CHEN-YP-2021

NCT02958111 📎

Regimen

Experimental
Metronomic capecitabine 650 mg/m² twice daily for 1 year (maintenance) after completion of CCRT
Control
Standard therapy (CCRT) alone, no adjuvant

Population

High-risk locoregionally advanced NPC (stage III-IVB, excluding T3-4N0 and T3N1), post-CCRT, no progression, multicentre mainland China

Key finding

The ONE positive modern adjuvant trial in locoregional NPC. After a decade of negative adjuvant results (including Chen L 2012, Chan 2018), metronomic low-dose continuous capecitabine for one year significantly improved 3-year failure-free survival by ~10 percentage points and halved the risk of recurrence or death (HR 0.50). The mechanism — sustained anti-angiogenic and immunomodulatory effects of metronomic dosing rather than cytotoxic killing — differs fundamentally from conventional adjuvant PF. Grade 3 toxicity was modest (17% vs 6%), with hand-foot syndrome as the main dose-limiting event and no treatment-related deaths.

Source: PMID 34111416

Timeline

    Guideline citations

    • NCCN NPC (p.42)