Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer.

Ravdin, Peter M.; Burris, Howard A.; Cook, Gayle; Eisenberg, Peter D.; Kane, Michael D.; Bierman, William A.; Mortimer, James A.; Genevois, Eric; Bellet, Robert E.

doi:10.1200/jco.1995.13.12.2879

Cited by 293 publications

(109 citation statements)

References 8 publications

Supporting

Mentioning

105

Contrasting

Unclassified

Order By: Relevance

“…With the development of new taxanes, and the demonstration of the significant antitumour activity in patients with advanced breast cancer (Ravdin et al, 1995;Valero et al, 1995;Marty et al, 1997;Valero, 1997), clinical research is now focused on integrating docetaxel into combination regimens and into neoadjuvant and adjuvant schedules for patients with operable breast cancer. The biological determinants of response and resistance to docetaxel are also being examined (Powles et al, 1995;O'Leary et al, 1998).…”

Section: Discussionmentioning

confidence: 99%

“…It is a promising candidate for new therapeutic strategies in patients with breast cancer, and is therefore potentially useful for neoadjuvant chemotherapy (Cortes and Pazdur, 1995;O'Leary et al, 1998;Costa et al, 1999). As a single agent, docetaxel has shown marked clinical activity in the treatment of anthracycline-resistant and chemotherapy-naïve (for metastatic disease) breast cancer, achieving response rates of 34 and 50 -72%, respectively (Ravdin et al, 1995;Valero et al, 1995;Marty et al, 1997;Valero, 1997). In a randomised phase III trial in first-line metastatic breast cancer docetaxel (100 mg m À2 ) exhibited superior efficacy and tolerability compared with doxorubicin (at the optimal dose of 75 mg m À2 ) (Chan et al, 1999).…”

mentioning

confidence: 99%

See 1 more Smart Citation

Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate

et al. 2003

View full text Add to dashboard Cite

Docetaxel (Taxotere s ), alone or in combination with other anticancer agents, has proven efficacy in the first-and second-line treatment of metastatic breast cancer. This phase II study investigated the efficacy and tolerability of docetaxel as neoadjuvant chemotherapy in women with stage II -III primary operable breast cancer. Patients (n ¼ 88) were treated with six cycles of docetaxel at 100 mg m À2 every 21 days, followed by definitive surgery and radiotherapy. After six cycles of docetaxel, the overall clinical response rate was 68.4% (CI 95%: 58.1 -78.7%), including 19.0% complete remissions. Breast conservation was achieved in 72.4% of patients. A high pathological complete response (pCR) rate in breast was confirmed in 15 patients (19.8% (CI 95%: 10.8 -28.8%)) on Chevallier's classification restricted to breast and in 27 patients (35.5% (CI 95%: 24.7 -46.3%)) on Sataloff's classification. After a median follow-up of 30.8 months, 19 recurrences were documented with a median time to first recurrence of 17.3 months. Patients with stage III tumours had more recurrences than patients with stage II tumours (P ¼ 0.02). The principal toxicity of docetaxel is myelosuppression and 70.5% of patients developed grade III or IV neutropenia with 13.6% developing neutropenic sepsis. There was no case of severe cardiac toxicity, thrombocytopenia or any other serious adverse events. In conclusion, neoadjuvant docetaxel induces a high pCR and breast-conservation rate. Docetaxel monotherapy is a highly effective regimen that merits formal comparison with currently used combination regimens in a randomised phase III study.

show abstract

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate

et al. 2003

View full text Add to dashboard Cite

show abstract

“…Based on their significant activity in the metastatic setting [2], the taxanes have also been extensively tested in the adjuvant setting in many randomized trials [3][4][5][6][7][8]; significant improvement in efficacy outcomes in terms of disease-free survival (DFS) [4,5] and overall survival (OS) [3,6,7] has been reported. Moreover, recently, a meta-analysis of 13 randomized studies including 22,903 patients demonstrated that the addition of a taxane to an anthracycline-based regimen improves DFS and OS of high-risk early breast cancer patients [9].…”

Section: Introductionmentioning

confidence: 99%

FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

Polyzos

Malamos²,

Boukovinas

et al. 2009

Breast Cancer Res Treat

View full text Add to dashboard Cite

International audienceA randomized multicenter phase III study was conducted to compare the sequential docetaxel followed by epirubicin/cyclophosphamide combination with that of FEC regimen as adjuvant chemotherapy in women with axillary node-positive early breast cancer. Seven hundred and fifty-six women with axillary lymph node-positive breast cancer were randomized to receive either 4 cycles of docetaxel (100 mg/m) followed by 4 cycles of epirubicin (75 mg/m) plus cyclophosphamide (700 mg/m) (experimental arm) or 6 cycles of FEC (epirubicin 75 mg/m, cyclophosphamide 700 mg/m, and 5-fluorouracil 700 mg/m; control arm). All regimes were administered every 3 weeks. The primary end point was five-year disease-free survival (DFS). After a median follow-up period of 5 years, 233 (30.8%) relapses had occurred (108 and 125 in the experimental and control arms, respectively; = 0.181). The five-year DFS was 72.6% (95% CI 63.8–81.3%) and 67.2% (95% CI 58.0–76.4%) for women randomized in the experimental and control arms, respectively ( = 0.041; log rank test). There was no difference in the overall survival between the two arms (83.8 and 81.4% in the experimental and control arms, respectively; = 0.533). The experimental arm was associated with increased neutropenia requiring administration of granulocyte colony-stimulating factor in 90.5% of the patients as compared with 74.1% in the control arm ( = 0.0001). The sequential docetaxel followed by epirubicin/cyclophosphamide adjuvant chemotherapy regimen resulted in improved five-year DFS in women with axillary node-positive early breast cancer at the expense of increased but manageable myelotoxicity

show abstract

“…Epirubicin, however, is less cardiotoxic than doxorubicin, showing a toxicity ratio of 1 : 1.8 when compared to the latter, while retaining similar activity and efficacy (Robert, 1993). Furthermore, the semisynthetic taxane docetaxel retains much of its therapeutic activity even in patients unresponsive to anthracyclines (Ten Bokkel-Huinink et al, 1994;Ravdin et al, 1995;Valero et al, 1995). In addition to the high clinical activity of the two drug classes and the lack of complete clinical cross-resistance, docetaxel and epirubicin have largely non-overlapping toxicity profiles and different mechanisms of action (topoisomerase II inhibition vs microtubular assembly disturbance).…”

mentioning

confidence: 99%

Weekly epirubicin plus docetaxel as first-line treatment in metastatic breast cancer

et al. 2007

View full text Add to dashboard Cite

This study was designed to evaluate the efficacy and tolerability of a weekly schedule of epirubicin in combination with docetaxel in the first-line treatment of patients with metastatic breast cancer (MBC). A total of 43 women with MBC not previously treated with chemotherapy for metastatic disease received weekly epirubicin 25 mg m À2 and docetaxel 25 mg m À2 for a maximum of five cycles (total cumulative epirubicin dose of p900 mg m À2 ). Dose reduction was not permitted. Objective response and evaluation of toxicity profile were the primary study end points; time to progression and overall survival were secondary end points. Patients were followed for a median of 21 (4 -38) months. Analysis was by intent to treat; 33 patients completed five cycles of therapy, and the median dose of epirubicin administered to the 43 patients was 23 mg m À2 . Twenty-five patients (58%) achieved a partial response and one (2%) achieved a complete response. An additional 12 patients (28%) had stable disease. The median time to progression was 11 months (95% confidence intervals (CI) 7 -14) overall, and 13 months (95% CI 12 -14) in the 26 patients who responded to treatment. Median overall survival was 25 months for responders and 14 months for nonresponders. Grade 3/4 neutropenia occurred in 16% of patients and in 6% of cycles. One patient developed cardiac toxicity (20% reduction in left ventricular ejection fraction). The combination of epirubicin plus docetaxel is highly active in MBC, with a manageable toxicity profile. Such a weekly schedule might provide a valuable treatment option for MBC.

show abstract

Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer.

Abstract: Docetaxel at this dose and schedule has a high level of antitumor activity in patients with treatment-refractory advanced breast cancer, and appears to be one of the most active agents for the treatment of this patient population.

Cited by 293 publications

References 8 publications

Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate

Neoadjuvant docetaxel for operable breast cancer induces a high pathological response and breast-conservation rate

FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG)

Weekly epirubicin plus docetaxel as first-line treatment in metastatic breast cancer

Contact Info

Product

Resources

About