JCO：治疗乳腺癌，紫杉醇周疗后再行FAC方案更有效
2013-06-08 JCO dxy
6月3日，在线发表于《临床肿瘤学杂志》上的一篇文章指出，对于具有高风险的淋巴结阴性乳腺癌患者，紫杉醇周疗后再行FAC化疗方案（氟尿嘧啶、多柔比星、环磷酰胺）能取得更好的疗效，患者的无进展生存期相对延长。 目前，大多数乳腺癌患者的淋巴结检查都为阴性。唯一的一项针对淋巴结阴性乳腺癌所做的研究（
6月3日，在线发表于《临床肿瘤学杂志》上的一篇文章指出，对于具有高风险的淋巴结阴性乳腺癌患者，紫杉醇周疗后再行FAC化疗方案（氟尿嘧啶、多柔比星、环磷酰胺）能取得更好的疗效，患者的无进展生存期相对延长。
目前，大多数乳腺癌患者的淋巴结检查都为阴性。唯一的一项针对淋巴结阴性乳腺癌所做的研究（西班牙乳腺癌研究小组9805）指出，多西他赛能够使此类乳腺癌患者受益，但其毒性作用明显。而该研究则证明了将紫杉醇纳入到蒽环类为基础的辅助治疗方案中能够改善淋巴结阴性乳腺癌患者的生存期且其毒性作用可控。
该试验中，研究人员评估了紫杉醇周疗（wP）在治疗淋巴结阴性乳腺癌方面的疗效及其安全性。
研究纳入了T1-T3/N0期的乳腺癌患者及至少具有一项复发高风险因素的乳腺癌患者（具体标准依据St. Gallen 1998年的标准）。
在经过一期手术后，1,925例患者被随机分配接受FAC治疗（氟尿嘧啶+多柔比星+环磷酰胺，共6周期）或FAC-wP治疗（先8周期紫杉醇周疗，再4周期氟尿嘧啶+多柔比星+环磷酰胺治疗）。
研究的主要终点为平均随访5年后的无病生存期（DFS）。次要终点包括毒性反应和总生存期。
结果表明，在平均随访63.3个月后，93%接受FAC-wP方案治疗的患者和90.3%接受FAC方案治疗的患者疾病无进展（风险比[HR], 0.73； 95% CI, 0.54 to 0.99；对数秩检验P = 0.04）。并且，接受FAC-wP方案治疗的患者中有31例死亡，而接受FAC方案治疗的患者中有40例死亡（其中有1例 vs 7例死于心血管疾病，HR, 0.79；95% CI, 0.49 to 1.26；对数秩检验P =0.31）。
试验中，FAC-wP治疗组对比FAC治疗组，出现的最相关的3/4级不良反应为发热性中性粒细胞减少症（2.7% vs 3.6%）、疲乏（7.9% vs 3.4%）、感觉神经病变（5.5% vs 0%）。
最终的结果表明，对于具有高风险因素的淋巴结阴性乳腺癌患者来说，紫杉醇周疗后再行氟尿嘧啶、多柔比星、环磷酰胺的联合方案（FAC-wP）比之于氟尿嘧啶、多柔比星、环磷酰胺的联合方案（FAC）更能够延长患者的无病生存期。并且，FAC-wP具有可控的毒性反应，特别是对心脏的长期影响方面。
Fluorouracil, Doxorubicin, and Cyclophosphamide (FAC) Versus FAC Followed by Weekly Paclitaxel As Adjuvant Therapy for High-Risk, Node-Negative Breast Cancer: Results From the GEICAM/2003-02 Study.
Abstract
PURPOSEAdding taxanes to anthracycline-based adjuvant therapy improves survival outcomes of patients with node-positive breast cancer (BC). Currently, however, most patients with BC are node negative at diagnosis. The only pure node-negative study (Spanish Breast Cancer Research Group 9805) reported so far showed a docetaxel benefit but significant toxicity. Here we tested the efficacy and safety of weekly paclitaxel (wP) in node-negative patients, which is yet to be established.Patients And methodsPatients with BC having T1-T3/N0 tumors and at least one high-risk factor for recurrence (according to St. Gallen 1998 criteria) were eligible. After primary surgery, 1,925 patients were randomly assigned to receive fluorouracil, doxorubicin, and cyclophosphamide (FAC) × 6 or FAC × 4 followed by wP × 8 (FAC-wP). The primary end point was disease-free survival (DFS) after a median follow-up of 5 years. Secondary end points included toxicity and overall survival.ResultsAfter a median follow-up of 63.3 months, 93% and 90.3% of patients receiving FAC-wP or FAC regimens, respectively, remained disease free (hazard ratio [HR], 0.73; 95% CI, 0.54 to 0.99; log-rank P = .04). Thirty-one patients receiving FAC-wP versus 40 patients receiving FAC died (one and seven from cardiovascular diseases, respectively; HR, 0.79; 95% CI, 0.49 to 1.26; log-rank P = .31). The most relevant grade 3 and 4 adverse events in the FAC-wP versus the FAC arm were febrile neutropenia (2.7% v 3.6%), fatigue (7.9% v 3.4%), and sensory neuropathy (5.5% v 0%). CONCLUSIONFor patients with high-risk node-negative BC, the adjuvant FAC-wP regimen was associated with a small but significant improvement in DFS compared with FAC therapy, in addition to manageable toxicity, especially regarding long-term cardiac effects.
Abstract
PURPOSEAdding taxanes to anthracycline-based adjuvant therapy improves survival outcomes of patients with node-positive breast cancer (BC). Currently, however, most patients with BC are node negative at diagnosis. The only pure node-negative study (Spanish Breast Cancer Research Group 9805) reported so far showed a docetaxel benefit but significant toxicity. Here we tested the efficacy and safety of weekly paclitaxel (wP) in node-negative patients, which is yet to be established.Patients And methodsPatients with BC having T1-T3/N0 tumors and at least one high-risk factor for recurrence (according to St. Gallen 1998 criteria) were eligible. After primary surgery, 1,925 patients were randomly assigned to receive fluorouracil, doxorubicin, and cyclophosphamide (FAC) × 6 or FAC × 4 followed by wP × 8 (FAC-wP). The primary end point was disease-free survival (DFS) after a median follow-up of 5 years. Secondary end points included toxicity and overall survival.ResultsAfter a median follow-up of 63.3 months, 93% and 90.3% of patients receiving FAC-wP or FAC regimens, respectively, remained disease free (hazard ratio [HR], 0.73; 95% CI, 0.54 to 0.99; log-rank P = .04). Thirty-one patients receiving FAC-wP versus 40 patients receiving FAC died (one and seven from cardiovascular diseases, respectively; HR, 0.79; 95% CI, 0.49 to 1.26; log-rank P = .31). The most relevant grade 3 and 4 adverse events in the FAC-wP versus the FAC arm were febrile neutropenia (2.7% v 3.6%), fatigue (7.9% v 3.4%), and sensory neuropathy (5.5% v 0%). CONCLUSIONFor patients with high-risk node-negative BC, the adjuvant FAC-wP regimen was associated with a small but significant improvement in DFS compared with FAC therapy, in addition to manageable toxicity, especially regarding long-term cardiac effects.
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