Department of Oncology, Jönköping, Region Jönköping County, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden; Department of Clinical Sciences Lund, Division of Oncology and Pathology, Lund University, Lund, Sweden.
Department of Clinical Sciences Lund, Division of Oncology and Pathology, Lund University, Lund, Sweden.
Eur J Cancer. 2019 Mar;110:53-61. doi: 10.1016/j.ejca.2018.12.034. Epub 2019 Feb 12.
The primary aim was to compare 2 years of adjuvant tamoxifen versus no systemic treatment in premenopausal patients with oestrogen receptor (ER)-positive tumours, regarding breast cancer-free interval (BCFi) and distant recurrence-free interval (D-RFi), with 30 years of follow-up and for specified intervals. Moreover, we aimed to investigate the effects of adjuvant tamoxifen on the incidence of secondary malignancies and survival after distant recurrence.
Premenopausal patients with primary breast cancer were randomised to 2 years of tamoxifen (n = 277) or no systemic treatment (n = 287), irrespective of ER status. Information regarding events was collected by a review of medical records and from national registers.
The median follow-up for all patients without events was 28 years, and only four of the patients alive had a follow-up of <20 years. With 30 years of follow-up, tamoxifen prolonged BCFi in the intention-to-treat population (hazard ratio [HR] = 0.76, 95% confidence interval (CI) 0.61-0.94, p = 0.011) compared with no treatment. In patients with ER-positive tumours (n = 362), tamoxifen prolonged BCFi (HR = 0.62, 95% CI 0.47-0.82, p = 0.001) and D-RFi (HR = 0.73, 95% CI 0.54-0.99, p = 0.043). The positive effect on BCFi was significant also for the interval >15-30 years (HR = 0.53, 95% CI 0.28-0.98, p = 0.042). For patients with ER-positive tumours who were diagnosed with distant recurrence (n = 165), survival after distant recurrence was shorter among tamoxifen-treated patients (median, 29 months versus 43 months). The incidence of contralateral breast cancer was 42% lower in the tamoxifen group (HR = 0.58, 95% CI 0.35-0.96, p = 0.035), whereas no differences were observed regarding other secondary malignancies.
With three decades of follow-up, 2 years of adjuvant tamoxifen reduced the incidence of breast cancer-related events and distant recurrence, and the carryover effect seems to extend beyond 15 years. Moreover, adjuvant tamoxifen seems to be associated with shorter survival after diagnosis of distant recurrence.
本研究旨在比较 2 年辅助他莫昔芬与无全身治疗用于雌激素受体（ER）阳性肿瘤的绝经前患者，以评估乳腺癌无病间隔（BCFi）和远处无复发生存（D-RFi），随访时间为 30 年，并对特定间隔进行分析。此外，我们还旨在研究辅助他莫昔芬对继发恶性肿瘤发病率和远处复发后生存的影响。
将原发性乳腺癌的绝经前患者随机分为 2 年他莫昔芬组（n=277）或无全身治疗组（n=287），无论 ER 状态如何。通过审查病历和国家登记册收集事件相关信息。
所有无事件患者的中位随访时间为 28 年，仅有 4 例存活患者的随访时间<20 年。在意向治疗人群中，他莫昔芬延长了 BCFi（风险比[HR]0.76，95%置信区间[CI]0.61-0.94，p=0.011）。在 ER 阳性肿瘤患者（n=362）中，他莫昔芬延长了 BCFi（HR 0.62，95%CI 0.47-0.82，p=0.001）和 D-RFi（HR 0.73，95%CI 0.54-0.99，p=0.043）。BCFi>15-30 年的间隔也有显著的正效应（HR 0.53，95%CI 0.28-0.98，p=0.042）。对于诊断为远处复发的 ER 阳性肿瘤患者（n=165），远处复发后接受他莫昔芬治疗的患者生存时间更短（中位数，29 个月比 43 个月）。与对照组相比，他莫昔芬组同侧乳腺癌的发病率降低了 42%（HR 0.58，95%CI 0.35-0.96，p=0.035），而其他继发性恶性肿瘤无差异。
经过 30 年的随访，2 年的辅助他莫昔芬降低了乳腺癌相关事件和远处复发的发生率，且这种持续效应似乎超过 15 年。此外，辅助他莫昔芬似乎与远处复发后生存时间缩短有关。
