Myeloprotection
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Positive Effects of Trilaciclib on Patient
POSITIVE EFFECTS OF TRILACICLIB ON PATIENT MYELOSUPPRESSION-RELATED SYMPTOMS AND FUNCTIONING: RESULTS FROM THREE PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED SMALL CELL LUNG CANCER TRIALS J Weiss1, K Skaltsa2, C Gwaltney2, D Daniel3, S Adler4, S Wolfe4, RK Malik4, SR Morris4, JM Antal4, Z Andric5 UNC Lineberger Comprehensive Cancer Center1; IQVIA2; Sarah Cannon, Tennessee Oncology – Chattanooga3; G1 Therapeutics4; Clinical Hospital Centre Bezanijska Kosa5 Conflict of Interest Disclosure Shannon Morris, MD, PhD • Salary: G1Therapeutics • Receipt of Intellectual Property Rights/Patent Holder: GlaxoSmithKline • Ownership Interest (stocks, stock options or other ownership interest excluding diversified mutual funds): G1 Therapeutics, GlaxoSmithKline Myelosuppression: despite the availability of interventions like G-CSF, ESAs and transfusions, there is still significant unmet medical need for patients 1st Line SCLC 2nd Line SCLC Current Incidence of Incidence of Current Unmet Needs Interventions Grade 3/41 Grade 3/42 ~70% bone pain (~25% severe3) induced by G-CSFs 54% Neutropenia 23% G-CSF (severe pain treated with NSAIDs, antihistamines, (3% FN) and opioids) Box warning for shortened overall survival and ESA rescue, Anemia 14% 31% increased risk of tumor progression; increased risk transfusion rescue of thromboembolic disease Thrombocytopenia 10% 54% Transfusion rescue No options other than transfusions Trilaciclib has the potential to prevent multi-lineage myelosuppression and reduce the need for these interventions and their associated side effects Sources: 1IMpower133 Trial, atezolizumab + E/P arm (n=198), NEJM, 2018; 2von Pawel J, et al. J Clin. Oncol. 2014;32:4012-4019; 2Kirshner et al: Prevention of pegfilgrastim-induced bone pain. JCO, 2012. Trilaciclib, a First-in-Class Myelopreservation Agent, Improves Patient Outcomes when Combined with Chemotherapy SCLC HSPC Trilaciclib transiently blocks progression through the cell cycle, thereby protecting HSPCs from damage by chemotherapy . -
Understanding the CBC
Understanding the CBC What is Hematology? Hematology is the science of blood and blood-forming tissues. Blood is made up of plasma and blood cells. Blood formation (hematopoesis) is a continuous process that occurs in the bone marrow. Within the bone marrow there is a pluripotent stem cell, the Mother Cell, the originator of all types of blood cells. The stem cell produces blood cells that exit the bone marrow and circulate in the blood system. Red cells circulate about four months, platelets last an average of ten days, and white cells range from only hours to a week or so. Stem cells that are found outside the bone marrow are called “peripheral stem cells” and are collected and frozen for stem cell transplants. What is a CBC? The CBC- the complete blood count, or the counts- is a lab test that will be ordered frequently on your child. This test determines the number, type, percentage, concentration and quality of the various types of blood cells that make up the blood. This test can be completed on blood that is collected by a finger stick, a lab draw from a central vein access and/or a straight draw from a peripheral vein, (usually from an arm, hand or foot). The CBC is commonly performed on an automated analyzer. However when abnormalities are noted in the blood, parts of the test can be completed manually. That is when the blood sample is viewed under the microscope. Some institutions commonly perform an extensively complete CBC and others may perform just specific aspects of the CBC. -
Azathioprine and Mercaptopurine Therapy
Patient & Family Guide 2021 Azathioprine and Mercaptopurine Therapy www.nshealth.ca Azathioprine and Mercaptopurine Therapy Your health care provider feels that treatment with azathioprine (a-za-THY-o-preen) (Imuran®) or mercaptopurine (mur-CAP-toe-pure-een) (6-MP) may help you manage an over-active immune response. This pamphlet will help you decide if this medication is right for you. It describes what azathioprine is, how it works, and possible side effects. What are azathioprine (AZA) and mercaptopurine (6-MP)? • The cells in your immune system fight infection and inflammation (swelling). • If your immune system is over-active, it can can cause inflammation and damage to body tissues and organs. • Diseases that cause an over-active immune response are: › Rheumatoid arthritis › Inflammatory bowel disease (IBD), such as Crohn’s disease and ulcerative colitis › Certain forms of liver disease • AZA is an immunosuppressive medication. It suppresses (weakens) the immune response, which lowers inflammation. 1 • 6-MP is very similar to AZA. It works much the same way, but your body breaks it down in a different way. This makes it less likely to cause nausea (feeling sick to your stomach) and vomiting (throwing up). 6-MP costs more than azathioprine. If you have nausea or vomiting when taking AZA, talk to your health care provider. How well does AZA work? Will it work for me? • AZA, when used alone, helps to control diseases that cause an over-active immune response in many people, including IBD. • Take this medication as told by your doctor. This increases the chance that it will work well. -
Bone Marrow Suppression (Myelosuppression) and Leukopenia/Neutropenia
Effects on the Hematopoietic System: Bone Marrow Suppression (Myelosuppression) and Leukopenia/Neutropenia Effects on the Hematopoietic System: Bone Marrow Suppression (Myelosuppression) and Leukopenia/Neutropenia Author: Ayda G. Nambayan, DSN, RN, St. Jude Children’s Research Hospital Erin Gafford, Pediatric Oncology Education Student, St. Jude Children’s Research Hospital; Nursing Student, School of Nursing, Union University Content Reviewed by: Monika Metzger, MD, St. Jude Children’s Research Hospital Cure4Kids Release Date: 6 June 2006 Leukopenia is a decrease in the absolute number of white blood cells, whereas neutropenia is the condition in which the absolute neutrophil count (ANC) is either < 500/mm3 or <1000/mm3 with a predictable decline to <500/mm3 in 24 to 48 hours. Leukopenia and neutropenia can be caused by cancer or by myelosuppression secondary to therapy (chemotherapy and radiation therapy). Infection is the most common complication associated with neutropenia and the major cause of morbidity and mortality in neutropenic patients with cancer. Important determinants of the risk of infection include the number of circulating neutrophils and the duration of the neutropenia. The lower the number of circulating neutrophils is and the longer the neutropenia lasts, the higher the incidence and the more severe the infections are. Children and adolescents with severe neutropenia (ANC< 500/mm3) are at risk of life- threatening bacterial, fungal and viral infections. If the patient has febrile neutropenia (A – 1), surveillance cultures and more blood tests should be conducted to determine whether infection is present and, if it is, where it is located. Assessment Patient assessment must include a careful history and physical examination. -
Severe Myelotoxicity Associated with Thiopurine S-Methyltransferase*3A
Case Report DOI: 10.4274/tjh.2013.0082 Severe Myelotoxicity Associated with Thiopurine S-Methyltransferase*3A/*3C Polymorphisms in a Patient with Pediatric Leukemia and the Effect of Steroid Therapy Pediatrik Bir Lösemi Olgusunda Tiyopurin S-Metiltransferaz *3A/*3C Polimorfizmi ile İlişkili Ağır Miyelotoksisite-Steroid Tedavisinin Etkisi Burcu Fatma Belen1, Türkiz Gürsel1, Nalan Akyürek2, Meryem Albayrak3, Zühre Kaya1, Ülker Koçak1 1Gazi University Faculty of Medicine, Department of Pediatric Hematology, Ankara, Turkey 2Gazi University Faculty of Medicine, Department of Pathology, Ankara, Turkey 3Kırıkkale University Faculty of Medicine, Department of Pediatric Hematology, Ankara, Turkey Abstract: Myelosuppression is a serious complication during treatment of acute lymphoblastic leukemia and the duration of myelosuppression is affected by underlying bone marrow failure syndromes and drug pharmacogenetics caused by genetic polymorphisms. Mutations in the thiopurine S-methyltransferase (TPMT) gene causing excessive myelosuppression during 6-mercaptopurine (MP) therapy may cause excessive bone marrow toxicity. We report the case of a 15-year-old girl with T-ALL who developed severe pancytopenia during consolidation and maintenance therapy despite reduction of the dose of MP to 5% of the standard dose. Prednisolone therapy produced a remarkable but transient bone marrow recovery. Analysis of common TPMT polymorphisms revealed TPMT *3A/*3C. Key Words: Myelosuppression, Thiopurine S-methyl transferase, Acute leukemia Özet: Miyelosupresyon, -
Prolonged Self-Resolving Neutropenia Following Asymptomatic COVID-19 Infection
Open Access Case Report DOI: 10.7759/cureus.16451 Prolonged Self-Resolving Neutropenia Following Asymptomatic COVID-19 Infection Shreya Desai 1 , Javairia Quraishi 1 , Dennis Citrin 2 1. Internal Medicine, Rosalind Franklin University of Medicine and Science, North Chicago, USA 2. Hematology and Oncology, Captain James A. Lovell Federal Health Care Center, North Chicago, USA Corresponding author: Shreya Desai, [email protected] Abstract Multiple hematologic complications have been reported as a result of the novel coronavirus disease 2019 (COVID-19) infection. These include leukopenia, lymphopenia, thrombocytopenia as well as increased risk of venous thromboembolism. Neutropenia is a relatively uncommon finding, especially in asymptomatic patients with no other evidence of systemic infection. A young, healthy male undergoing training for the Navy was admitted with rhabdomyolysis following intense physical activity. He was incidentally noted to have severe neutropenia with the white blood cell (WBC) count of 2.1 × 109/L and an absolute neutrophil count (ANC) of 355 cells/μL one month following prior asymptomatic COVID-19 infection. Further evaluation was negative for other infectious processes, nutritional deficiency, or underlying malignancy. Given young age without comorbidities and lack of febrile illness, watchful waiting was recommended in lieu of bone marrow biopsy which resulted in spontaneous resolution of neutropenia and normalization of WBC. The authors argue that although most hematologic complications of COVID-19 are reported in symptomatic patients, asymptomatic patients also appear to have a risk of developing hematologic complications including bone marrow suppression. Watchful waiting may be an appropriate diagnostic approach in such young, healthy individuals. Categories: Internal Medicine, Infectious Disease, Hematology Keywords: coronavirus disease (covid-19), neutropenia, asymptomatic covid-19, leukopenia, bone marrow biopsy Introduction Neutropenia is defined as an absolute neutrophil count (ANC) less than 1500 cells/µL [1]. -
Diffuse Alveolar Hemorrhage in Acute Myeloid Leukemia Sowmya Nanjappa, MBBS, MD, Daniel K
Case Series Diffuse Alveolar Hemorrhage in Acute Myeloid Leukemia Sowmya Nanjappa, MBBS, MD, Daniel K. Jeong, MD, Manjunath Muddaraju, MD, Katherine Jeong, MD, Eboné D. Hill, MD, and John N. Greene, MD Summary: Diffuse alveolar hemorrhage is a potentially fatal pulmonary disease syndrome that affects individuals with hematological and nonhematological malignancies. The range of inciting factors is wide for this syndrome and includes thrombocytopenia, underlying infection, coagulopathy, and the frequent use of anticoagulants, given the high incidence of venous thrombosis in this population. Dyspnea, fever, and cough are commonly pre- senting symptoms. However, clinical manifestations can be variable. Obvious bleeding (hemoptysis) is not always present and can pose a potential diagnostic challenge. Without prompt treatment, hypoxia that rapidly progresses to respiratory failure can occur. Diagnosis is primarily based on radiological and bronchoscopic findings. This syndrome is especially common in patients with hematological malignancies, given an even greater propensity for thrombocytopenia as a result of bone marrow suppression as well as the often prolonged immunosuppression in this patient population. The syndrome also has an increased incidence in individuals with hematological malignancies who have received a bone marrow transplant. We present a case series of 5 patients with acute myeloid leukemia presenting with diffuse alveolar hemorrhage at our institution. A comparison of clinical manifestations, radio- graphic findings, treatment course, and outcomes are described. A review of the literature and general overview of the diagnostic evaluation, differential diagnoses, pathophysiology, and treatment of this syndrome are discussed. Introduction 5 patients. The median patient age was 57 years (range, Diffuse alveolar hemorrhage (DAH) is a potentially fa- 51–70 years). -
Immunomodulators
Fact Sheet News from the IBD Help Center IMMUNOMODULATORS Medical treatment for Crohn’s disease and ulcerative colitis has two main goals: achieving remission (control or resolution of inflammation leading to symptom resolution with healing of the inflamed tissue) and then maintaining remission. To accomplish these goals, treatment is aimed at controlling the ongoing inflammation in the intestine—the cause of inflammatory bowel disease (IBD) symptoms. As the name implies, immunomodulators modify the activity of the immune system, in turn, decreasing the inflammatory response. Immunomodulators are most often used in organ transplantation to prevent rejection of the new organ as well as in autoimmune diseases such as rheumatoid arthritis. Since the late 1960s, they have also been used to treat people with IBD, where the normal regulation of the immune system is affected. Immunomodulators, by themselves or with another agent, may be appropriate in the following treatment situations: • Nonresponse or intolerance to aminosalicylates, antibiotics, or corticosteroids • Steroid-dependent disease or frequent need for steroids • Perianal (around the anus) disease that does not respond to antibiotics • Fistulas (abnormal channels between two loops of intestine, or between the intestine and another structure—such as the skin) • To bolster or optimize the effect of a biologic drug and prevent the development of resistance to biologic drugs • To prevent recurrence after surgery Because it can take up to three to six months to see an improvement in symptoms with immunomodulators, steroids may be started at the same time to produce a faster response. Lower doses of the steroid may be utilized in some cases, producing fewer side effects. -
Investor Day March 6, 2019
Investor Day March 6, 2019 www.g1therapeutics.com NASDAQ: GTHX 1 Forward-looking statements This presentation and the accompanying oral commentary contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this presentation include, but are not limited to the following: the therapeutic potential of trilaciclib, lerociclib and G1T48; initial success in our ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; our development of trilaciclib to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; our product candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any; we may not have the ability to recruit, enroll and complete clinical trials for, obtain approvals for, or commercialize any of our product candidates; we face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do; we may incur additional costs or experience delays in completing clinical trials; future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain; and market conditions. -
Pancytopenia Secondary to SARS-Cov 2 Infection-A Case Reprt
Pancytopenia Secondary to SARS-CoV 2 Infection-A Case Reprt Neeraj Sharma ( [email protected] ) Military Hospital Namkum https://orcid.org/0000-0002-6676-6100 Rajat Shukla Military Hospital Namkum Rachna Warrier Military Hospital Namkum Kunal Kumar Military Hospital Namkum Nalin Singh Military Hospital Namkum Sourav Ghose MH Namkum Vivek Kumar Military Hospital Namkum Research Article Keywords: Pancytopenia, SARS CoV-2 infection, COVID 19 disease Posted Date: June 29th, 2021 DOI: https://doi.org/10.21203/rs.3.rs-657352/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/10 Abstract Pancytopenia is a condition when person has low count of all three types of blood cells causing a triage of anemia, leukopenia and thrombocytopenia. It should not be considered as a disease in itself but rather the sign of a disease that needs to be further evaluated. Among the various causes, viral infections like Human Immunodeciency Virus, Cytomegalovirus, Epstein-Barr virus and Parvovirus B19 have been implicated. Pancytopenia is a rare complication and not commonly seen in patients with COVID 19 disease. Here, we report a case of pancytopenia in previously immunocompetent elderly male patient with SARS-CoV2 infection. Introduction The most common haematological and immunological ndings of coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) are elevated inammatory markers, hypercoagulable state and lymphopenia. Pancytopenia is a rare complication and not commonly seen in immunocompetent patients with COVID 19 disease. The common causes of pancytopenia in clinical practice are megaloblastic anemia, hypersplenism, drug induced bone marrow toxicity, leukaemia, radiation therapy, chemotherapy, immunosuppressive medications, connective tissue diseases and infections1. -
Cancer and Leukemia Group B
Protocol Update #11 XX/XX/17 ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY _________________________________________ PROTOCOL UPDATE TO CALGB 10701/CTSU 10701 _________________________________________ A PHASE II STUDY OF DASATINIB (SPRYCEL®) (IND #73969, NSC #732517) AS PRIMARY THERAPY FOLLOWED BY TRANSPLANTATION FOR ADULTS ≥ 18 YEARS WITH NEWLY DIAGNOSED PH+ ACUTE LYMPHOBLASTIC LEUKEMIA BY CALGB, ECOG AND SWOG Investigational Agent: Dasatinib (IND #73969, NSC # 732517 will be supplied by NCI DCTD Companion Studies for Alliance Institutions: CALG 8461 (required), 9665 (optional) Companion Study for ECOG-ACRIN Institutions: E3903 (required) X Update: Status Change: Eligibility changes Activation Therapy / Dose Modifications / Study Calendar changes Closure Informed Consent changes Suspension / temporary closure Scientific / Statistical Considerations changes Reactivation X Data Submission / Forms changes Editorial / Administrative changes Other : Expedited review is allowed. IRB approval (or disapproval) is required within 90 days. Please follow your IRB of record guidelines. UPDATES TO THE PROTOCOL: Section 6.1 Data Submission - In the data submission table, the form “C10701 ABL1 Mutational Analysis Form” has been added prior to “During Treatment (Course I).” This form must be completed for all patients and mailed to the Alliance Statistics and Data Center. - In the data submission table, under “During Treatment (Course VI) and Post-Treatment Follow-Up,” the form “C10701 ABL1 Mutational Analysis Form” has been added. This form must be completed for all patients and mailed to the Alliance Statistics and Data Center. 1 Section 10.13 Filgrastim (G-CSF: Granulocyte Colony-Stimulating Factor; Neupogen; recombinant- methionyl human granulocyte-colony stimulating factor; r-methHuG-CSF; filgrastim-sndz, Zarxio(R)) Zarxio can be used in place of neupogen, therefore, the text “filgrastim-sndz, Zarxio(R)” has been added to the end of the section title. -
G1 Therapeutics Presents Two Posters at ISPOR Describing The
G1 Therapeutics Presents Two Posters at ISPOR Describing the Estimated Economic Impact of Treating Myelosuppression Among Patients with Extensive-Stage Small Cell Lung Cancer May 17, 2021 - A Cost-Benefit Model of Administration of COSELATM (trilaciclib) Prior to Chemotherapy Estimates Measurable Per-Patient Cost Savings - - Myelosuppression Poses a Substantial Burden on the Health Care System Among Patients with Small Cell Lung Cancer, According to an Analysis of SEER-Medicare Data - RESEARCH TRIANGLE PARK, N.C., May 17, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today presented two scientific posters at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) describing the estimated economic impact of treating myelosuppression among patients with extensive-stage small cell lung cancer. The posters are available in the scientific publications section of the G1’s website. COSELA was approved by the U.S. Food and Drug Administration on February 12, 2021 to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. Cost-Benefit Analysis of Trilaciclib for the Prevention of Chemotherapy-Induced Myelosuppression in Extensive-Stage Small Cell Lung Cancer (Deniz, B. et al.) (poster) The first poster details a cost-benefit model estimating the economic value from a U.S. commercial payer perspective of using COSELA™ (trilaciclib) prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). According to the model, the estimated potential total cost savings per patient is $15,006 – savings that are based on a projected reduction in myelosuppressive adverse events (AEs) and their associated treatment costs.