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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 Lung Cancer

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

Locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.
Unresectable, locally advanced or metastatic non-small-cell lung cancer who have not previously received chemotherapy for this condition (first-line)

Locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.

Two pivotal clinical trials, TAX 317 by Shepherd and colleagues and TAX 320 by Fossella and colleagues, have demonstrated the effectiveness and well-established safety profile of Taxotere^® in the treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.^1,2

Proven Survival Advantage and Tumor Response

The TAX 317 trial comparing Taxotere^® (n=55) with best supportive care (BSC)* (n=49) demonstrated a long survival advantage and proven tumor response with Taxotere^®. The TAX 320 trial comparing Taxotere^® (n=125) with vinorelbine or ifosfamide (n=123) also demonstrated a long survival and proven tumor response with Taxotere^®.^1-3

Survival and Tumor Response in TAX 317 and TAX 320 Trials^1–3

	TAX 317			TAX 320
	Taxotere® 75 mg/m² (n=55)	BSC (n=49)	P value	Taxotere® 75 mg/m² (n=125)	vinorelbine or ifosfamide (n=123)	P value
Median survival	7.5 months	4.6 months	.01	5.7 months	5.6 months	.13 NS
1-year survival	37%	12%	≤.05	30%	20%	≤.05
Response rate	5.5%	N/A	—	5.7%	0.8%	NS

Preservation of Performance Status and Weight

The TAX 317 trial demonstrated significant preservation of patient performance status and weight vs. BSC.^1,4

The Taxotere^® group showed a significantly smaller amount of deterioration in ECOG performance status vs. BSC (0.65 mean decrease vs. 1.09 mean decrease, P<0.05).
98% of patients in the Taxotere^® group did not experience >10% weight loss vs. 78% of patients in the BSC group.^1,4

Well Established Safety Profile

The TAX 317 and TAX 320 trials also demonstrated a well-established safety profile in Taxotere^® patients vs. BSC and in Taxotere^® patients vs. vinorelbine or ifosfamide.^1-3

Lower rates of asthenia, but higher rates of neutropenia
Incidence of most non-hematologic grade 3/4 adverse events <5%^1-3

Unresectable, Locally Advanced or Metastatic Non-Small-Cell Lung Cancer who have not previously received chemotherapy for this condition (first-line)

A pivotal trial, TAX 326 by Fossella and colleagues, has demonstrated the effectiveness and well-established profile of first-line therapy with Taxotere^® + cisplatin in the treatment of unresectable, locally advanced or metastatic NSCLC.^3,5

Proven Survival Advantage

The TAX 326 trial comparing Taxotere^® + cisplatin (n=408) with vinorelbine + cisplatin (n=405) demonstrated a survival advantage and proven tumor response with Taxotere^® + cisplatin.^3,5

Proven First-line Survival and Tumor Response in TAX 326 Trial^3,5

Proven first-line survival and tumor response

Endpoint	Taxotere® cisplatin (n=408)	vinorelbine + cisplatin (n=405)	P value
Median survival	10.9 months	10.0 months	.122 (NS)
Overal response rate^*	31.6%	24.4%	NS

The second comparison in the study, Taxotere^® + carboplatin vs vinorelbine + cisplatin, did not demonstrate superior survival (9.1 months vs 10.0 months, P=NS)²

*Overall response rate is defined as complete response + partial response.

Proven survival in patients age 65 years and older

In patients age 65 years and older (n=148), median survival with Taxotere^® + cisplatin was 12.1 months (95%, CI=9.3–14.0 months).^3,5

Proven Safety

The TAX 326 trial demonstrated a well-established safety profile in Taxotere^® + cisplatin patients vs. vinorelbine + cisplatin, with incidence of most non-hematologic grade 3/4 adverse events
≤ 5%.^3,5

Grade 3/4 adverse events
Adverse event		Taxotere^® 75 mg/m² + cisplatin 75 mg/m² (n=406) % of patients	Vinorelbine 25 mg/m² + cisplatin 75 mg/m² (n=396) % of patients
Hematologic	Neutropenia	74	78
	Febrile neutropenia	5	5
	Thrombocytopenia	3	4
	Anemia	7	25
	Infection	8	8
Non-hematologic	Fever in absence of infection	<1	1
	Hypersensitivity reaction^*	3	<1
	Fluid retention^†	2	2
	Pleural effusion	2	2
	Peripheral edema	<1	<1
	Weight gain	<1	<1
	Neurosensory	4	4
	Neuromotor	3	6
	Skin	<1	1
	Nausea	10	17
	Vomiting	8	16
	Diarrhea	7	3
	Anorexia^†	5	5
	Stomatitis	2	1
	Asthenia^†	12	14
	Nail disorder^†	<1	0
	Myalgia^†	<1	<1

^* Replaces NCI term "Allergy."
^† COSTART term and grading system.

High number of patient receiving planned course of therapy

In TAX 326, patients in the Taxotere^® + cisplatin group received more cycles and had fewer delays than patients in the vinorelbine + cisplatin group.⁵

Fewer first-line treatment discontinuations due to adverse events with Taxotere^® + cisplatin vs. vinorelbine + cisplatin (15.7% vs. 22.5%)
Higher median number of first-line treatment cycles with Taxotere^® + cisplatin vs. vinorelbine + cisplatin (5 vs. 4)
Fewer patients experiencing first-line treatment delays with Taxotere^® + cisplatin vs. vinorelbine + cisplatin (11.8% vs. 16.1%)^3,5

In addition, more patients in the Taxotere^® + cisplatin group completed all 6 treatment cycles vs. patients in the vinorelbine + cisplatin group (49.8% vs. 33.6%).^3,5

Higher dose intensity

The Taxotere^® + cisplatin group experienced a higher dose intensity vs. the vinorelbine + cisplatin group.⁵

Relative Dose Intensity^3,5

Relative dose intensity for patients

The recommended first-line dosing for Taxotere^® + cisplatin is Taxotere^® 75 mg/m² 1-hour I.V. infusion + cisplatin 75 mg/m² q 3 weeks.³
The dosing for the control arm was vinorelbine 25 mg/m² on days 1, 8, 15, 22 + cisplatin 100 mg/m² on day 1 q 4 weeks.⁵

References

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.
Taxotere^® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; Rev.December 2006.
Data on file, sanofi-aventis. Clinical study report: a multicenter, randomized phase III study of docetaxel (RP56976, Taxotere^®) versus best supportive care in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. Rhône-Poulenc Rorer. June 14, 1999.
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.

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 Lung Cancer