基于奥沙利铂的辅助化疗治疗 III 期结肠癌的真实世界耐受性和结局-剂量强度是否重要？

Real-world tolerance and outcomes of oxaliplatin-based adjuvant chemotherapy for stage III colon cancer-Does dose intensity matter?

机构信息

Medical Oncology, Liverpool Hospital, Sydney, New South Wales, Australia.

Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia.

出版信息

Asia Pac J Clin Oncol. 2024 Feb;20(1):63-70. doi: 10.1111/ajco.13965. Epub 2023 May 22.

DOI:10.1111/ajco.13965

PMID:37211922

Abstract

INTRODUCTION

Fluoropyrimidine and oxaliplatin-based adjuvant chemotherapy delivered as 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX), or capecitabine and oxaliplatin (CAPOX) is the standard of care for resected stage III colon cancer. Without randomized trial data, we compared real-world dose intensity, survival outcomes, and tolerability of these regimens.

METHODS

Records of patients treated with FOLFOX or CAPOX in the adjuvant setting for stage III colon cancer across four institutions in Sydney during 2006-2016 were reviewed. The relative dose intensity (RDI) of fluoropyrimidine and oxaliplatin of each regimen, disease-free survival (DFS), overall survival (OS), and incidence of grade ≥2 toxicities were compared.

RESULTS

Characteristics of patients receiving FOLFOX (n = 195) and CAPOX (n = 62) were evenly matched. FOLFOX patients had a higher mean RDI for both fluoropyrimidine (85% vs. 78%, p < 0.01) and oxaliplatin (72% vs. 66%, p = 0.06). In spite of a lower RDI, CAPOX patients trended toward a better 5-year DFS (84% vs. 78%, HR = 0.53, p = 0.068) and similar OS (89% vs. 89%, HR = 0.53, p = 0.21) compared to the FOLFOX group. This difference was most pronounced in the high-risk (T4 or N2) group where 5-year DFS was 78% versus 67% (HR = 0.41, p = 0.042). Patients receiving CAPOX experienced more grade ≥2 diarrhea (p = 0.017) and hand-foot syndrome (p < 0.001) but not peripheral neuropathy or myelosuppression.

CONCLUSION

In a real-world setting, patients who received CAPOX had similar OS rates when compared to those receiving FOLFOX in the adjuvant setting in spite of lower RDI. In the high-risk population, CAPOX appears to demonstrate a superior 5-year DFS over FOLFOX.

摘要

简介

氟嘧啶和奥沙利铂为基础的辅助化疗，以氟尿嘧啶、亚叶酸钙和奥沙利铂（FOLFOX）或卡培他滨和奥沙利铂（CAPOX）的形式给药，是 III 期结肠癌切除后的标准治疗方法。没有随机试验数据，我们比较了这些方案的真实世界剂量强度、生存结果和耐受性。

方法

回顾了 2006 年至 2016 年期间，悉尼四家机构接受 FOLFOX 或 CAPOX 辅助治疗 III 期结肠癌的患者的记录。比较了每个方案氟嘧啶和奥沙利铂的相对剂量强度（RDI）、无病生存期（DFS）、总生存期（OS）和≥2 级毒性的发生率。

结果

接受 FOLFOX（n=195）和 CAPOX（n=62）的患者特征均匀匹配。FOLFOX 患者氟嘧啶（85% vs. 78%，p<0.01）和奥沙利铂（72% vs. 66%，p=0.06）的平均 RDI 更高。尽管 RDI 较低，但 CAPOX 患者的 5 年 DFS （84% vs. 78%，HR=0.53，p=0.068）和 OS（89% vs. 89%，HR=0.53，p=0.21）趋势优于 FOLFOX 组。在高危（T4 或 N2）组中，这种差异最为明显，5 年 DFS 为 78%，而 FOLFOX 组为 67%（HR=0.41，p=0.042）。接受 CAPOX 的患者更易发生≥2 级腹泻（p=0.017）和手足综合征（p<0.001），但周围神经病变或骨髓抑制发生率无差异。