Mecapegfilgrastim for Prophylaxis of Immunochemotherapy‐Induced Neutropenia in Patients With Diffuse Large B‐Cell Lymphoma: A Multicenter Pilot Trial
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2026
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| author | Jie Wang He Li Qiaochu Lin Yong Guo Hongbing Ma Bing Xiang Chenlu Yang Kai Shen Chunlan Zhang Kun Yang Chunrong Ma Hong Zhai Jin Wei Yan Zuo Jie Zhou Ting Niu |
| author_facet | Jie Wang He Li Qiaochu Lin Yong Guo Hongbing Ma Bing Xiang Chenlu Yang Kai Shen Chunlan Zhang Kun Yang Chunrong Ma Hong Zhai Jin Wei Yan Zuo Jie Zhou Ting Niu Jie Wang He Li Qiaochu Lin Yong Guo Hongbing Ma Bing Xiang Chenlu Yang Kai Shen Chunlan Zhang Kun Yang Chunrong Ma Hong Zhai Jin Wei Yan Zuo Jie Zhou Ting Niu |
| collection | Wiley Open Access |
| contents | Mecapegfilgrastim for Prophylaxis of Immunochemotherapy‐Induced Neutropenia in Patients With Diffuse Large B‐Cell Lymphoma: A Multicenter Pilot Trial Jie Wang He Li Qiaochu Lin Yong Guo Hongbing Ma Bing Xiang Chenlu Yang Kai Shen Chunlan Zhang Kun Yang Chunrong Ma Hong Zhai Jin Wei Yan Zuo Jie Zhou Ting Niu Cancer Medicine ABSTRACT Background This study evaluated the efficacy and safety of mecapegfilgrastim for preventing immunochemotherapy‐induced neutropenia in treatment‐naive patients with diffuse large B‐cell lymphoma (DLBCL). Methods In this open‐label, multicenter exploratory trial, patients were randomized in a 2:1 ratio to receive mecapegfilgrastim or no prophylaxis. All participants received 4 cycles of R‐CHOP or R‐CHOP‐like regimens. The primary endpoint was the incidence of grade ≥ 3 neutropenia during cycle 1. Results Between October 2021 and June 2024, 42 patients were enrolled (mecapegfilgrastim: n = 28; control: n = 14). Grade ≥ 3 neutropenia in cycle 1 occurred in 32.14% of the mecapegfilgrastim group versus 64.29% in the control group. Across all cycles, mecapegfilgrastim consistently reduced grade ≥ 3 neutropenia; nadir neutrophil counts were higher and the need for short‐acting granulocyte colony‐stimulating factor was lower in the mecapegfilgrastim group (all nominal p ≤ 0.05). No cases of febrile neutropenia occurred in the mecapegfilgrastim group, compared to one case in the control group. Objective response rates were 75.0% (95% CI: 55.1, 89.3) and 57.1% (95% CI: 28.9, 82.3), respectively (nominal p = 0.298). Mecapegfilgrastim reduced the incidence of grade ≥ 3 neutropenia regardless of treatment response. Grade ≥ 3 treatment‐emergent adverse events (TEAEs) occurred in 42.9% of the mecapegfilgrastim group and 92.9% of controls; serious TEAEs were reported in 7.1% of patients in both groups. Conclusions Mecapegfilgrastim demonstrated a favorable safety profile and potential efficacy in reducing the incidence and severity of neutropenia in DLBCL patients receiving R‐CHOP or R‐CHOP‐like regimens. These findings may support its prophylactic use in this population and warrant validation in larger trials. Trial Registration chictr.org.cn : ChiCTR2100048196. Registered on July 4, 2021 10.1002/cam4.71821 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| doi_str_mv | 10.1002/cam4.71821 |
| format | Artículo Open Access |
| id | wiley_oa_10_1002_cam4_71821 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| publishDate | 2026 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Mecapegfilgrastim for Prophylaxis of Immunochemotherapy‐Induced Neutropenia in Patients With Diffuse Large B‐Cell Lymphoma: A Multicenter Pilot Trial Jie Wang He Li Qiaochu Lin Yong Guo Hongbing Ma Bing Xiang Chenlu Yang Kai Shen Chunlan Zhang Kun Yang Chunrong Ma Hong Zhai Jin Wei Yan Zuo Jie Zhou Ting Niu Cancer Medicine Mecapegfilgrastim for Prophylaxis of Immunochemotherapy‐Induced Neutropenia in Patients With Diffuse Large B‐Cell Lymphoma: A Multicenter Pilot Trial Jie Wang He Li Qiaochu Lin Yong Guo Hongbing Ma Bing Xiang Chenlu Yang Kai Shen Chunlan Zhang Kun Yang Chunrong Ma Hong Zhai Jin Wei Yan Zuo Jie Zhou Ting Niu Cancer Medicine ABSTRACT Background This study evaluated the efficacy and safety of mecapegfilgrastim for preventing immunochemotherapy‐induced neutropenia in treatment‐naive patients with diffuse large B‐cell lymphoma (DLBCL). Methods In this open‐label, multicenter exploratory trial, patients were randomized in a 2:1 ratio to receive mecapegfilgrastim or no prophylaxis. All participants received 4 cycles of R‐CHOP or R‐CHOP‐like regimens. The primary endpoint was the incidence of grade ≥ 3 neutropenia during cycle 1. Results Between October 2021 and June 2024, 42 patients were enrolled (mecapegfilgrastim: n = 28; control: n = 14). Grade ≥ 3 neutropenia in cycle 1 occurred in 32.14% of the mecapegfilgrastim group versus 64.29% in the control group. Across all cycles, mecapegfilgrastim consistently reduced grade ≥ 3 neutropenia; nadir neutrophil counts were higher and the need for short‐acting granulocyte colony‐stimulating factor was lower in the mecapegfilgrastim group (all nominal p ≤ 0.05). No cases of febrile neutropenia occurred in the mecapegfilgrastim group, compared to one case in the control group. Objective response rates were 75.0% (95% CI: 55.1, 89.3) and 57.1% (95% CI: 28.9, 82.3), respectively (nominal p = 0.298). Mecapegfilgrastim reduced the incidence of grade ≥ 3 neutropenia regardless of treatment response. Grade ≥ 3 treatment‐emergent adverse events (TEAEs) occurred in 42.9% of the mecapegfilgrastim group and 92.9% of controls; serious TEAEs were reported in 7.1% of patients in both groups. Conclusions Mecapegfilgrastim demonstrated a favorable safety profile and potential efficacy in reducing the incidence and severity of neutropenia in DLBCL patients receiving R‐CHOP or R‐CHOP‐like regimens. These findings may support its prophylactic use in this population and warrant validation in larger trials. Trial Registration chictr.org.cn : ChiCTR2100048196. Registered on July 4, 2021 10.1002/cam4.71821 http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| title | Mecapegfilgrastim for Prophylaxis of Immunochemotherapy‐Induced Neutropenia in Patients With Diffuse Large B‐Cell Lymphoma: A Multicenter Pilot Trial |
| topic | Cancer Medicine |
| url | https://onlinelibrary.wiley.com/doi/10.1002/cam4.71821 |