Τίτλος:
Postoperative dose-dense sequential chemotherapy with epirubicin, paclitaxel and CMF in patients with high-risk breast cancer: Safety analysis of the Hellenic Cooperative Oncology Group randomized phase III trial HE 10/00
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background: A randomized phase III trial in high-risk breast cancer patients was conducted, to further explore the impact of dose-density in the adjuvant treatment for breast cancer. The safety analysis is presented. Patients and methods: From October 2000 until June 2005, 1121 node-positive patients were randomized to sequential dose-dense epirubicin 110 mg/m2 and paclitaxel (Taxol®, Bristol Myers-Squibb, Princeton, New Jersey, USA) 250 mg/m2 (group A), or concurrent epirubicin 83 mg/m2 and paclitaxel 187 mg/m2 (group B), both followed by three cycles of 'intensified' combination chemotherapy with cyclophosphamide, methotrexate and fluorouracil (CMF). Granulocyte colony-stimulating factor was given prophylactically with the dose-dense treatments. Results: Median dose intensity of epirubicin and paclitaxel was double in group A, as designed, with significantly less cycles administered at full dose (P < 0.001). Median cumulative dose of all drugs and total treatment duration, however, were identical between groups. Severe taxane-related toxic effects were more frequent in group A, while severe thrombocytopenia was low and present only in group A. There were no differences in the rates of other hematological toxic effects, including febrile neutropenia. The rates of secondary malignancies were low. Conclusion: Both regimens as used in the present study are well tolerated and safe. The rates of severe taxane-related toxic effects and thrombocytopenia, although low overall, are significantly increased with the dose-dense sequential regimen. © The Author 2007. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Συγγραφείς:
Fountzilas, G.
Dafni, U.
Gogas, H.
Linardou, H.
Kalofonos, H.P.
Briasoulis, E.
Pectasides, D.
Samantas, E.
Bafaloukos, D.
Stathopoulos, G.P.
Karina, M.
Papadimitriou, C.
Skarlos, D.
Pisanidis, N.
Papakostas, P.
Markopoulos, C.
Tzorakoeleftherakis, E.
Dimitrakakis, K.
Makrantonakis, P.
Xiros, N.
Polichronis, A.
Varthalitis, I.
Karanikiotis, C.
Dimopoulos, A.M.
Περιοδικό:
Annals of Oncology
Λέξεις-κλειδιά:
antihistaminic agent; cyclophosphamide; dexamethasone; epirubicin; erythropoietin; exemestane; fluorouracil; granulocyte colony stimulating factor; heparin; hydrocortisone; methotrexate; ondansetron; paclitaxel; tamoxifen, acute granulocytic leukemia; adult; aged; anemia; arthralgia; article; blood toxicity; breast cancer; bronchopneumonia; bronchospasm; cardiotoxicity; central nervous system disease; chemotherapy induced emesis; clinical trial; colorectal cancer; combination chemotherapy; controlled clinical trial; controlled study; coughing; disease severity; drug fatality; drug hypersensitivity; drug megadose; drug safety; drug substitution; drug tolerability; drug withdrawal; dyspnea; endometrium cancer; erythrocyte transfusion; face erythema; fatigue; febrile neutropenia; female; follow up; gastrointestinal hemorrhage; grand mal seizure; health care organization; high risk patient; human; hypotension; infection; leukopenia; liver toxicity; lung cancer; lung disease; lung embolism; major clinical study; male; malignant neoplastic disease; mucosa inflammation; multiple cycle treatment; myalgia; nausea; neurotoxicity; neutropenia; ovary cancer; pain; peripheral neuropathy; phase 3 clinical trial; postoperative care; priority journal; randomized controlled trial; sensory neuropathy; thrombocytopenia; treatment duration, Adult; Aged; Androstadienes; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Carcinoma; Chemotherapy, Adjuvant; Combined Modality Therapy; Cyclophosphamide; Dose-Response Relationship, Drug; Epirubicin; Estrogens; Female; Fluorouracil; Granulocyte Colony-Stimulating Factor; Hematologic Diseases; Humans; Lymphatic Metastasis; Mastectomy; Methotrexate; Middle Aged; Neoplasms, Hormone-Dependent; Neoplasms, Second Primary; Paclitaxel; Peripheral Nervous System Diseases; Tamoxifen
DOI:
10.1093/annonc/mdm539
