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Two years of an antibody given every two months after chemotherapy more than doubled the time before follicular lymphoma came back, but after nine years the two groups were equally likely to be alive.
PRIMA is the trial that made rituximab maintenance a routine offer in follicular lymphoma, and the trial that shows most clearly why a progression-free survival benefit is not the same as a survival benefit. It ran at 223 centres in 25 countries. Patients with previously untreated high tumour burden follicular lymphoma received one of three immunochemotherapy induction regimens in routine use; the 1,018 who reached a complete or partial response were randomised to rituximab 375 mg per square metre every eight weeks for two years, or to observation.
The first report, at a median follow-up of 36 months, gave three-year progression-free survival of 74.9 per cent with maintenance against 57.6 per cent with observation (hazard ratio 0.55, 95 per cent confidence interval 0.44 to 0.68). The final report, after nine years, kept the effect: median progression-free survival 10.5 years against 4.1 years (hazard ratio 0.61, 0.52 to 0.73). Ten-year overall survival was approximately 80 per cent in both arms, with a p value of 0.7948, and no new safety signals.
Six extra years before the next treatment is a large thing in a disease people live with for decades, and it is the right thing to put in front of someone deciding. So is the fact that it did not change how long they lived, and that two further years of an antibody carries infection risk and clinic visits. Both numbers belong in the conversation.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,018 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (median)primary | Rituximab maintenance | 505 | 10.5 years | 0.61 (0.52 to 0.73) | - | link |
| Observation | 513 | 4.1 years | ||||
| Overall survival at 10 years | Rituximab maintenance | - | 80% | - | 0.7948 | - |
| Observation | - | 80% |
The number to give a patient deciding about maintenance: a median of six and a half extra years before the next treatment, and no difference in how long they live. Both halves belong in the conversation.
The trial that made two years of rituximab maintenance a routine offer after first-line immunochemotherapy for follicular lymphoma with a high tumour burden.
Shares Gilles Salles, Maintenance and consolidation in lymphoma: where it works and where it does not, LYSA (The Lymphoma Study Association), Maintenance therapy and the tag lymphoma-evidence.
Shares Sustained progression-free survival benefit of rituximab maintenance in patients with follicular lymphoma: long-term results of the PRIMA study, FLIPI, FLIPI2 and POD24 (follicular lymphoma risk), Prednisone, Vincristine and the tag lymphoma-evidence.
Shares Gilles Salles, Maintenance and consolidation in lymphoma: where it works and where it does not, LYSA (The Lymphoma Study Association), Maintenance therapy and the tag lymphoma-evidence.
Shares GALLIUM, CD20, Prednisone, Vincristine and the tag lymphoma-evidence.
Shares GALLIUM, CD20, Prednisone, Vincristine and the tag lymphoma-evidence.
Shares RELEVANCE, Maintenance and consolidation in lymphoma: where it works and where it does not, Watchful waiting, and how it differs from active surveillance, Patients lack understanding, navigation and agency and the tag lymphoma-evidence.
Shares Watchful waiting, and how it differs from active surveillance, FLIPI, FLIPI2 and POD24 (follicular lymphoma risk), CD20, Rituximab and the tag lymphoma-evidence.
Shares Prednisone, Vincristine, Rituximab, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.