Randomized Crossover Pharmacokinetic Study of Solvent-Based Paclitaxel and nab-Paclitaxel
Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound ( nab ) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; T...
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| Published in | Clinical cancer research Vol. 14; no. 13; pp. 4200 - 4205 |
|---|---|
| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Philadelphia, PA
American Association for Cancer Research
01.07.2008
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 1078-0432 1557-3265 |
| DOI | 10.1158/1078-0432.CCR-07-4592 |
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| Abstract | Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound ( nab ) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation
alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol),
and leads to improved tolerability of the drug.
Patients and Methods: Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab -paclitaxel (260 mg/m 2 as a 30-minute infusion) or sb-paclitaxel (175 mg/m 2 as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried
out for the first cycle of sb-paclitaxel and the first two cycles of nab -paclitaxel.
Results: Seventeen patients were treated, with 14 receiving at least one cycle each of nab -paclitaxel and sb-paclitaxel. No change in nab -paclitaxel pharmacokinetics was found between the first and second cycles ( P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations ( P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab -paclitaxel administration, due to the increased free fraction (0.063 ± 0.021 versus 0.024 ± 0.009; P < 0.001).
Conclusion: This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because
systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least
in part, previous observations that the administration of nab -paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel. |
|---|---|
| AbstractList | Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug.PURPOSEAbraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug.Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m(2) as a 30-minute infusion) or sb-paclitaxel (175 mg/m(2) as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel.PATIENTS AND METHODSPatients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m(2) as a 30-minute infusion) or sb-paclitaxel (175 mg/m(2) as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel.Seventeen patients were treated, with 14 receiving at least one cycle each of nab-paclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 +/- 0.021 versus 0.024 +/- 0.009; P < 0.001).RESULTSSeventeen patients were treated, with 14 receiving at least one cycle each of nab-paclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 +/- 0.021 versus 0.024 +/- 0.009; P < 0.001).This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel.CONCLUSIONThis study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel. Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound ( nab ) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug. Patients and Methods: Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab -paclitaxel (260 mg/m 2 as a 30-minute infusion) or sb-paclitaxel (175 mg/m 2 as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab -paclitaxel. Results: Seventeen patients were treated, with 14 receiving at least one cycle each of nab -paclitaxel and sb-paclitaxel. No change in nab -paclitaxel pharmacokinetics was found between the first and second cycles ( P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations ( P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab -paclitaxel administration, due to the increased free fraction (0.063 ± 0.021 versus 0.024 ± 0.009; P < 0.001). Conclusion: This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab -paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel. Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug. Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m(2) as a 30-minute infusion) or sb-paclitaxel (175 mg/m(2) as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel. Seventeen patients were treated, with 14 receiving at least one cycle each of nab-paclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 +/- 0.021 versus 0.024 +/- 0.009; P < 0.001). This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel. Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug. Patients and Methods: Patients with malignant solid tumors were randomized to receive the recommended single-agent dose of nab-paclitaxel (260 mg/m2 as a 30-minute infusion) or sb-paclitaxel (175 mg/m2 as a 3-hour infusion). After cycle 1, patients crossed over to the alternate treatment. Pharmacokinetic studies were carried out for the first cycle of sb-paclitaxel and the first two cycles of nab-paclitaxel. Results: Seventeen patients were treated, with 14 receiving at least one cycle each of nab-paclitaxel and sb-paclitaxel. No change in nab-paclitaxel pharmacokinetics was found between the first and second cycles (P = 0.95), suggesting limited intrasubject variability. Total drug exposure was comparable between the two formulations (P = 0.55) despite the dose difference. However, exposure to unbound paclitaxel was significantly higher after nab-paclitaxel administration, due to the increased free fraction (0.063 ± 0.021 versus 0.024 ± 0.009; P < 0.001). Conclusion: This study shows that paclitaxel disposition is subject to considerable variability depending on the formulation used. Because systemic exposure to unbound paclitaxel is likely a driving force behind tumoral uptake, these findings explain, at least in part, previous observations that the administration of nab-paclitaxel is associated with augmented antitumor efficacy compared with solvent-based paclitaxel. |
| Author | Michael J. Hawkins Jacquin Jones Neil Desai William L. Dahut Erin R. Gardner Jeanny B. Aragon-Ching William D. Figg Charity D. Scripture Alex Sparreboom |
| AuthorAffiliation | 3 Abraxis BioScience, Inc., Los Angeles, CA, 90025 1 Clinical Pharmacology Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, MD, 21702 2 Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892 |
| AuthorAffiliation_xml | – name: 2 Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, 20892 – name: 3 Abraxis BioScience, Inc., Los Angeles, CA, 90025 – name: 1 Clinical Pharmacology Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, MD, 21702 |
| Author_xml | – sequence: 1 givenname: Erin R surname: GARDNER fullname: GARDNER, Erin R organization: Clinical Pharmacology Program, Science Applications International Corporation-Frederick, Inc., National Cancer Institute-Frederick, Frederick, Maryland, United States – sequence: 2 givenname: William L surname: DAHUT fullname: DAHUT, William L organization: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, United States – sequence: 3 givenname: Charity D surname: SCRIPTURE fullname: SCRIPTURE, Charity D organization: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, United States – sequence: 4 givenname: Jacquin surname: JONES fullname: JONES, Jacquin organization: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, United States – sequence: 5 givenname: Jeanny B surname: ARAGON-CHING fullname: ARAGON-CHING, Jeanny B organization: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, United States – sequence: 6 givenname: Neil surname: DESAI fullname: DESAI, Neil organization: Abraxis BioScience, Inc, Los Angeles, California, United States – sequence: 7 givenname: Michael J surname: HAWKINS fullname: HAWKINS, Michael J organization: Abraxis BioScience, Inc, Los Angeles, California, United States – sequence: 8 givenname: Alex surname: SPARREBOOM fullname: SPARREBOOM, Alex organization: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, United States – sequence: 9 givenname: William D surname: FIGG fullname: FIGG, William D organization: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, United States |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20748242$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/18594000$$D View this record in MEDLINE/PubMed |
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| Keywords | Antineoplastic agent Organic solvent Randomization Taxane derivatives Paclitaxel Pharmacokinetics Antimitotic Crossover study |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Current Address: Hawkins Oncology Associates, Marina Del Ray, CA. Current Address: Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee, 38105. |
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| PublicationTitle | Clinical cancer research |
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| Publisher | American Association for Cancer Research |
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| Snippet | Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound ( nab ) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that... Purpose: Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this... Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in... |
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| SubjectTerms | Adult Aged Albumins - pharmacokinetics Albumins - therapeutic use anoparticle Antineoplastic agents Antineoplastic Agents, Phytogenic - pharmacokinetics Biological and medical sciences Breast Neoplasms - drug therapy Carcinoma - drug therapy Cross-Over Studies Fallopian Tube Neoplasms - drug therapy Female Humans Male Medical sciences Middle Aged Ovarian Neoplasms - drug therapy Paclitaxel - pharmacokinetics Paclitaxel - therapeutic use pharmacokinetics Pharmacology. Drug treatments Prostatic Neoplasms - drug therapy Solvents - chemistry taxane |
| Title | Randomized Crossover Pharmacokinetic Study of Solvent-Based Paclitaxel and nab-Paclitaxel |
| URI | http://clincancerres.aacrjournals.org/content/14/13/4200.abstract https://www.ncbi.nlm.nih.gov/pubmed/18594000 https://www.proquest.com/docview/69288564 https://pubmed.ncbi.nlm.nih.gov/PMC2661025 |
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