Preoperative chemotherapy in primary operable breast cancer: Results from the European Organization for Research and Treatment of Cancer trial 10902

Preoperative chemotherapy in primary operable breast cancer: Results from the European Organization for Research and Treatment of Cancer trial 10902
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DOI:
10.1200/jco.2001.19.22.4224
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发表时间:
2001-11-15
影响因子:
45.3
通讯作者:
Duchateau, L
Duchateau, L
中科院分区:
医学1区
文献类型:
--
作者:
van der Hage, JA;van de Velde, CJH;Duchateau, L

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目的:评估原发性可手术乳腺癌患者术前新辅助化疗是否能获得更好的总生存率(OS)和无复发生存率,以及术前化疗是否比术后化疗允许更多的保乳手术。患者和方法:698名乳腺癌患者(T1 c、T2、T3、T4 b、NO至1和MO)入选一项随机III期试验,该试验比较了4个周期的氟尿嘧啶、表阿霉素、术前给予环磷酰胺与术后给予相同的方案(第一个周期在术后36小时内给予)。随访患者的OS、无进展生存期(PFS)和局部复发率(LRR)。PFS(风险比,1.15; P = .27)和至LRR的时间(风险比,1.13; P = .61)。57例患者(23%)降级的术前化疗,而14例(18%)进行乳房切除术,而不是计划的乳房,保存therapy.Conclusion:使用术前化疗产生类似的结果,PFS,OS和局部控制相比,传统的术后化疗。此外,术前化疗使更多的患者接受保乳手术治疗。由于术前化疗与术后化疗相比不能改善疾病结局,未来的试验应包括生活质量研究,以调查患者是否会从这种治疗方式中获益。(C)2001年,美国临床肿瘤学会。
Purpose: To evaluate whether preoperative neoadjuvant chemotherapy in patients with primary operable breast cancer results in better overall survival (OS) and relapse-free survival rates and whether preoperative chemotherapy permits more breast-conserving surgery procedures than postoperative chemotherapy.Patients and Methods: Six hundred ninety-eight breast cancer patients (T1c, T2, T3,T4b, NO to 1, and MO) were enrolled onto a randomized phase III trial that compared four cycles of fluorouracil, epirubicin, and cyclophosphamide administered preoperatively versus the same regimen administered postoperatively (the first cycle administered within 36 hours after surgery). Patients were followed up for OS, progression-free survival (PFS), and locoregional recurrence (LRR).Results: At a median follow-up of 56 months, there was no significant difference in terms of OS (hazards ratio, 1. 16, P = .38), PFS (hazards ratio, 1.15; P = .27), and time to LRR (hazards ratio, 1.13; P = .61). Fifty-seven patients (23%) were downstaged by the preoperative chemotherapy, whereas 14 patients (18%) underwent mastectomy and not the planned breast,conserving therapy.Conclusion: The use of preoperative chemotherapy yields similar results in terms of PFS, OS, and locoregional control compared with conventional postoperative chemotherapy. In addition, preoperative chemotherapy enables more patients to be treated with breast-conserving surgery. Because preoperative chemotherapy does not improve disease outcome compared with postoperative chemotherapy, future trials should involve quality-of-life studies to investigate whether patients will benefit from this treatment modality. (C) 2001 by American Society of Clinical Oncology.