Association of early disease progression and very poor survival in the GALLIUM study in follicular lymphoma: benefit of obinutuzumab in reducing the rate of early progression

Abstract

We evaluated early disease progression and its impact on overall survival in previously untreated follicular lymphoma patients in GALLIUM (NCT01332968), and investigated the effect on early disease progression of the 2 randomization arms: obinutuzumab- versus rituximab-based immunochemotherapy. Cause-specific Cox regression was used to estimate the effect of treatment on the risk of disease progression or death due to disease progression within 24 months of randomization and to analyze overall survival in patients with or without disease progression after 24 months. Mortality in both groups was analyzed 6, 12, and 18 months post-randomization (median follow-up, 41 months). Fewer early disease progression events occurred in obinutuzumab (57/601) versus rituximab (98/601) immunochemotherapy patients, with an average risk reduction of 46.0% (95% CI: 25.0-61.1%; cumulative incidence rate 10.1% versus 17.4%). At a median post-progression follow-up of 22.6 months, risk of mortality increased markedly following a progression event (HR of time-varying progression status, 25.5 [95% CI: 16.2-40.3]). Mortality risk was higher the earlier patients progressed within the first 24 months. Age-adjusted HR for overall survival after 24 months in surviving patients with disease progression versus those without was 12.2 (95% CI: 5.6-26.5). Post-progression survival was similar by treatment arm. In conclusion, obinutuzumab plus chemotherapy was associated with a marked reduction in the rate of early disease progression events relative to rituximab plus chemotherapy. Early disease progression in patients with follicular lymphoma was associated with poor prognosis, with mortality risk higher after earlier progression. Survival post-progression did not seem to be influenced by treatment arm. .

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