The following is a summary of “Randomized Phase III Trial Evaluating Subcutaneous Rituximab for the First-Line Treatment of Low–Tumor Burden Follicular Lymphoma: Results of a LYSA Study,” published in the July 2023 issue of Oncology by Cartron, et al.
For a study, researchers sought to evaluate the efficacy of short rituximab maintenance using the subcutaneous (SC) route in patients with low-tumor burden follicular lymphoma (FL) and its impact on progression-free survival (PFS).
A prospective randomized trial involved patients with confirmed CD20+ low-tumor burden FL. Participants were randomly assigned to two treatment arms: the control arm received intravenous (IV) rituximab at a dose of 375 mg/m2 on days 1, 8, 15, and 22, while the experimental arm received IV rituximab on day 1 followed by SC rituximab at a total dose of 1,400 mg on days 8, 15, and 22, with maintenance at months 3, 5, 7, and 9. The primary endpoint was progression-free survival (PFS), and secondary endpoints included safety, overall response rates, time to next treatment (TTNT), and overall survival (OS).
A total of 202 patients with low-tumor burden FL were included, with 100 patients in the experimental arm and 102 patients in the control arm. The 4-year PFS was significantly higher in the experimental arm (58.1%, 95% CI: 47.5 to 67.4) compared to the control arm (41.2%, 95% CI: 30.6 to 51.6) (hazard ratio 0.585, 95% CI: 0.393 to 0.871; P = 0.0076). The experimental arm also demonstrated higher complete response rates (59.0%, 95% CI: 48.7 to 68.7) compared to the control arm (36.3%, 95% CI: 27.0 to 46.4) (P = 0.001). There were no significant differences in TTNT and OS between the two arms. Complete response was associated with longer PFS and TTNT. Higher rituximab exposure during the first three months after treatment initiation was independently associated with improved complete response, PFS, and TTNT.
The use of short rituximab maintenance through the SC route in patients with low-tumor burden FL, combined with induction therapy, improved progression-free survival. Notably, the key factor influencing patient outcomes was the higher rituximab exposure during the first three months after treatment initiation.