{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T01:16:04Z","timestamp":1778634964901,"version":"3.51.4"},"reference-count":25,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2013,5,14]],"date-time":"2013-05-14T00:00:00Z","timestamp":1368489600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"published-print":{"date-parts":[[2014,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Limited clinical data are available regarding the safety of docetaxel in metastatic breast cancer patients with liver dysfunction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Eligible patients had breast cancer with impaired liver function secondary to hepatic metastases and were candidates for docetaxel therapy. They were assigned to one of five groups on the basis of total bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase levels. All other causes of liver dysfunction were excluded, and bile duct obstruction was corrected, if possible, prior to study entry. Patients received docetaxel every three weeks. The chemotherapy dose was chosen on the basis of the patient\u2019s level of hepatic dysfunction and escalated as tolerated. The primary outcome of this study was safety. The secondary outcomes were pharmacokinetic data and efficacy in terms of time to disease progression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Twenty-three patients were enrolled. No unexpected toxicities occurred. Grade 3\/4 fatigue (65%), neutropenia (30%), myalgias (26%), neutropenic fever (26%), vomiting (9%), and rash (9%) were the most common serious adverse events. The median time to progression was three months (range 1\u201318 months). Pharmacokinetic results indicated that patients with more severe hepatic dysfunction may have been underdosed based on our conservative dosing strategy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Docetaxel can be administered to patients with metastatic breast cancer and liver dysfunction after dose attenuation. However, because of a narrow therapeutic index in this clinical setting, therapy should be closely monitored with subsequent dose escalation when possible.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/1078155213480536","type":"journal-article","created":{"date-parts":[[2013,5,15]],"date-time":"2013-05-15T20:49:05Z","timestamp":1368650945000},"page":"120-129","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Pilot study to assess toxicity and pharmacokinetics of docetaxel in patients with metastatic breast cancer and impaired liver function secondary to hepatic metastases"],"prefix":"10.1177","volume":"20","author":[{"given":"Karen","family":"Eckmann","sequence":"first","affiliation":[{"name":"Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura B","family":"Michaud","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edgardo","family":"Rivera","sequence":"additional","affiliation":[{"name":"Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Banner MD Anderson Cancer Center, Gilbert, AZ, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy L","family":"Madden","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Experimental Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Esparza-Guerra","sequence":"additional","affiliation":[{"name":"Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; U.S. Oncology, The Woodlands, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jitesh","family":"Kawedia","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel J","family":"Booser","sequence":"additional","affiliation":[{"name":"Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marjorie C","family":"Green","sequence":"additional","affiliation":[{"name":"Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabriel N","family":"Hortobagyi","sequence":"additional","affiliation":[{"name":"Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicente","family":"Valero","sequence":"additional","affiliation":[{"name":"Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2013,5,14]]},"reference":[{"key":"bibr1-1078155213480536","first-page":"1030","volume-title":"Diseases of the breast","author":"Miksad R","year":"2009","edition":"4"},{"key":"bibr2-1078155213480536","first-page":"303","volume":"167","author":"Cheidozi LC","year":"1988","journal-title":"Surg Gynecol Obstet"},{"key":"bibr3-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2010-0350"},{"key":"bibr4-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1097\/PPO.0b013e3181629a7b"},{"key":"bibr5-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-005-9117-4"},{"key":"bibr6-1078155213480536","first-page":"94","volume":"12","author":"Holmes FA","year":"1993","journal-title":"Proc Am Soc Clin Oncol"},{"key":"bibr7-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1993.11.10.1943"},{"key":"bibr8-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1995.13.12.2886"},{"key":"bibr9-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.annonc.a010544"},{"key":"bibr10-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(05)70094-2"},{"key":"bibr11-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.10.3362"},{"key":"bibr12-1078155213480536","first-page":"139","volume":"13","author":"Venook AP","year":"1994","journal-title":"Proc Am Soc Clin Oncol"},{"key":"bibr13-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.5.1811"},{"key":"bibr14-1078155213480536","volume-title":"Paclitaxel (package insert)","author":"Bristol-Myers Squibb Co","year":"2011"},{"key":"bibr15-1078155213480536","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1998.16.1.187"},{"key":"bibr16-1078155213480536","unstructured":"Sanofi-Aventis.\n                      Taxotere\n                      \u00ae (\n                      package insert\n                      ). 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