PHILADELPHIA—A single four-dose cycle of rituximab (Rituxan) produced an overall response rate of 72% and median progression-free survival of 2.78 years in a phase II trial in patients with newly diagnosed, asymptomatic, advanced-stage follicular grade 1 non-Hodgkin’s lymphoma (NHL).
Thomas E. Witzig, MD, of the Mayo Clinic, reporting on behalf of the North Central Cancer Treatment Group (NCCTG), presented the results in a poster at the 44th Annual Meeting of the American Society of Hematology (ASH abstract 1398). Dr. Witzig said that rituximab offers an appealing nonchemo-therapy alternative to observation in this group of patients.
The trial enrolled 36 previously untreated patients with biopsy-proven follicular grade 1 NHL and measurable stage III or IV disease. Patients were CD20+ and had performance status (PS) 0 to 2.
Patients were treated with four weekly doses of rituximab 375 mg/m2 IV, with no further maintenance therapy. All patients completed treatment as planned. Follow-up included physical examination, laboratory tests, and CT scans every 3 months during the first year and every 6 months thereafter.
The study accrued patients between July of 1999 and May of 2001; 43% were male, 89% were PS 0, and 11% were PS 1. The median age was 59 years (range, 29 to 83). Six patients (17%) had elevated lactate dehydrogenase (LDH) levels at baseline.
Fourteen patients (39%) had a low International Prognostic Index (IPI), 16 (46%) had low-intermediate IPI, and 6 (17%) had high-intermediate IPI. None had B symptoms.
Dr. Witzig reported that the overall response rate was 72%, including 13 (36%) complete responses. To date, 16 patients remain in unmaintained remission and 18 have progressed, including three who died of their disease. Two patients died without disease progression. Median progression-free survival was 2.78 years. Median time to subsequent chemotherapy has not yet been reached.