Objectives: Primary orbital malignant lymphoma (POML) is a rare malignancy, thus treatment remains to be defined. The present study was designed to define if the use of radiotherapy is sufficient in these patients or if the use of adjuvant chemotherapy would improve the outcome.
Methods: Between 1983 and 1995, 98 previously untreated patients diagnosed with POML, stage IE, were randomly allocated to receive either radiotherapy (34-40 Gy) or the same radiotherapy combined with chemotherapy including anthracycline. The median follow-up was 11.4 years (range 9.8-10.8 years).
Results: Complete response was similar in both arms: 98% (95% confidence interval, CI: 89-100%) in the radiotherapy arm, and 100% (95% CI: 89-100%) in the combined therapy group. At a median follow-up of 16.4 years, event-free survival was 94% (95% CI: 87-100%) and 85% (95% CI: 88-100%), respectively. Overall survivals were: 96% (95% CI: 89-99%) and 91% (95% CI: 83-98%). No statistical differences were found. Acute and late toxicities were mild.
Conclusions: The addition of chemotherapy is of no further benefit, since the results did not differ, thus, radiotherapy will be considered as the treatment of choice in POML patients.
Copyright 2006 S. Karger AG, Basel.