Phase II Study of Weekly Paclitaxel for Docetaxel-Resistant Metastatic Breast Cancer in Japan
Department of Surgical Oncology, Osaka University Graduate School of Medicine, 2-2 E10 Yamadaoka, Suita, Osaka, 565-0871, Japan.The Breast Journal (Impact Factor: 1.41). 11/2004; 10(6):509-13. DOI: 10.1111/j.1075-122X.2004.21555.x
The purpose of the study was to evaluate the efficacy of weekly paclitaxel (PTX) against metastatic breast cancer (MBC) that was resistant to docetaxel (DTX) given every 3 weeks. A multicenter phase II study was performed. Women with MBC resistant to DTX were eligible for enrollment. DTX resistance was defined as no tumor response to DTX and stable disease, partial response, or complete response to DTX preceding disease progression. PTX 80 mg/m(2) was administered over 1 hour once a week for 3 weeks per 4-week cycle. Among 47 enrolled patients, 46 patients were assessable for response and toxicity. The overall objective response rate (complete responses [CRs] and partial responses [PRs]) was 17.4% and overall clinical benefit rate (CRs, PRs, and stable disease >or=24 weeks) was 26.1%. The median time to progression was 11 weeks. There were a few severe hematologic toxicities related to the therapy, with grade 4 neutropenia (4.3%) and thrombocytopenia (2.2%). Grade 3 anaphylaxis and grade 3 neuropathy were observed in one patient (2.2%) each. The median delivered dose intensity was 77.6 mg/m(2)/week, 97.1% of the planned dose intensity. Weekly PTX has activity in patients with MBC resistant to DTX every 3 weeks.
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ABSTRACT: We conducted a multicenter phase II trial to determine the efficacy/safety of capecitabine and weekly paclitaxel, a combination with preclinical evidence of synergy, in patients with metastatic breast cancer (MBC) previously treated with a taxane. Eligibility criteria included measurable MBC, history of every-3-week taxane therapy (adjuvant or for MBC), and no previous taxane on a weekly basis, capecitabine, or infusional 5-fluorouracil. Patients received capecitabine 825 mg/m2 per dose orally twice daily (1650 mg/m2 per day) on days 1-14 and weekly paclitaxel 80 mg/m2 intravenously on days 1 and 8, followed by a 1-week rest period (every-3-week cycle) until progression or intolerable toxicity. Fifty-four women were treated, most with previous every-3-week taxane exposure as adjuvant therapy (n=43) rather than for MBC (n=11). The median number of delivered cycles was 7, with dose modifications in 30 patients. The intent-to-treat objective response rate (primary study endpoint) was 59% (95% confidence interval, 46%-72%), including 7 complete and 25 partial responses. Three patients had stable disease for>or=6 months, for a clinical benefit rate of 65% (95% confidence interval, 51%-76%). Median objective response duration, time to progression, and overall survival were 8.1 months, 8.4 months, and 21.6 months, respectively. Grade 3/4 treatment-related adverse events consisted of neutropenia (13%), anemia (2%), hand-foot skin reaction (20%), fatigue (7%), diarrhea (4%), nausea/vomiting (4%), and pain (2%). No patients developed grade 3/4 neuropathy. Capecitabine and weekly paclitaxel were highly active with acceptable tolerability in patients with MBC previously treated with a taxane, consistent with our recently published experience in taxane-naive women with MBC.Clinical Breast Cancer 03/2007; 7(6):465-70. DOI:10.3816/CBC.2007.n.003 · 2.11 Impact Factor
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ABSTRACT: The management of early breast cancer has evolved rapidly in recent years. Consequently, the range of first-line treatment options for metastatic breast cancer (MBC) is becoming increasingly complicated and therapy depends on a complex interaction of tumor, patient, and physician variables. Arguably one of the most important factors determining choice of first-line chemotherapy is prior adjuvant therapy. We have reviewed data from large, randomized clinical trials to identify the most effective regimens and help clinicians to select first-line treatment based on previous adjuvant therapy. In this review we provide recommendations on the most appropriate first-line therapy according to the type of previous adjuvant therapy. With such a wide array of treatment options available, none is likely to become the gold-standard first-line treatment for MBC. Furthermore, as increasing emphasis is placed on the quality as well as the duration of survival after development of MBC, treatment decisions should take into account tumor characteristics, toxicity, convenience, potential impact on quality of life, and patient preference, in addition to robust efficacy data.The Oncologist 08/2007; 12(7):785-97. DOI:10.1634/theoncologist.12-7-785 · 4.87 Impact Factor
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ABSTRACT: Epothilones are cytotoxic macrolides that share a similar mechanism of action with the taxanes but demonstrate antitumor activity in taxane-resistant settings. Six epothilones are in early clinical trials for cancer treatment. This review summarizes data from phase II clinical studies of the epothilones ixabepilone (BMS-247550), patupilone (EPO906), and KOS-862. Data were identified by searches of PubMed and of the proceedings of the American Society of Clinical Oncology annual meetings and the Federation of European Cancer Societies biennial conference for the period 2000-2006. Studies were included if safety and efficacy data were available for at least 10 patients with a given tumor type in a standard phase II design. Epothilones have demonstrated activity in lung, ovarian, breast, prostate, and renal carcinomas and in non-Hodgkin's lymphoma in phase II studies. Little or no evidence of clinical activity has been reported in studies of epothilones in other tumor types. Preliminary data indicate that epothilones can be combined safely with other cytotoxic agents such as carboplatin. The epothilones may play a role as an alternative to taxanes if activity in resistant settings can be confirmed together with an acceptable toxicity profile. Randomized studies are awaited to investigate the utility of epothilones in single-agent and combination regimens.Annals of Oncology 08/2007; 18 Suppl 5(Suppl 5):v28-34. DOI:10.1093/annonc/mdm176 · 7.04 Impact Factor
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