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Long‐term results of a phase II trial with frontline concurrent chemoradiotherapy followed by consolidation chemotherapy for localized nasal natural killer/T‐cell lymphoma
Author(s) -
Tsai HuiJen,
Lin ShengFung,
Chen ChuChih,
Chen TsaiYun,
Su WuChou,
Hwang WenLi,
Lin JinChing,
Chiou TzeonJye,
Kao WeioYau,
Chiu ChangFang,
Chang YiFang,
Chang Jeffrey S.,
Chang MingChih,
Su IhJen
Publication year - 2015
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12405
Subject(s) - medicine , etoposide , regimen , phases of clinical research , lymphoma , dexamethasone , leukopenia , clinical endpoint , gastroenterology , chemotherapy , surgery , clinical trial
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 cG y 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 ( NCT 00292695). 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 .