Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer.

Valero, Vicente; Holmes, Frankie A.; Walters, Ronald S.; Theriault, Richard L.; Esparza, Laura; Fraschini, Giuseppe; Fonseca, Gustavo; Bellet, Robert E.; Buzdar, Aman U.; Hortobágyi, Gabriel N.

doi:10.1200/jco.1995.13.12.2886

Cited by 354 publications

(132 citation statements)

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“…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).…”

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confidence: 99%

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

et al. 2003

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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.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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

et al. 2003

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“…This trial was designed over twenty years ago, and it is possible that newer regimes are more effective. The addition of taxanes to anthracyclines, for instance, has been shown to improve response rates in metastatic disease and to add benefit in the treatment of early stage disease such that taxane-anthracycline combination regimens are now considered standard in the adjuvant and neoadjuvant setting [22][23][24]. Schedules with shorter intervals between doses of chemotherapy, so-called dose-dense, are also more effective [25].…”

Section: Discussionmentioning

confidence: 99%

Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944)

Kimmick

Duggan

Bhalla

et al. 2008

Breast Cancer Res Treat

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Purpose-To describe long-term results of a multimodality strategy for stage III breast cancer utilizing neoadjuvant doxorubicin followed by mastectomy, CMF, and radiotherapy.Patients and methods-Women with biopsy-proven, clinical stage III breast cancer and adequate organ function were eligible. Neoadjuvant doxorubicin (30 mg/m 2 days 1-3, every 28 days for 4 cycles) was followed by mastectomy, in stable or responding patients. Sixteen weeks of postoperative CMF followed (continuous oral cyclophosphamide (2 mg/kg/day); methotrexate (0.7 mg/kg IV) and fluorouracil (12 mg/kg IV) weekly, weeks 1-8, and than biweekly, weeks 9-16). Radiation therapy followed adjuvant chemotherapy.Results-Clinical response rate was 71% (79/111, 95% CI = 62-79%), with 19% complete clinical response. Pathologic complete response was 5% (95% CI = 2-11%). Median follow-up is 15.6 years. Half of the patients progressed by 2.2 years; half died by 5.4 years (range 6 months-15 years). The hazard of dying was greatest in the first 5 years after diagnosis and declined thereafter. Time to progression and overall survival were predicted by number of pathologically involved lymph nodes (TTP: HR [10 vs. 1 node] 2.40, 95% CI = 1.63-3.53, P < 0.0001; OS: HR 2.50, 95% CI = 1.74-3.58, P < 0.0001).Conclusions-After multimodality treatment for locally advanced breast cancer, long-term survival was correlated with the number of pathologically positive lymph nodes, but not to clinical response. The hazard of death was highest during the first 5 years after diagnosis and declined thereafter, indicating a possible intermediate endpoint for future trials of neoadjuvant treatment.

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“…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).…”

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

et al. 2007

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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.

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Phase II trial of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer.

Cited by 354 publications

References 15 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

Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944)

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

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