GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T‐cell lymphoma: a prospective multicentre study

Summary Early‐stage natural killer/T‐cell lymphoma (NK/TCL) patients usually receive a combination of chemotherapy and radiotherapy, but the optimal treatment approach has not yet been established. This study aimed to investigate the efficacy and safety profile of a novel chemotherapy regimen and sandwiched radiotherapy in early‐stage NK/TCL. Patients with newly diagnosed stage IE/IIE disease were eligible. Patients were initially treated with two courses of the GELAD regimen (gemcitabine 1·0 g/m 2 day 1, etoposide 60 mg/m 2 days 1–3, pegaspargase 2000 units/m 2 day 4, and dexamethasone 40 mg days 1–4), followed by intensity‐modulated radiotherapy (IMRT; 50–56 Gy in 25–28 fractions) and two additional courses of GELAD chemotherapy. A total of 52 patients were enrolled. The overall response rate and complete response rate per Lugano 2014 criteria were 94·2% and 92·3% respectively. With a median follow‐up of 32 months, the estimated four‐year overall survival rate and progression‐free survival rate were 94·2% [95% confidence interval (CI), 83·2% to 93·1%] and 90·4% (95% CI, 78·4% to 95·9%) respectively. The most common adverse events were related to pegaspargase. Haematological toxicities were mild, with grade 3/4 neutropenia in 15·4% of patients. Our study provides a new approach with high activity and improved safety for the treatment of early‐stage NK/TCL patients. This study was registered at www.clinicaltrials.gov as NCT02733458.