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ALLG trial: Ibrutinib plus R-mini-CHOP in older patients with newly diagnosed DLBCL
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ALLG (ACTRN12615000551594), a multicenter phase II trial, evaluated the efficacy and safety of the addition of ibrutinib to R-mini-CHOP in patients aged ≥75 years with previously untreated DLBCL.1 Treatment consisted of six 21-day cycles of ibrutinib + R-mini-CHOP followed by two 21-day cycles of R-ibrutinib. Results from the trial were published in the Blood Advances by Verner et al.1 |
| Key learnings |
| With a median follow-up of 35.5 months, the median OS was 72 months and median PFS was 40 months. The 2-year PFS and OS rates were 68% and 60%, respectively. The ORR was 76%, with a CR rate of 71%. |
| The most common AEs reported were infections (53.2%), diarrhea (44.3%), fatigue (40.5%), and limb edema (29.1%). Grade ≥3 AE and SAEs were reported in 68% and 67% of patients, respectively. In total, 34 deaths were reported due to PD (n = 17) and treatment-related AEs (n = 5). |
| The EORTC QLQ demonstrated improvements in functional and symptom scales during and after treatment in responders. |
| Overall, promising efficacy and safety data from the ALLG study suggest that ibrutinib + R-mini-CHOP could be a viable treatment option for elderly patients with ND DLBCL. |
Abbreviations: AE, adverse event; CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisone; CR, complete response; DLBCL, diffuse large B-cell lymphoma; EORTC QLQ, European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire; ND, newly diagnosed; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R, rituximab, SAE, serious adverse event.
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