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UCBG 2-08:UNICANCER-PACS08 随机 III 期试验辅助治疗 5 年疗效结果,早期预后不良乳腺癌患者接受 FEC100 治疗后,分别给予多西他赛或伊沙匹隆治疗。

UCBG 2-08: 5-year efficacy results from the UNICANCER-PACS08 randomised phase III trial of adjuvant treatment with FEC100 and then either docetaxel or ixabepilone in patients with early-stage, poor prognosis breast cancer.

机构信息

ICO René Gauducheau, Saint-Herblain, France.

Gustave Roussy, Villejuif, France.

出版信息

Eur J Cancer. 2018 Nov;103:184-194. doi: 10.1016/j.ejca.2018.06.025. Epub 2018 Sep 26.

Abstract

PURPOSE

UNICANCER-PACS08 compared adjuvant FEC (5-FU; epirubicin; cyclophosphamide) then docetaxel to FEC then ixabepilone in poor prognosis early breast cancer (BC). We evaluated whether replacing docetaxel with ixabepilone would increase 5-year disease-free survival (DFS).

PATIENTS AND METHODS

Triple-negative breast cancer (TNBC) or oestrogen receptor (ER)+/progesterone receptor (PR)-/HER2- BC patients were randomised to receive standard FEC (3 cycles) followed by 3 cycles of either docetaxel (100 mg/m) or ixabepilone (40 mg/m). Radiotherapy was mandatory after conservative surgery; ER+ patients received endocrine therapy.

RESULTS

Seven hundred sixty-two patients were enrolled between October 2007 and September 2010. Baseline characteristics were balanced between arms. Median follow-up was 66.7 months. Median DFS was not reached; 5-year DFS rate was 76% with docetaxel and 79% with ixabepilone (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.58-1.10; p = 0.175). Median overall survival (OS) was not reached; 5-year OS rate was 86% versus 84% (HR = 0.97; 95% CI = 0.66-1.42; p = 0.897). TNBC patients treated with ixabepilone had a 23% lower risk of relapse compared to docetaxel (HR for DFS = 0.77; 95% CI = 0.53-1.11; p = 0.168). DFS was longer with ixabepilone than docetaxel in patients with grade II-III lymphocytic infiltration (HR = 0.55; 95% CI = 0.29-1.05; p = 0.063). All patients experienced ≥1 adverse events (AEs): 75% reported grade III-IV AEs and two (<1%) had grade V AEs (both with neutropenia and infection receiving ixabepilone).

CONCLUSION

After adjuvant FEC, ixabepilone was comparable to docetaxel for treating poor prognosis early BC patients. The benefit of ixabepilone in subgroups (patients with TNBC and grade II-III lymphocytic infiltration) requires further evaluation.

摘要

目的

UNICANCER-PACS08 比较了辅助 FEC(5-FU;表柔比星;环磷酰胺)序贯多西他赛与 FEC 序贯伊沙匹隆在预后不良的早期乳腺癌(BC)中的疗效。我们评估了用伊沙匹隆替代多西他赛是否会增加 5 年无病生存率(DFS)。

患者和方法

三阴性乳腺癌(TNBC)或雌激素受体(ER)+/孕激素受体(PR)-/HER2-BC 患者随机接受标准 FEC(3 个周期)序贯多西他赛(100mg/m)或伊沙匹隆(40mg/m)3 个周期。保乳手术后必须进行放疗;ER+患者接受内分泌治疗。

结果

2007 年 10 月至 2010 年 9 月期间共纳入 762 例患者。两组患者的基线特征均衡。中位随访时间为 66.7 个月。中位 DFS 未达到;5 年 DFS 率为多西他赛组 76%,伊沙匹隆组 79%(风险比[HR] 0.80;95%置信区间[CI] 0.58-1.10;p=0.175)。中位总生存(OS)未达到;5 年 OS 率为多西他赛组 86%,伊沙匹隆组 84%(HR 0.97;95%CI 0.66-1.42;p=0.897)。与多西他赛相比,伊沙匹隆治疗的 TNBC 患者复发风险降低 23%(DFS 的 HR 为 0.77;95%CI 0.53-1.11;p=0.168)。在淋巴细胞浸润程度为 II-III 级的患者中,伊沙匹隆的 DFS 长于多西他赛(HR 0.55;95%CI 0.29-1.05;p=0.063)。所有患者均发生≥1 例不良事件(AE):75%报告了 3 级-4 级 AE,2 例(<1%)发生了 5 级 AE(均为中性粒细胞减少症和感染,接受伊沙匹隆治疗)。

结论

在辅助 FEC 后,伊沙匹隆与多西他赛在治疗预后不良的早期 BC 患者方面疗效相当。亚组(TNBC 患者和淋巴细胞浸润程度为 II-III 级的患者)中伊沙匹隆的获益需要进一步评估。

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