Effectiveness of pegfilgrastim prophylaxis in preventing febrile neutropenia during R-FC chemoimmunotherapy for chronic lymphocytic leukemia: A multicenter prospective phase II study
- 주제(키워드) prophylaxis , neutropenia , pegfilgrastim , chronic lymphocytic leukemia , R-FC regimen
- 주제(기타) Oncology
- 설명문(일반) [Jeon, Youngwoo; Cho, Seok-Goo] Catholic Univ Korea, Yeouido St Marys Hosp, Coll Med, Lymphoma & Cell Therapy Res Ctr, Yeouido St, Seoul, South Korea; [Jeon, Youngwoo; Cho, Seok-Goo] Catholic Univ Korea, Inst Translat Res & Mol Imaging, Seoul, South Korea; [Yang, Duk-Hwan] Chonnam Natl Univ, Hwasun Hosp, Dept Hematol Oncol, Hwasun, South Korea; [Oh, Suk-Joong] Hanyang Univ Seoul Hosp, Dept Hematol & Oncol, Seoul, South Korea; [Park, Jin-Hee] Cachon Univ Gil Med Ctr, Dept Hematol & Oncol, Incheon, South Korea; [Kim, Jung-Ah] Catholic Univ Korea, St Vincents Hosp, Coll Med, Dept Hematol & Oncol, Suwon, South Korea; [Kim, Sung-Young] Konkuk Univ, Med Ctr, Dept Hematol, Seoul, South Korea; [Choi, Chul-Won] Korea Univ Guro Hosp, Dept Hematol & Oncol, Seoul, South Korea; [Lee, Won-Sik] Inje Univ, Busan Paik Hosp, Dept Internal Med, Hemato Oncol, Busan, South Korea; [Kim, In-Ho] Seoul Natl Univ Hosp, Dept Hematol & Oncol, Seoul, South Korea; [Mun, Yeung-Chul] Ewha Womans Univ, Mok Dong Med Ctr, Dept Hematol & Oncol, Seoul, South Korea; [Min, Gi June; Eom, Ki-Seong; Cho, Seok-Goo] Catholic Univ Korea, Catholic Hematol Hosp, Seoul St Marys Hosp, Coll Med,Div Lymphoma Myeloma, Seoul St, Seoul, South Korea
- 등재 SCIE, SCOPUS
- OA유형 Green Published, gold
- 발행기관 FRONTIERS MEDIA SA
- 발행년도 2023
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000208761
- 본문언어 영어
- Published As https://doi.org/10.3389/fonc.2023.998014
- PubMed 37056335
초록/요약
BackgroundA chemotherapy of rituximab, fludarabine and cyclophosphamide (R-FC) has been accepted as a promising frontline chemotherapy in selected patients with chronic lymphocytic leukemia (CLL). Although R-FC regimen is a relatively dose-dense regimen and neutropenia incidence is more than 50%, primary prophylactic pegfilgrastim was not fully recommended in the clinical field. Therefore, the study evaluated the prophylactic effectiveness of pegfilgrastim to reduce the incidence of febrile neutropenia associated with R-FC of patients with CLL. Patients and methodsA single-arm, multicenter, prospective phase II study was designed to assess the efficacy of prophylactic pegfilgrastim. Thirty-four CLL patients were enrolled and analyzed for neutropenia and other related factors, and comparative analysis was performed with historical cohort. ResultsCompared with our historical cohort, incidence of grade 3-4 neutropenia and febrile neutropenia was remarkably reduced during any cycle of chemotherapy (14.7% vs. 48.2% of study cohort vs. historical cohort during C1, 5.9% vs. 65.8% during C2, 12.9% vs. 80.6% during C3, 10% vs. 84.6% during C4, 3.4% vs. 83.6% during C5, and 10.7% vs. 85.7% during C6, p <0.001). Also, cumulative incidence of disrupted chemotherapy was noticeably reduced in study cohort on any cycles of R-FC regimen (8.8% vs. 22.2% of study cohort vs. historical cohort on C2, 9.7% vs. 25.2% on C3, 13.4% vs. 26.9% on C4, 13.8% vs. 45.2% on C5, 17.9% vs. 47.3% on C6, p=0.007). In addition, treatment-related mortality was 5.9%, which significantly reduced compared to 9.6% of our historical cohort (HR 0.64, 95% CI 0.42-0.79, P = 0.032). ConclusionPrimary prophylactic pegfilgrastim is effective in the prevention of neutropenia/febrile neutropenia, and infection-related mortality during R-FC regimen in patients with CLL.
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