UNICANCER-PEGASE 07 研究：一项评价新辅助剂量密集化疗后接受多西紫杉醇-5FU 方案辅助治疗炎性乳腺癌的随机 III 期临床试验。
UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer.
机构信息
Department of Medical Oncology, Institut Paoli-Calmettes, Marseille Centre de Recherche en Cancérologie de Marseille, INSERM U1068, CNRS 7258, Aix-Marseille Univ, Marseille.
Department of Medical Oncology, Institut Curie, Université Paris Descartes, Paris.
出版信息
Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.
BACKGROUND
Inflammatory breast cancer (IBC) is a rare and aggressive disease requiring a multimodal treatment. We evaluated the benefit of adding docetaxel-5-fluorouracil (D-5FU) regimen after preoperative dose-intense (DI) epirubicin-cyclophosphamide (EC) and locoregional treatment in IBC patients.
PATIENTS AND METHODS
PEGASE 07 was a national randomized phase III open-label study involving 14 hospitals in France. Women with nonmetastatic IBC were eligible and randomly assigned to receive either four cycles of DI EC (E 150 mg/m(2) and C 4000 mg/m(2) every 3 weeks with repeated hematopoietic stem cell support), then mastectomy with axillary lymph node dissection, and radiotherapy (arm A) or the same treatment followed by four cycles of D-5FU (D 85 mg/m(2), day 1 and 5FU 750 mg/m(2)/day continuous infusion, days 1-5 every 3 weeks) administered postradiotherapy (arm B). Patients with hormone receptor-positive tumors received hormonal therapy. Disease-free survival (DFS) was the primary end point. Secondary end points included tolerance, pathological complete response (pCR) rate, and overall survival (OS).
RESULTS
Between January 2001 and May 2005, 174 patients were enrolled and treated (87 in each arm). Median follow-up was similar in both arms: 59.6 months [95% confidence interval (CI) 58.4-60.3] in arm A and 60.5 months (95% CI 58.3-61.4) in arm B. The estimated 5-year DFS rates were not different: 55% (95% CI 43.9-64.7) in arm A and 55.5% (95% CI 44.3-65.3) in arm B [hazard ratio (HR) = 0.94 (0.61-1.48); P = 0.81]. Identical results were observed for 5-year OS: 70.2% (95% CI 59.1-78.8) in arm A and 70% (95% CI 58.8-78.7) in arm B [HR = 0.93 (0.55-1.60); P = 0.814]. Following DI EC induction, in-breast and global (breast plus nodes) pCR were 28.9% and 20.1%, respectively. Estrogen receptor and pCR status were independently associated with survival.
CONCLUSION
The addition of D-5FU after preoperative DI EC and standard local therapy did not improve DFS in IBC.
CLINICAL TRIAL NUMBER
ClinicalTrials.gov identifier: NCT02324088.
背景
炎性乳腺癌（IBC）是一种罕见且侵袭性的疾病，需要采用多模式治疗。我们评估了在 IBC 患者接受术前剂量密集（DI）表柔比星-环磷酰胺（EC）和局部区域治疗后，添加多西紫杉醇-5-氟尿嘧啶（D-5FU）方案的益处。
患者和方法
PEGASE 07 是一项全国性的随机 III 期开放标签研究，涉及法国的 14 家医院。患有非转移性 IBC 的女性符合条件，并随机分配接受四周期 DI EC（E 150 mg/m²和 C 4000 mg/m²，每 3 周重复一次造血干细胞支持），然后行乳房切除术和腋窝淋巴结清扫术，以及放疗（A 组）或相同的治疗后，接受四周期 D-5FU（D 85 mg/m²，第 1 天和 5FU 750 mg/m²/天连续输注，第 1-5 天每 3 周），在放疗后给予（B 组）。激素受体阳性肿瘤患者接受激素治疗。无病生存期（DFS）是主要终点。次要终点包括耐受性、病理完全缓解（pCR）率和总生存期（OS）。
结果
2001 年 1 月至 2005 年 5 月，共纳入并治疗了 174 名患者（每组 87 名）。两组的中位随访时间相似：A 组为 59.6 个月（95%置信区间[CI]为 58.4-60.3），B 组为 60.5 个月（95%CI 为 58.3-61.4）。估计的 5 年 DFS 率无差异：A 组为 55%（95%CI 为 43.9-64.7），B 组为 55.5%（95%CI 为 44.3-65.3）[风险比（HR）=0.94（0.61-1.48）；P=0.81]。5 年 OS 也观察到相同的结果：A 组为 70.2%（95%CI 为 59.1-78.8），B 组为 70%（95%CI 为 58.8-78.7）[HR=0.93（0.55-1.60）；P=0.814]。在 DI EC 诱导后，乳腺内和全局（乳腺加淋巴结）pCR 分别为 28.9%和 20.1%。雌激素受体和 pCR 状态与生存独立相关。
结论
在术前 DI EC 和标准局部治疗后添加 D-5FU 并未改善 IBC 的 DFS。
临床试验编号
ClinicalTrials.gov 标识符：NCT02324088。
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