When mantle cell lymphoma comes back after treatment or does not respond to it, this study compared two drugs: ibrutinib tablets (an oral targeted drug) and temsirolimus injections. With ibrutinib, the disease took on average more than twice as long to get worse (about 14.6 months vs 6.2 months), and there were fewer severe side effects and fewer people stopping treatment because of side effects.
Relapsed or refractory mantle cell lymphoma after at least one rituximab-containing therapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Ibrutinib | 560 mg once daily | Oral | Continuous |
Dose from the RAY trial (versus temsirolimus).
On the page “Lymphoma” · Treatment regimens and dosing: mantle cell lymphoma
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Ibrutinib 560 mg orally daily.
Temsirolimus IV: 175 mg on days 1, 8 and 15 of the first cycle; then 75 mg on days 1, 8 and 15 of subsequent 21-day cycles.
Source of the regimen details: Abstract of the paper in PubMed
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.
Patients with centrally confirmed relapsed or refractory mantle cell lymphoma who had previously received at least one rituximab-containing regimen.
Primary outcome: progression-free survival assessed by a blinded independent review committee; intention-to-treat analysis.
Ibrutinib was better tolerated than temsirolimus: treatment-emergent grade 3 or higher adverse events in 94 patients (68%) versus 121 patients (87%), and discontinuation of study drug due to adverse events 9 (6%) versus 36 (26%).
RAY showed, in a randomised phase 3 trial, the superiority of ibrutinib over temsirolimus in relapsed or refractory mantle cell lymphoma, in both progression-free survival and tolerability, and according to the authors supports the favourable benefit–risk ratio of ibrutinib in this setting.
Open-label design (although the primary outcome was assessed by a blinded independent committee); the comparison was only with temsirolimus and not with other second-line treatments; at the time of this report the trial was ongoing, and the abstract does not report overall survival data.
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.
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