Obinutuzumab for the First-Line Treatment of Follicular Lymphoma
A newer report of this study has been published: Obinutuzumab Versus Rituximab Immunochemotherapy in Previously Untreated iNHL: Final Results From the GALLIUM Study (2023)
- Study type
- Clinical trial
- Study name
- GALLIUM
- Phase
- Phase 3
- Design
- Randomised, multicentre, comparative trial (obinutuzumab-based versus rituximab-based)
- Sample size
- 1202 patients (601 in each group)
- Source
- N Engl J Med · 2017
- Trial registration
- NCT01332968
In plain words
In this large study, two treatments were compared for patients with newly diagnosed advanced follicular lymphoma: treatment with obinutuzumab and treatment with rituximab. Patients in the obinutuzumab group went longer without the disease growing or coming back. On the other hand, severe side effects and reactions during the infusion were more common in this group. The choice of treatment should be made with your treating doctor, taking each patient's situation into account.
Key results
Treatment arms and regimens
Obinutuzumab 1000 mg (flat dose) IV on days 1, 8 and 15 of cycle 1 and day 1 of subsequent cycles, with each centre's chosen chemotherapy (CHOP, CVP or bendamustine) for 6 to 8 cycles; patients with at least a partial response: obinutuzumab 1000 mg every 2 months until progression or for up to 2 years.
Rituximab with the same chemotherapy for 6 to 8 cycles; responders: rituximab every 2 months for up to 2 years. Rituximab dose in the full text.
Source of the regimen details: FDA label for GAZYVA (Clinical Studies section, GALLIUM trial); rituximab dose in the full text
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with previously untreated advanced-stage follicular lymphoma.
Endpoints
Primary endpoint: investigator-assessed progression-free survival (PFS). Other endpoints included PFS by independent review, other time-to-event endpoints, response rate and safety.
Safety and side effects
Grade 3 to 5 adverse events were more frequent in the obinutuzumab group (74.6% versus 67.8%), as were serious adverse events (46.1% versus 39.9%). Rates of fatal adverse events were similar (4.0% versus 3.4%). The most common adverse events were infusion-related reactions, attributed by the investigators mainly to obinutuzumab in 353 of 595 patients (59.3%; 95% CI 55.3 to 63.2) and to rituximab in 292 of 597 patients (48.9%; 95% CI 44.9 to 52.9) (P<0.001). Nausea and neutropenia were also common.
Clinical significance and place in guidelines
This study showed that obinutuzumab-based first-line therapy improves progression-free survival compared with rituximab, although with more high-grade adverse events. According to the abstract, this was an interim analysis, and an effect on overall survival was not shown. The status of approvals and formal clinical guideline recommendations should be checked separately.
Limitations
The results come from a preplanned interim analysis with a median follow-up of 34.5 months. The primary endpoint was investigator-assessed. Serious and high-grade adverse events were more frequent in the obinutuzumab group. The study was funded by F. Hoffmann-La Roche.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.