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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 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. 3

This indication approval is based on the TAX 325 clinical trial, comparing Taxotere® + cisplatin and 5-FU (TCF) to cisplatin + 5-FU (CF). TAX 325 is the largest international phase III trial in previously untreated advanced gastric cancer (n=445).1

Proven Overall Survival

In TAX 325 trial, the TCF group showed longer median overall survival than the CF group.2

  • 9.2 vs. 8.6 months, respectively (P=0.0201; hazard ratio [HR]=1.29; 95% confidence interval [CI]=1.04-1.61)2

Overall Survival TAX 325 Trial2

Taxotere® 325 longer median Overall Survival
Significantly longer median survival with TCF
Significantly longer median survival with TCF vs CF:9.2 months vs 8.6 months (P=.0201; HR=1.29 [95% CI=1.04-1.61])

The TCF group also showed a significantly reduced risk of mortality.1

  • 22% reduction in risk of mortality, (HR=1.29 [95% CI=1.04-1.61])2

Well Established Safety Profile

The TAX 325 trial also demonstrated a well-established safety profile in Taxotere® vs. CF patients

  • Adverse events may be addressed with dose modification and/or appropriate treatment
  • Febrile neutropenia and/or neutropenic infection occurred at lower rates when secondary prophylaxis with G-CSF was used1

Adverse Reactions:

Neutropenia

In TAX 325, a majority of patients (82.3%) who received TCF experienced grade 3/4 neutropenia. This is comparable to the incidence of grade 3/4 neutropenia when Taxotere® is used in the other combination regimens; with TAC (Taxotere® + doxorubicin + cyclophosphamide) in adjuvant breast cancer, 65.5% of patients had grade 3/4 neutropenia, and with Taxotere® + cisplatin in first-line advanced NSCLC, the incidence was 74%.

Thrombocytopenia

Grade 3/4 anemia (18.2% vs 25.6%) and thrombocytopenia (7.7% vs 13.5%) were reduced in the TCF arm as compared with CF

Neurosensory

Some grade 3/4 non-hematologic toxicities (including lethargy, neurosensory, diarrhea) were increased in the TCF arm.

Combination Therapy with TAXOTERE® in gastric adenocarcinoma

Data in the following table are based on the experience of 221 patients with advanced gastric adenocarcinoma and no history of prior chemotherapy for advanced disease, who were treated with TAXOTERE® 75 mg/m in combination with cisplatin and fluorouracil.
 

Clinically Important Treatment Emergent Adverse Events Regardless of Relationship to Treatment in the Gastric Cancer Study
TCF
n=221		 CF
n=224
Adverse Event Any
%		 G3/4
%		 Any
%		 G3/4
%
Anemia 96.8 18.2 93.3 25.6
Neutropenia 95.5 82.3 83.3 56.8
Fever in the absence of infection 35.7 1.8 22.8 1.3
Thrombocytopenia 25.5 7.7 39.0 13.5
Infection 29.4 16.3 22.8 10.3
Febrile neutropenia 16.4 N/A 4.5 N/A
Neutropenic infection 15.9 N/A 10.4 N/A
Allergic reactions 10.4 1.8 5.8 0
Fluid retention * 14.9 0 4.0 0.4
Edema* 13.1 0 3.1 0.4
Lethargy 62.9 21.3 58.0 17.9
Neurosensory 38.0 7.7 24.6 3.1
Neuromotor 8.6 3.2 7.6 2.7
Dizziness 15.8 4.5 8.0 1.8
Alopecia 66.5 5.0 41.1 1.3
Rash/itch 11.8 0.9 8.5 0.0
Nail changes 8.1 0.0 0.0 0.0
Skin desquamation 1.8 0.0 0.4 0.0
Nausea 73.3 15.8 76.3 18.8
Vomiting 66.5 14.9 73.2 18.8
Anorexia 50.7 13.1 54.0 11.6
Stomatitis 59.3 20.8 61.2 27.2
Diarrhea 77.8 20.4 49.6 8.0
Constipation 25.3 1.8 33.9 3.1
Esophagitis/dysphagia/odynophagia 16.3 1.8 13.8 4.9
Gastrointestinal pain/cramping 11.3 1.8 7.1 2.7
Cardiac dysrhythmias 4.5 2.3 2.2 0.9
Myocardial ischemia 0.9 0.0 2.7 2.2
Tearing 8.1 0 2.2 0.4
Altered hearing 6.3 0 12.5 1.8
Clinically important TEAEs were determined based upon frequency, severity, and clinical impact of the
adverse event.
*Related to treatment

Longer Time-to-Disease Progression

The TCF group experienced a significantly delayed median time-to-disease progression vs. the CF group.1

  • 5.6 months vs. 3.7 months (P=.0004; HR=1.47 [95% CI=1.19-1.83])1

Time-to-Disease Progression TAX 325 Trial1

Significantly delayed disease progression with TCF
Taxotere® 325 time to disease Progression
TCF significantly delayed median time to progression vs CF: 5.6 months vs 3.7 months (P=.0004; HR=1.47 [95% CI=1.19-1.83])

The TCF group also demonstrated a 32% reduction in the risk of disease progression (HR=1.47 [95% CI=1.19-1.83]).2

Greater Tumor Response

In the TAX 325 trial, the TCF group experienced significantly more tumor shrinkage than the CF group.2

Overall Response Rate TAX 325 Trial1

Significantly more tumor shrinkage with TCF
Taxotere® 325 overall response rate significantly more tumor shrinkage
Overall response rate was significantly higher for TCF vs CF (P=.0106)

Duration of Therapy

Patients in the TCF group remained on therapy longer than patients in the CF group (18 weeks vs. 16 weeks).3

Patients in the TCF group also experienced a higher median relative dose intensity (RDI) vs. CF.3

  • Taxotere® median RDI: 0.92
  • Cisplatin median RDI: 0.91
  • 5-FU median RDI: 0.892

Visit the adverse events section for more information about the safety of Taxotere® in the treatment of gastric cancer.

References

  1. Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; Rev.December 2006.
  2. Data on file, sanofi-aventis. Clinical study report: open label, randomized multicenter phase II/III study of docetaxel in combination with cisplatin or docetaxel in combination with fluorouracil and cisplatin compared to the combination of cisplatin and fluorouracil in patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (XRP6976E/325A Taxotere®). April 26, 2005.
  3. 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.


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).

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US.DOC.07.09.026  Last update:  October 2007