The Role of Thalidomide as Maintenance in Nasal Lymphoma

Abstract

NK T-cell lymphoma nasal type, is a rare presentation of malignant lymphoma, and until  now the best treatment has not well defined, the use of radiotherapy it is considered the best treatment , but relapse is common, and use of chemotherapy is necessary. We performed an  open label clinical trial , combined the best cytotoxic agents that had employed, aggressive radiotherapy , and introduced the use of maintenance , with low doses of thalidomide. Between August 2010 to December 2018,  166 patients fulfilled the criteria entry; early stage, previously untreated, were enrolled. They received 3 cycles of gemcitabine, methotrexate, etoposide and dexamethasone, following for intensive modulated radiotherapy: 50 Gy in 25 sessions, and another 3 additional cycles of chemotherapy. Patients who achieved complete response were allocated to received thalidomide, oral, 100 mg daily , days to 21 in each cycle of 28 days; and no further treatment (control group) Complete response was obtained in 131 cases (81 %); actuarial curves at 5-years, showed that progression-free survival was worse : 60.8 (95% Confidence Interval (CI): 56.3% to 63.6%) in patients that did not received maintenance: 60.8% : 83.5% (95%CI: 75.2%- 89.1%)(p < 0.001), also  overall survival were worse in patients that not  received maintenance  : 56.8% (95% CI: 49.3% to 61.5%) compared with maintenance group: 77.8% (95%CI: 72.3% to 89.6%) p < 0.001. Acute toxicities were minimal and well controlled, no late toxicities has been observed.

Conclusion: We show in the present study that the use of the best individual drugs , aggressive radiotherapy improve the complete response rate, and the used of thalidomide employed as maintenance  improve outcome, well  controlled toxicities. Is evident that other studies were performed to define if the present regimen is the best option in these special setting of patients.