PurposeThe incidence of and risk factors for febrile neutropenia (FN) in Japanese non-Hodgkin B-cell lymphoma (B-NHL) patients receiving rituximab, cyclophosphamide, doxorubicin, vincristine, and predonisolone (R-CHOP) chemotherapy are unknown. We conducted this study to address this issue.MethodsIn this single-center, retrospective, observational study, 466 patients with B-NHL who completed an R-CHOP regimen within a 7-year period and who planned to undergo at least three cycles of this regimen were analyzed. The following FN-related factors were assessed: fever, infection, disease state, neutrophil count, and prophylactic interventions such as use of antibiotics and/or granulocyte colony-stimulating factor (G-CSF). We simulated the FN incidence and 95% confidence interval (CI) of patients without prophylaxis with G-CSF (cycle 1) using bootstrap sampling.ResultsThe incidence of FN was 9.1% (42 of 462) in cycle 1 and 12.3% (57 of 462 patients) throughout all cycles, with 73.7% (42/57) developing FN during cycle 1. Risk factors for FN among patients with B-NHL treated with R-CHOP were albumin <35 g/L (p = 0.0047), relative dose intensity <85% (p = 0.0007), and lack of prophylaxis with G-CSF (p = 0.0006) in cycle 1. In the simulation analysis, the estimated FN incidence in cycle 1 was 16.2% (95% CI [10.9–22.2]).ConclusionsAt 9.1% in cycle 1 and 12.3% throughout all cycles, the incidence of FN was lower than previously reported, possibly reflecting the appropriate use of G-CSF in this clinical setting. For patients with risk factors, the prophylaxis with G-CSF may decrease the occurrence of FN.
Introduction Mantle cell lymphoma (MCL) is a rare B-cell non-Hodgkin lymphoma (NHL) accounting for 5 percent of NHLs. Most patients with MCL are 60 years of age and older. The prognosis of patients with MCL is moderately aggressive and variable; the median overall survival is 3-5years. MCL international prognostic index(MIPI)is related to prognosis of the patients with MCL, however, it is unclear whether MIPI predicts outcomes of MCL over sixties. Out therapeutic strategy in elderly patients with newly diagnostic MCL is not high-dose chemotherapy with autologous stem cell transplantation. Instead of aggressive chemotherapy, Rituximab maintenance is considered as an effective and feasible option. Thus, we investigated whether MCL international prognostic index (MIPI) relates overall survival (OS) or progression free survival (PFS), and whether maintenance therapy with Rituximab improved OS or PFS in patients with newly diagnosed MCL patients 60 and older. Methods We analyzed retrospectively 60 years of age and older patients with MCL who have achieved complete response (CR) or partial response (PR) after induction chemotherapy with rituximab at our hospital from December 2005 to February 2015. Two of primary refractory patients were excluded because analysis is for patients who are eligible for rituximab maintenance therapy. The patients were diagnosed by hematopathologist in our hospital. According to the MIPI, patients were stratified into low risk (0 patients, 0%), intermediate risk (9 patients, 41%), and high risk (13 patients, 59 %). Induction chemotherapy regimens were six cycles of R-CHOP (rituximab-cyclophosphamide-doxorubicin-vincristine-prednisone), four cycle of R-hyper CVAD/MA (rituximab-cyclophosphamide-vincristine-doxorubicin-dexamethasone alternating with rituximab-methotrexate-cytarabine), six cycles of R-CVP (rituximab- cyclophosphamide-vincristine-predonisone), R-VP16 (rituximab-etoposide), or six cycles of VR-CAP (bortezomib-rituximab-cyclophosphamide-doxorubicin- predonisone). Rituximab maintenance therapy started 6 months after the last induction chemotherapy and underwent four weekly infusion every 6 months for 2 years. Results A total of 22 MCL patients were analyzed. The number of patients who had achieved CR was 14 and PR was 8. 14 of 22 patients were treated rituximab maintenance. Median age was 73 years old. MIPI could predict OS of MCL. 3-year-OS was significantly superior intermediate risk to MIPI high risk (3-years-OS: 87.5 %vs.51.9 %,p=0.0232), whereas PFS didn't have correlation with MIPI(3-years PFS70.0 %vs.38.5 %,p=0.136). 3-years OS was significantly superior maintenance group to no maintenance group (3-years survival rate 91.7 % vs. 25.0 %, p=0.00188, figure 1), and 3-years PFS tend to improve in the maintenance group (3-years PFS, 65.8 % vs.25.0 %, p=0.0773, figure 2). Conclusion: In this study, MIPI correlates with OS, however doesn't show with PFS. Rituximab maintenance therapy is effective, and prolongs OS for 60 years of age and older patients with MCL. Figure 1. Figure 1. Figure 2. Figure 2. Disclosures Nishimura: Chugai Pharmaceutical CO., LTD.: Consultancy. Mishima:Chugai Pharmaceutical CO., LTD.: Consultancy. Yokoyama:Chugai Pharmaceutical CO., LTD.: Consultancy. Hatake:Chugai Pharmaceutical CO., LTD.: Other: lecture speaking.
Background Myelosuppressive chemotherapy-induced febrile neutropenia (FN) is a life-threatening condition. Patients receiving granulocyte colony-stimulating factors (G-CSF) have shorter duration of neutropenia, faster recovery from fever, and shorter duration of antibiotics use. Most strategies for FN prevention using daily G-CSF and pegfilgrastim are based on overseas studies. Data on Japanese patients were lacking; thus, we previously determined the incidence of FN in non-Hodgkin B cell lymphoma (B-NHL) patients at our center. Here, we aimed to gain additional insights into pegfilgrastim use in this population. Methods This single-center, retrospective, observational study (STOP FN in NHL 2) enrolled patients with B-NHL who underwent a regimen comprising rituximab and CHOP therapy over a 2-year period (January 2015-June 2017). The incidence of FN in cycle 1 of chemotherapy, risk factors for FN development, and use of daily G-CSF and pegfilgrastim were evaluated. Results We evaluated 239 patients: 61 patients did not receive G-CSF and 178 received G-CSF. The incidence of FN was 10.5% (95% confidence interval [CI] 6.9-15.1%) in cycle 1 and 13.0% (95% CI 9.0-17.9%) in all cycles. The FN incidence was significantly lower (P = 0.0008) in patients receiving daily G-CSF and pegfilgrastim than patients not receiving G-CSF. Significant risk factors for FN were age ≥ 65 years, albumin < 3.5 g/dL, hemoglobin < 12 g/dL, and no prophylaxis with daily G-CSF/pegfilgrastim during cycle 1. Conclusions The incidence of FN in cycle 1 and in all cycles and the identified risk factors were similar with those we previously reported; thus, our results validate previous findings. Trial registration UMIN000029534.Keywords Febrile neutropenia . Incidence . Japan . Non-Hodgkin B cell lymphoma . R-CHOP . Risk factor Background Myelosuppressive chemotherapy-induced febrile neutropenia (FN) is a life-threatening condition associated with increased morbidity and mortality [1, 2] that often results in extended hospitalization and death [3]. FN may lead to unwanted chemotherapy dose reductions or may halt treatment altogether, which can compromise treatment outcomes [2].According to the current Japanese guidelines [4], all patients who present an FN incidence ≥ 20% should receive prophylaxis granulocyte colony-stimulating factor (G-CSF), regardless of the presence or absence of risk factors, in order to prevent and treat FN induced by chemotherapy [5]. Further, all patients with risk factors for FN and FN incidence of 10 to < 20% should receive prophylaxis with G-CSF [4].Findings from this study were presented as a poster presentation at the
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