https://scholars.lib.ntu.edu.tw/handle/123456789/551254
標題: | A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline | 作者: | RUEY-LONG HONG CHING-HUNG LIN Chao T.-Y. Kao W.-Y. Wang C.-H. Hsieh R.K. Hwang W.-S. |
公開日期: | 2008 | 卷: | 61 | 期: | 5 | 起(迄)頁: | 847-853 | 來源出版物: | Cancer Chemotherapy and Pharmacology | 摘要: | Purpose: The two main goals of this phase-I study were to determine the maximum-tolerated dose (MTD) and to characterize the toxicity of the combination of pegylated liposomal doxorubicin (PLD; Lipo-Dox) and paclitaxel (PTX) administered on a 3-week schedule in patients with metastatic breast cancer (MBC) who had previously been treated with anthracycline-based therapy. Methods: This phase-I study was performed via a two-staged dose escalation schema. The initial doses were PLD 30 mg/m2 and PTX 150 mg/m2, administered intravenously once every 21 days. The dose of PLD was escalated in increments of 5 mg/m2 until the MTD was reached, at which time the PTX was then increased in increments of 10 mg/m2 until the MTD was reached. Results: Twenty-three patients received between 1 and 13 treatment cycles. In stage I of the study, 14 patients received a fixed dose of PTX 150 mg/m2 while PLD escalated from 30 mg/m2. At 40 mg/m 2, PLD resulted in dose-limiting toxicities (DLT) including febrile neutropenia and palmar-plantar erythrodysesthesia that occurred in two of five patients. In stage II of the study, nine patients received fixed dose of PLD 35 mg/m2 and escalating doses of PTX starting at 160 mg/m2. At PTX 170 mg/m2 and dose-limiting neutropenic fever occurred in two of five patients. Out of 19 evaluable patients, 10 (52.6%) achieved objective response (one complete response and nine partial response), and 5 had stable disease. Conclusions: The maximal tolerated doses of PLD and PTX are 35 and 160 mg/m2, respectively, administered every 3 weeks. The combination of PLD (30-35 mg/m2) and PTX (150-160 mg/m2) constitutes an active regimen with mild toxicity that merits further study. ? 2007 Springer-Verlag. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-39749160998&doi=10.1007%2fs00280-007-0542-4&partnerID=40&md5=a4fcb802044a037c3fd07e0f9dd50e4e https://scholars.lib.ntu.edu.tw/handle/123456789/551254 |
ISSN: | 0344-5704 | DOI: | 10.1007/s00280-007-0542-4 | SDG/關鍵字: | anthracycline; cimetidine; cyclophosphamide; dexamethasone; diphenhydramine; doxorubicin; epirubicin; fluorouracil; paclitaxel; adult; aged; alanine aminotransferase blood level; anemia; article; aspartate aminotransferase blood level; asthenia; breast cancer; breast metastasis; cancer chemotherapy; cancer survival; clinical article; clinical trial; diarrhea; drug dose escalation; drug dose increase; drug dose reduction; drug hypersensitivity; drug megadose; edema; febrile neutropenia; female; hand foot syndrome; human; maximum tolerated dose; multicenter study; multiple cycle treatment; nausea and vomiting; neutropenia; phase 1 clinical trial; priority journal; salvage therapy; sensory neuropathy; side effect; stomatitis; thrombocytopenia; treatment response; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Doxorubicin; Drug Administration Schedule; Female; Fever; Foot Dermatoses; Hand Dermatoses; Humans; Liposomes; Maximum Tolerated Dose; Middle Aged; Neoplasm Metastasis; Neutropenia; Paclitaxel; Paresthesia; Polyethylene Glycols; Salvage Therapy; Treatment Outcome |
顯示於: | 腫瘤醫學研究所 |
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