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Pre-med sheets for Lung, Prostate, Gastric, and Head and Neck Cancer.

IMPORTANT SAFETY INFORMATION

WARNING
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)

Continued below

Efficacy and Safety

Taxotere^® (docetaxel) is indicated for the following tumor types. Please click here to learn about:

Breast Cancer
Lung Cancer
Prostate Cancer
Gastric Cancer
Head & Neck Cancer

To see full Prescribing Information, click here

Breast Cancer

Taxotere^® (docetaxel) is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.¹

Taxotere^® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable, node-positive breast cancer.¹

Pivotal Trials

Pivotal trials supporting these indications include the following:

TAX 303: Chan et al. Taxotere^® vs. doxorubicin²
TAX 304: Nabholtz et al. Taxotere^® vs. mitomycin C + vinblastine³
BCIRG 001/TAX 316: Nabholtz et al. Taxotere^® + doxorubicin + cyclophosphamide vs. 5-fluorouracil + doxorubicin + cyclophosphamide⁴

Learn about clinical trials demonstrating the effectiveness of Taxotere^® in treating breast cancer.

Non–Small-Cell Lung Cancer

Taxotere^® in combination with cisplatin is indicated as first-line therapy for patients with unresectable, locally advanced or metastatic non–small-cell lung cancer (NSCLC) who have not previously received chemotherapy for this condition.¹

Taxotere^® as a single agent is indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.¹

Pivotal Trials

Pivotal trials supporting these indications include the following:

TAX 326: Fossella et al. Taxotere^® + cisplatin vs. vinorelbine + cisplatin⁵
TAX 317: Shepherd et al. Taxotere^® vs. best supportive care⁶
TAX 320: Fossella et al. Taxotere^® vs. vinorelbine or ifosfamide⁷

Learn about clinical trials demonstrating the effectiveness of Taxotere^® in treating NSCLC.

Prostate Cancer

Taxotere^® (docetaxel) in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone-refractory) metastatic prostate cancer (AIPC). ¹

Pivotal Trial

The pivotal trial supporting this indication includes:

TAX 327: Tannock IF et al. Taxotere+prednisone vs. mitoxantrone+prednisone ⁸

Learn about clinical trials demonstrating the effectiveness of Taxotere^® in treating prostate cancer.

Gastric Cancer

Taxotere^® (docetaxel) is approved for first line treatment of advanced gastric adenocarcinoma, including adenocarcinoma of gastroesophageal junction.

It is the first FDA-approved treatment for the advanced gastric cancer demonstrating a survival advantage in more than a decade. ⁹

Pivotal Trial

The pivotal trial supporting this indication includes:

TAX 325: Moiseyenko et al.Taxotere+cisplatin+5FU vs. cisplatin+5FU ⁹

Learn about clinical trials demonstrating the effectiveness of Taxotere^® in treating advanced gastric cancer.

Head and Neck Cancer

Taxotere^® (docetaxel) in combination with cisplatin and fluorouracil (TPF) is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).¹

Taxotere sequential therapy brings together advances in induction and local therapy, offering physicians and their patients an important option for treating locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Pivotal Trials

The following pivotal trials support this indication:

TAX 323 study: Vermorken et al. Taxotere + cisplatin + fluorouracil (TPF) followed by RT vs. cisplatin + fluorouracil (PF) followed by RT¹,¹¹
TAX 324 study: Posner et al. Taxotere + cisplatin + fluorouracil (TPF) vs. cisplatin + fluorouracil (PF), followed by chemoradiotherapy¹

Learn about clinical trials demonstrating the effectiveness of Taxotere^® in treating head and neck cancer.

References

Taxotere^® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; November 2007.
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.
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.
Data on file, Aventis Pharmaceuticals Inc. Clinical study report: A multicenter phase III randomized trial comparing docetaxel in combination with doxorubicin and cyclophosphamide (TAC) versus 5-fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of operable breast cancer patients with positive axillary lymph nodes. Study number RP56976V-316. 2004.
Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non–small-cell lung cancer: the TAX 326 Study Group. J Clin Oncol. 2003;21:3016-3024.
Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non–small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol. 2000;18:2095-2103.
Fossella FV, DeVore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non–small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol. 2000;18:2354-2362.
Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.
Moiseyenko VM, Ajani J, Tjulandin SA, et al. Randomized controlled phase III trial (TAX 325) comparing docetaxel (T) combined with cisplatin (C) and 5-flourouracil (F) to CF in patients with metastatic gastric adenocarcinoma (MGC). J Clin Oncol. 2005 ASCO Meeting Proceedings; Vol 23, No 16S (June 1 Supplement), 2005: 4002.
Sanofi-aventis Indication Letter, "Taxotere^® (docetaxel) Injection Concentrate Receives FDA Approval for the induction Treatment of Locally Advanced Head and Neck Cancer." Bridgewater, NJ.
Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007;357:1705-1715.

IMPORTANT SAFETY INFORMATION

WARNING:

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 and PRECAUTIONS 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 transaminase (SGOT) and/or serum glutamic-pyruvic transaminase (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
- Hypersensitivity reactions require immediate discontinuation of Taxotere^® infusion and administration of appropriate therapy (see WARNINGS AND PRECAUTIONS section of the prescribing information)
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 (see CONTRAINDICATIONS 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 WARNINGS and PRECAUTIONS section of the prescribing information)

Additional Warnings

All patients should be premedicated with oral corticosteroids such as dexamethasone (see DOSAGE AND ADMINISTRATION section of the prescribing information)
Neutropenia (<2,000 neutrophils/mm³) occurs in virtually all patients given 60-100 mg/m² of Taxotere^® and grade 4 neutropenia (<500 cells/mm³) occurs in 85% of patients given 100 mg/m² and 75% of patients given 60 mg/m²
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^®
Patients with pre-existing effusions should be closely monitored from the first dose for possible exacerbation of the effusions.

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.
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

Please see accompanying 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 fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, 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 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).