Long-term results of a phase II trial with frontline concurrent chemoradiotherapy followed by consolidation chemotherapy for localized nasal natural killer/T-cell lymphoma

Purpose A phase II trial was conducted to evaluate the therapeutic efficacy and safety profiles of frontline concurrent chemoradiotherapy (CCRT) plus consolidation chemotherapy for patients with stage I/II nasal natural killer/T‐cell lymphoma (NKTCL). Patients and methods Patients with newly diagnosed, measurable stage I/II nasal NKTCL were eligible. The CCRT included two cycles of the DEP regimen (dexamethasone, etoposide, and cisplatin) every 4 wk with concurrent 5040 cGy radiation in 28 fractions for 5 wk. Patients without disease progression after CCRT were subjected to two cycles of DVIP consisted of dexamethasone, etoposide, ifosphamide, mesna, and cisplatin every 4 wk. The primary endpoint was tumor response rate, and secondary endpoints were survival and toxicities. This phase II study has been registered in the ClinicalTrials.gov (NCT00292695). Results Thirty‐three patients received CCRT, and 29 patients received two cycles of consolidation DVIP after CCRT. Among the 32 evaluable patients, 20 achieved complete response and 6 achieved partial response. The overall and complete response rate was 81% (95% CI, 68–95%) and 63% (95% CI, 46–79%), respectively. The 2‐yr and 5‐yr progression‐free survival rate for intention‐to‐treat population was 64% (95% CI, 47–80%) and 60% (95% CI, 39–73%), respectively; while the corresponding overall survival rate was 73% (95% CI, 57–88%) and 66% (95% CI, 50–83%), respectively. The most common treatment‐related grade 3/4 adverse event was leukopenia (85%). Conclusion Frontline CCRT plus consolidation chemotherapy is feasible and effective for treating localized nasal NKTCL.