A randomized phase 2 trial comparing 3-hour versus 96-hour infusion schedules of paclitaxel for the treatment of metastatic breast cancer Journal Article

Authors: Moulder, S. L.; Holmes, F. A.; Tolcher, A. W.; Thall, P.; Broglio, K.; Valero, V.; Buzdar, A. U.; Arbuck, S. G.; Seidman, A.; Hortobagyi, G. N.
Article Title: A randomized phase 2 trial comparing 3-hour versus 96-hour infusion schedules of paclitaxel for the treatment of metastatic breast cancer
Abstract: BACKGROUND: This study was performed to compare efficacy and toxicity profiles of paclitaxel using 3-hour versus 96-hour infusion schedules. METHODS: Patients with metastatic breast cancer (MBC) were randomly assigned to receive paclitaxel starting at a dose of 250 mg/m2 intravenously (iv) over 3 hours every 21 days or paclitaxel starting at a dose of 140 mg/m2 iv over 96 hours every 21 days. Stratification variables included number of prior chemotherapy regimens and previous response to anthracyclines. Response was assessed every 2 cycles using bidimensional measurements. Patients were allowed to cross over at disease progression or therapy intolerance. RESULTS: A total of 214 patients received therapy (107 patients per arm). Response rates were similar: 23.4% in the 3-hour arm and 29.9% in the 96-hour arm (P = .28). The median duration of response (8.9 months vs 5.7 months; P =.75) and progression-free survival (5.0 months vs 3.8 months; P = .17) slightly favored the 96-hour arm. Overall survival was slightly longer in the 3-hour arm (14.2 months vs 12.7 months; P = .57). One patient who crossed over to the 96-hour arm (N 1/4 18) developed a partial response; no response was noted with crossover to the 3-hour arm (N = 10). Myalgia/arthralgia and neuropathy were more frequent in the 3-hour arm, whereas mucositis, neutropenic fever/infection, and diarrhea were more common in the 96-hour arm. CONCLUSIONS: Paclitaxel given by 3-hour or 96-hour infusion was active in MBC. The 96-hour paclitaxel regimen did not significantly improve response or time to disease progression, was more cumbersome to administer, and was associated with greater myelosuppression (but less neuropathy and myalgia) compared with the 3-hour schedule. © 2010 American Cancer Society.
Keywords: adult; cancer chemotherapy; cancer survival; controlled study; aged; aged, 80 and over; disease-free survival; middle aged; survival rate; major clinical study; overall survival; clinical trial; fatigue; doxorubicin; cancer growth; diarrhea; paclitaxel; metastasis; progression free survival; controlled clinical trial; infection; sensory neuropathy; breast cancer; bone marrow suppression; mucosa inflammation; neuropathy; randomized controlled trial; stomatitis; thrombocytopenia; vomiting; myalgia; drug administration schedule; antineoplastic agents, phytogenic; drug resistance, neoplasm; breast neoplasms; arthralgia; asthenia; febrile neutropenia; dosage schedule comparison; neoplasm metastasis; drug dose regimen; metastatic breast cancer; infusions, intravenous; motor neuropathy; chemotherapy regimen; infusion schedule; toxicity profile; infusion rate
Journal Title: Cancer
Volume: 116
Issue: 4
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2010-02-15
Start Page: 814
End Page: 821
Language: English
DOI: 10.1002/cncr.24870
PUBMED: 20052721
PROVIDER: scopus
PMCID: PMC3806193
Notes: --- - "Export Date: 20 April 2011" - "CODEN: CANCA" - "Source: Scopus"
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  1. Andrew D Seidman
    254 Seidman