Venturini M, Bruzzi P, Del Mastro L, Garrone O, Bertelli G, Guelfi M, Pastorino S, Rosso R, Sertoli M R
Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
J Clin Oncol. 1996 Mar;14(3):764-73. doi: 10.1200/JCO.1996.14.3.764.
To evaluate the effect of previous adjuvant chemotherapy with or without anthracyclines on overall survival (OS), progression-free survival (PFS), and objective response (OR) rates of metastatic breast cancer patients treated with cyclophosphamide, epidoxorubicin, and fluorouracil (CEF) as first-line chemotherapy.
Three-hundred twenty-six assessable metastatic breast cancer patients entered onto four consecutive randomized trials performed in our Institution and North-West Oncology Group (GONO) cooperative centers from 1983 to 1994. Patients received CEF-based chemotherapy as first-line therapy and were then evaluated. One hundred forty-four patients (44%) did not receive previous adjuvant chemotherapy, and 143 (44%) and 39 (12%) patients received cyclophosphamide, methotrexate, and fluorouracil (CMF)-based and anthracycline-based adjuvant chemotherapy, respectively.
ORs to CEF chemotherapy were observed in 161 patients (49.4%). On univariate analysis, patients who had received prior adjuvant chemotherapy had a significantly lower probability of response than patients who did not: 43% versus 58% (P=.02). No difference between CMF-based (OR rate, 43%) and anthracycline-based (OR rate, 44%) adjuvant chemotherapy was observed. Stepwise logistic regression analysis indicated that adjuvant chemotherapy (P=.005), bone as dominant metastatic site (P=.02), and previous hormonotherapy for metastatic disease (P=.005) were the most important factors in predicting a poor OR rate. The median PFS and OS times of the whole group were 9.8 and 17.9 months, respectively. Patients who did not receive adjuvant chemotherapy had a longer survival time (21.1 months) compared with patients previously treated with CMF-based (15.3 months) or anthracycline-based (15.8 months) adjuvant chemotherapy. Multivariate analysis confirmed adjuvant chemotherapy to be among the strongest prognostic factors associated with both a poor PFS and OS.
Previous adjuvant chemotherapy adversely affects OR, PFS, and OS in metastatic breast cancer patients treated with the CEF regimen as first-line chemotherapy. No difference was observed between patients previously treated with CMF-based or anthracycline-based adjuvant chemotherapy.
评估既往接受或未接受含蒽环类药物的辅助化疗对接受环磷酰胺、表柔比星和氟尿嘧啶（CEF）作为一线化疗的转移性乳腺癌患者的总生存期（OS）、无进展生存期（PFS）和客观缓解（OR）率的影响。
1983年至1994年期间，326例可评估的转移性乳腺癌患者参加了在我们机构和西北肿瘤协作组（GONO）合作中心进行的四项连续随机试验。患者接受以CEF为基础的化疗作为一线治疗，随后进行评估。144例患者（44%）未接受过既往辅助化疗，143例（44%）和39例（12%）患者分别接受了以环磷酰胺、甲氨蝶呤和氟尿嘧啶（CMF）为基础的辅助化疗和以蒽环类药物为基础的辅助化疗。
161例患者（49.4%）观察到对CEF化疗有OR。单因素分析显示，接受过既往辅助化疗的患者缓解概率显著低于未接受过辅助化疗的患者：43%对58%（P = 0.02）。未观察到以CMF为基础的辅助化疗（OR率43%）和以蒽环类药物为基础的辅助化疗（OR率44%）之间存在差异。逐步逻辑回归分析表明，辅助化疗（P = 0.005）、骨为主要转移部位（P = 0.02）和既往对转移性疾病进行的激素治疗（P = 0.005）是预测OR率低的最重要因素。全组的中位PFS和OS时间分别为9.8个月和17.9个月。未接受辅助化疗的患者生存期更长（21.1个月），而既往接受以CMF为基础（15.3个月）或以蒽环类药物为基础（15.8个月）辅助化疗的患者生存期较短。多因素分析证实辅助化疗是与PFS和OS不良相关的最强预后因素之一。
既往辅助化疗对接受CEF方案作为一线化疗的转移性乳腺癌患者的OR、PFS和OS有不利影响。既往接受以CMF为基础或蒽环类药物为基础辅助化疗的患者之间未观察到差异。
