Use Of Granulocyte Colony-stimulating Factor Research Articles

Granulocyte-colony stimulating factor in decompensated liver cirrhosis: a meta-analysis of four randomized controlled trials.

Decompensated liver cirrhosis (DC) has high mortality, but liver transplantation is limited due to organ scarcity and contraindications for transplantation. Granulocyte-colony stimulating factor (GCSF) shows potential for liver disease treatment with its regenerative and immunomodulatory properties. To assess the controversial use of GCSF in DC, a meta-analysis of randomized controlled trials (RCTs) compared survival benefits in patients receiving GCSF plus standard medical therapy (SMT) versus SMT alone. A literature search was performed in four databases from data inception up to December 2022, and all registered randomized controlled (RCTs) evaluating GCSF-based therapies for cirrhotic patients were included. A study combining four RCTs assessed the impact of GCSF with SMT in 595 patients with decompensated cirrhosis. The results indicated that GCSF + SMT led to higher odds of survival compared to SMT alone [risk ratio 1.28, 95% CI (1.08-1.5)]. Heterogeneity existed among the studies, but overall, GCSF showed potential in improving survival. The intervention group exhibited improved Child-Pugh-Turcotte scores [-2.51, CI (-4.33 to -0.70)], and increased CD34 levels, but no significant improvement in MELD scores. These findings suggest GCSF may benefit patients with decompensated cirrhosis in terms of survival and liver function. These results suggest that the combination of GCSF and SMT may have a positive impact on the survival rate and improvement in CPT score in patients with DC. Further RCTs are needed to shed more light on this promising modality in end-stage liver disease.

Neutropenia - when is GCSF support indicated?

Many systemic treatments used in genitourinary oncology negatively affect haematopoiesis, thus leading to neutropenia. Neutropenic patients are vulnerable to bacterial, and other infections. Often fever is the only symptom in these patients. Neutropenic fever is a major threat for these patients, as it may lead to life-threatening therapy complications that significantly impair the patient's quality of life, Moreover, it may also worsen the prognosis due to therapy delays or necessary dose modifications. Granulocyte colony stimulating factors (GCSF), which can improve neutrophil granulocyte formation, are used both for supportive treatment in febrile neutropenia and for its prophylaxis. The correct indication for such GCSF support depends on the general risk of febrile neutropenia of the therapy used, as well as on individual patient factors and the treatment intent (palliative vs. curative). Based on the current recommendations both of the German and international guidelines, this article aims to provide an up-to-date and practice-oriented overview of the use of GCSF in uro-oncology.

AML consolidation therapy: timing matters.

Infections due to severe neutropenia are the most common therapy-associated causes of mortality in patients with acute myeloid leukemia (AML). New strategies to lessen the severity and duration of neutropenia are needed. Cytarabine is commonly used for AML consolidation therapy; we compared high- and intermediate-dose cytarabine administration on days 1, 2, and 3 (AC-123) versus days 1, 3, and 5 (AC-135) in consolidation therapy of AML. Recently, clinical trials demonstrated that high-dose AC-123 resulted in a shortened white blood cell (WBC) recovery time compared with high-dose AC-135. Our main hypothesis is that this is also the case for different cytarabine dosage, granulocyte colony-stimulating factor (G-CSF) administration, and cycle lengths. We analyzed 334 treatment schedules on virtual cohorts of digital twins. Comparison of 32,565 simulated consolidation cycles resulted in a reduction in the WBC recovery time for AC-123 in 99.6% of the considered cycles (median reduction 3.5 days) without an increase in the number of leukemic blasts (lower value in 94.2% of all cycles), compared to AC-135. Our numerical study supports the use of AC-123 plus G-CSF as standard conventional AML consolidation therapy to reduce the risk for life-threatening infectious complications.

Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis

BackgroundThe tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is made by ex vivo priming matured autologous dendritic cells (DCs) with yeast cell wall particles (YCWPs) loaded with autologous tumor lysate...

Evaluation of a Weight-Based Mycophenolate Mofetil Dosing Protocol for Kidney Transplant Maintenance Immunosuppression

To evaluate the safety and efficacy of weight-based mycophenolate mofetil (MMF) dosing in adult kidney transplant recipients (KTR), this single-center retrospective study of adult KTR compared biopsy-proven acute rejection (BPAR), infections, hospitalizations, granulocyte colony-stimulating factor (G-CSF) use, and MMF dose changes within one year of transplant pre-and post-implementation of a weight-based MMF dosing protocol. Adult patients who received a kidney transplant at University Health Transplant Institute were reviewed for inclusion. Patients in the weight-based MMF group received 1000 mg twice daily by the first clinic visit if ≥ 80 kg, 750 mg twice daily if 50-79 kg, and 500 mg twice daily if < 50 kg. Patients in the fixed-dose MMF group received MMF 1000 mg twice daily. A total of 170 KTR (50.0% ≥ 80 kg, 44.1% 50-79 kg, 5.9% < 50 kg) were included. Baseline characteristics were similar between groups. The majority of patients were middle-aged Hispanic males and received lymphocyte-depleting induction therapy. Incidences of BPAR, infection, and hospitalization were similar between both groups at one-year post-transplant. Weight-based MMF dosing is safe and effective in adult KTR.

Real-world data analysis of perioperative chemotherapy patterns, G-CSF use, and FN status in patients with early breast cancer

PurposeThis study aimed to describe perioperative chemotherapy patterns, granulocyte colony-stimulating factor (G-CSF) use, and febrile neutropenia (FN) status in patients with early breast cancer (EBC) using real-world data in Japan.MethodsThis retrospective observational study used anonymized claims data. The included patients were ≥ 18 years old, were female, and had breast cancer diagnosis and surgery records between January 2010 and April 2020. Measures included perioperative chemotherapy, G-CSF use (daily and primary prophylaxis [PP]), and FN and FN-related hospitalization (FNH), all examined annually. Perioperative chemotherapy was examined separately for human epidermal growth factor receptor 2-positive/negative (HER2±). A multivariate logistic regression was used to explore the factors associated with FNH.ResultsOf 32,597 patients, those with HER2 + EBC treated with anthracycline-based regimens followed by taxane + trastuzumab + pertuzumab increased since 2018, and those with HER2 − EBC treated with doxorubicin/epirubicin + cyclophosphamide followed by taxane and dose-dense regimens increased after 2014. The proportion of patients prescribed daily G-CSF declined after 2014, whereas that of pegfilgrastim PP increased. The incidence proportion of FN remained at approximately 24–31% from 2010 to 2020, while that of FNH declined from 14.5 to 4.0%. The odds of FNH were higher in those aged ≥ 65 years and lower with pegfilgrastim PP administration.ConclusionDespite the increasing use of escalated regimens in the last 5–6 years, FNH continuously declined, and the odds of FNH were lower among patients treated with pegfilgrastim PP. These results may suggest the contribution of PP in part to suppressing FNH levels over the last 5–6 years.

Possible advantage of granulocyte colony-stimulating factor in breast cancer chemotherapy during COVID-19 pandemic: A single center experience in Japan.

e12505 Background: The COVID-19 pandemic seems to be ongoing in many countries, including Japan. ASCO and ESMO guidelines recommend treatment with during chemotherapy, and their use also reduces the risk of febrile neutropenia. On the other hand, there is a report that use of granulocyte colony-stimulating factor (G-CSF) increases the risk of admission and mortality due to COVID-19, so appropriate G-CSF use is still under discussion. Methods: Breast cancer patients treated with chemotherapy at our hospital from October 2020 to December 2022 were included in this study. We retrospectively collected patient data, including chemotherapy regimens, G-CSF use, COVID-19 infection, and COVID-19 severity, from electronic medical records. Results: Twenty-four patients (two bilateral breast cancers) received chemotherapy during this period. Twenty-three patients were female (95.8%) and one was male (4.2%), the mean age was 58.7 (34–79) years; 11 (45.8%) had early-stage breast cancer and 14 (58.3%) had advanced or recurrent breast cancer (one patient with early-stage breast cancer developed recurrent breast cancer during the study period). Seventeen cases (65.4%) were ER positive and nine cases (34.6%) were negative, 15 cases (57.7%) were PgR positive and 11 cases (42.3%) were negative, and six cases (23.1%) were HER2 positive and 20 cases (76.9%) were negative. The major chemotherapy regimens were ddAC in three patients (12.5%), AC in eight patients (33.3%), wPTX in 11 patients (45.8%), DTX in four patients (16.7%), TC in one patient (4.2%) and S-1 in eight patients (33.3%). Some patients also received treatment with anti-HER2 or anti-VEGF drugs or an immune check-point inhibitor but we did not consider these. Of the 13 patients who received AC, DTX and TC, 11 patients received PEG-GCSF in all their cycles. Among all patients receiving, COVID-19 symptoms were suspected on four occasions, and the COVID-19 antigen test was conducted, but all were negative, so no cases of COVID-19 were observed. Of the 46 cycles of AC, DTX, and TC, the proportion of patients with suspected COVID-19 symptoms who underwent antigen testing tended to be lower in the PEG-GCSF group (37 cycles) than in the no PEG-GCSF group (nine cycles) (2.7% vs. 22.2%; p = 0.0933, Fisher’s exact test). Conclusions: In this study, we did not find any cases of COVID-19 infection during chemotherapy, and so were unable to analyze the association between G-CSF use and COVID-19 infection severity. However, we did observe a trend toward a lower rate of potential COVID-19 with administration of PEG-GCSF. This might reflect a better quality of life for breast cancer chemotherapy patients.

G-CSF rescue of FOLFIRINOX-induced neutropenia leads to systemic immune suppression in mice and humans

BackgroundRecombinant granulocyte colony-stimulating factor (G-CSF) is routinely administered for prophylaxis or treatment of chemotherapy-induced neutropenia. Chronic myelopoiesis and granulopoiesis in patients with cancer has been shown to induce immature monocytes...

Single Dose of Granulocyte-Colony Stimulating Factor Use to Improve Intracytoplasmic Sperm Injection Outcomes

Receptive endometrium is essential for successful embryo implantation and is created by the synergistic activities of estrogen and progesterone, as well as support from other endocrine, paracrine, and autocrine pathways. Granulocyte Colony Stimulating Factor (G-CSF) may play a crucial role in modulating the immune response to enhance implantation. To estimate the role of granulocyte-colony stimulating factor on the clinical intracytoplasmic sperm injection (ICSI) outcome parameters. A prospective comparative study with random sample selection was carried out from 2021 to 2023 at the High Institute for Infertility Diagnosis and Assisted Reproductive Technologies, Al-Nahrain University. It included 80 women with infertility, with or without previous failure trials of intracytoplasmic sperm injection, who completed IVF and ICSI protocols and reached the day of embryo transfer. On the day of embryo transfer, patients were divided into two groups: 49 patients received no additional treatment (group 1), and 31 patients received granulocyte-colony stimulating factor subcutaneous injection within one hour of embryo transfer (group 2). The implantation rate was 13.3% in group 2 compared to 7.6% in group 1. The chemical and clinical pregnancy rates were 29.0% and 25.8% in group 2, while group 1 had 18.4% for both chemical and clinical pregnancy rates. The pregnancy and implantation rates were slightly higher in group 2, but the difference was not significant. More research is needed to support the use of G-CSF as a standard treatment in ICSI patients.

Cyclic neutropenia and concomitant IgA nephropathy: a case report

BackgroundIgA nephropathy (IgAN) is universally recognized as one of the most common primary glomerular diseases in all ages. Cyclic neutropenia (CN) is a rare haematologic disorder that is associated with mutations of the ELANE gene. The co-occurrence of IgAN and CN is extremely rare. This is the first case report of a patient with IgAN and genetically confirmed CN.Case presentationWe report a case of a 10-year-old boy who presented with recurrent viral upper respiratory tract infections accompanied by several episodes of febrile neutropenia, haematuria, proteinuria and acute kidney injury. Upon first admission, his physical examination was unremarkable. His kidney function was impaired, whereas his urine microscopy showed evidence of macroscopic haematuria and proteinuria. Further workup showed elevated IgA. The renal histology was consistent with mesangial and endocapillary hypercellularity with mild crescentic lesions, while immunofluorescence microscopy showed IgA-positive staining, which was characteristic of IgAN. Moreover, genetic testing confirmed the clinical diagnosis of CN, therefore Granulocyte colony-stimulating factor (G-CSF) was initiated to stabilize the neutrophil count. Regarding proteinuria control, the patient was initially treated with an Angiotensin-converting-enzyme inhibitor for approximately 28 months. However, due to progressive proteinuria (> 1 g/24 h), Corticosteroids (CS) were added for a period of 6 months according to the revised 2021 KDIGO guidelines with favorable outcome.ConclusionsPatients with CN are more susceptible to recurrent viral infections, which can trigger IgAN attacks. In our case CS induced remarkable proteinuria remission. The use of G-CSF contributed to the resolution of severe neutropenic episodes, viral infections and concomitant AKI episodes, contributing to better prognosis of IgAN. Further studies are mandatory to determine whether there is a genetical predisposition for IgAN in children with CN.

185O Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): A detailed safety analysis of the randomized, phase III DESTINY-Breast04 trial

DESTINY-Breast04 (NCT03734029) demonstrated significantly improved overall and progression-free survival (PFS) with T-DXd vs TPC in pts with HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization-negative) mBC, with manageable safety. Here, we report additional safety data. Pts with centrally confirmed HER2-low mBC, treated with 1-2 prior lines of chemotherapy, were randomly assigned 2:1 to receive T-DXd or TPC. An analysis of selected treatment-emergent adverse events (TEAEs) and age (<65 vs ≥65 years [y]) was done; endpoints included time to first onset (TTO), duration of first event (DUR), and resolution. At data cutoff (January 11, 2022), median (m) treatment duration was 8.2 months (mo; range [r], 0.2-33.3) for T-DXd vs 3.5 mo (r, 0.3-17.6) for TPC. Exposure-adjusted incidence rates (EAIRs; per pt-y) for any-grade TEAEs were lower for T-DXd vs TPC (1.30 vs 2.66). mTTO and mDUR of any-grade interstitial lung disease (ILD) in pts treated with T-DXd were 129 days (d; r, 26-710 d) and 47 d (r, 13-365 d). 13 pts had adjudicated drug-related grade 1 ILD; of those pts, 6 were rechallenged with T-DXd after resolution (details to be presented). Incidence of any-grade drug-related neutropenia (NP) and febrile NP was lower for T-DXd vs TPC; subsequent granulocyte colony-stimulating factor use was 6.7% vs 19.8%. Nausea/vomiting (N/V) events in T-DXd vs TPC were 79.5% vs 35.5%. T-DXd-treated pts received more antiemetic prophylaxis (AP; 50.9%) vs TPC-treated pts (37.2%); 92.3% of T-DXd and 68.8% of TPC N/V events in AP-treated pts resolved. Incidence of any-grade drug-related TEAE was consistent between pts aged <65 y and ≥65 y. For T-DXd, incidence of grade ≥3 TEAEs and TEAEs associated with drug discontinuations (DD) was higher in pts aged ≥65 y compared to those aged <65 y; the most common TEAE associated with DD was ILD/pneumonitis. However, mPFS favored T-DXd over TPC in all patients, regardless of age. EAIR, TTO, and DUR data for selected TEAEs will be presented. T-DXd demonstrated a manageable safety profile to support its use as the new standard of care in pts with HER2-low mBC.

MP32-04 GEMCITABINE–CISPLATIN VERSUS MVAC CHEMOTHERAPY IN UROTHELIAL CARCINOMA: A NATIONWIDE COHORT STUDY

You have accessJournal of UrologyCME1 Apr 2023MP32-04 GEMCITABINE–CISPLATIN VERSUS MVAC CHEMOTHERAPY IN UROTHELIAL CARCINOMA: A NATIONWIDE COHORT STUDY Se Young Choi, Jong Hyun Tae, Byung Hoon Chi, In Ho Chang, Tae-Hyoung Kim, Soon Chul Myung, Jung Hoon Kim, Jin Wook Kim, and Yong Seong Lee Se Young ChoiSe Young Choi More articles by this author , Jong Hyun TaeJong Hyun Tae More articles by this author , Byung Hoon ChiByung Hoon Chi More articles by this author , In Ho ChangIn Ho Chang More articles by this author , Tae-Hyoung KimTae-Hyoung Kim More articles by this author , Soon Chul MyungSoon Chul Myung More articles by this author , Jung Hoon KimJung Hoon Kim More articles by this author , Jin Wook KimJin Wook Kim More articles by this author , and Yong Seong LeeYong Seong Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003265.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: This study assessed the trends in methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) and gemcitabine–cisplatin (GC) regimens in Korean patients with metastatic urothelial carcinoma (UC) and compared the side effects and overall survival (OS) rates of the two regimens using nationwide population-based data. METHODS: The data of patients diagnosed with UC between 2004 and 2016 were collected using the National Health Insurance Service database. The overall treatment trends were assessed according to the chemotherapy regimens. The MVAC and GC groups were matched by propensity scores. Cox proportional hazard analysis and Kaplan–Meier analysis were performed to assess survival. RESULTS: Of 3,108 patients with UC, 2,880 patients were treated with GC and 228 (7.3%) were treated with MVAC. The transfusion rate and volume were similar in both the groups, but the granulocyte colony-stimulating factor (G-CSF) usage rate and number were higher in the MVAC group than in the GC group. Both groups had similar OS. Multivariate analysis revealed that the chemotherapy regimen was not a significant factor for OS. Subgroup analysis revealed that a period of ≥3 months from diagnosis to systemic therapy enhanced the prognostic effects of the GC regimen. CONCLUSIONS: The GC regimen was widely used as the first-line chemotherapy in more than 90% of our study population with metastatic UC. The MVAC regimen showed similar OS to the GC regimen but needed greater use of G-CSF. The GC regimen could be a suitable treatment option for metastatic UC after ≥3 months from diagnosis. Source of Funding: This research was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Science, ICT & Future Planning (NRF-2022R1A2C2008207) © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e441 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Se Young Choi More articles by this author Jong Hyun Tae More articles by this author Byung Hoon Chi More articles by this author In Ho Chang More articles by this author Tae-Hyoung Kim More articles by this author Soon Chul Myung More articles by this author Jung Hoon Kim More articles by this author Jin Wook Kim More articles by this author Yong Seong Lee More articles by this author Expand All Advertisement PDF downloadLoading ...

Use of granulocyte colony-stimulating factor in patients with chemotherapy-induced neutropaenia.

Febrile neutropaenia (FN) and resultant infections are the major cause of treatment-related morbidity and mortality in patients receiving chemotherapy. Clinical practice guidelines recommend the use of granulocyte colony-stimulating factors (G-CSF) to reduce the risk of FN and ensuing complications in patients receiving chemotherapy. Despite these recommendations, inappropriate usage of G-CSF has been reported. To assess prescribing patterns and adherence to international guidelines of G-CSF in adult patients with chemotherapy-induced neutropaenia (CIN) at the haematology oncology wards of the Dr George Mukhari Academic Hospital (DGMAH) and compliance to guidelines. Medical records of adult patients who received G-CSF were reviewed retrospectively between 01 January 2018 and 31 July 2018. Of the 128 patient files screened, 57 cases met the inclusion criteria. Duration of treatment with G-CSF was not in accordance with guidelines in more than 50% of the patients and in 43.86%, G-CSF dosing deviated from recommended guidelines. The study demonstrated over-prescribing of G-CSF due to either increased doses or duration of G-CSF therapy. Although prescribed for the correct indication, the dosage was often too high or the duration was too long, even once an acceptable neutrophil nadir count was reached. Interventions to optimise the use of G-CSF are required and the pharmacist may play a role in this regard. The administration of the correct doses of G-CSF can reduce both the severity and duration of neutropaenia. Over-prescribing and incorrect dosing may contribute to patient morbidity and add to the financial burden of healthcare.

The Role of Granulocyte-Colony Stimulating Factor Biosimilars for Supportive Cancer Care: A Year in Review

This year-in-review article provides insights into clinical updates relating to granulocyte-colony stimulating factor (G-CSF) biosimilars research presented at five key congresses in 2022. These include the American Society of Clinical Oncology (ASCO) 55th Annual Meeting (3rd–7th June 2022, Chicago, Illinois, USA), European Society for Medical Oncology (ESMO) Congress (9th–13th September 2022, Paris, France), ESMO Asia Congress (2nd–4th December 2022, Singapore), San Antonio Breast Cancer Symposium (SABCS; 6th–10th December 2022, Texas, USA), and American Society of Hematology (ASH) 64th Annual Meeting and Exposition (10th–13th December 2022, New Orleans, Louisiana, USA). Alongside reviewing the current research presented at these key congresses, with a focus on the use of G-CSF agents and biosimilars in patients undergoing treatment for breast, colorectal, and gynaecological cancers, this article provides an overview of current guidelines on the use of G-CSF in supportive cancer care to manage chemotherapy-induced febrile neutropenia and explores trends in G-CSF biosimilars research.

Update Management of Chemotherapy-Induced Neutropenia: A Narrative Literature Review

One of the most frequent and significant complicated side effects of myelosuppressive drugs is neutropenia. Neutropenia is not only associated with high morbidity but also mortality. Generally, the onset of neutropenia occurs within 3-7 days after the administration of anticancer agents. Approximately 5-30% of patients will develop febrile neutropenia. The highest incidence occurs during the first cycle of chemotherapy. This literature review aimed to describe chemotherapy-induced neutropenia and its prevention and management. Administration of granulocyte colony-stimulating factor as prophylaxis can prevent neutropenia-induced anticancer drugs. The use of granulocyte colony-stimulating factor (G-CSF) as therapeutic is contradictive, and some guidelines recommend not to use the G-CSF for therapeutic purposes. Up to 70% of mortality among these populations was associated with gram-negative sepsis, therefor empirical antibiotics, and antifungals are the keys to the management of neutropenia. In conclusion, prevention and appropriate management of neutropenia are extremely important in the treatment of patients with cancer.

Associations of granulocyte colony-stimulating factor with toxicities and efficacy of chimeric antigen receptor T-cell therapy in relapsed or refractory multiple myeloma

Background aimsFew studies have reported the associations of granulocyte colony-stimulating factor (G-CSF) with cytokine release syndrome (CRS), neurotoxic events (NEs) and efficacy after chimeric antigen receptor (CAR) T-cell therapy for relapsed or refractory (R/R) multiple myeloma (MM). We present a retrospective study performed on 113 patients with R/R MM who received single anti-BCMA CAR T-cell, combined with anti-CD19 CAR T-cell or anti-CD138 CAR T-cell therapy. MethodsEight patients were given G-CSF after successful management of CRS, and no CRS re-occurred thereafter. Of the remaining 105 patients that were finally analyzed, 72 (68.6%) received G-CSF (G-CSF group), and 33 (31.4%) did not (non G-CSF group). We mainly analyzed the incidence and severity of CRS or NEs in two groups of patients, as well as the associations of G-CSF timing, cumulative dose and cumulative time with CRS, NEs and efficacy of CAR T-cell therapy. ResultsBoth groups of patients had similar duration of grade 3–4 neutropenia, and the incidence and severity of CRS or NEs.There were also no differences in the incidence and severity of CRS or NEs between patients with the timing of G-CSF administration ≤3 days and those >3 days after CAR T-cell infusion. The incidence of CRS was greater in patients receiving cumulative doses of G-CSF >1500 μg or cumulative time of G-CSF administration >5 days. Among patients with CRS, there was no difference in the severity of CRS between patients who used G-CSF and those who did not. The duration of CRS in anti-BCMA and anti-CD19 CAR T-cell–treated patients was prolonged after G-CSF administration. There were no significant differences in the overall response rate at 1 and 3 months between the G-CSF group and the non–G-CSF group. ConclusionsOur results showed that low-dose or short-time use of G-CSF was not associated with the incidence or severity of CRS or NEs, and G-CSF administration did not influence the antitumor activity of CAR T-cell therapy.

Gemcitabine–cisplatin versus MVAC chemotherapy for urothelial carcinoma: a nationwide cohort study

This study assessed the trends in methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) and gemcitabine–cisplatin (GC) regimens in Korean patients with metastatic urothelial carcinoma (UC) and compared the side effects and overall survival (OS) rates of the two regimens using nationwide population-based data. The data of patients diagnosed with UC between 2004 and 2016 were collected using the National Health Insurance Service database. The overall treatment trends were assessed according to the chemotherapy regimens. The MVAC and GC groups were matched by propensity scores. Cox proportional hazard analysis and Kaplan–Meier analysis were performed to assess survival. Of 3108 patients with UC, 2,880 patients were treated with GC and 228 (7.3%) were treated with MVAC. The transfusion rate and volume were similar in both the groups, but the granulocyte colony-stimulating factor (G-CSF) usage rate and number were higher in the MVAC group than in the GC group. Both groups had similar OS. Multivariate analysis revealed that the chemotherapy regimen was not a significant factor for OS. Subgroup analysis revealed that a period of ≥ 3 months from diagnosis to systemic therapy enhanced the prognostic effects of the GC regimen. The GC regimen was widely used as the first-line chemotherapy in more than 90% of our study population with metastatic UC. The MVAC regimen showed similar OS to the GC regimen but needed greater use of G-CSF. The GC regimen could be a suitable treatment option for metastatic UC after ≥ 3 months from diagnosis.

A retrospective review of primary prophylaxis with granulocyte-colony stimulating factor (G-CSF) for patients with genitourinary malignancies receiving chemotherapy during the COVID-19 pandemic and implications for the future.

115 Background: To mitigate the risks of chemotherapy associated neutropenia, during the COVID-19 pandemic, all genitourinary (GU) cancer patients treated with chemotherapy at the Princess Margaret Cancer Centre (PMCC) were offered primary prophylaxis with GCSF. We hypothesize that this reduced rates of febrile neutropenia, hospitalizations, healthcare costs and improved overall outcomes, compared to GU cancer patients treated with chemotherapy without GCSF in the 2 years prior to the pandemic. Methods: We performed a retrospective review of GU cancer patients, receiving curative or palliative intent chemotherapy, with or without primary GCSF prophylaxis between January 2018 and June 2022. GCSF was given either as a single dose or as consecutive doses post chemotherapy. Main outcomes were incidence of febrile neutropenia, hospitalization, health care expenditures as well as disease specific outcomes. Results: Overall, 248 patients with prostate cancer (44%), urothelial cancers (33%) germ cell (21%), and rare GU cancers (4%) were identified. Median age was 70 (range 19-91), 92% were male, 65% were ECOG 0/1. Treatment intent was neoadjuvant (13%), adjuvant (20%), or palliative (67%). Main regimens used were docetaxel, cabazitaxel, carboplatin, cisplatin/etoposide, gemcitabine/cisplatin and BEP. Median follow-up was 10.5 months (0.23-52.3 months). A total of 206/248 received primary GCSF prophylaxis. During chemotherapy, the median white blood cell levels were higher in the GCSF group compared to the non-GCSF group (14.1*10*9/L vs 2.90*10*9/L, p&lt;0.0001); and neutropenia rates were markedly lower (2% vs. 93%, P=&lt;0.0001). Hospital admission rates were significantly lower in G-CSF users compared to non-users (19% vs. 69%, P&lt;0.0001). Symptomatic disease progression 13% was the leading cause of admission in the G-CSF group. Infectious causes such as UTI, pneumonia, COVID-19, and sepsis were seen in only 12% of the G-CSF group compared to 31% in the non-users. G-CSF was generally well tolerated with just 0.97% discontinuing G-CSF. Conclusions: During the COVID-19 pandemic, primary prophylactic G-CSF use in GU cancer patients, undergoing chemotherapy significantly lowered rates of both febrile neutropenia and hospitalizations and could be a cost-effective strategy in this patient population that warrants further study.

Family Knowledge, Attitudes, and Practices Toward Severe Congenital Neutropenia.

Severe congenital neutropenia is a rare disorder. The survival and quality of life of patients radically improved through infection prevention, use of granulocyte colony-stimulating factor, and the appropriate use of antibiotics during infections. The aim of this study was to evaluate the precautions taken by families to prevent infections, the level of knowledge regarding the disease, and the impact of external factors such as education and economic status on behavior and compliance in patients and caregivers in terms of the following treatment protocols. Questionnaires were designed with the aim of determining how the social, cultural, and economic conditions of the families of children with severe congenital neutropenia affected their behavior and knowledge levels. They were completed using one-on-one video interviews with the caregivers. Thirty-one patients from 25 families were enrolled into the study. No correlations between family disease knowledge, parent education levels, working status of the mother, sibling numbers, economic status, ease of hospital access, and/or residential location were found. An increase in disease knowledge of patients and caregivers, as well as proven approaches to living with the disease, would directly correlate to increased life quality and long-term survival rates of patients.

Clinical benefit of granulocyte-colony stimulating factor (GCSF) use during chemoimmunotherapy treatment for metastatic pancreatic adenocarcinoma (mPDAC).

757 Background: GCSF is used for primary/secondary prophylaxis of chemotherapy(chemo)-associated neutropenia in patients (pts) with mPDAC. GCSF may also increase the populations of healthy, naïve immune cells in an otherwise immunologically dysregulated and cold environment, potentially augmenting therapy outcome with immunomodulatory (IO) agents. Here, we describe the impact of GCSF administration on OS, PFS, and time on treatment (TOT) in the setting of mPDAC for (1) a trial in which pts were administered chemo-IO combinations and (2) a synthetic control arm using retrospective real-world data from pts who received standard-of-care (SOC) chemo (PASCAL). Methods: PRINCE is a ph1b/2 study evaluating gemcitabine (gem) and nab-paclitaxel (NP) ± sotigalimab (sotiga; CD40 agonist) ± nivolumab (nivo; anti-PD1) for pts with mPDAC (NCT0324250), where prophylactic GCSF use was prohibited. PASCAL pts received SOC gem/NP and primary/secondary GCSF use was allowed. In this retrospective analysis, GCSF use was defined as receiving at least 1 dose of GCSF anytime during treatment. OS, PFS, and TOT and associated HRs and CIs were calculated using Kaplan-Meier and Cox methods. PFS data not available for PASCAL. Results: 32/123 (26%) and 16/68 (24%) pts received GCSF in PRINCE and PASCAL, with 84% and 88% of pts receiving at least 1 dose within the first 3 cycles, respectively. In PRINCE, GCSF use was associated with significant improvements in OS (HR [95% CI]: 0.62 [0.40-0.97]), PFS (0.71 [0.47-1.08]), and TOT (0.67 [0.45-1.01]). These improvements were most notable in the sotiga-containing arms (table). In the absence of IO treatment, however, no statistical significance was observed in PASCAL (HR [95% CI]: OS = 0.81 [0.44-1.51]; TOT = 0.90 [0.51-1.58]). Additional work is ongoing to understand the association of GCSF usage with known prognostic factors. Conclusions: These analyses suggest that GCSF use may enhance the clinical benefits of chemo-IO in mPDAC. These potential benefits of GCSF usage warrant further evaluation in other chemo-IO trials as well as prospective evaluation in pre-clinical and clinical settings. Clinical trial information: NCT03214250 . [Table: see text]