Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
Frontier Science Foundation Hellas, Athens, Greece.
Br J Cancer. 2022 Nov;127(10):1799-1807. doi: 10.1038/s41416-022-01963-8. Epub 2022 Sep 1.
Patients with small node-negative HER2-positive breast cancer are commonly treated with paclitaxel and 1 year of adjuvant trastuzumab. We performed a sub-analysis of the ALTTO trial to explore the long-term outcomes of patients with small node-negative tumours.
The ALTTO trial randomised 8381 patients with early HER2-positive BC treated with adjuvant chemotherapy (anthracycline/taxane- or taxane/carboplatin-based), to trastuzumab (T), lapatinib (L), their sequence (T → L) or their combination (L + T). Patients with tumours ≤3 cm and node-negative were included in this sub-analysis.
A total of 2821 patients were analysed (median follow-up of 7 years). The median age was 52 years, and most patients had tumours ≤2 cm (64.3%). The 7-year disease-free survival (DFS) was 88.1% (95% CI: 86.7-89.3%). DFS was similar for arms T, T + L and T⟶L and significantly lower for arm L (stratified log-rank P = 0.031). The 7-year overall survival rate was 95.9% (95% CI: [95.0-96.6%) and the 7-year time-to-distant recurrence was 93.4% (95% CI: 92.3-94.4%).
With most patients treated with anthracycline-based regimens, ALTTO shows that patients with small tumours treated with trastuzumab and concomitant chemotherapy have excellent long-term outcomes, similar to those of the APT trial.
Clinicaltrials.gov identifier NCT00490139.
HER2 阳性的小淋巴结阴性乳腺癌患者通常接受紫杉醇和 1 年辅助曲妥珠单抗治疗。我们对 ALTTO 试验进行了亚组分析,以探讨小淋巴结阴性肿瘤患者的长期结局。
ALTTO 试验将 8381 例接受辅助化疗(蒽环类药物/紫杉烷或紫杉烷/卡铂为基础)的早期 HER2 阳性 BC 患者随机分为曲妥珠单抗(T)、拉帕替尼(L)、序贯(T→L)或联合(L+T)治疗组。该亚组分析纳入了肿瘤≤3cm 和淋巴结阴性的患者。
共分析了 2821 例患者(中位随访 7 年)。中位年龄为 52 岁,大多数患者肿瘤直径≤2cm(64.3%)。7 年无病生存率(DFS)为 88.1%(95%CI:86.7-89.3%)。T、T+L 和 T→L 组的 DFS 相似,而 L 组的 DFS 显著较低(分层对数秩检验 P=0.031)。7 年总生存率为 95.9%(95%CI:[95.0-96.6%),7 年远处复发时间为 93.4%(95%CI:92.3-94.4%)。
在大多数接受蒽环类药物为基础的治疗方案的患者中,ALTTO 表明接受曲妥珠单抗和联合化疗治疗的小肿瘤患者具有极好的长期结局,与 APT 试验相似。
Clinicaltrials.gov 标识符 NCT00490139。