氟尿嘧啶、表柔比星和环磷酰胺对比氟尿嘧啶、多柔比星和环磷酰胺用于晚期乳腺癌的III期随机研究：一项意大利多中心试验

Phase III randomized study of fluorouracil, epirubicin, and cyclophosphamide v fluorouracil, doxorubicin, and cyclophosphamide in advanced breast cancer: an Italian multicentre trial.

作者信息

Ambrosini G, Balli M, Garusi G, Demicheli R, Jirillo A, Bonciarelli G, Bruscagnin G, Fila G, Bumma C, Lacroix F, Buzzi F, Di Costanzo F, Padalino D, Brugia M, Calabresi F, Natali M, Cartei G, Chiesa G, Blasina B, Ciambellotti E, Moro G, D'Aquino S, Altavilla G, Adamo V, De Maria D, Falchi A M, Bertoncelli P, Farris A, Fiorentino M, Fornasiero A, Fosser V, Daniele O, Foggi C M, Speranza G B, Sartori S, Camilluzzi E, Gallo L, Poggio R, Secondo V, Gambi A, Grignani F, Capodicasa E, Lopez M, Papaldo P, Di Lauro L, Vici P, Marenco G, Folco U, Bonanni F, Marsilio P, Palazzotto G, Di Carlo A, Cusimano M P, Pastorino G, Puccetti C, Giusto M, Rausa L, Gebbia N, Palmeri S, D'Alessandro N, Saccani F, Becchi G, Schieppati G, Spinelli I, Tagliagambe A, Tonato M, Minotti V, Ardia A, Viaro D, De Micheli P, Zingali G, Sacchetti G, Intini C

机构信息

Medical Department, Farmitalia Carlo Erba, Milano, Italy.

出版信息

J Clin Oncol. 1988 Jun;6(6):976-82. doi: 10.1200/JCO.1988.6.6.976.

DOI:10.1200/JCO.1988.6.6.976

PMID:2897433

Abstract

From February 1983 to January 1985, 497 patients with advanced breast cancer were randomly allocated to receive either epirubicin or doxorubicin in the following combination chemotherapy regimen: fluorouracil (5-FU) 500 mg/m2 intravenous (IV) on days 1 and 8; epirubicin or doxorubicin 50 mg/m2 IV on day 1; cyclophosphamide 500 mg/m2 IV on day 1 (FEC or FAC). Cycles were repeated every 21 days until progression or to cumulative doses of 700 mg/m2 for epirubicin and 550 mg/m2 for doxorubicin. Dose reductions were applied according to the standard criteria. Activity was evaluated in 443 patients (222 in the FEC arm and 221 in the FAC arm). The two experimental groups were comparable in age, performance status, menopausal status, histology, previous treatments, and site of the disease. The overall response rate (complete response and partial response [CR + PR]) was not significantly different: 53.6% for FEC and 56.5% for FAC. The median time to progression was 273 days for FEC and 314 days for FAC; the median survival time was 591 and 613 days, respectively. Leukopenia, anemia, nausea, and vomiting were significantly lower in patients treated with FEC. As for cardiotoxicity, four cases of congestive heart failure (CHF) were recorded among patients treated with FAC while only one was observed in the FEC group. These results indicate that epirubicin in a combination chemotherapy regimen is as active as doxorubicin and is significantly less toxic.

摘要

1983年2月至1985年1月，497例晚期乳腺癌患者被随机分配接受表柔比星或多柔比星，采用以下联合化疗方案：氟尿嘧啶（5-FU）500mg/m²静脉注射（IV），第1天和第8天给药；表柔比星或多柔比星50mg/m²静脉注射，第1天给药；环磷酰胺500mg/m²静脉注射，第1天给药（FEC或FAC）。每21天重复一个周期，直至病情进展或表柔比星累积剂量达700mg/m²、多柔比星累积剂量达550mg/m²。根据标准标准进行剂量调整。对443例患者（FEC组222例，FAC组221例）进行了活性评估。两个实验组在年龄、体能状态、绝经状态、组织学、既往治疗及疾病部位方面具有可比性。总缓解率（完全缓解和部分缓解[CR+PR]）无显著差异：FEC组为53.6%，FAC组为56.5%。FEC组疾病进展的中位时间为273天，FAC组为314天；中位生存时间分别为591天和613天。FEC治疗的患者白细胞减少、贫血、恶心和呕吐的发生率显著更低。至于心脏毒性，FAC治疗的患者中有4例发生充血性心力衰竭（CHF），而FEC组仅观察到1例。这些结果表明，联合化疗方案中的表柔比星与多柔比星活性相当，但毒性显著更低。