Phase I/II study of concurrent chemoradiotherapy for localized nasal NK/T-cell lymphoma: Final results of JCOG0211

8549 Background: Nasal NK/T-cell lymphoma is rare and its standard therapy has not been established. Tumor cells express P-glycoprotein concerning multi-drug resistance (MDR). Anthracycline-containing chemotherapy is not effective and %2-yr overall survival (OS) of radiotherapy (RT) alone is only 45%. Methods: To explore a more effective treatment for localized nasal NK/T-cell lymphoma, we conducted a phase I/II study of concurrent chemoradiotherapy consisted of 50 Gy of RT and 3 courses of DeVIC [carboplatin (CBDCA), etoposide (ETP), ifosfamide (IFM), dexamethasone (DMS)]. Patients (Pts) with newly-diagnosed, localized (IE & contiguous IIE with cervical node involvement) diseases, 20–69 years of age and PS 0–2 were eligible. The 3-D conformal RT planning was required to cover adequately target volumes (2 cm margin to gross tumor, entire nasal cavities and nasopharynx) and to minimize doses to organs at risk. Primary endpoint of the phase II portion was 2-yr OS and the enrollment of 24 pts to the phase II portion was planned. Based on the results of the phase I portion (ASH 2005, #2685), 2/3-dose of DeVIC (CBDCA 200mg/m2 d1 IV, ETP 67mg/m2 d1–3 IV, IFM 1.0g/m2 d1–3 IV, DMS 40mg/body d1–3 IV; every 3 wks) was applied for the phase II portion. RT quality assurance review confirmed no protocol violation (ASTRO 2008, #2682). Results: From Sep 2003 to Dec 2006, 33 pts were enrolled in the phase I/II study. 27 pts evaluated in the phase II portion showed the following features: age 21–68 yrs (median 56), M:F=17:10, stage IE 18, stage IIE 9, B symptom (+) 10, elevated serum LDH 5, PS2 2. With a median follow-up of 32 months (range, 24–62), %2-yr OS was 78% (95% CI, 57–89). Of 26 pts evaluable for response, 20 achieved CR, 1 PR, 2SD, and 3PD. %CR and %ORR were 77% (95% CI, 56–91) and 81%, respectively. The most common grade 3 non-hematologic toxicities were mucositis due to RT (30%) and infection (30%). Grade 4 hyponatremia and dermatitis due to RT were observed in each 1 pt. No treatment-related death was observed. Conclusions: Concurrent chemoradiotherapy using MDR-non-related agents and ETP is a safe and effective treatment for localized nasal NK/T-cell lymphoma, providing the basis for subsequent studies. No significant financial relationships to disclose.