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suibowen2010

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[交流] 求高人帮翻译一段说明书急~

1 General
Responding patients may not experience an improvement in performance status on therapy and
may experience worsening. The relationship between changes in performance status, response to
therapy, and treatment-related side effects has not been established.

2 Cutaneous
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 Dose Adjustments
During Treatment (2.7)]. The discontinuation rate due to skin toxicity was 1.6% (15/965) for
metastatic breast cancer patients. Among 92 breast cancer patients premedicated with 3-day
corticosteroids, there were no cases of severe skin toxicity reported and no patient discontinued
TAXOTERE due to skin toxicity.

3 Fluid Retention
Severe fluid retention has been reported following TAXOTERE therapy [see Boxed Warning,
Premedication Regimen (2.6)]. Patients should be premedicated with oral corticosteroids prior
to each TAXOTERE administration to reduce the  incidence and severity of fluid retention [see
Premedication Regimen (2.6)]. Patients with pre-existing effusions should be closely monitored
from the first dose for the possible exacerbation of the effusions.

When fluid retention occurs, peripheral edema usually starts in the lower extremities and may
become generalized with a median weight gain of 2 kg.

Among 92 breast cancer patients premedicated  with 3-day corticosteroids, moderate fluid
retention occurred in 27.2% and severe fluid retention in 6.5%. The median cumulative dose to
onset of moderate or severe fluid retention was 819 mg/m2. 9.8% (9/92) of patients discontinued
treatment due to fluid retention: 4 patients discontinued with severe fluid retention; the
remaining 5 had mild or moderate fluid retention. The median cumulative dose to treatment
discontinuation due to fluid retention was 1021 mg/m2. Fluid retention was completely, but
sometimes slowly, reversible with a median of 16 weeks from the last infusion of TAXOTERE
to resolution (range: 0 to 42+ weeks). Patients developing peripheral edema may be treated with
standard measures, e.g., salt restriction, oral diuretic(s).

4 Neurologic
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 Dose Adjustments During Treatment (2.7)]. Patients who experienced
neurotoxicity in clinical trials and for whom follow-up information on the complete resolution of
the event was available had spontaneous reversal of symptoms with a median of 9 weeks from
onset (range: 0 to 106 weeks). Severe peripheral motor neuropathy mainly manifested as distal
extremity weakness occurred in 4.4% (42/965).

5 Asthenia
Severe asthenia has been reported in 14.9% (144/965) of metastatic breast cancer patients but has
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.

6. ADVERSE  REACTIONS
Adverse reactions are described for TAXOTERE according to indication.

6.1  Clinical Trial Experience

• Breast Cancer

Monotherapy with TAXOTERE for locally advanced or metastatic breast cancer after
failure of prior chemotherapy
TAXOTERE 100 mg/m2: Adverse drug reactions occurring in at least 5% of patients are
compared for three populations who received TAXOTERE administered at 100 mg/m2
as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function
tests; and an additional 61 patients with various tumor types who had abnormal liver function
tests at baseline. These reactions were described using COSTART terms and were considered
possibly or probably related to TAXOTERE. At least 95% of these patients did not receive
hematopoietic support. The safety profile is generally similar in patients receiving TAXOTERE
for the treatment of breast cancer and in patients with other tumor types (See Table 4).

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