GeparOcto 试验随机 III 期生存分析比较了高强度密集剂量表柔比星、紫杉醇、环磷酰胺与每周紫杉醇、脂质体多柔比星（三阴性乳腺癌加卡铂）在高危早期乳腺癌患者中的新辅助化疗。
Survival analysis of the randomised phase III GeparOcto trial comparing neoadjuvant chemotherapy of intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for patients with high-risk early breast cancer.
机构信息
National Center for Tumour Diseases, University Hospital and German Cancer Research Center, Heidelberg, Germany.
Medical Clinic II, University Hospital Frankfurt, Germany.
出版信息
Eur J Cancer. 2022 Jan;160:100-111. doi: 10.1016/j.ejca.2021.10.011. Epub 2021 Nov 17.
BACKGROUND
GeparOcto demonstrated that pathological complete response (pCR) of intense dose-dense epirubicin, paclitaxel and cyclophosphamide (iddEPC) was comparable to weekly paclitaxel/non-pegylated liposomal doxorubicin (plus carboplatin (PM(Cb) in triple-negative breast cancer [TNBC]) in high-risk early breast cancer (BC). Here, we report time-to-event secondary end-points.
PATIENTS AND METHODS
Patients were randomised to receive 18 weeks of E (150 mg/m) followed by P (225 mg/m) followed by C (2000 mg/m), each q2w or weekly P (80 mg/m) plus M (20 mg/m) plus, in TNBC, Cb (AUC 1.5). Patients with human epidermal growth factor receptor 2-positive (HER2+)BC received trastuzumab (6[loading dose 8]mg/kg q3w) and pertuzumab (420[840]mg q3w) with P and C cycles.
RESULTS
945 patients started treatment (iddEPC n = 470; PM(Cb) n = 475). After a median follow-up of 47.0 (range 1.6-61.5) months, 162 (75 in iddEPC; 87 in PM(Cb)) invasive disease-free survival (iDFS) events and 79 (41 in iddEPC; 38 in PM(Cb)) deaths were reported. No significant difference was observed in 4-year iDFS (81.9% iddEPC versus 79.7% PM(Cb), HR = 1.16 [95%CI 0.85-1.59], log-rank p = 0.334) or 4-year overall survival (OS) (90.3% iddEPC versus 90.6% PM(Cb), HR = 0.90 [95%CI 0.58-1.40], log-rank p = 0.637) overall and in HER2+ and TNBC subgroups. HR+/HER2- BC patients, however, had significantly better 4-year iDFS (77.9% iddEPC versus 62.5% PM, HR = 2.11 [95%CI 1.08-4.10], log-rank p = 0.025) and 4-year OS with iddEPC (94.7% iddEPC versus 80.1% PM, HR = 3.26 [95%CI 1.06-10.00], log-rank p = 0.029).
CONCLUSION
While there was no difference in survival for the entire cohort, the HR+/HER2-subgroup significantly benefits from iddEPC. This supports the concept of an additional effect of NACT beyond pCR in patients with HR+/HER2- BC. CLINICALTRIALS.
GOV IDENTIFIER
NCT02125344.
背景
GeparOcto 研究表明，在高危早期乳腺癌（BC）中，密集剂量表柔比星、紫杉醇和环磷酰胺（iddEPC）的病理完全缓解（pCR）与每周紫杉醇/非聚乙二醇脂质体阿霉素（加卡铂（PM（Cb））在三阴性乳腺癌（TNBC）中相当。在这里，我们报告时间事件次要终点。
患者和方法
患者被随机分配接受 18 周的 E（150mg/m），然后是 P（225mg/m），然后是 C（2000mg/m），每 2 周一次，或每周 P（80mg/m）加 M（20mg/m），在 TNBC 中加 Cb（AUC 1.5）。人表皮生长因子受体 2 阳性（HER2+）BC 患者接受曲妥珠单抗（6[负荷剂量 8]mg/kg q3w）和帕妥珠单抗（420[840]mg q3w）加 P 和 C 周期。
结果
945 名患者开始治疗（iddEPC n=470；PM（Cb）n=475）。中位随访 47.0（范围 1.6-61.5）个月后，报告了 162 例（iddEPC 75 例；PM（Cb）87 例）侵袭性无病生存（iDFS）事件和 79 例（iddEPC 41 例；PM（Cb）38 例）死亡。4 年 iDFS（iddEPC 为 81.9%，PM（Cb）为 79.7%，HR=1.16[95%CI 0.85-1.59]，对数秩检验 p=0.334）或 4 年总生存（OS）（iddEPC 为 90.3%，PM（Cb）为 90.6%，HR=0.90[95%CI 0.58-1.40]，对数秩检验 p=0.637）总体以及 HER2+和 TNBC 亚组均无显著差异。然而，HR+/HER2-BC 患者 4 年 iDFS（iddEPC 为 77.9%，PM 为 62.5%，HR=2.11[95%CI 1.08-4.10]，对数秩检验 p=0.025）和 4 年 OS（iddEPC 为 94.7%，PM 为 80.1%，HR=3.26[95%CI 1.06-10.00]，对数秩检验 p=0.029）明显更好。
结论
尽管整个队列的生存无差异，但 HR+/HER2-亚组从 iddEPC 中显著获益。这支持了在 HR+/HER2-BC 患者中，NACT 除了 pCR 之外还有额外疗效的概念。临床试验。
GOV IDENTIFIER
NCT02125344。
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