A response‐adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD) followed by rituximab maintenance appeared effective and tolerable as a salvage therapy for follicular lymphoma patients. The results of the RBMDGELTAMO08 phase 2 trial (ClinicalTrials.gov identifier: NCT01133158) were recently published in Cancer Medicine.1
The research included 60 patients with follicular lymphoma that relapsed or became refractory to first‐line rituximab‐containing immunotherapy. All of the patients received 3 treatment cycles with RBMD. Further RBMD treatment depended on response; patients who achieved a complete response (CR) received 1 additional cycle and patients who received a partial response (PR) received 3 additional cycles. Patients who achieved a response went on to receive rituximab maintenance therapy for 2 years.
Overall, after 3 treatment cycles, 33 patients (55%) achieved a CR or unconfirmed complete response (uCR) and 24 (40%) achieved a PR. The 24 patients who achieved a PR received 3 additional cycles, which resulted in 10 patients (41.7%) going on to achieve a CR or uCR and 11 patients (45.8%) maintaining PR.
After induction therapy, 53 patients (88.3%) achieved a response, which included 42 (70%) CRs or uCRs and 11 (18.3%) PRs. No statistically significant difference in progression-free survival was seen between patients who received 4 versus 6 cycles (P = 0.6665).
As for safety, 53 of 60 patients (88.3%) had 1 or more grade 3 or 4 adverse event (AE) during induction therapy and 24 of 43 patients (55.8%) had 1 or more grade 3 or 4 AE during maintenance therapy. Hematological events were the most common grade 3 or 4 AE during induction therapy, which included lymphopenia (70%) and neutropenia (60%). During maintenance therapy, the most common grade 3 or 4 AEs were neutropenia (27.3%) and lymphopenia (25%).
“This response‐adapted treatment with RBMD followed by rituximab maintenance is an effective and well‐tolerated salvage treatment for relapsed/refractory follicular lymphoma following first‐line immunochemotherapy,” the authors wrote.
- Peñalver FJ, Márquez JA, Durán S, et al. Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial [published online October 1, 2019]. Cancer Med. doi:10.1002/cam4.2555