{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:19:32Z","timestamp":1790209172909,"version":"4.1.0"},"reference-count":0,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[1995,4]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Since liposomal encapsulation of anticancer drugs may enhance antitumor activity while reducing toxicity in vitro, we evaluated liposomally encapsulated daunorubucin (DaunoXome; Vestar, Inc, San Dimas, CA) for safety, pharmacokinetics, and potential efficacy in patients with AIDS-related Kaposi's sarcoma (AIDS-KS). <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> Forty patients with advanced AIDS-KS were accrued. Successive cohorts received DaunoXome at doses of 10, 20, 30, and 40 mg\/m2 given once every 3 weeks, and 40, 50, and 60 mg\/m2 given once every 2 weeks. Selected KS and solid-tumor patients underwent pharmacokinetic evaluation. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> The area under the plasma concentration curve (AUC) ranged from 16.9 micrograms.h\/mL to 375.3 micrograms.\/mL and the alpha half-life ranged from 7.8 to 8.3 hours at 10 mg\/m2 to 60 mg\/m2, respectively. Both pharmacokinetic profiles were significantly better compared with free daunorubicin. DaunoXome was well tolerated with no significant alopecia, mucositis, or vomiting. Neutropenia (&lt; 1,000\/microL occurred in 17% of cycles and was severe (&lt; 500\/microL) in only 2%. Anemia and thrombocytopenia were uncommon. Other adverse events included mild to moderate fatigue, nausea, and diarrhea. Even after cumulative doses greater than 1,000 mg\/m2, no significant declines in cardiac function were observed. Twenty-two patients who received 50 and 60 mg\/m2 were assessable for tumor response; 12 (55%) had a partial response (PR) or clinical complete response (CR). The median survival duration in all patients was 9 months. Prognostic factors for short survival were low CD4 lymphocyte counts (P = .004) and prior anthracycline therapy (P = .02). <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> DaunoXome has an improved pharmacokinetic profile compared with free daunorubicin, and is well tolerated. DaunoXome can be given safely at doses up to 60 mg\/m2 every 2 weeks and has significant antitumor activity in patients with AIDS-KS. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.1995.13.4.996","type":"journal-article","created":{"date-parts":[[2017,2,23]],"date-time":"2017-02-23T13:06:40Z","timestamp":1487855200000},"page":"996-1003","source":"Crossref","is-referenced-by-count":198,"title":["Phase I\/II clinical and pharmacokinetic evaluation of liposomal daunorubicin."],"prefix":"10.1200","volume":"13","author":[{"given":"P S","family":"Gill","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B M","family":"Espina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F","family":"Muggia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Cabriales","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Tulpule","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J A","family":"Esplin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H A","family":"Liebman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E","family":"Forssen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M E","family":"Ross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A M","family":"Levine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.1995.13.4.996","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T19:55:16Z","timestamp":1653508516000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.1995.13.4.996"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1995,4]]},"references-count":0,"journal-issue":{"issue":"4","published-print":{"date-parts":[[1995,4]]}},"alternative-id":["10.1200\/JCO.1995.13.4.996"],"URL":"https:\/\/doi.org\/10.1200\/jco.1995.13.4.996","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[1995,4]]}}}