新辅助卡培他滨与氟尿嘧啶输注治疗局部进展期直肠癌的真实世界结局。

Real-world outcomes for neoadjuvant capecitabine versus infusional 5-fluorouracil in the treatment of locally advanced rectal cancer.

机构信息

Division of Personalised Oncology, Walter and Eliza Hall, Melbourne, Victoria, Australia.

Department of Medical Biology, University of Melbourne, Melbourne, Victoria, Australia.

出版信息

Intern Med J. 2021 Aug;51(8):1262-1268. doi: 10.1111/imj.15045.

DOI:10.1111/imj.15045

PMID:32896960

Abstract

BACKGROUND

Neoadjuvant chemoradiation therapy is standard-of-care treatment for locally advanced rectal cancer (LARC). A pathological complete response (pCR) following chemoradiation therapy is an early indicator of treatment benefit and associated with excellent survival outcomes, with capecitabine largely replacing infusional 5-fluorouracil as the choice in routine care of LARC.

AIMS

To analyse the uptake of capecitabine usage over time, and on the back of clinical trial data demonstrating equivalence between fluoropyrimidines, confirm that efficacy is maintained in the real-world setting.

METHODS

We analysed data from a prospectively maintained colorectal cancer database at three Australian hospitals including patients diagnosed from January 2009 to December 2018. Pathological response was determined as either complete or incomplete and compared for patients receiving 5-FU or capecitabine.

RESULTS

A total of 657 patients was analysed, 498 receiving infusional 5-FU and 159 capecitabine. Capecitabine use has markedly increased from approval in 2014 in Australia, now being used in more than 80% of patients. Patient characteristics were similar by treatment, including age, tumour location and pre-treatment stage. pCR was reported in 22/159 (13.8%) of capecitabine-treated patients and 118/380 (23.7%) that received 5-FU (P ≤ 0.01). More capecitabine-treated patients received post-operative oxaliplatin (44.2% vs 6.3%, P < 0.01). Two-year progression-free survival was similar (84.9% vs 88.0%, P = 0.34).

CONCLUSIONS

Capecitabine is now the dominantly used neoadjuvant chemotherapy in LARC. Capecitabine use was associated with a lower rate of pCR versus infusional 5-FU, a difference not explained by examined patient or tumour characteristics. Poor treatment compliance with oral therapy in the real-world setting is one possible explanation.

摘要

背景

新辅助放化疗是局部晚期直肠癌（LARC）的标准治疗方法。放化疗后病理完全缓解（pCR）是治疗获益的早期指标，与极好的生存结果相关，卡培他滨在 LARC 的常规治疗中已基本取代了输注 5-氟尿嘧啶。

目的

分析卡培他滨的使用随时间的变化，并根据氟嘧啶类药物等效性的临床试验数据，证实其在真实环境中的疗效得以维持。

方法

我们分析了澳大利亚三家医院前瞻性维护的结直肠癌数据库中的数据，包括 2009 年 1 月至 2018 年 12 月期间诊断的患者。病理反应确定为完全或不完全缓解，并比较了接受 5-FU 或卡培他滨治疗的患者。

结果

共分析了 657 例患者，其中 498 例接受了输注 5-FU，159 例接受了卡培他滨。自 2014 年卡培他滨在澳大利亚获得批准以来，其使用量显著增加，现在超过 80%的患者使用。两种治疗方法的患者特征相似，包括年龄、肿瘤位置和治疗前分期。卡培他滨治疗组 pCR 报告率为 159 例中的 22 例（13.8%），5-FU 治疗组 380 例中的 118 例（23.7%）（P≤0.01）。更多接受卡培他滨治疗的患者接受了术后奥沙利铂治疗（44.2%对 6.3%，P<0.01）。两年无进展生存率相似（84.9%对 88.0%，P=0.34）。