IELSG32
IELSG32 built the MATRix regimen that is now the standard first treatment for lymphoma confined to the brain: adding rituximab and thiotepa to methotrexate and cytarabine doubled the complete remission rate, and its second part showed that a stem cell transplant works as well as whole-brain radiotherapy for consolidation, with less harm to thinking.
Overview
IELSG32 was an international randomised phase 2 trial in 227 patients with newly diagnosed primary CNS lymphoma. The first randomisation compared four courses of high-dose methotrexate and cytarabine alone (arm A), with rituximab (arm B), or with rituximab and thiotepa (arm C, the MATRix regimen). Patients with responsive or stable disease were then randomised to whole-brain radiotherapy of 36 Gy or high-dose carmustine and thiotepa with autologous stem cell transplant.
Complete remission after induction was 49 percent with MATRix against 23 percent with methotrexate-cytarabine alone and 30 percent with rituximab added, with more grade 4 haematological toxicity but similar infections; 6 percent of patients died of toxicity. In the second randomisation two-year failure-free survival was 76 percent after radiotherapy and 75 percent after transplant, with cognitive function preserved after transplant and impaired attention and executive function after radiotherapy. The corpus's primary CNS lymphoma page cites IELSG32 for thiotepa-based chemotherapy with autologous transplant.
- 49 vs 30 out of 100 had no sign of cancer on scans or tests with MATRix: methotrexate, cytarabine, thiotepa, rituximab compared with Methotrexate + cytarabine + rituximab; 19 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Methotrexate + cytarabine 23 of 100.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 76 vs 75 out of 100 alive at 2 years with Whole-brain radiotherapy 36 Gy with or without 9 Gy boost compared with Carmustine-thiotepa conditioning and autologous stem cell transplant; 1 more per 100.
- Roughly one extra person helped for every 100 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 6 out of 100 people reached this endpoint with All induction arms.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Newly diagnosed primary central nervous system lymphoma in immunocompetent patients aged 18 to 70: a first randomisation between high-dose methotrexate and cytarabine alone, with rituximab, or with rituximab and thiotepa (MATRix), and a second randomisation between whole-brain radiotherapy and carmustine-thiotepa conditioned autologous transplant as consolidation. People in a different situation may not see the same effect.
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.
227 enrolled.
95% CI 38 to 60; 219 of 227 assessable across the three arms · 95% CI 21 to 42 · 95% CI 14 to 31
Source95% CI 65 to 87 · 95% CI 64 to 86
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete remission after induction chemotherapyprimary | MATRix: methotrexate, cytarabine, thiotepa, rituximab | - | 49% | - | - | link |
| Methotrexate + cytarabine + rituximab | - | 30% | ||||
| Methotrexate + cytarabine | - | 23% | ||||
| Failure-free survival at 2 years after the second randomisationprimary | Whole-brain radiotherapy 36 Gy with or without 9 Gy boost | - | 76% | - | - | link |
| Carmustine-thiotepa conditioning and autologous stem cell transplant | - | 75% | ||||
| Deaths from toxicity during induction | All induction arms | 219 | 6% | - | - | link |
Autologous transplant is an effective consolidation that avoids the neurotoxicity of whole-brain radiotherapy, and IELSG43 later showed it beats non-myeloablative consolidation.
MATRix became the reference induction for fit patients with primary CNS lymphoma and the control arm of later randomised trials.
Similar pages
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