KEY TAKEAWAYS
- The phase 3 POLAR BEAR study evaluated pola-R-miniCHP as a potential primary treatment for elderly or frail DLBCL patients compared to the current standard, R-mini-CHOP.
- The trial suggested that both treatment methods are tolerable for the elderly and frail. While the new treatment didn’t show a higher risk of hematological toxicity, infections, or neuropathy, it did result in more gastrointestinal complications.
This study aimed to assess the effectiveness of pola-R-miniCHP as the primary treatment for elderly or frail diffuse large B-cell lymphoma (DLBCL) patients compared to the current standard, R-mini-CHOP. This analysis focused on safety data from the initial 127 trial participants.
The study enrolled patients (pts) diagnosed with DLBCL who were either older than 80 or between 75-80 but considered frail based on a Comprehensive Geriatric Assessment. Participants were equally assigned to either the conventional R-miniCHOP or the test regimen, R-pola-miniCHP, for six cycles. The latter replaces vincristine with polatuzumab vedotin (1.8 mg/kg, day 1). The study has planned to enroll 300 pts in total. For this segment, the study reported the most severe adverse event per category per CTCAE v 5 standards. Grade 1-2 hematological toxicity wasn’t mandatory for reporting as per the protocol.
From August 2020 to January 2023, 127 participants were enrolled across 37 locations in Sweden, Norway, Denmark, Finland, and Italy. Of these, 62 were in the standard group, and 65 in the test group. The average follow-up time for survivors was 11.4 months. 20 pts (16%) were younger than 80 and were included due to their frailty. The vast majority (69%) were aged between 80-90. 12% had a performance status of 3. As of the last data check, 291 cycles of R-mini-CHOP and 276 of R-pola-mini-CHP were administered. Hematological toxicity levels (grade 3-4) were consistent between both treatments. Infection rates stood at 14% for both. However, the pola group had twice the gastrointestinal issues, notably diarrhea (31%), when compared to the R-mini-CHOP group (16%). There was no clear difference in peripheral neuropathy grade 1-2. The pola group reported more varied grade 1-2 events. During this phase, eight deaths occurred due to adverse reactions; six were from the pola group, with two linked to polatuzumab vedotin (both pneumonia-related).
Both treatments were deemed acceptable for the elderly and frail. Substituting vincristine with polatuzumab vedotin in the R-mini-CHOP didn’t lead to increased risks of hematological toxicity, infections, or neuropathy. However, there was a noticeable uptick in gastrointestinal complications. Physicians need to closely monitor these side effects when treating older pts using this regimen.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04332822
Jerkeman, M., Leppä, S., Hamfjord, J., Brown, P., Ekberg, S., José María Ferreri, A. INITIAL SAFETY DATA FROM THE PHASE 3 POLAR BEAR TRIAL IN ELDERLY OR FRAIL PATIENTS WITH DIFFUSE LARGE CELL LYMPHOMA, COMPARING R-POLA-MINI-CHP AND R-MINI-CHOP. EHA Library. Leppä S. 06/08/2023; 387927; S227.
