Metronomic capecitabine as maintenance treatment after first line induction with XELOX for metastatic colorectal cancer patients.

Abstract

ABSTRACT:

Maintenance treatment after first-line chemotherapy for patients with metastatic colorectal cancer (mCRC) is a priority strategy. However, which medicine is chosen is controversial. This study aimed to determine the efficacy and safety of maintenance treatment with metronomic capecitabine vs observation.In this randomized controlled trial, patients who completed 18 weeks of induction chemotherapy with XELOX and achieved disease control were randomly assigned centrally (1:1) to receive maintenance therapy with metronomic chemotherapy or observation until disease progression. The primary endpoint was progression-free survival from randomization; secondary endpoints included overall survival and safety. Analyses were performed by intention to treat.Between January 1st, 2017 and December 31th 2018, 48 patients were enrolled and randomly assigned to receive maintenance treatment with metronomic capecitabine (n = 25) or only observation (n = 23). The median progression-free survival in the metronomic capecitabine group was 5.66 (95% confidence interval [CI] 5.25-6.07) months vs 3.98 (95%CI 3.71-4.24) months in the observation group (hazard ratio 0.11, 95% [CI] 0.04-0.26, P = .000). There was no statistically significant difference in median overall survival: 23.82 (95% CI 22.38-25.25) months in the metronomic capecitabine group vs 21.81 (95% CI 20.23-23.38) months in the observation group (hazard ratio 0.49, 95% CI 0.21-1.11, P = .087). Subgroup analyses were generally consistent with the primary finding. Similar safety profiles were observed in both arms. The most frequent adverse events in metronomic capecitabine group included neutropenia, diarrhea, hand-foot skin reaction, and mucositis.Maintenance therapy with metronomic capecitabine can be considered an alternative option following first-line chemotherapy of XELOX in patients with metastatic colorectal cancer with controlled toxicities.

• Authors: Rui Geng, Gang Wang, Lei Qiu, Bing Liu, Fan Yang, Jingyu Zhang, Yongchang Miao
• Journal: Medicine (Medicine (Baltimore)) Vol. 99 Issue 51 Pg. e23719 (Dec 18 2020) ISSN: 1536-5964 [Electronic] United States
• PMID: 33371122 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Antimetabolites, Antineoplastic
• Oxaloacetates
• Capecitabine

Topics

• Administration, Metronomic
• Aged
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Capecitabine (administration & dosage, adverse effects, therapeutic use)
• Colorectal Neoplasms (drug therapy, pathology)
• Female
• Humans
• Induction Chemotherapy
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Oxaloacetates (administration & dosage, adverse effects, therapeutic use)
• Progression-Free Survival