure and neutropenia, and describe differences in neutropenic response by vitamin supplementation status and between Japanese and Western patients.</jats:p> <jats:p>Experimental Design: An eight-compartment population pharmacokinetic/pharmacodynamic model was used to describe the absolute neutrophil count (ANC)-time profile (neutropenic response) following pemetrexed doses of 300 to 1,400 mg/m2 administered every 21 days. The analyses pooled data from 13 studies including 279 patients (161 supplemented with oral folic acid and intramuscular vitamin B12, and 118 unsupplemented; 248 Western and 31 Japanese) who received 857 treatment cycles.</jats:p> <jats:p>Results: Vitamin supplementation status, ethnic origin, and drug exposure were the dominant predictors of neutropenic response. Vitamin supplementation diminishes neutropenic response to pemetrexed. Model-predicted ANC nadirs for the “typical” Western patient receiving 500 mg/m2 pemetrexed ± vitamin supplementation were 2.74 × 109/L and 1.70 × 109/L, respectively. Japanese patients had a less pronounced neutropenic response to pemetrexed relative to Western patients. The model-predicted ANC nadir for Japanese patients receiving 500 mg/m2 pemetrexed with vitamin supplementation was 2.66 × 109/L. Values for the 1,000 mg/m2 dose with vitamin supplementation were 1.91 × 109/L and 1.34 × 109/L for Japanese and Western patients, respectively. Increased albumin, decreased cystathionine, and decreased body surface area were also associated with increased neutropenic response.</jats:p> <jats:p>Conclusions: The neutropenic response to higher pemetrexed doses administered with vitamin supplementation is tolerable. All other factors equal, Japanese patients have a lesser neutropenic response to pemetrexed relative to Western patients.</jats:p> |
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| imprint | American Association for Cancer Research (AACR), 2009 |
| imprint_str_mv | American Association for Cancer Research (AACR), 2009 |
| institution | DE-Bn3, DE-Brt1, DE-Zwi2, DE-D161, DE-Gla1, DE-Zi4, DE-15, DE-Pl11, DE-Rs1, DE-105, DE-14, DE-Ch1, DE-L229, DE-D275 |
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| language | English |
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| physical | 346-354 |
| publishDate | 2009 |
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| publisher | American Association for Cancer Research (AACR) |
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| series | Clinical Cancer Research |
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| spelling | Latz, Jane E. Schneck, Karen Lee Nakagawa, Kazuhiko Miller, Mary Alice Takimoto, Chris H. 1078-0432 1557-3265 American Association for Cancer Research (AACR) Cancer Research Oncology http://dx.doi.org/10.1158/1078-0432.ccr-08-0791 <jats:title>Abstract</jats:title> <jats:p>Purpose: The objectives of the analysis were to characterize the time course of neutropenia after pemetrexed administration using an established semimechanistic-physiologic model, characterize the relationship between pemetrexed exposure and neutropenia, and describe differences in neutropenic response by vitamin supplementation status and between Japanese and Western patients.</jats:p> <jats:p>Experimental Design: An eight-compartment population pharmacokinetic/pharmacodynamic model was used to describe the absolute neutrophil count (ANC)-time profile (neutropenic response) following pemetrexed doses of 300 to 1,400 mg/m2 administered every 21 days. The analyses pooled data from 13 studies including 279 patients (161 supplemented with oral folic acid and intramuscular vitamin B12, and 118 unsupplemented; 248 Western and 31 Japanese) who received 857 treatment cycles.</jats:p> <jats:p>Results: Vitamin supplementation status, ethnic origin, and drug exposure were the dominant predictors of neutropenic response. Vitamin supplementation diminishes neutropenic response to pemetrexed. Model-predicted ANC nadirs for the “typical” Western patient receiving 500 mg/m2 pemetrexed ± vitamin supplementation were 2.74 × 109/L and 1.70 × 109/L, respectively. Japanese patients had a less pronounced neutropenic response to pemetrexed relative to Western patients. The model-predicted ANC nadir for Japanese patients receiving 500 mg/m2 pemetrexed with vitamin supplementation was 2.66 × 109/L. Values for the 1,000 mg/m2 dose with vitamin supplementation were 1.91 × 109/L and 1.34 × 109/L for Japanese and Western patients, respectively. Increased albumin, decreased cystathionine, and decreased body surface area were also associated with increased neutropenic response.</jats:p> <jats:p>Conclusions: The neutropenic response to higher pemetrexed doses administered with vitamin supplementation is tolerable. All other factors equal, Japanese patients have a lesser neutropenic response to pemetrexed relative to Western patients.</jats:p> Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients Clinical Cancer Research |
| spellingShingle | Latz, Jane E., Schneck, Karen Lee, Nakagawa, Kazuhiko, Miller, Mary Alice, Takimoto, Chris H., Clinical Cancer Research, Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients, Cancer Research, Oncology |
| title | Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_full | Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_fullStr | Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_full_unstemmed | Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_short | Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| title_sort | population pharmacokinetic/pharmacodynamic analyses of pemetrexed and neutropenia: effect of vitamin supplementation and differences between japanese and western patients |
| title_unstemmed | Population Pharmacokinetic/Pharmacodynamic Analyses of Pemetrexed and Neutropenia: Effect of Vitamin Supplementation and Differences between Japanese and Western Patients |
| topic | Cancer Research, Oncology |
| url | http://dx.doi.org/10.1158/1078-0432.ccr-08-0791 |