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Taxotere® Treatment for Breast Cancer

Several clinical trials have proven the efficacy and safety of Taxotere® (docetaxel) in the treatment of breast cancer for:

Locally Advanced or Metastatic Breast Cancer

A number of clinical trials have demonstrated the effectiveness and well-established safety profile of Taxotere® in the treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy. In fact, Taxotere® was the first agent to show a survival advantage in anthracycline-resistant metastatic breast cancer patients (11.4 months).1

Proven Survival Advantage

The TAX 304 trial by Nabholtz and colleagues demonstrated an overall survival advantage with Taxotere®, including a 31% improvement in median overall survival. The Taxotere® group (n=203) showed significantly longer overall survival vs. the mitomycin C + vinblastine group (n=189) (11.4 months vs. 8.7 months, P=.01, log-rank test).1

TAX 304 Median Overall Survival (Intent-to-Treat Population)1,2

31% improvement in median overall survival
Taxotere® 304 31% Improvement in median overall survival
In a separate dose-ranging study, TAX313, median overall survival (intent-to-treat), in the 100 mg/m2, 75 mg/m/2, and 60 mg/m2 arms was 12.3 months, 10.3 months, and 10.6 months, respectively—with no statistically significant difference in overall survival across arms (P=NS)2

Well Established Safety Profile

  • Incidence of severe (grade 3 or 4) neurosensory events (5.5%) and thrombocytopenia (9.2%)
  • Cardiotoxcity and hand-and-foot syndrome not reported
  • More than 10 years of proven clinical use

Proven Response Rates

Clinical trials have demonstrated a significant advantage in overall response rates with Taxotere® vs. other regimens. In fact, the TAX 303 trial by Chan and colleagues proved Taxotere® (n=161) to be the first agent to demonstrate higher response rates than doxorubicin (n=165) after failure of prior chemotherapy.5

In addition to TAX 303, the TAX 304 trial has demonstrated a significant advantage in overall response rates with Taxotere®.1,3

Overall Response Rates in Phase III Trials (Intent-to-Treat Population)1–3,5

Proven response rates in multiple phase III studies
Taxotere® 304 proven response rates in multiple phases
TAX 313: Proven overall response rates at 3 doses (60 mg/m2, 75 mg/m2, and 100 mg/m2)

Taxotere® was also studied in 3 single-arm Japanese studies at a dose of 60 mg/m2, in 174 patients who had received prior chemotherapy for locally advanced or metastatic breast cancer. Among 26 patients whose best response to an anthracycline had been progression, the response rate was 34.6% (95% CI=17.2%-55.7%), similar to the response rate in single-arm 100 mg/m2 studies1

Adjuvant Treatment of Operable, Node-Positive Breast Cancer

A pivotal phase III trial, BCIRG (Breast Cancer International Research Group) 001, has demonstrated the effectiveness and well-established safety profile of Taxotere® plus doxorubicin and cyclophosphamide in the adjuvant treatment of patients with operable, node-positive breast cancer.6

BCIRG 001, a multicenter, randomized, phase III trial by Martin and colleagues, compared Taxotere® + doxorubicin + cyclophosphamide (TAC) (n=745) to 5-fluorouracil + doxorubicin + cyclophosphamide (FAC) (n=746).6

Proven Survival Advantage

The TAC group demonstrated a significantly longer disease-free survival than the FAC group (75% vs. 68% at 5 years, P=.001).6

Disease-Free Survival Advantages Demonstrated in the Adjuvant Setting6

Disease free graph showing survival Advantages in Adjuvant setting
*A hazard ratio (HR) <1 indicates that TAC is associated with longer disease-free survival compared with FAC.

Overall risk of recurrence significantly reduced, based on a median follow-up of 55 months (P=.001)

  • 28% reduction in the risk of recurrence (HR=0.72, 95% CI=0.59-0.88)
  • Estimated rates for DFS at 5 years were 75% for TAC and 68% for FAC (P=.001)

The Taxotere® prescribing information reports the following: TAC showed significantly longer disease-free survival than FAC (HR-0.74, 95% CI=0.60-0.92; stratified log rank P=.0047) The overall reduction in risk for ER/PR+ patients (HR-0.76, 95% CI=0.59-0.98) and a 32% reduction in the risk of recurrence was reported for ER/PR- patients (HR-0.76, 95% CI=0.48-0.97). The overall reduction in the risk of recurrence for patients with 1-3 positive nodes was 36% (HR-0.64, 95% CI=0.47-0.87) with a 16% reduction for patients with 4 or more positive nodes (HR-0.64, 95% CI=0.63-1.12)

Well Established Safety Profile

  • Taxotere® is Cremophor® free
  • Taxotere® is formulated with polysorbate 80
  • Prophylactic G-CSF may be used to mitigate the risk of hematologic toxicities

In addition, the TAC group demonstrated a reduction in risk of recurrence, regardless of estrogen receptor (ER)/progesterone receptor (PR) status.

Reduced Risk of Recurrence6

Reduced Risk of Recurrence table
*A hazard ratio (HR) <1 indicates that TAC is associated with longer disease-free survival compared with FAC.

Reduction in risk of recurrence, based on nodal status

  • 39% reduction in the risk of recurrence for patients with 1-3 positive nodes (HR=0.61, 95% CI=0.46-0.82)
  • 17% reduction in the risk of recurrence for patients with >4 positive nodes (HR=0.83, 95% CI=0.63-1.08)

The TAC group also demonstrated a longer overall survival than the FAC group (87% vs. 81% at 5 years, P=.008).2,6

Overall Survival Advantages Demonstrated in the Adjuvant Setting2,6

Taxotere® overall survival Advantages in Adjuvant setting
*A (HR) <1 indicates that TAC is associated with longer overall survival compared with FAC.

Risk of mortality reduced, regardless of ER/PR status1

Overall
Survival		 ER/PR+ ER/PR- All TAC
patients
31%
HR=0.69
95% CI=0.49-0.99		 34%
HR=0.66
95% CI=0.44-0.98		 31%
HR=0.69
95% CI=0.53-0.90
An HR < indicates that TAC is associated with longer overall survival compared with FAC.

Reduction in risk of mortality, based on nodal status

  • 55% reduction in the risk of mortality for patients with 1-3 positive nodes (HR=0.45, 95% CI=0.29-0.70)
  • 7% reduction in the risk of mortality for patients with >4 positive nodes (HR=0.93, 95% CI=0.66-1.32)

Median follow-up of 55 months

  • 30% reduction in the risk of mortality (HR=0.70, 95% CI=0.53-0.91)
  • Estimated rates for OS at 5 years were 87% for TAC and 81% for FAC

References

  1. Nabholtz J–M, Senn HJ, Bezwoda WR, et al. Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. J Clin Oncol. 1999;17:1413–1424.
  2. Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; Rev.December 2006.
  3. Jones SE, Erban J, Overmoyer B, et al. Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol. 2005;23:5542–5551.
  4. Montero A, Fossella F, Hortobagyi G, et al. Docetaxel for treatment of solid tumors: a systematic review of clinical data. Lancet Oncol. 2005;6:229–239.
  5. Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17:2341–2354.
  6. Martin M, Pienkowski T, Mackey J, et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005;352:2302–2313.
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US.DOC.07.09.020  Last update:  October 2007
WARNING
  • Taxotere® should be administered only under the supervision of a qualified physician experienced in the use of antineoplastic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available
  • The incidence of treatment-related mortality associated with Taxotere® therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Taxotere® as a single agent at a dose of 100 mg/m2 (see WARNINGS section of the prescribing information)
  • Taxotere® should generally not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with serum glutamic-oxaloacetic transferase (SGOT) and/or serum glutamic-pyruvic transferase (SGPT) > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN
    • Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death
    • Patients with isolated elevations of transaminase > 1.5 X ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death
    • Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere® therapy and reviewed by the treating physician
  • Taxotere® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3
    • In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood-cell counts should be performed on all patients receiving Taxotere®
  • Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone premedication
    • Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions
  • Taxotere® must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with polysorbate 80
    • All patients should be premedicated with oral corticosteroids such as dexamethasone (see DOSAGE AND ADMINISTRATION section of the prescribing information)
  • Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) (see PRECAUTIONS section of the prescribing information)

Additional Warnings
  • Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere® in adjuvant therapy of breast cancer

  • Taxotere® can cause fetal harm when administered to pregnant women. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Taxotere®


    • Precautions
  • Localized erythema of the extremities with edema followed by desquamation has been observed

    • — In case of severe skin toxicity, an adjustment in dosage is recommended (see DOSAGE AND ADMINISTRATION section of the prescribing information)
  • Severe neurosensory symptoms (paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%

    • — When these symptoms occur, dosage must be adjusted; if symptoms persist, treatment should be discontinued (see DOSAGE AND ADMINISTRATION section of the prescribing information)
  • Severe asthenia was reported in 14.9% (144/965) of metastatic breast cancer patients, but led to treatment discontinuation in only 1.8%

    • — Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease
  • In patients treated with TCF for gastric cancer, the incidence of serious adverse events was higher in patients >65 years than in younger patients. Adverse events (all grades) occurring at rates >10% higher in elderly patients included lethargy, stomatitis, diarrhea, dizziness, edema, and febrile neutropenia/neutropenic infection.

    • Please see important safety information and full prescribing information, including boxed WARNING.

    Taxotere Indications

    Breast Cancer
    TAXOTERE® is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy
    TAXOTERE® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer

    Non-Small Cell Lung Cancer
    TAXOTERE®, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy
    TAXOTERE® in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic NSCLC who have not previously received chemotherapy for this condition.

    Prostate Cancer
    TAXOTERE® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

    Gastric Cancer
    TAXOTERE® in combination with cisplatin and flouroucil is indicated for the treatment of patients with advanced gastric adenocercinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

    Head and neck Cancer
    TAXOTERE® in combination with cisplatin and flourouracil is indicated for the induction treatment of patients with locally advanced squamous cell cercinoma of the head and neck (SCCHN).