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Product Centers | ELLENCE® (epirubicin hydrochloride injection)
 
ELLENCE(R) (epirubicin hydrochloride injection) Indication Statement ELLENCE Injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.

Safety
Incidence of congestive heart failure (CHF) with ELLENCE

Line chart showing incidence of congestive heart failure (CHF) with ELLENCE

For epirubicin: a retrospective analysis, including 9144 patients, mostly with solid tumors in advanced stages. For doxorubicin: a retrospective analysis including 3941 evaluable patients from NIH-sponsored studies between March 1970 and March 1977 (reference: Praga et al, after Von Hoff et al). Praga utilizes data from an original analysis conducted by Von Hoff (see table 2, Von Hoff et al) that groups patients in dose increments of 50 mg/m2 and depicts these data within a Kaplan-Meier chart. These data are derived from meta-analyses of multiple trials and do not represent a head-to-head study; thus the clinical relevance remains to be established.

  • The difference in the cardiotoxicity profiles of ELLENCE versus doxorubicin is well documented3-6

Rate of acute secondary leukemia (ASL) up to 10 years after treatment

  • No new cases of ASL between 5- and 10-year follow-ups of pivotal trials
    - 0.4% in FASG 05, 1.4% in NCIC MA-5 7
  • 0.55% 8-year cumulative probability of acute myelogenous leukemia or myelodysplastic syndrome (n=7110)

For combination adjuvant therapy in patients with resected node-positive breast cancer

Clinically relevant adverse events from initiation of treatment7

Table of clinically relevant adverse events from initiation of treatment

FEC & CEF = cyclophosphamide + epirubicin + fluorouracil; CMF = cyclophosphamide
+ methotrexate + fluorouracil NA = not available.
Grade 1 or 2 changes in transaminase levels were observed but were more frequently seen with CMF than with CEF.

View the efficacy information related to this safety and tolerability information.

References: 1. Praga C, Trave F, Petroccione A. Anthracycline-induced cardiotoxicity and its relevance in cancer treatment. In: Nimmo WS,Tucker GT, eds. Clinical Measurement in Drug Evaluation. Boca Raton, Fla: Wolfe Publishing Ltd; 1991:131-142. 2.Von Hoff DD, Layard MW, Basa P, et al. Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med. 1979;91:710-717. 3. French Epirubicin Study Group. A prospective randomized phase III trial comparing combination chemotherapy with cyclophosphamide, fluorouracil, and either doxorubicin or epirubicin. J Clin Oncol. 1988;6:679-688. 4. Italian Multicentre Breast Study With Epirubicin. Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial. J Clin Oncol. 1988;6:976-982. 5. Lopez M, Papaldo P, Di Lauro L, Vici P, Carpano S, Conti EM. 5-Fluorouracil, Adriamycin, cyclophosphamide (FAC) vs 5-fluorouracil, epirubicin, cyclophosphamide (FEC) in metastatic breast cancer. Oncology. 1989;46:1-5. 6. Hortobagyi GN, Yap HY, Kau SW, et al. A comparative study of doxorubicin and epirubicin in patients with metastatic breast cancer. Am J Clin Oncol. 1989;12:57-62. 7. Data on file. Pfizer Inc, New York, NY.