Background
Open-label, multicenter, randomized phase 3 trial (N=238) in high-risk locoregionally advanced nasopharyngeal carcinoma (T4N0-2M0 or TanyN3M0). Compared induction paclitaxel-cisplatin-capecitabine (TPC) vs cisplatin-fluorouracil (PF), each followed by concurrent chemoradiotherapy. Mature 5-year update of the primary failure-free survival endpoint.
Results
Interventions and follow up: Arm A: TPC — paclitaxel + cisplatin + capecitabine, two 21-day induction cycles, then concurrent chemoradiotherapy (n=118)
Arm B: PF — cisplatin + fluorouracil, two 21-day induction cycles, then concurrent chemoradiotherapy (n=120)
Primary endpoint: failure-free survival (FFS)
mFollow up: 89.1 months
Results: FFS (5-yr): 77.6% vs 62.9% (HR 0.52, 95% CI 0.34–0.82)
DMFS (5-yr): 87.8% vs 78.8% (HR 0.51, 95% CI 0.28–0.95)
LRRFS (5-yr): 92.0% vs 82.1% (HR 0.43, 95% CI 0.21–0.88)
OS (5-yr): 89.6% vs 82.2% (HR 0.51, 95% CI 0.27–0.95)
Arm B: PF — cisplatin + fluorouracil, two 21-day induction cycles, then concurrent chemoradiotherapy (n=120)
Primary endpoint: failure-free survival (FFS)
mFollow up: 89.1 months
Results: FFS (5-yr): 77.6% vs 62.9% (HR 0.52, 95% CI 0.34–0.82)
DMFS (5-yr): 87.8% vs 78.8% (HR 0.51, 95% CI 0.28–0.95)
LRRFS (5-yr): 92.0% vs 82.1% (HR 0.43, 95% CI 0.21–0.88)
OS (5-yr): 89.6% vs 82.2% (HR 0.51, 95% CI 0.27–0.95)
Adverse events
Grade 3–4 (any): 57.6% (TPC, 68/118) vs 65.8% (PF, 79/120)
Adherence: similar between arms
Adherence: similar between arms
Conclusions
In high-risk LA-NPC, TPC induction produced durable improvements in 5-year FFS, distant metastasis-free, locoregional relapse-free, and overall survival versus PF, without added toxicity. TPC is a capecitabine-based induction alternative that improves long-term disease control before chemoradiotherapy.
Key Limitations
Single-country (China), EBV-endemic NPC population limits generalizability; open-label design; modest sample size (N=238) yields wide confidence intervals on secondary survival endpoints; primary FFS benefit was previously reported and this is the mature update rather than a first readout.
Clinical Context
Induction chemotherapy before concurrent chemoradiotherapy is standard for high-risk LA-NPC (NCCN, ESMO), with gemcitabine-cisplatin and TPF among preferred regimens. TPC offers an oral-fluoropyrimidine induction backbone with a favorable long-term efficacy and tolerability profile. No new regulatory action; informs regimen selection.