A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline.

A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline. Research Abstract Details 

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A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline. Abstract Text:

Ruey-Long Hong,Ching-Hung Lin,Tsu-Yi Chao,Woei-You Kao,Cheng-Hsu Wang,Ruey Kuen Hsieh,Wei-Shou Hwang,

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/m(2) and PTX 150 mg/m(2), administered intravenously once every 21 days. The dose of PLD was escalated in increments of 5 mg/m(2) until the MTD was reached, at which time the PTX was then increased in increments of 10 mg/m(2) 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/m(2) while PLD escalated from 30 mg/m(2). 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/m(2) and escalating doses of PTX starting at 160 mg/m(2). At PTX 170 mg/m(2) 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/m(2), respectively, administered every 3 weeks. The combination of PLD (30-35 mg/m(2)) and PTX (150-160 mg/m(2)) constitutes an active regimen with mild toxicity that merits further study.

A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline. Publishing Authors By Initials

RL Hong,CH Lin,TY Chao,WY Kao,CH Wang,RK Hsieh,WS Hwang,

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A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Cancer chemotherapy and pharmacology

VOLUME: 61

Page Numbers: 847-53

Journal Abbreviation: Cancer Chemother. Pharmacol.

ISSN: 0344-5704

DAY: 4

MONTH: 07

YEAR: 2007

A phase-I study evaluating the combination of pegylated liposomal doxorubicin and paclitaxel as salvage chemotherapy in metastatic breast cancer previously treated with anthracycline. Information

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LANGUAGE: eng

NlmUniqueID: 7806519

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AFFILIATION: Department of Oncology, National Taiwan University Hospital, No 7, Chung-Shan South Rd, Taipei, 10016, Taiwan, rlhong@ha.mc.ntu.edu.tw.

Country: Germany

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MEDLINETA: Cancer Chemother Pharmacol

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