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

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.

Capecitabine Maintenance Chemotherapy in the Treatment of Metastatic Colorectal Cancer: A Meta-Analysis

“…The first patient enrollment started in July 2010. 16 Two were published as full texts, 16 19 and one trial has not been published but available with a conference presentation. 20…”

“…In terms of safety outcomes, any adverse events were reported in one study 20 while all studies reported grade ≥ 3 adverse events. 16 19 QoL was assessed and reported in one trial using Eq. (5D).…”

“…Any adverse events were reported in one study 20 while all three studies reported grade ≥ 3 events. 16 19 20 Two studies used the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0), 16 19 while Adams used the CTCAE version 4.0. 20…”

“…The first patient enrollment started in July 2010. 16 Two were published as full texts, 16,19 and one trial has not been published but available with a conference presentation. 20 The study population of all three studies were adult patients (!18 years old) with mCRC who completed recommended first-line chemotherapy and achieved disease control, either with partial response, complete response, or stable disease.…”

What is the real value of metronomic chemotherapy in the treatment of gastrointestinal cancer?

“…For mCRC, the role of mCap ± BVZ has shown encouraging results in palliative settings and maintenance therapy for 1 stline responders [27]. In HCC, mCap improved OS compared to BSC beyond sorafenib, with better results in good performance patients (18).…”