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- W2952693306 abstract "Background: Febrile neutropenia (FN) is the most important side effect of chemotherapy in diffuse large B cell lymphoma (DLBCL) causing not only treatment-related morbidity but also suboptimal chemotherapy delivery. Prophylactic use of granulocyte colony stimulating factor (G-CSF) or pegylated G-CSF (Peg-G-CSF) is known to reduce the incidence of both neutropenia and FN. We conducted a prospective registry study to evaluate prophylactic effect of Peg-G-CSF in DLBCL patients treated with R-CHOP regimen (ClinicalTrials.gov Identifier: NCT02474550). Patients and Method: Since January 1st 2015, after written informed consent, patients receiving R-CHOP therapy with curative intent were registered and prospectively monitored. All patients were pathologically confirmed with DLBCL according to World Health Organization Classification 2008. Prophylactic Peg-G-CSF (pegfilgrastim 6mg) was administered 24 hours after R-CHOP chemotherapy subcutaneously. The incidence of neutropenia and neutropenic fever were studied. Febrile neutropenia (FN) is defined as an oral temperature >38.5°C or two consecutive readings of >38.0°C for 2h and an absolute neutrophil count <0.5 × 109/l, or expected to fall below 0.5 × 109/l. We compared the outcomes of the cohort with those of the PROCESS cohort*. This analysis was performed as of December 11st 2018. Results: A total of 5357 cycles in 992 patients of this cohort and 2581cycles in 487 patients from the PROCESS cohort were included in the analysis. Base-line characteristics were summarized in Table 1. Median age at diagnosis was 62 (19-86) with a predominance of males (56.5%). Most patients had extranodal involvement (90.2%) and 369 patients (37.2%) had two or more extra-nodal involvements. The most common extranodal involvement sites were stomach (15.6%), bone (12.3%), intestine (9.7%) and lung (7.6%). All clinical characteristics were well- matched between the two cohorts other than age at diagnosis. Grade 4 neutropenia was developed in 286 patients (28.8%) with an overall incidence of 11.7% in the cycles and FN developed in 133 (13.4%) patients with an overall incidence of 4.2%, which were significantly lower in this cohort (Neutropenia 11.7% vs. 38.1% p=0.000; FN 13.4% vs 23.7% p=0.000) (Table 2.). Forty-seven patients (35.9%) had multiple episodes of FN. Most patients (80.4%) experienced the first episode of FN within three cycles. Treatment-related mortality (TRM) was significantly lower in this cohort (3.1% vs. 5.5%, p=0.032), mainly due to the low incidence of early infection-related death (1.6% vs. 4.5%, p=0.0001) (Table 2). In this cohort, 765 (77.1%) patients completed 6 cycles of R-CHOP therapy. Dose delays more than 3days and 5days were less common (18.1% vs. 23.7%, p=0.000; 12.0% vs 18.3% p=0.000) with Peg-G-CSF prophylaxis compared to the PROCESS cohort (Table 3). Dose reductions more than 20% in delivery of cyclophosphamide and doxorubicin happened in 13.3% and 19.5% of the cycles, respectively. Overall, more patients received ≥80% ARDI (average relative dose intensity, cyclophosphamide and doxorubicin) with a prophylactic use of Peg-G-CSF (73.2% vs. 70.9%, p=0.039). Among pretreatment clinical characteristics analyzed, age over 65, female gender, ECOG performance status 2 or higher, stage IV, and albumin level less than 3.5mg/dl were related with the development of FN (Table 4.). Multivariate analysis showed that age, gender, ECOG PS and albumin level were significantly related to FN (Table 5). Conclusion: Prophylactic use of Peg-G-CSF reduced the incidence of neutropenia and FN significantly in patients with DLBCL receiving R-CHOP therapy when compared to the control cohort, which resulted in the reduction of early infection-related deaths. In addition, Peg-GCSF support significantly improved dose-delay and ARDI. However, the patients who were elderly, female gender, with poor performance status and low albumin level still had high incidence of FN. 1. Kim SJ, Hong JS, Chang MH, Kim JA, Kwak JY, Kim JS, Yoon DH, Lee WS, Do YR, Kang HJ, Eom HS, Park Y, Won JH, et al. Highly elevated serum lactate dehydrogenase is associated with central nervous system relapse in patients with diffuse large B-cell lymphoma: results of a multicenter prospective cohort study. Oncotarget. 2016;7:72033-43. 2. Hong JS, Kim SJ, Chang MH, Kim JA, Kwak JY, Kim JS, Yoon DH, Lee WS, Do YR, Kang HJ, Eom HS, Park Y, Won JH, Mun YC, Kim HJ, Kwon JH, Kong JH, Oh SY, Lee S, Bae SH, Yang DH, Jun HJ, Lee HS, Yun HJ, Lee SI, Kim MK, Yi JH, Lee JH, Kim WS, Suh C. Improved prognostic stratification using NCCN- and GEMTAMO- international prognostic index in patients with diffuse large B-cell lymphoma. Oncotarget. 2017;8:92171-82. Keywords: diffuse large B-cell lymphoma (DLBCL); fever; G-CSF." @default.
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- W2952693306 date "2019-06-01" @default.
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- W2952693306 title "A PROSPECTIVE REGISTRY STUDY OF PEG-G-CSF PROPHYLAXIS FOR PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (CISL 1403)" @default.
- W2952693306 doi "https://doi.org/10.1002/hon.122_2631" @default.
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