Phase II study of first-line intensity-modulated radiotherapy (IMRT) followed by gemcitabine, dexamethasone, and cisplatin for high-risk early-stage extranodal nasal-type NK/T-cell lymphoma: the GREEN study
Mené en Chine sur 40 patients atteints d'un lymphome T ou NK extra-ganglionnaire de type nasal et de stade précoce (durée médiane de suivi : 60,1 mois), cet essai de phase II évalue l'efficacité, du point de vue du taux de survie sans progression et du taux de survie globale à 2 ans, et la toxicité d'une radiothérapie avec modulation d'intensité suivie d'un traitement par gemcitabine-dexaméthasone-cisplatine
Purpose : To investigate the efficacy and toxicity profile of sequential intensity-modulated radiotherapy (IMRT) followed by GDP (gemcitabine, dexamethasone, and cisplatin) on previously untreated high-risk early-stage upper aerodigestive tract NK/T-cell lymphoma (UADT-NKTCL). Methods : A phase II study was designed and forty high-risk patients with stage I(E)/II(E) UADT-NKTCL were enrolled between June 2010 and June 2014. High-risk patients were defined as those with at least one pre-defined risk factor: age > 60 years, elevated serum lactate dehydrogenase, regional lymph node involvement, B symptoms, and primary tumor invasion. Patients received extended involved-site IMRT and GDP chemotherapy. The primary endpoint was the 2-year progression-free survival (PFS) rate. Secondary endpoints were the 2-year overall survival (OS) rate, overall response rate (ORR), and toxicity. Results : Median follow-up time was 60.1 months. The ORR and complete remission rate were 97.5% and 95.0%. The 2- and 5-year PFS rates were 84.7% and 79.4%, and the corresponding OS rates were 89.9% and 82.1%, respectively. The most frequent radiation-induced toxicities were mild mucositis and skin reaction. Grade 3/4 neutropenia (12/40), thrombocytopenia (7/40), and anemia (2/40) were observed during chemotherapy. Conclusions : First-line IMRT followed by GDP represents an effective and well-tolerated protocol for high-risk early-stage UADT-NKTCL.