title: Weekly docetaxel versus CMF as adjuvant chemotherapy for elderly breast cancer patients: safety data from the multicentre phase 3 randomised ELDA trial.
abstract: Within an ongoing multicentre phase 3 randomised trial (ELDA, cancertrials.gov ID: NCT00331097), early breast cancer patients, 65-79 years old, with average to high risk of recurrence, are randomly assigned to receive CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, fluorouracil 600 mg/m2, days 1-8) or docetaxel (35 mg/m2 days 1-8-15), every 4 weeks. Here we report an unplanned safety analysis prompted by an amendment introducing creatinine clearance as a tool to adjust methotrexate dose. Before such change, 101 patients with a median age of 70 were randomly assigned CMF (53 patients) or docetaxel (48 patients). At least one grades 3-4 toxic event of any type was reported in 40 (75.5%) and 19 (39.6%) patients with CMF and docetaxel, respectively (p=0.0002). Grades 3-4 hematological events were observed in 37 (69.8%) vs. 4 (8.3%) cases (p<0.0001) and grades 3-4 non-hematological toxicity in 12 (22.6%) vs. 15 (31.2%) patients (p=0.11), with CMF and docetaxel, respectively. A higher incidence of anemia, neutropenia, thrombocytopenia and febrile neutropenia was reported with CMF. Constipation, mucositis, nausea and vomiting were more common with CMF; diarrhoea, abdominal pain, dysgeusia, neuropathy and liver toxicity were more frequent with docetaxel. No significant interaction was found between the occurrence of severe toxicity and baseline variables, including creatinine clearance and geriatric activity scales. In conclusion, weekly docetaxel appears to be less toxic than CMF in terms of hematological toxicity.
authors.affiliation: National Cancer Institute, Naples, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Nuzzo
authors.forename: Alessandro
authors.initials: A
authors.lastname: Morabito
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Maio
authors.forename: Francesca
authors.initials: F
authors.lastname: Di Rella
authors.forename: Adriano
authors.initials: A
authors.lastname: Gravina
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Labonia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Landi
authors.forename: Carmen
authors.initials: C
authors.lastname: Pacilio
authors.forename: Maria Carmela
authors.initials: MC
authors.lastname: Piccirillo
authors.forename: Emanuela
authors.initials: E
authors.lastname: Rossi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Aiuto
authors.forename: Renato
authors.initials: R
authors.lastname: Thomas
authors.forename: Stefania
authors.initials: S
authors.lastname: Gori
authors.forename: Mariantonietta
authors.initials: M
authors.lastname: Colozza
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
authors.forename: Rossella
authors.initials: R
authors.lastname: Lauria
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Signoriello
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Andrea
authors.initials: A
authors.lastname: de Matteis
mesh_terms: D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007558:Italy; D008727:Methotrexate / Q000008:administration & dosage; D010349:Patient Compliance; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate