Results of a Controlled Clinical Trial Radiotherapy versus Combined Therapy in the Management of Stage IE Orbital...

The aim of the present study was to compare the usefulness of radiotherapy (34-40 Gy, median 3.8 Gy) versus radiotherapy following by adjuvant chemotherapy in the management of 73 patients with stage I marginal zone B cell lymphoma (MZBCL) of the orbit. Complete response was similar in both arms: 95% (95% confidence interval (CI): 89-99%) in the radiotherapy group and 100% (95% CI: 92-104%) in the combined therapy arm. At a median follow-up of 8 years no median has been reached in event free survival (EFS) and overall survival (OS). At 8-years EFS shown that 87% (95%CI: 82-93%) and 82%, (95%CI: 78-87%), respectively remain in first complete response (p=0.6). OS was very similar 87% (95% CI: 84-89%) and 90%, (95% CI: 84-95%), respectively (p=0.5). Because we use low-radiation therapy (<50Gy) acute and late toxicities were mild. We concluded that combined therapy it is not useful in the treatment of MZBCL primary of the orbit and confirm that radiotherapy is the treatment of choice in this setting of patients.