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Background Chemotherapy-induced thrombocytopenia (CIT) is a potentially serious complication that can lead to chemotherapy dose delays, dose reductions, or discontinuation, and increases the risk of serious bleeding events. The objectives of this study were to characterize the incidence, clinical consequences, and economic costs of CIT in current US clinical practice. Methods A retrospective cohort design and data from two US private healthcare claims repositories (01/2010–12/2016) were employed. Study population comprised adults who received selected myelosuppressive chemotherapy regimens for solid tumors or non-Hodgkin’s lymphoma. CIT was identified based on: diagnosis code for thrombocytopenia or bleeding; procedure code for platelet transfusion or bleeding control; or drug code for thrombopoietin-receptor agonist. Incidence of CIT was evaluated during the chemotherapy course (max. no. cycles = 8), and associated consequences and costs (2016US$) were evaluated during the cycle of the CIT episode. Results Among 215,508 cancer chemotherapy patients, CIT incidence during the course (mean no. cycles = 4.6) was 9.7% (95% CI: 9.6–9.8), and ranged from 6.1% (5.9–6.3) for regimens containing cyclophosphamide to 13.5% (12.7–14.3) for regimens containing gemcitabine; among all patients, incidence was 2.7% (2.6–2.8) in cycle 1, 2.7% (2.6–2.8) in cycle 2, and 2.9% (2.9–3.0) in cycles thereafter. One-third of CIT episodes were managed in hospital, and for the subset of patients hospitalized with a first-listed diagnosis of CIT, mean length of stay was 4.6 (4.4–5.0) days and mean cost of inpatient care was $36,448 (32,332-41,331). Across cycles with CIT, mean cost of CIT-related care was $2179 (2029-2329), comprising $1024 (881–1167) for inpatient care and $1153 (1119-1187) for outpatient care. Conclusions In this retrospective evaluation of cancer chemotherapy patients, CIT incidence was high, especially among patients receiving gemcitabine-based regimens, and the costs of CIT-related care were substantial. Accordingly, interventions aimed at identifying and targeting high-risk patients for preventative measures may yield substantial clinical and economic benefits.

Background Febrile neutropenia (FN) is a common occurrence during chemotherapy. Granulocyte colony-stimulating factors (G-CSFs) can significantly reduce the risk of FN. International guidelines recommend G-CSF for patients receiving chemotherapy with FN risk of ≥20% or 10% to 20% with defined risk factors. Prophylaxis is not typically recommended for FN risk of < 10%; however, few studies have investigated FN incidence in lower-risk patients in real-world settings and tried to identify higher-risk subgroups. Methods This real-world prospective, observational, multinational study aims to estimate the rate of development of FN with a chemotherapy line expected to be associated with a 10% to 20% risk of FN. Eligible patients (> 18 years of age) will have a solid tumour or Hodgkin/non-Hodgkin lymphoma and a planned chemotherapy regimen with expected risk of FN of 10% to 20% (according to published guidelines). Patients will be observed for the duration of the chemotherapy line (first cycle administered without FN prophylaxis). Primary endpoint is incidence of FN after the first chemotherapy cycle. Secondary outcomes include: FN-associated morbidity and mortality; time to first FN occurrence; other FN risk factors and impact of FN on quality of life. A risk model using occurrence of FN as a binary outcome will be developed. Data will be stratified by age, comorbidities and other risk factors. Discussion This study will provide insight into the real FN risk for common chemotherapy regimens and predictive factors for FN, including patients generally excluded from randomised clinical trials, from which reported FN rates have been variable. This study builds on knowledge of predictive factors from other research and will provide information on patients with 10% to 20% FN risk.

Purpose Guidelines recommend primary prophylactic (PP) granulocyte colony stimulating factor (G-CSF) for prevention of febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy with high risk (HR: > 20%), or intermediate risk (IR:10–20%) of FN and ≥ 1 patient risk factor (e.g., age ≥ 65y). The current retrospective cohort study describes patterns of PP-G-CSF in older Medicare patients undergoing myelosuppressive chemotherapy with HR/IR of FN. Methods Patients aged ≥ 66y initiating chemotherapy regimens with HR/IR of FN to treat breast, colorectal, lung, or ovarian cancer, or Non-Hodgkin’s Lymphoma were selected using Medicare 20% sample (2013–2015) and 100% cancer patient (2014–2017) data. PP-G-CSF use was identified in the first cycle. Timing of pegfilgrastim pre-filled syringe (PFS) administration, proportion of patients completing all cycles (adherence) with pegfilgrastim PFS or on-body injector (OBI), and duration of short-acting G-CSF (sG-CSF) was described across all cycles. Results Of 64,893 patients receiving HR/IR for FN, 71% received HR and 29% IR regimens. Overall, PP-G-CSF use in the first cycle was 53% (HR: 74%; IR: 44%) and varied across cancers. Adherence with pegfilgrastim was slightly higher among OBI initiators (78%) than PFS (74%). Number of PP-sG-CSF administrations (mean [SD]) per cycle was 5.1 (SD: 2.7) overall, 5.4 (2.6) for HR, and 4.9 (2.7) for IR. Conclusion Despite cancer treatment guidelines recommending PP-G-CSF use to reduce risk of FN associated with HR and IR (with ≥ 1 patient risk-factor) regimens, PP-G-CSF remains underutilized in older patients, across cancer types and regimens. Opportunities exist for improvement in use of PP-G-CSF.

To evaluate the possible changes of the oral microbiome during myelosuppressive chemotherapy (CT) and to investigate the potential relationship between the oral microbiome, the presence of oral mucositis (OM) and febrile neutropenia (FN). A prospective, longitudinal, observational study was conducted in patients receiving myelosuppressive CT for a solid tumor or lymphoma. Oral rinsing samples were retrieved before, during and after the start of CT, but also when OM or FN was present. The samples were analyzed using 16S rRNA gene amplicon sequencing and statistical analysis was performed using alpha (Shannon) and beta (PERMANOVA) diversity analyses. Furthermore, differential abundances were analyzed using ALDEx2v1.32.0. Differences between groups were calculated using the Mann Whitney -test, Kruskal-Wallis test and Wilcoxon Signed Rank using R. Forty-six patients, with a mean follow up of 114 days, were included for analysis and a total of 138 oral rinsing samples were available in the CLR-transformed data for PERMANOVA and 137 samples-for alpha diversity calculation. Significant changes in alpha diversity were seen when OM or FN was present. Moreover, significant changes were seen in beta diversity during the course of the CT treatment and when OM was present. Genera showing substantial changes in relative abundance were during the course of CT treatment and and when OM was present. Changes in the oral microbiome were observed during the CT-regimen and when OM was present. Furthermore, changes of the oral microbiota during FN episodes were observed; however, larger studies should be performed to substantiate our results.

Introduction: Febrile neutropenia (FN) is a potential life-threatening complication of myelosuppressive chemotherapy, particularly when induced by infection. There is evidence that FN can originate from the oral cavity, but its contribution to FN is largely understudied in patients treated for solid tumors. The aim of this study was to assess the prevalence of FN in these patients and to evaluate its relation with dental foci and oral mucositis.Material and Methods: A prospective longitudinal observational study was conducted. Patients diagnosed with solid tumors and lymphoma scheduled to be treated with myelosuppressive chemotherapy with an intermediate risk of developing FN were included. A pre-chemotherapy dental examination was performed and patients were followed during and after chemotherapy regimen. During subsequent hospital visits for chemotherapy administration, the oral cavity was inspected and oral mucositis (OM) was scored using the CTC-AE version 3.0. When patients presented with fever, a comprehensive full body examination including laboratory/microbiological/imaging investigation was performed.Results: Eighty-eight patients were included. Pre-chemotherapy, 39 patients (44.3%) were diagnosed with a dental focus. During chemotherapy, 46 patients developed OM (53.4%), of which 15 patients had a maximum score of grade II (ulcerative mucositis). Ten patients developed FN during the follow-up period. Patients with FN more often suffered from ulcerative OM compared to patients without FN; both FN and mucositis risk was associated with the myelotoxicity of chemotherapy. However, no relation could be established between the presence of dental foci prior to chemotherapy and the development of FN (p > 0.05).Conclusion: A significant relation was identified between ulcerative OM and FN, but no robust conclusions could be drawn with respect to a relationship between the presence of dental foci and FN.

Purpose To evaluate moderate (grade 2, hemoglobin <10 g/dl) and severe (grade 3+, hemoglobin <8 g/dl) anemia as potential risk factors for DDR in the first line course of chemotherapy. While chemotherapy-induced neutropenia has been shown to be associated with dose delay/reduction (DDR) in several studies, the effect of anemia is less well studied. Methods We identified 3955 Kaiser Permanente patients diagnosed with incident non-Hodgkin’s lymphoma ( n  = 574), breast ( n  = 2043), lung ( n  = 463), gastric ( n  = 113), ovarian ( n  = 204), or colorectal cancers ( n  = 558) between 2010 and 2012. Generalized linear mixed effects models were used to study the effect of anemia in subsequent cycles, adjusting for demographics, comorbidities, chemotherapy cycle, neutropenia, thrombocytopenia, and liver and renal function. Results We found that moderate (grade 2) to severe (grade 3–4) anemia increased the risk of DDR in subsequent chemotherapy cycles [odds ratio (OR) = 1.46, 95 % CI (1.32, 1.62) and OR = 2.02 (1.41, 2.89)], respectively, compared to grade 1 or no anemia. Both stage I–III and IV patients with grade 2 or greater anemia were at higher risk for DDR than patients with grade 1 or no anemia [OR stage IV, grade 2  = 1.94 (1.58, 2.38); OR stage IV, grade 3/4  = 2.83 (1.42, 5.62) and OR stage I–III, grade 2  = 1.33 (1.18, 1.49); OR stage I–III, grade 3–4  = 1.81 (1.18, 2.76)]. Conclusions These results provide insight into novel risk factors for chemotherapy dose modification that may inform clinicians on management strategies to optimize treatment outcomes.

Abstract Administering myelosuppressive chemotherapy to patients with aggressive malignant hematologic disorders typically poses serious infectious complications, which can be exacerbated by the presence of active COVID-19 infection. We report on a case of a successfully treated fit elderly woman with refractory acute myeloid leukemia (AML) who also had mild COVID-19 infection and detectable viral load at the time she was found to have recurrent disease. Prior to initiation of reinduction treatment with cytarabine/idarubicin, this 2-dose COVID-19-vaccinated patient received antiviral therapy with remdesivir with resolution of upper respiratory symptoms. This was followed by sotrovimab on the third day of chemotherapy. Throughout her hospital course, she remained hemodynamically stable with one episode of neutropenic fever without other identified infections. Symptomatic reactivation of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 was not observed. After achieving biopsy-confirmed morphologic remission of AML and with neutrophil recovery, the patient gradually cleared the virus, eventually testing negative on polymerase chain reaction test of the nasopharynx. This case underlines the importance of considering initiation of timely chemotherapy, although myelosuppressive, in appropriate patients with aggressive hematologic malignancies and concomitant SARS-CoV-2. It demonstrates management of active COVID-19 infection in this group of patients and the dynamics of SARS-CoV-2 viral load during leukemia treatment.

Background Several options for granulocyte colony-stimulating factor (G-CSF) prophylaxis of chemotherapy-induced febrile neutropenia are available to patients worldwide. We have developed a novel patient-reported outcome measure, the Satisfaction and Experience Questionnaire for G-CSF (SEQ-G-CSF), to help understand patients’ perspectives of and satisfaction with different G-CSF options. Results Three oncology nurses and 40 adult oncology patients in the United States were enrolled and participated in focus group discussions to develop and refine the SEQ-G-CSF. Nurses had ≥ 5 years of experience treating oncology patients and were currently involved in the management of oncology patients receiving G-CSF prophylaxis. The patients had breast cancer, lung cancer, non-Hodgkin lymphoma, or prostate cancer (10 patients in each group) and were receiving G-CSF prophylaxis via injection or the on-body injector (OBI) device. The preliminary SEQ-G-CSF contained an item relevance questionnaire and three SEQ modules (sociodemographic, medical history, and G-CSF–related healthcare characteristics questionnaires). Twenty-one patients (53% of total sample size) discussed their experience and satisfaction with G-CSF. Their most common experiences were G-CSF effectiveness, convenience and benefits of the OBI, and relationships with healthcare providers. Side effects and having to undergo additional treatment were also reported. Satisfaction with aspects of G-CSF included the OBI and effectiveness of G-CSF treatment; dissatisfaction included inconvenience (having to return to the clinic the next day and administration of the injection) and the insurance approval process. The SEQ-G-CSF was finalized after three rounds of cognitive interviews and includes five domains related to general satisfaction (one item), treatment burden (four items), travel burden (two items), time burden (four items), and treatment compliance (two items). Conclusions The SEQ-G-CSF is a novel instrument that quantifies a patient’s experience and satisfaction with different G-CSF options using 13 easy-to-understand items. This study provides evidence for the content validity of SEQ-G-CSF. Although further psychometric testing is required, the SEQ-G-CSF may be a useful addition to clinical trials, observational studies, and clinical practice.

Purpose The purposes of this study, in children who were assessed 1 week after the administration of myelosuppressive chemotherapy were: to compare the total and subscale scores on a generic measure of health-related quality of life (HRQOL) to normative data from healthy children and describe the relationships between demographic, clinical, and symptom characteristics of children with cancer and generic and disease-specific dimensions of HRQOL. Methods Patients ( n  = 61) were predominantly male (52.5%), minority (63.9%), and 14.7 years of age. Children completed the Memorial Symptom Assessment Scale for 10- to 18-year olds, the PedsQL™ Generic and Cancer Modules, and the Karnofsky Performance Status (KPS) scale 1 week after the start of a chemotherapy cycle. Results The mean number of symptoms per patient was 10.6. Compared with the normative sample, children with cancer reported significantly lower scores for the total scale and all of the subscales except emotional and social functioning. No significant differences were found between any demographic characteristics and total or subscale scores on the generic or disease-specific measures of HRQOL. Lower KPS scores were associated with poorer generic and disease-specific HRQOL scores. In addition, a higher number of symptoms was associated with poorer generic and disease-specific HRQOL scores. Finally, higher symptom distress scores were associated with poorer generic and disease-specific HRQOL scores. Conclusion Among the demographic, clinical, and symptom characteristics studied, poorer functional status and higher symptom burden were associated with significant decreases in HRQOL in children who received myelosuppressive chemotherapy.

A pharmacokinetics (PK)/pharmacodynamics (PD) study (EudraCT number 2015‐002966‐21) was conducted to investigate the biosimilarity of Pelmeg® (pegfilgrastim), a biosimilar to EU‐authorized Neulasta®, which is used in the clinic for prevention of chemotherapy‐induced neutropenia. The single‐dose, randomized, double‐blind, two‐way crossover study comprised 171 healthy male subjects, receiving Pelmeg and Neulasta (6 mg as subcutaneous injection) in a sequential manner. Primary PK endpoints were the area under the concentration curve from time zero to last measurable concentration (AUC0‐last) and the maximum concentration (Cmax). The primary PD endpoint was the area under the effect curve (AUEC0‐last) for absolute neutrophil count (ANC). Safety and immunogenicity were also assessed. Comparability was demonstrated for both PK endpoints, with geometric mean ratios (test/reference) for AUC0‐last and Cmax of 95.2% and 92.8%, respectively. The corresponding confidence intervals (CIs; 94.3%) were [86.6%;104.7%] for AUC0‐last and [84.4%;102.2%] for Cmax, both being within the equivalence margin of 80.0% to 125.0%. Likewise, PD comparability was demonstrated, with the geometric mean ratio (test/reference) of AUEC0‐last of 100.2%, with a corresponding CI (95%) of 98.7%‐101.8%. No clinically meaningful differences were observed for safety and immunogenicity between Pelmeg and Neulasta. Pelmeg was found to be highly similar to the reference product.