Introduction: Neutropenia remains a common adverse event in lymphoma patients undergoing chemotherapy. Prophylaxis with granulocyte colony-stimulating factor (G-CSF) can effectively prevent chemotherapy-induced neutropenia in clinical setting. Here we explored the efficacy and safety of mecapegfilgrastim, a long-acting G-CSF, in preventing chemotherapy-induced neutropenia for patients with diffuse large B-cell lymphoma (DLBCL).
Methods: In this multicenter, open-label, randomized controlled trial (ChiCTR2100048196), DLBCL patients aged 18-75 years with normal organ function and no prior chemotherapy were randomized 2:1 to the study or control group. Both groups received 4 cycles of standard R-CHOP or R-CHOP-like regimens. In the study group, mecapegfilgrastim 6 mg was administered 24-48 hours after chemotherapy per cycle, whereas no prophylaxis for neutropenia was given to the control group. Neutrophil count <0.5×109/L in the study group and <1.0×109/L in the control triggered rhG-CSF administration until count increased to ≥5.0×109/L. For the study group, blood tests for complete blood counts were performed on days 1, 5, 7, 9, 13, and 17 (±1 day) in cycle 1, and days 1, 5, 9, and 13 (±1 day) in cycles 2-4. For the control group, blood tests are performed on days 1, 5, 9, and 13 (±1 day) in each cycle. The primary endpoint was the incidence of grade ≥3 neutropenia during the first chemotherapy cycle.
Results: From Oct 2021 to June 2024, 42 patients were enrolled. For 28 patients in the study group, the median age was 58 years (range, 34 to 76) and 15 patients (53.6%) were females. Of 14 patients in the control group, the median age was 46 years (range, 26 to 74) and 8 patients (57.1%) were females. Baseline neutrophil count was 4.3 (±2.8)×109/L and 4.1 (±2.3)×109/L in the study and control groups, respectively. White blood cell count, hemoglobin level and platelet count were comparable between groups. During the first chemotherapy cycle, 9 patients (32.1% [95% CI, 15.9 to 52.4]) in the study group and 9 patients (64.3% [95% CI, 35.1 to 87.2]) in the control group experienced grade ≥3 neutropenia, with a numerical difference of -32.1% (95% CI, -58.2 to 0) between groups (nominal P=0.096). Throughout the treatment cycles, the study group showed 57.1% reduction (95% CI, 27.5 to 75.0]; nominal P=0.001) in the incidence of grade ≥3 neutropenia compared with the control group (10 [35.7%] vs 13 [92.9]). No febrile neutropenia was reported in either group. Short-acting G-CSF was required in 3 patients (10.7%) from the study group and 9 (64.3%) from the control group. Twelve (42.9%) patients in the study group and 13 patients (92.9%) in the control group experienced grade ≥3 TEAEs, including neutrophenia (10 [35.7%] and 13 [92.9%]), leukopenia (9 [32.1%] and 8 [57.1%]) and lung infection (3 [10.7%] and 1 [7.1%]). The incidence of serious TEAEs was 7.1% in both groups, and one patient in the study group died due to interstitial lung disease, all of which were deemed unrelated to mecapegfilgrastim.
Conclusions: Mecapegfilgrastim demonstrated a good safety profile and a nonsignificant trend towards reduced incidence of grade 3/4 chemotherapy-induced neutropenia in DLBCL patients, underscoring its potential as a prophylactic option. Further study is warranted to validate these findings.
No relevant conflicts of interest to declare.
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