Randomized, multicenter phase 3 study evaluating radiotherapy versus concurrent chemoradiotherapy in nasopharyngeal carcinoma patients achieving CR/PR after induction chemotherapy

Cancer research · Nasopharyngeal carcinoma

IC + RT demonstrated a favorable safety profile compared with IC+CCRT in nasopharyngeal carcinoma patients achieving CR/PR after induction chemotherapy.

Background: This study compared the efficacy and safety of radiotherapy (RT) versus concurrent chemoradiotherapy (CCRT) in nasopharyngeal carcinoma (NPC) patients who achieved complete or partial response (CR/PR) following induction chemotherapy. Methods: In this multicenter, randomized, open‑label, phase 3 non‑inferiority trial, 220 newly diagnosed stage III–IVb NPC patients who achieved CR/PR after induction chemotherapy were randomized (1:1) to receive either IC + RT or IC + CCRT. Primary endpoint was progression‑free survival (PFS); secondary endpoints included overall survival (OS) and adverse event incidence. Results: 109 patients received IC + RT and 111 received IC + CCRT. Median follow‑up was 57 months. Five‑year PFS rates were 87.0% (IC + RT) versus 80.7% (IC + CCRT) (P = 0.21). No significant differences were observed in local relapse‑free survival, regional relapse‑free survival, locoregional relapse‑free survival, distant metastasis‑free survival, or OS (all P > 0.05). Grade 3–4 hematologic and gastrointestinal toxicities were significantly lower in the IC + RT group. Grade 1–2 deafness/otitis and liver dysfunction were also less frequent in the IC + RT group. Conclusions: In NPC patients achieving CR/PR after induction chemotherapy, IC + RT demonstrated a favorable safety profile compared with IC + CCRT. Survival outcomes were numerically comparable, but the early termination of the trial and limited statistical power preclude a definitive non‑inferiority claim. These hypothesis‑generating findings warrant validation in future adequately powered trials.

This trial informs clinicians that adding radiotherapy alone after induction chemotherapy offers a safer alternative to concurrent chemoradiotherapy without compromising preliminary efficacy in nasopharyngeal carcinoma, while highlighting the need for larger, adequately powered studies to confirm non‑inferiority.

Evidence level: Megerősített klinikai bizonyíték. Több vagy erősebb humán vizsgálat támogatja.

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