PO.CL09.02 · 临床研究
影响新辅助化疗后有残留病灶的三阴性乳腺癌患者辅助卡培他滨相对剂量强度的实践模式
Practice patterns impacting relative dose intensity of adjuvant capecitabine among triple negative breast cancer patients with residual disease following neoadjuvant chemotherapy
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
背景：本研究旨在识别卡培他滨处方中的真实世界实践模式因素，并评估哪些因素导致更高的相对剂量强度（RDI），以帮助解决限制评估辅助卡培他滨真实世界疗效能力的剂量策略变异性。
方法：这项机构回顾性研究纳入了2016年1月1日至2023年12月31日间诊断为三阴性乳腺癌、新辅助化疗后有残留病灶并接受≥1剂辅助卡培他滨的患者。我们的目的是检查影响实现RDI>66%的因素，标准剂量基于共8个周期、每周期21天的卡培他滨。因素包括放射治疗、剂量减少、处方方案、年龄、种族、肿瘤分级、淋巴结状态、肿瘤大小、残留癌负荷、淋巴血管侵犯以及新辅助pembrolizumab和carboplatin。我们还使用预定义百分位（0-66%、67-92%和93-100%）检查RDI是否影响浸润性无病生存期（iDFS）和总生存期（OS）。
结果：在83例总患者中，45例RDI≤66，29例RDI>67-92，9例RDI≥92-100。在上述所有临床病理因素中，仅卡培他滨采用7天处方方案（28天周期）对实现RDI>66%的能力有实质性降低（p=0.0234）。在检查单变量iDFS时，各RDI百分位之间未见统计学显著差异（p=0.667），但较高RDI组中观察到iDFS改善的趋势。5年iDFS：RDI≤66为78.4%，RDI>67-92为77.9%，RDI>93-100为88.9%。OS方面同样如此，各RDI百分位之间未见统计学显著差异（p=0.395），但当RDI超过66%时观察到OS改善的趋势。5年OS：RDI≤66为82.1%，RDI>67-92为92.7%，RDI>92-100为88.9%。
结论：真实世界实践模式可能存在差异，但本研究表明，实施每周卡培他滨给药频率能显著影响实现更高RDI值的能力。虽然iDFS或OS未见统计学差异，但对于RDI≤66%者记录到结局恶化的趋势。
查看英文原文 English abstract
Background: This study aims to identify real-world practice pattern factors in capecitabine prescribing and assess which factors lead to higher relative dose intensity (RDI) to help address the variability in dosing strategies that limits the ability to assess the real-world effectiveness of adjuvant capecitabine.
Methods: This institutional retrospective study involved patients diagnosed with triple negative breast cancer from 1/1/2016 to 12/31/2023 who had residual disease following neoadjuvant chemotherapy and received ≥1 dose of adjuvant capecitabine. Our objective was to examine factors that influence the achievement of an RDI >66%, with standard dosing based on a total of 8 cycles of capecitabine over 21-day cycles. Factors included radiation therapy, dose reductions, prescribing schedule, age, race, tumor grade, nodal status, tumor size, residual cancer burden, lymphovascular invasion, and neoadjuvant pembrolizumab & carboplatin. We also examined whether RDI impacts invasive disease-free survival (iDFS) and overall survival (OS) using pre-defined percentiles (0-66%, 67-92%, & 93-100%).
Results: Of the 83 total patients, 45 were RDI≤66, 29 were RDI>67-92, & 9 were RDI≥92-100. Among all clinicopathologic factors listed above, only the use of a 7-day prescribing schedule for capecitabine (28-day cycle) had a meaningful reduction on one's ability to reach an RDI of >66% (p=0.0234). When examining univariate iDFS, no statistically significant difference was noted between RDI percentiles (p=0.667) but a trend towards improved iDFS was noted among higher RDI groups. The 5-year iDFS was 78.4% for RDI≤66, 77.9% for RDI>67-92, & 88.9% for RDI>93-100. Similarly for OS, no statistically significant difference was noted between RDI percentiles (p=0.395), but a trend towards improved OS was noted when RDI exceeded 66%. The 5-year OS was 82.1% for RDI≤66, 92.7% for RDI>67-92, & 88.9% for RDI>92-100.
Conclusion: Real world practice patterns can differ, but the implementation of weekly capecitabine dosing frequency has been shown in this study to significantly influence the ability to achieve higher RDI values. While no statistical difference in iDFS or OS was noted, a trend towards worsening outcomes was recorded for those with an RDI≤66%.
利益披露 Disclosure
A. House, None..
P. Thakur, None..
B. Hoeting, None..
R. Johnson, None..
B. Sandoval, None..
J. Stephens, None..
D. G. Stover, None..
S. Sardesai, None..
T. Jitwatcharakomol, None..
S. Beyer, None..
A. M. Roy, None..
N. Lopetegui-Lia, None..
D. M. Quiroga, None..
A. P. Davenport, None..
G. Bader, None..
N. O. Williams, None..
R. Wesolowski, None..
M. E. Gatti-Mays, None..
K. C. C. Johnson, None.