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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

Taxotere^® Treatment for Prostate Cancer

The TAX 327 clinical trial by Tannock and colleagues is the first phase III trial to demonstrate a significant benefit in androgen-independent (hormone-refractory) metastatic prostate cancer (AIPC).^1,2

TAX 327, completed in January 2006, compares Taxotere^®(docetaxel) + prednisone with mitoxantrone + prednisone. According to the study researchers, Taxotere^® + prednisone is the only treatment regimen proven to significantly extend survival in patients with metastatic AIPC.^1,2

The Taxotere^® + prednisone group was randomized to two arms:

Taxotere^® 75 mg/m² q 3 weeks + prednisone 5 mg po bid continuously (n=335)^*
Taxotere^® 30 mg/m² weekly + prednisone 5 mg po bid continuously (n=334)^1–3^*

^*Administration of study medication: Taxotere^® administered every 3 weeks for 10 cycles; Taxotere^® are 2=Taxotere^® administered for the first 5 weeks of 2 6-week cycle for 5 cycles; control arm=mitoxantrone administered every 3 weeks for 10 cycles

The weekly Taxotere^® arm demonstrated no overall survival advantage compared with the mitoxantrone arm.

The mitoxantrone + prednisone group received mitoxantrone 12 mg/m² q 3 weeks + prednisone 5 mg po bid continuously (n=337).^1–3

Proven Prolonged Survival

In TAX 327, the Taxotere^® q 3 weeks + prednisone group showed significantly longer median survival vs. mitoxantrone + prednisone (18.9 months vs. 16.5 months, P=.0094).^1,2

Taxotere^® q 3 weeks + prednisone: 95% CI, 17.0–21.2 months
Mitoxantrone + prednisone: 95% CI, 14.4–18.6 months^1,2

TAX 327 Survival Rates^1,2

Significantly longer median survival

24% reduced risk of mortality

27.6% 2-year survival advantage

Taxotere® graph showing Tax 327 Survival Rates

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

The Taxotere^® q 3 weeks + prednisone group also showed a 24% reduced risk of mortality.^1,2

Well Established Safety Profile³

The TAX 327 trial also demonstrated a well-established safety profile in Taxotere^® + prednisone patients vs. mitoxantrone + prednisone

Incidence of most grade 3/4 adverse events < 5%

Adverse event	Grade 3/4^§
Adverse event	Taxotere^® q 3 wk + prednisone % of patients n=332	Mitoxantrone = prednisone % of patients n=335
Hermatologic
Anemia	4.9	1.8
Neutropenia	32.0	21.7
Thromboctopenia	0.6	1.2
Febrile neutropenia^±	NA	NA
Infection	5.7	4.2
Toxic Death^¶	0.3	0.6
Non-hematologic
Epistaxis	0.3	0.0
Allergic reactions	0.6	0.0
Fluid Retention^#	0.6	0.3
Weight gain^#	0.3	0.0
Peripheral edema^#	0.3	0.0
Neuropathy sensory	1.8	0.3
Neuropathy motor	1.5	0.9
Rash/Desquamation	0.3	0.6
Alopecia^**	NA	NA
Nail changes	0.0	0.0
Nausea	2.7	1.5
Diarrhea	2.1	1.2
Stomatitis/Pharyngitis	0.9	0.0
Taste disturbance	0.0	0.0
Vomiting	1.5	1.5
Anorexia	1.2	0.3
Cough	0.0	0.0
Dyspnea	2.7	0.9
Cardiac left-ventricular function^‡	0.3	1.2
Fatigue	4.5	5.1
Myalgia	0.3	0.9
Tearing	0.6	0.0
Arthralgia	0.6	1.2

Grades 1 and 2 refer to mild and moderate adverse events, respectively.
^§Grade 3 adverse events are classified as severe; grade 4 adverse events are classified as life-threatening or debilitating.
^± A grade 3/4 rating for febrile neutropenia is not applicable (NA) because defined as grade 4 neutropenia with grade ≥ 1 fever (≥38°C) without infection.
^¶ A grade 3/4 rating is not applicable (NA) to toxic death because it is defined as grade 5. Toxic death is both a hematologic and non-hematologic adverse event. The percentages listed are for deaths due to drug-related toxicity within 30 days of last infusion.
^# Related to treatment.
^** A grade 3/4 rating for alopecia is not applicable (NA) because alopecia is not defined as severe, life threatening, or debilitating; it is therefore classified as grade 1 or 2.
^# Related to treatment.
^‡ Left-ventricular function tests (eg, radionuclide angiography or echocardiography) evaluate how effectively myocardium pumps blood, measured in “ejection fraction” of blood. Patients with grade 3/4 left-ventricular systolic dysfunction have congestive heart failure with ejection fractions 40%.

High number of patients completing planned course of therapy

Out of 10 scheduled cycles, patients in the Taxotere^® q 3 weeks + prednisone arm completed a median of 9.5 cycles vs. 5.0 cycles in the mitoxantrone + prednisone arm.¹

Discontinuation rate due to disease progression was 37.9% for the Taxotere^® q 3 weeks + prednisone arm and 56.4% for the mitoxantrone + prednisone arm.
Discontinuation rate due to adverse events was 10.7% for the Taxotere^® q 3 weeks + prednisone arm and 9.8% for the mitoxantrone + prednisone arm.³

Additionally, Taxotere^® q 3 weeks + prednisone was well tolerated in the elderly population.²

References

Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. Engl J Med. 2004;351:1502-1512.
Taxotere^® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; Rev.December 2006.
Data on file, sanofi-aventis. Clinical study report: a multicenter phase III randomized trial comparing Taxotere^® administered either weekly or every three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone-refractory prostate cancer. Study number RP56976-V-327. 2004.

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).

Taxotere® Treatment for Prostate Cancer