On Friday 15th June an oral abstract session took place at the 23rd Congress of the European Hematology Association (EHA). Abstract S102 was presented by Mathias Rummel, University Hospital Giessen, Germany, on the outcomes of the StiL NHL7-2008 MAINTAIN trial.
The MAINTAIN trial is a prospective, randomized, multi-center phase II study assessing two-years rituximab maintenance compared with observation after first-line treatment with bendamustine plus rituximab (B-R) in patients with non-Hodgkin lymphoma (NHL) and small lymphocytic leukemia. The results presented focused on patients with marginal zone lymphoma (MZL). The objective of the StiL NHL7-2008 study was to demonstrate progression-free survival (PFS) improvement of 2-year rituximab maintenance over observation after induction with B-R.
- The primary endpoint was progression-free survival (PFS) and the secondary endpoints were overall survival (OS), time to next treatment (TTNT), response rates, adverse events, short- and long-term toxicity, secondary primary malignancies
- 104 patients diagnosed with MZL were randomized to receive either B-R and then observation (n = 51) or B-R and then 2 years’ rituximab maintenance every 2 months (n = 53)
- After 78-month median follow-up, the PFS for observation was a median of 92 months vs R-maintenance was not yet reached, hazard ratio 0.33 (95% CI, 0.16–0.71), P = 0.0047
- After 78-month median follow-up the difference in OS was not significantly different. For the observation group the median OS was not yet reached for both observation and R-maintenance, hazard ratio 0.53 (95% CI 0.20–1.43), P = 0.2143
- The most frequent grade ≥3 adverse events (AEs) for observation vs R-maintenance
- Infections = 4% vs 6%
- Gastrointestinal = 0% vs 6%
- 28 patients died during the study due to lymphoma (6%), infection (4%), secondary malignancy (2%) and other/unknown reason (8%)
Dr Rummel concluded that the 2 years R-maintenance cohort had prolonged PFS after B-R but there was no statistically significant difference in OS between the two groups. He noted that the study confirmed high anti-lymphoma activity of B-R in patients with MZL. Additionally, Dr Rummel said that B-R followed by R-maintenance appeared to be a very effective treatment approach in patients with nodal and splenic MZL.
Rummel M. Two years rituximab maintenance vs. observation after first line treatment with bendamustine plus rituximab in patients with marginal zone lymphoma (MZL): Results of the STIL NHL7-2008 MAINTAIN trial. Abstract S102. 23rd Congress of EHA, Stockholm, Sweden