Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, non-Hodgkin's lymphoma, advanced/metastatic soft tissue sarcoma, superficial bladder cancer. Prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta multifocal papillary cancers (Grade 2 and 3).

Clinical Evidence

Consistent survival across epirubicin-based treatment regimens^2,3

In comparing 4 cycles every 3 weeks of epirubicin 100 mg/m² IV followed by 4 cycles of cyclophosphamide/methotrexate/fluorouracil (ECMF) or CMF alone, relapse-free and overall survival rates were significantly higher in the ECMF groups than in the CMF-alone groups (2-year relapse-free survival, 91% vs 85%; 5-year relapse-free survival, 76% vs 69%; 2-year overall survival, 95% vs 92%; 5-year overall survival, 82% vs 75%; p<0.001 by the log-rank test for all comparisons).²

In patients with axillary node-positive breast cancer who had undergone a radical mastectomy or lumpectomy plus axillary dissection, 6 cycles every 4 weeks of cyclophosphamide 75 mg/m² po x 14 days + epirubicin 60 mg/m² IV (days 1 and 8) + 5-fluorouracil 500 mg/m² IV (days 1 and 8) (CEF) + prophylactic antibiotics vs 6 cycles every 4 weeks of cyclophosphamide 100 mg/m² po x 14 days + methotrexate 40 mg/m² IV (days 1 and 8) + 5-fluorouracil 600 mg/m² IV (days 1 and 8) (CMF)^3,4:

In patients with axillary node-positive breast cancer, 6 cycles of either 5-fluorouracil 500 mg/m², epirubicin 100 mg/m² and cyclophosphamide 500 mg/m² IV on day 1 of each 21-day cycle (FEC-100) vs 5-fluorouracil 500 mg/m², epirubicin 50 mg/m² and cyclophosphamide 500 mg/m² IV on day 1 of each 21-day cycle (FEC-50)^5,6:


Safety Profile¹

CI:	Hypersensitivity to anthracyclines. Persisting myelosuppression or severe stomatitis induced by previous drug therapy or radiotherapy (RT); generalized infections; marked hepatic impairment; history of or in the presence of cardiac impairment. Previous maximum cumulative doses of anthracyclines, mitozantrone or mitomycin-C treatments. Contraindicated for intravesical use where invasive tumours have penetrated the bladder wall; urinary infections, bladder inflammation or catheterization problems are present. Pregnancy and lactation.

SP:	Cardiovascular disease, concomitant or previous radiation of the mediastinal-pericardial area, hypertensive cardiomyopathy, previous therapy with other anthracyclines/anthracenediones or treatment with other potentially cardiotoxic agents, hepatic impairment. Monitor haematological and cardiac function regularly. Do not give IM/SC. Do not extravasate.

AR:	Myelosuppression, leukopenia, neutropenia, thrombocytopenia, mild anaemia, secondary infections; congestive heart failure, ECG changes, cardiomyopathy, tachyarrhythmias; gastrointestinal disturbances, mucositis; alopecia, injection site reactions; dehydration; red discolouration of urine.

DI:	Other antitumour drugs especially cardiotoxic ones; cardioactive compounds, eg, calcium-channel blockers; propranolol. Concurrent mediastinal radiotherapy.

Dosages¹

IV or intravesical use only. Lifetime cumulative dose limit: 1,000 mg/m² body surface area (BSA). IV inj 75–90 mg/m² as a single injection at 21-day intervals. Treatment of breast cancer Up to 135 mg/m² as a single agent and 120 mg/m² in combination every 3–4 weeks. Adjuvant treatment of early breast cancer patients with positive lymph nodes 100–120 mg/m² every 3–4 weeks. Heavily pretreated patients, patients with pre-existing bone marrow depression or in the presence of neoplastic bone marrow infiltration Starting dose ≤75–90 mg/m². Intravesical Treatment of papillary transitional cell carcinoma of the bladder 8 weekly instillations of 50 mg. Local toxicity (chemical cystitis) Dose reduction up to 30 mg. Carcinoma in situ Depending on tolerability, dose may be increased up to 80 mg. Prophylaxis of recurrences after transurethral resection of superficial tumours 4 weekly instillations of 50 mg followed by 11 monthly instillations at the same dosage.

Strengths¹

10 mg/5 mL, 50 mg/25 mL.

Packing¹

Vial 10 mg/5 mL x 1's. 50 mg/25 mL x 1's.

References

1. MIMS Annual Hong Kong. 2007/2008 edition.
2. Poole CJ, et al. N Engl J Med 2006;355:1851-1862.
3. Levine MN, et al. J Clin Oncol 1998;16:2651-2658.
4. Levine MN, et al. J Clin Oncol 2005;23:5166-5170.
5. French Adjuvant Study Group. J Clin Oncol 2001;19:602-611.
6. Bonneterre J, et al. Proc Am Soc Clin Oncol 2003;22 (Abstr 93).

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