TY - JOUR
T1 - Dose-dense therapy with weekly 1-hour paclitaxel infusions in the treatment of metastatic breast cancer
AU - Seidman, Andrew D.
AU - Hudis, Clifford A.
AU - Albanell, Juan
AU - Albanel, J.
AU - Tong, William
AU - Tepler, Isidore
AU - Currie, Violante
AU - Moynahan, Mary Ellen
AU - Theodoulou, Maria
AU - Gollub, Mark
AU - Baselga, José
AU - Norton, Larry
PY - 1998/10
Y1 - 1998/10
N2 - Purpose: To evaluate the efficacy and toxicity of paclitaxel administered as a 1 -hour infusion on weekly basis, without interruption, to patients with metastatic breast cancer who had received prior therapy. Patients and Methods: Thirty patients with metastatic breast cancer received sustained weekly paclitaxel therapy at an initial dose of 100 mg/m2 until disease progression. Prior therapy included adjuvant only (n = 17), metastatic only (n = 7), or both (n = 6). Eighteen patients had received prior anthracycline therapy, 12 of whom had demonstrated progression of disease within 12 months of it. All patients were assessable for efficacy; 29 patients were assessable far toxicity. Pharmacokinetic studies of paclitaxel were also performed. Results: A total of 469 weekly paclitaxel infusions were administered to 30 patients (median, 14 infusions/patient). The median delivered dose-intensity was 91 mg/m2/wk (range, 80 to 108). The overall response rate was 53% (95% confidence interval [Cl], 34% to 72%), with 10% complete responses (CRs) and 43% partial responses (PRs). Median response duration was 7.5 months (range, 2 to 11+). Responses were observed in nine of 18 (50%) patients with prior anthracycline therapy, including six of 12 (50%) with disease progression on anthracycline within 1 year (three of four within 6 months). Therapy was well tolerated and remarkable for a lack of overall and cumulative myelosuppression. Grade 3/4 neutropenia occurred in four patients; febrile neutropenia was not observed. Peripheral neuropathy prohibited dose escalation above 100 mg/m2, and grade 3 neuropathy was observed in two of 21 patients at ≤ 100 mg/m2. Conclusion: Weekly paclitaxel therapy is active and well tolerated in patients with metastatic breast cancer. Weekly therapy should be considered as a current clinical option for these patients and should be incorporated into future comparative clinical trials.
AB - Purpose: To evaluate the efficacy and toxicity of paclitaxel administered as a 1 -hour infusion on weekly basis, without interruption, to patients with metastatic breast cancer who had received prior therapy. Patients and Methods: Thirty patients with metastatic breast cancer received sustained weekly paclitaxel therapy at an initial dose of 100 mg/m2 until disease progression. Prior therapy included adjuvant only (n = 17), metastatic only (n = 7), or both (n = 6). Eighteen patients had received prior anthracycline therapy, 12 of whom had demonstrated progression of disease within 12 months of it. All patients were assessable for efficacy; 29 patients were assessable far toxicity. Pharmacokinetic studies of paclitaxel were also performed. Results: A total of 469 weekly paclitaxel infusions were administered to 30 patients (median, 14 infusions/patient). The median delivered dose-intensity was 91 mg/m2/wk (range, 80 to 108). The overall response rate was 53% (95% confidence interval [Cl], 34% to 72%), with 10% complete responses (CRs) and 43% partial responses (PRs). Median response duration was 7.5 months (range, 2 to 11+). Responses were observed in nine of 18 (50%) patients with prior anthracycline therapy, including six of 12 (50%) with disease progression on anthracycline within 1 year (three of four within 6 months). Therapy was well tolerated and remarkable for a lack of overall and cumulative myelosuppression. Grade 3/4 neutropenia occurred in four patients; febrile neutropenia was not observed. Peripheral neuropathy prohibited dose escalation above 100 mg/m2, and grade 3 neuropathy was observed in two of 21 patients at ≤ 100 mg/m2. Conclusion: Weekly paclitaxel therapy is active and well tolerated in patients with metastatic breast cancer. Weekly therapy should be considered as a current clinical option for these patients and should be incorporated into future comparative clinical trials.
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U2 - 10.1200/JCO.1998.16.10.3353
DO - 10.1200/JCO.1998.16.10.3353
M3 - Article
C2 - 9779712
AN - SCOPUS:0031757277
SN - 0732-183X
VL - 16
SP - 3353
EP - 3361
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 10
ER -