PO.CL09.02 · 临床研究
辅助剂量密集化疗与早期、淋巴结阴性、HER2阴性乳腺癌无复发生存期的改善无关
Adjuvant dose-dense chemotherapy is not associated with improved recurrence-free survival in early-stage, node-negative, HER2-negative breast cancer
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
引言：辅助剂量密集（DD）化疗可改善早期、淋巴结阳性乳腺癌的结局，尽管证据有限且毒性增加，仍常被外推至淋巴结阴性疾病。DD化疗是否在这一低危人群中带来获益尚不明确。
方法：回顾性识别年龄≥18岁、T1-T2、淋巴结阴性、HER2阴性乳腺癌且接受辅助DD或非DD化疗的女性患者。无复发生存期（RFS）定义为从根治性手术至首次记录复发的时间；无复发患者在其最后一次无病临床或影像学评估时进行右删失。使用逆Kaplan-Meier法估算中位随访时间。使用log-rank检验比较RFS，并使用多变量Cox比例风险回归估算校正后风险比（HR）。
结果：共纳入139例患者，其中50例（36%）接受DD化疗。接受DD化疗的患者更年轻（50岁vs 56岁，P<0.001），T2肿瘤比例更高（48% vs 27%，P=0.012），在激素受体状态、肿瘤病灶性或淋巴血管侵犯方面无显著差异。在中位随访9.9年（95% CI：9.0-11.2）期间，17例患者（12%）发生复发（DD组7/50 [14%]，非DD组10/89 [11%]）。DD组与非DD组之间RFS无差异（log-rank P=0.509）。在校正年龄、激素受体状态、T分期、肿瘤病灶性和淋巴血管侵犯后，DD化疗与复发风险降低无关（HR：0.97 [95% CI：0.26-3.26]，P=0.961）。这些发现在各T分期中一致，T1（log-rank P=0.947）或T2（log-rank P=0.755）亚组中RFS均无差异，治疗方案与T分期之间无显著交互作用（交互作用P=0.512）。
结论：即使在校正临床和病理特征后，DD化疗与早期、淋巴结阴性、HER2阴性乳腺癌患者复发风险的降低无关。尽管受复发事件数量较少的限制，这些发现提示在这一低危人群中常规使用DD化疗可能并不合理。需要更大规模的前瞻性研究以确定是否有任何亚组患者能获得有意义的获益。
查看英文原文 English abstract
Introduction: Adjuvant dose-dense (DD) chemotherapy improves outcomes in early-stage, node-positive breast cancer and is often extrapolated to node-negative disease despite limited evidence and increased toxicity. Whether DD chemotherapy confers benefit in this low-risk population remains unclear.
Methods: Females aged ≥ 18 years with T1-T2, node-negative, HER2-negative breast cancer who received adjuvant DD or non-DD chemotherapy were retrospectively identified. Recurrence-free survival (RFS) was defined as the time from definitive surgery to first documented recurrence; patients without recurrence were right-censored at their last disease-free clinical or imaging assessment. Median follow-up duration was estimated using the reverse Kaplan-Meier method. RFS was compared using log-rank tests, and adjusted hazard ratios (HRs) were estimated using multivariable Cox proportional hazards regression.
Results: A total of 139 patients were included, 50 (36%) of whom received DD chemotherapy. Patients treated with DD chemotherapy were younger (50 vs. 56 years, P < 0.001) and had higher rates of T2 tumors (48% vs. 27%, P = 0.012), with no significant differences in hormone receptor status, tumor focality, or lymphovascular invasion. Over a median follow-up duration of 9.9 years (95% CI: 9.0-11.2), 17 patients (12%) developed recurrence (7/50 [14%] in the DD group and 10/89 [11%] in the non-DD group). There was no difference in RFS between DD and non-DD groups ( P log-rank = 0.509). After adjustment for age, hormone receptor status, T stage, tumor focality, and lymphovascular invasion, DD chemotherapy was not associated with reduced recurrence risk (HR: 0.97 [95% CI: 0.26-3.26], P = 0.961). These findings were consistent across T stages, with no difference in RFS in either T1 ( P log-rank = 0.947) or T2 ( P log-rank = 0.755) subgroups, and no significant interaction between treatment regimen and T stage ( P interaction = 0.512).
Conclusions: DD chemotherapy was not associated with a reduction in recurrence risk among patients with early-stage, node-negative, HER2-negative breast cancer, even after adjustment for clinical and pathological characteristics. Although limited by a low number of recurrence events, these findings suggest that routine use of DD chemotherapy in this low-risk population may not be justified. Larger prospective studies are needed to identify whether any subset of patients derives meaningful benefit.
利益披露 Disclosure
J. Shpigelman, None..
T. Alsebai, None..
K. Robinson, None..
A. Nimavat, None..
R. Cossyleon, None..
K. Rao, None.