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Important Safety Info.

Clinical Pharmacology

Mechanism Of Action

Pharmacokinetics Profile

Drug Interactions

Adverse Events

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Adverse Events: Lung Cancer

Locally Advanced or Metastatic Non–Small-Cell Lung Cancer (NSCLC) after failure of platinum-based chemotherapy (second-line)
Unresectable, Locally Advanced or Metastatic NSCLC who have not previously received chemotherapy for this condition (first-line)

Locally Advanced or Metastatic NSCLC after failure of platinum-based chemotherapy (second-line)

Taxotere^® (docetaxel) Injection Concentrate 75 mg/m²

The following table summarizes adverse events from two clinical trials of Taxotere^® 75 mg/m² in the treatment of locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy:

TAX 317 comparing Taxotere^® 75 mg/m² to best supportive care (BSC)*
TAX 320 comparing Taxotere^® 75 mg/m² to vinorelbine or ifosfamide¹

These adverse events were described using National Cancer Institute (NCI) Common Toxicity Criteria regardless of relationship to study treatment, except for the hematologic toxicities or otherwise noted.

Adverse Events With Taxotere^® 75 mg/m²: TAX 317 and TAX 320 Trials*

Adverse Event	Taxotere^® 75 mg/m² (n=176) %	Best Supportive Care (n=49) %	Vinorelbine/ Ifosfamide (n=119) %
Neutropenia Any Grade 3/4	84.1 65.3	14.3 12.2	83.2 57.1
Leukopenia Any Grade 3/4	83.5 49.4	6.1 0	89.1 42.9
Thrombocytopenia Any Grade 3/4	8.0 2.8	0 0	7.6 1.7
Anemia Any Grade 3/4>	91.0 9.1	55.1 12.2	90.8 14.3
Febrile Neutropenia^†	6.3	NA	0.8
Infection Any Grade 3/4	33.5 10.2	28.6 6.1	30.3 9.2
Treatment Related Mortality	2.8	NA	3.4
Hypersensitivity Reactions Any Grade 3/4	5.7 2.8	0 0	0.8 0
Fluid Retention Any Severe	33.5 2.8	ND	22.7 3.4
Neurosensory Any Grade 3/4	23.3 1.7	14.3 6.1	28.6 5.0
Neuromotor Any Grade 3/4	15.9 4.5	8.2 >6.1	10.1 3.4
Skin Any Grade 3/4	19.9 0.6	6.1 2.0	16.8 0.8
Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4	33.5 5.1 21.6 2.8 22.7 2.8	30.6 4.1 26.5 2.0 6.1 0	31.1 7.6 21.8 5.9 11.8 4.2
Alopecia	56.3	34.7	49.6
Asthenia Any Severe^‡	52.8 18.2	57.1 38.8	53.8 22.7
Stomatitis Any Grade 3/4	26.1 1.7	6.1 0	7.6 0.8
Pulmonary Any Grade 3/4	40.9 21.0	49.0 28.6	45.4 18.5
Nail Disorder Any Severe^‡	11.4 1.1	0 0	1.7 0
Myalgia Any Severe^‡	6.3 0	0 0	2.5 0
Arthralgia Any Severe^‡	3.4 0	2.0 0	1.7 0.8
Taste Perversion Any Severe^‡	5.7 0.6	0 0	0 0

^* Normal baseline liver function tests: Transaminases < 1.5 times upper limit of normal (ULN) or alkaline phosphatase < 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN.

^† Febrile neutropenia: Absolute neutrophil count (ANC) grade 4 with fever > 38°C with intravenous antibiotics and/or hospitalization.

^‡ COSTART term and grading system.

NA = Not applicable.
ND = Not done.

Unresectable, Locally Advanced or Metastatic NSCLC who have not previously received chemotherapy for this condition (first-line)

Taxotere^® 75 mg/m²
The following table summarizes adverse events from the TAX 326 clinical trial comparing Taxotere^® 75 mg/m² + cisplatin 75 mg/m² to vinorelbine 25 mg/m² + cisplatin 100 mg/m² in the treatment of unresectable, locally advanced or metastatic NSCLC.¹
Adverse events were described using the NCI Common Toxicity Criteria except where otherwise noted.¹

Adverse Events With Taxotere^® 75 mg/m²: TAX 326 Trial

Adverse Event	Taxotere^® 75 mg/m² + Cisplatin 75 mg/m² (n=406) %	Vinorelbine 25 mg/m² + Cisplatin 100 mg/m² (n=396) %
Neutropenia Any Grade 3/4	91 74	90 78
Febrile Neutropenia	5	5
Thrombocytopenia Any Grade 3/4	15 3	15 4
Anemia Any Grade 3/4	89 7	94 25
Infection Any Grade 3/4	35 37	8 8
Fever in Absence of Infection Any Grade 3/4	33 < 1	29 1
Hypersensitivity Reaction* Any Grade 3/4	12 3	4 < 1
Fluid Retention^† Any All severe or life-threatening events Pleural effusion Any All severe or life-threatening events Peripheral edema Any All severe or life-threatening events Weight gain Any All severe or life-threatening events	54 2 23 2 34 < 1 15 < 1	42 2 22 2 18 < 1 19 < 1
Neurosensory Any Grade 3/4	47 4	42 4
Neuromotor Any Grade 3/4	19 3	17 6
Skin Any Grade 3/4	16 < 1	14 1
Nausea Any Grade 3/4	72 10	76 17
Vomiting Any Grade 3/4	55 8	61 16
Diarrhea Any Grade 3/4	47 7	25 3
Anorexia^† Any All severe or life-threatening events	42 5	40 5
Stomatitis Any Grade 3/4	24 2	21 1
Alopecia Any Grade 3	75 < 1	42 0
Asthenia^† Any All severe or life-threatening events	74 12	75 14
Nail Disorder^† Any All severe events	14 < 1	< 1 0
Myalgia^† Any All severe events	18 < 1	12 < 1

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

Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the Taxotere^® + cisplatin arm and in 37 patients (9.3%) in the vinorelbine + cisplatin arm.¹
Deaths within 30 days of last study treatment attributed to study drug occurred in nine patients (2.2%) in the Taxotere^® + cisplatin arm and in eight patients (2.0%) in the vinorelbine + cisplatin arm.¹

Addressing Adverse Events

The occurrence of side effects or special considerations may require Taxotere^® dosing adjustments in certain individuals. Please visit the dosing adjustment guidelines section of this site for more information about dose adjustments.

For more information on Taxotere^® adverse events and important safety information, please refer to the Taxotere^® full prescribing information.

Reference

Taxotere^® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; March 2007.

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)
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
- 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.

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 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).

Adverse Events: Lung Cancer

Locally Advanced or Metastatic NSCLC after failure of platinum-based chemotherapy (second-line)

Taxotere® (docetaxel) Injection Concentrate 75 mg/m2

Unresectable, Locally Advanced or Metastatic NSCLC who have not previously received chemotherapy for this condition (first-line)

Taxotere^® (docetaxel) Injection Concentrate 75 mg/m²