Paclitaxel activity in heavily pretreated breast cancer: a National Cancer Institute Treatment Referral Center trial.

1995 ◽  
Vol 13 (8) ◽  
pp. 2056-2065 ◽  
Author(s):  
J S Abrams ◽  
D A Vena ◽  
J Baltz ◽  
J Adams ◽  
M Montello ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Progressive Disease ◽  
Overall Response Rate ◽  
Metastatic Breast ◽  
Investigational Drug ◽  
Single Institution ◽  
Doxorubicin Treatment ◽  
Heavily Pretreated ◽  
Pretreated Patients

PURPOSE To provide paclitaxel, an investigational drug at the inception of this study, to women with chemotherapy-refractory metastatic breast cancer and to evaluate response and toxicity in these patients. PATIENTS AND METHODS Two hundred sixty-seven patients with progressive disease (PD) following at least two chemotherapy regimens for metastatic breast cancer and a contraindication to further doxorubicin treatment received paclitaxel either at 175 mg/m2 intravenously (IV) over 24 hours or at 135 mg/m2 if they had prior irradiation to 30% of marrow-bearing bone or a cumulative dose of mitomycin > or = 20 mg/m2. RESULTS In a subgroup of patients (n = 172) with measurable disease, four complete responses (CRs) and 36 partial responses (PRs) occurred, for an overall response rate of 23% (95% confidence interval [CI], 17% to 30%). No differences in response rates were noted according either to the number of prior chemotherapy regimens received or to whether patients were considered refractory to doxorubicin. The dose and schedule used in this trial resulted in febrile neutropenia in 45% of patients and a hospitalization rate of 49%. CONCLUSION Paclitaxel's activity in this multiinstitutional trial in heavily pretreated patients confirms the encouraging results attained in single-institution trials. Although at this dose and schedule paclitaxel may be considered too myelosuppressive for palliative care, supportive measures such as colony-stimulating factors and antibiotics were not used prophylactically. Current research efforts are focusing on whether paclitaxel's activity against breast cancer is dose- and/or schedule-dependent, and on what role it has in patients with less advanced disease.

Phase II Study of Temsirolimus (CCI-779), a Novel Inhibitor of mTOR, in Heavily Pretreated Patients With Locally Advanced or Metastatic Breast Cancer

2005 ◽  
Vol 23 (23) ◽  
pp. 5314-5322 ◽  
Author(s):  
Stephen Chan ◽  
Max E. Scheulen ◽  
Stephen Johnston ◽  
Klaus Mross ◽  
Fatima Cardoso ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adverse Events ◽  
Dose Level ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Heavily Pretreated ◽  
Pretreated Patients ◽  
Grade 3 ◽  
Time To Tumor Progression

Purpose In this study, two doses of temsirolimus (CCI-779), a novel inhibitor of the mammalian target of rapamycin, were evaluated for efficacy, safety, and pharmacokinetics in patients with locally advanced or metastatic breast cancer who had been heavily pretreated. Patients and Methods Patients (n = 109) were randomly assigned to receive 75 or 250 mg of temsirolimus weekly as a 30-minute intravenous infusion. Patients were evaluated for tumor response, time to tumor progression, adverse events, and pharmacokinetics of temsirolimus. Results Temsirolimus produced an objective response rate of 9.2% (10 partial responses) in the intent-to-treat population. Median time to tumor progression was 12.0 weeks. Efficacy was similar for both dose levels but toxicity was more common with the higher dose level, especially grade 3 or 4 depression (10% of patients at the 250-mg dose level, 0% at the 75-mg dose level). The most common temsirolimus-related adverse events of all grades were mucositis (70%), maculopapular rash (51%), and nausea (43%). The most common, clinically important grade 3 or 4 adverse events were mucositis (9%), leukopenia (7%), hyperglycemia (7%), somnolence (6%), thrombocytopenia (5%), and depression (5%). Conclusion In heavily pretreated patients with locally advanced or metastatic breast cancer, 75 and 250 mg temsirolimus showed antitumor activity and 75 mg temsirolimus showed a generally tolerable safety profile.

Intermittent Capecitabine Monotherapy with Lower Dose Intensity in Heavily Pretreated Patients with Metastatic Breast Cancer

2007 ◽  
Vol 93 (2) ◽  
pp. 129-132 ◽  
Author(s):  
Tomo Osako ◽  
Yoshinori Ito ◽  
Shunji Takahashi ◽  
Nahomi Tokudome ◽  
Takuji Iwase ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Dose Intensity ◽  
Heavily Pretreated ◽  
Pretreated Patients

Vinorelbine as a 96-Hour Continuous Infusion in Heavily Pretreated Patients with Metastatic Breast Cancer: A Cooperative Study by the GEICAM Group

2003 ◽  
Vol 3 (6) ◽  
pp. 399-404 ◽  
Author(s):  
Carlos Jara-Sánchez ◽  
Miguel Martín ◽  
Jose A. García-Sáenz ◽  
Agustí Barnadas ◽  
Antonio Fernández-Aramburo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Continuous Infusion ◽  
Metastatic Breast ◽  
Cooperative Study ◽  
Heavily Pretreated ◽  
Pretreated Patients

Predictive factors for efficacy of capecitabine in heavily pretreated patients with metastatic breast cancer

2008 ◽  
Vol 63 (5) ◽  
pp. 865-871 ◽  
Author(s):  
Tomo Osako ◽  
Yoshinori Ito ◽  
Masaru Ushijima ◽  
Shunji Takahashi ◽  
Nahomi Tokudome ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Predictive Factors ◽  
Metastatic Breast ◽  
Heavily Pretreated ◽  
Pretreated Patients

Phase II Evaluation of Thalidomide in Patients With Metastatic Breast Cancer

2000 ◽  
Vol 18 (14) ◽  
pp. 2710-2717 ◽  
Author(s):  
Said M. Baidas ◽  
Eric P. Winer ◽  
Gini F. Fleming ◽  
Lyndsay Harris ◽  
James M. Pluda ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Progressive Disease ◽  
Single Agent ◽  
Metastatic Breast ◽  
Complete Response ◽  
Pharmacokinetic Studies ◽  
Angiogenic Growth Factors ◽  
Heavily Pretreated ◽  
Dose Levels

PURPOSE: To determine the efficacy, safety, pharmacokinetics, and effect on serum angiogenic growth factors of two dose levels of thalidomide in patients with metastatic breast cancer. PATIENTS AND METHODS: Twenty-eight patients with progressive metastatic breast cancer were randomized to receive either daily 200 mg of thalidomide or 800 mg to be escalated to 1,200 mg. Fourteen heavily pretreated patients were assigned to each dose level. Each cycle consisted of 8 weeks of treatment. Pharmacokinetics and growth factor serum levels were evaluated. RESULTS: No patient had a true partial or complete response. On the 800-mg arm, 13 patients had progressive disease at or before 8 weeks of treatment and one refused to continue treatment. The dose was reduced because of somnolence to 600 mg for five patients and to 400 mg for two and was increased for one to 1,000 mg and for four to 1,200 mg. On the 200-mg arm, 12 patients had progressive disease at or before 8 weeks and two had stable disease at 8 weeks, of whom one was removed from study at week 11 because of grade 3 neuropathy and the other had progressive disease at week 16. Dose-limiting toxicities included somnolence and neuropathy. Adverse events that did not require dose or schedule modifications included constipation, fatigue, dry mouth, dizziness, nausea, anorexia, arrhythmia, headaches, skin rash, hypotension, and neutropenia. Evaluation of circulating angiogenic factors and pharmacokinetic studies failed to provide insight into the reason for the lack of efficacy. CONCLUSION: Single-agent thalidomide has little or no activity in patients with heavily pretreated breast cancer. Further studies that include different patient populations and/or combinations with other agents might be performed at the lower dose levels.

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