TY - JOUR
T1 - Weekly docetaxel versus CMF as adjuvant chemotherapy for elderly breast cancer patients
T2 - Safety data from the multicentre phase 3 randomised ELDA trial
AU - Nuzzo, Francesco
AU - Morabito, Alessandro
AU - De Maio, Ermelinda
AU - Di Rella, Francesca
AU - Gravina, Adriano
AU - Labonia, Vincenzo
AU - Landi, Gabriella
AU - Pacilio, Carmen
AU - Piccirillo, Maria Carmela
AU - Rossi, Emanuela
AU - D'Aiuto, Giuseppe
AU - Thomas, Renato
AU - Gori, Stefania
AU - Colozza, Mariantonietta
AU - De Placido, Sabino
AU - Lauria, Rossella
AU - Signoriello, Giuseppe
AU - Gallo, Ciro
AU - Perrone, Francesco
AU - de Matteis, Andrea
PY - 2008/5
Y1 - 2008/5
N2 - 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.
AB - 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.
KW - Adjuvant
KW - Breast cancer
KW - CMF
KW - Docetaxel
KW - Elderly
KW - Phase 3
UR - http://www.scopus.com/inward/record.url?scp=41249088803&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=41249088803&partnerID=8YFLogxK
U2 - 10.1016/j.critrevonc.2007.10.006
DO - 10.1016/j.critrevonc.2007.10.006
M3 - Article
C2 - 18160303
AN - SCOPUS:41249088803
VL - 66
SP - 171
EP - 180
JO - Critical Reviews in Oncology/Hematology
JF - Critical Reviews in Oncology/Hematology
SN - 1040-8428
IS - 2
ER -