The FDA on August 15, 2019 granted accelerated approval to ROZLYTREK® for adults and pediatric patients 12 years of age and older with solid tumors that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. ROZLYTREK® is a product of Genentech Inc.
Tag: General Medical Oncology & Hematology
TURALIO® (Pexidartinib)
The FDA on August 2, 2019 approved TURALIO® capsules for adult patients with symptomatic Tenosynovial Giant Cell Tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO® is the first systemic therapy approved for patients with TGCT. TURALIO® is a product of Daiichi Sankyo, Inc.
Anticonvulsant Prophylaxis and Steroid Use in Adults with Metastatic Brain Tumors ASCO and SNO Endorsement of the Congress of Neurological Surgeons Guidelines
SUMMARY: Brain metastases are the most common intracranial tumors in adults in the United States. In patients with systemic malignancies, brain metastases occur in 10-30% of adults, with Lung, Breast, and Melanoma continuing to be the leading cause of brain metastases. The incidence of brain metastases may be on the rise due to both improved imaging techniques, as well as better control of extracerebral disease from advances in systemic therapy.
The Congress of Neurological Surgeons (CNS) developed a series of guidelines for the treatment of adult patients with metastatic brain tumors, including systemic therapy and supportive care topics. The ASCO/SNO (Society of NeuroOncology) Expert Panel determined that the recommendations from the CNS anticonvulsants and steroids guidelines, published January 9, 2019, are clear, thorough, and based on the most relevant scientific evidence. ASCO/SNO endorsed these two CNS guidelines with minor alterations. This guideline was developed by a multidisciplinary Expert Panel that included a patient representative and an ASCO guidelines staff member with health research methodology expertise.
Guideline Questions
CNS Anticonvulsant Guideline
1) Do prophylactic antiepileptic drugs decrease the risk of seizures in nonsurgical patients with brain metastases who are otherwise seizure free?
2) Do prophylactic antiepileptic drugs decrease the risk of seizures in patients with brain metastases and no prior history of seizures in the postoperative setting?
CNS Steroids Guideline
1) Do steroids improve neurologic symptoms and/or quality of life in patients with metastatic brain tumors compared with supportive care only or other treatment options?
2) If steroids are administered, what dose should be given?
Target Population
Adults with metastatic brain tumors.
Target Audience
Medical oncologists, Neurologists, and others who provide care for adults with metastatic brain tumors.
Recommendations
CNS Anticonvulsants Guideline:
1) Prophylactic antiepileptic drugs are not recommended for routine use in patients with brain metastases who did not undergo surgical resection and who are otherwise seizure free.
2) Routine postcraniotomy antiepileptic drug use for seizure-free patients with brain metastases is not recommended.
CNS Steroids Guideline: Steroid Therapy Versus No Steroid Therapy
Patients with asymptomatic brain metastases without mass effect:
Insufficient evidence exists to make a treatment recommendation for this clinical scenario.
Patients with brain metastases with mild symptoms related to mass effect:
1) Corticosteroids are recommended to provide temporary symptomatic relief of symptoms related to increased intracranial pressure and edema secondary to brain metastases. It is recommended for patients who are symptomatic from metastatic disease to the brain that a starting dose of Dexamethasone 4 to 8 mg/day be considered. Patients with brain metastases with moderate to severe symptoms related to mass effect
2) Corticosteroids are recommended to provide temporary symptomatic relief of symptoms related to increased intracranial pressure and edema secondary to brain metastases. If patients exhibit severe symptoms that are consistent with increased intracranial pressure, it is recommended that higher doses, such as Dexamethasone 16 mg/day or more, be considered.
Choice of steroid:
If corticosteroids are administered, Dexamethasone is the best drug choice, given the available evidence.
Duration of corticosteroid administration:
Corticosteroids, if administered, should be tapered as rapidly as possible, but no faster than clinically tolerated, on the basis of an individualized treatment regimen and a full understanding of the long-term sequelae of corticosteroid therapy.
ASCO/SNO Expert Panel comment: The Panel’s expert opinion is that, given the important adverse effects of steroids, the minimum effective dose (often no more than 4 mg) should be used where possible and night-time doses of steroids should be avoided to minimize toxicity.
Note regarding CNS Level 3 recommendation classification: CNS defines a Level 3 recommendation as, one based on “Evidence from case series, comparative studies with historical controls, case reports, and expert opinion, as well as significantly flawed randomized controlled trials”
Anticonvulsant Prophylaxis and Steroid Use in Adults With Metastatic Brain Tumors: ASCO and SNO Endorsement of the Congress of Neurological Surgeons Guidelines. Chang SM, Messersmith H, Ahluwalia M, et al. J Clin Oncol 2019;37:1130-1135
ASCO/ASH Update on Erythropoiesis Stimulating Agents for Cancer-Associated Anemia
SUMMARY: The American Society of Clinical Oncology (ASCO) along with American Society of Hematology (ASH) updated recommendations for use of Erythropoiesis Stimulating Agents (ESAs) in patients with cancer. The primary literature review included 15 meta-analyses of Randomized Clinical Trials and two Randomized Clinical Trials. These recommendations were developed using a systematic review of the literature from January, 2010, through May, 2018, and clinical experience.
Guideline question: When and how should Erythropoiesis Stimulating Agents (ESAs) be used to manage anemia in adults with cancer?
Target population: Adults with Cancer and Anemia.
Target audience: Oncologists, Hematologists, Oncology Nurses, Oncology Pharmacists, and other health care professionals who care for patients with cancer, and patients with cancer.
RECOMMENDATIONS
Clinical question 1: To reduce the need for RBC transfusions, should ESAs be offered to patients who have chemotherapy-associated anemia?
Recommendation 1.1. Depending on clinical circumstances, ESAs may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to less than 10 g/dL. RBC transfusion is also an option, depending on the severity of the anemia or clinical circumstances
Recommendation 1.2. ESAs should not be offered to patients with chemotherapy-associated anemia whose cancer treatment is curative in intent
Clinical question 2: To reduce the need for RBC transfusions, should ESAs be offered to anemic patients with cancer who are not receiving concurrent myelosuppressive chemotherapy?
Recommendation 2.1. ESAs should not be offered to most patients with nonchemotherapy-associated anemia
Recommendation 2.2. ESAs may be offered to patients with lower risk MyeloDysplastic Syndromes and a serum Erythropoietin level 500 IU/L or less.
Clinical question 3: What special considerations apply to adult patients with nonmyeloid hematologic malignancies who are receiving concurrent myelosuppressive chemotherapy?
Recommendation 3. In patients with Myeloma, Non-Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia, clinicians should observe the hematologic response to cancer treatment before considering an ESA. Particular caution should be exercised in the use of ESAs concomitant with treatment strategies and diseases where risk of thromboembolic complications is increased (see Recommendations 4 and 6). In all cases, blood transfusion is a treatment option that should be considered
Clinical question 4: What examinations and diagnostic tests should be performed before making a decision about using an ESA to identify patients who are likely to benefit from an ESA?
Recommendation 4. Before offering an ESA, clinicians should conduct an appropriate history, physical examination, and diagnostic tests to identify alternative causes of anemia aside from chemotherapy or an underlying hematopoietic malignancy. Such causes should be appropriately addressed before considering the use of ESAs. Suggested baseline investigations include thorough drug exposure history, peripheral blood smear review, analyses where indicated, for Iron, TIBC, Ferritin, Transferrin saturation, Folate, Vitamin B12, or Hemoglobinopathy screening, assessment of Reticulocyte count, occult blood loss and renal Insufficiency and baseline Erythropoietin level and TSH. Investigations may also include Direct Antiglobulin Testing (eg, Coombs test) for patients with Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, or a history of autoimmune disease.
Clinical question 5: Among adult patients who receive an ESA for chemotherapy-associated anemia, do Darbepoetin, Epoetin beta and alfa originator, and currently available biosimilars of Epoetin alfa differ with respect to safety or efficacy?
Recommendation 5. The Expert Panel considers Epoetin beta and alfa, Darbepoetin, and biosimilar Epoetin alfa to be equivalent with respect to effectiveness and safety
Clinical question 6: Do ESAs increase the risk of thromboembolism?
Recommendation 6. ESAs increase the risk of thromboembolism, and clinicians should carefully weigh the risks of thromboembolism and use caution and clinical judgment when considering use of these agents
Clinical question 7: Among adult patients who will receive an ESA for chemotherapy-associated anemia, what are recommendations for ESA dosing and dose modifications?
Recommendation 7. It is recommended that starting and modifying doses of ESAs follow FDA guidelines
Clinical question 8: Among adult patients who will receive an ESA for chemotherapy-associated anemia, what is the recommended target HgB level?
Recommendation 8. HgB may be increased to the lowest concentration needed to avoid or reduce the need for RBC transfusions, which may vary by patient and condition
Clinical question 9: Among adult patients with chemotherapy-associated anemia who do not respond to ESA therapy (less than 1 to 2 g/dL increase in HgB or no decrease in transfusion requirements), does continuation of ESA therapy beyond 6-8 weeks provide a benefit?
Recommendation 9. ESAs should be discontinued in patients who do not respond within 6-8 weeks. Patients who do not respond to ESA treatment should be reevaluated for underlying tumor progression, Iron deficiency, or other etiologies for anemia
Clinical question 10: Among adult patients with chemotherapy-associated anemia, does Iron supplementation concurrent with an ESA reduce transfusion requirements?
Recommendation 10. Iron replacement may be used to improve HgB response and reduce RBC transfusions for patients receiving ESA with or without iron deficiency. Baseline and periodic monitoring of Iron, total Iron-Binding Capacity, Transferrin saturation, or Frritin levels is recommended
Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. Bohlius J, Bohlke K, Castelli R, et al. Blood Advances 2019;3:1197-1210
Vitiligo Associated with Reduced Risk of Internal Malignancies
SUMMARY: Vitiligo is a common acquired skin disorder affecting 1% of the population worldwide. Vitiligo is generally considered to be an autoimmune disorder and is characterized by destruction of melanocytes resulting in patchy loss of skin pigmentation. CD8 positive T cells have been implicated in the progression of Vitiligo. Approximately 15-25% of individuals with Vitiligo are also affected by at least one other autoimmune disorder, such as autoimmune Thyroid disease, Rheumatoid arthritis, type 1 Diabetes, Psoriasis, Pernicious anemia, Addison disease, or Systemic Lupus Erythematosus.
There is epidemiologic evidence demonstrating reduced risks of both Melanoma and non-Melanoma skin cancers (NMSCs) in patients with Vitiligo, suggesting that Vitiligo-associated autoimmunity exerts immune surveillance on skin cells other than melanocytes. Further, it has been shown that the occurrence of de novo Vitiligo following treatment with Immune Checkpoint Inhibitors may be a surrogate marker for improved survival in patients with advanced Melanoma. This suggests that increased T-cell activity following blockade of immune checkpoints, targets cancer cells as well as melanocytes in the skin.
The benefit of increased T-cell activity on cancers of internal organs in patients with Vitiligo, however has been unclear. In this publication, the authors evaluated whether autoreactive T-cell responses to melanocytes in patients with Vitiligo would affect tumor immunosurveillance in different internal organs.
We conducted a nationwide population-based cohort study to explore the risk of internal malignancies in patients with Vitiligo using the 10-year Korean National Health Insurance (NHI) claims database from 2007-2016. This study included 101,078 patients with Vitiligo and 202,156 controls without Vitiligo. Patients were 20 years or older with Vitiligo and had at least two contacts with a physician. The authors examined the overall risk for the development of internal malignancies and organ-specific cancer risks in each group.
It was noted that after the analysis was adjusted for age, sex, and comorbidities, the overall risk of internal malignancies was significantly lower in patients with Vitiligo than in controls (HR=0.86; P<0.001). This risk reduction was more so in men than in women and younger patients 20-30 yrs old with Vitiligo, had notably reduced risk than patients 40 yrs or older. With regards to organ-specific malignancies, patients with Vitiligo had a remarkably decreased risk of cancer in the Colon and Rectum (HR=0.62; P<0.001), Ovary (HR=0.62; P<0.001), and Lung (HR=0.75; P<0.001).
It was concluded that Vitiligo was associated with a reduced risk of internal malignancies overall. The authors from the findings of this study postulated that autoimmune diseases, including Vitiligo, may provide immune surveillance for the development of cancer beyond the targeted organ. Markedly Reduced Risk of Internal Malignancies in Patients With Vitiligo: A Nationwide Population-Based Cohort Study. Bae JM, Chung KY, Yun SJ, et al. J Clin Oncol 2019;37:903-911
FDA Approves JAKAFI® for Acute GVHD
SUMMARY: The FDA on May 24, 2019 approved JAKAFI® (Ruxolitinib) for steroid-refractory acute Graft-Versus-Host Disease (GVHD) in adult and pediatric patients 12 years and older. Acute GVHD is a frequent and severe inflammatory complication of allogeneic Hematopoietic Cell Transplantation (HCT), and is a reaction of donor immune cells against host tissues. It is estimated that in the US over 8000 patients undergo allogeneic HCT each year and about 35-50% of recipients will develop acute GVHD, which remains a significant cause of morbidity and mortality in allogeneic HCT recipients. Following the preparative regimen, a series of inflammatory reactions lead to damage to the host epithelial cells by activated donor T cells. GVHD can be acute or chronic, with acute GVHD typically occurring within the first 100 days following an allogeneic transplant. Approximately 40% of patients with acute GVHD have severe disease, with a one year survival of 50% or less. Acute GVHD typically involves the skin, often starting in the palms and soles (rash/dermatitis), liver (hepatitis/jaundice), and gastrointestinal tract (abdominal pain/diarrhea). Acute GVHD is a clinical diagnosis, although histologic confirmation may be extremely helpful, if the symptoms and presentation are atypical.
Risk factors for the development of acute GVHD include degree of HLA disparity, gender disparity, increased age of both the recipient and the donor, multiparous female donors, ineffective GVHD prophylaxis, intensity of the transplant conditioning regimen and the source of graft (peripheral blood or bone marrow greater than umbilical cord blood).
Patients with acute GVHD are often treated by optimizing their immunosuppression and adding methylprednisolone, with approximately 50% of patients responding to this intervention. If symptoms do not improve after a week or if progression is noted after 3 days of treatment, patients receive salvage immunosuppressive intervention, since no standard treatment with meaningful benefit has been identified.
JAKAFI® (Ruxolitinib) is a potent JAK1 and JAK2 inhibitor and exerts its mechanism of action by targeting and inhibiting the dysregulated JAK2-STAT signaling pathway. JAKAFI® in animal models was shown to reduce IL-1β, IL-6, or IFN-γ and TNF and other cytokines implicated in lymphocyte activation characteristic of GVHD.
In previously published studies, JAKAFI® when used in patients with refractory GVHD demonstrated an Overall Response Rate of 85% in acute or chronic GVHD, with a 25% Complete Remission rate.
The present FDA approval was based on data from REACH1 study, which is an open-label, single-arm, multicenter, phase II trial of JAKAFI® in combination with corticosteroids, in patients with steroid-refractory grade II-IV acute GVHD. Of the 71 patients enrolled in this study, 49 patients were refractory to steroids alone, 12 patients had received two or more prior therapies for GVHD and 10 patients did not otherwise meet the FDA definition of steroid-refractory state. JAKAFI® was administered at 5 mg orally twice daily, and the dose could be increased to 10 mg twice daily after three days, in the absence of toxicity.
The Primary endpoint of this trial was the Day 28 Overall Response Rate (ORR), defined as a Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR), based on the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. The Day 28 ORR in the 49 patient’s refractory to steroids alone was 57% with a CR rate of 31%. The most frequently reported adverse reactions were infections (55%) and edema (51%), and the most common laboratory abnormalities were anemia, thrombocytopenia and neutropenia.
It was concluded that for patients with acute GVHD who do not adequately respond to steroids, therapies are limited and JAKAFI® is a new treatment option that fulfills this unmet need. Results from REACH1, a Single-Arm Phase 2 Study of Ruxolitinib in Combination with Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Vs-Host Disease. Jagasia M, Perales M-A, Schroeder MA, et al. Blood 2018 132:601; doi: https://doi.org/10.1182/blood-2018-99-116342
JAKAFI® (Ruxolitinib)
The FDA on May 24, 2019 approved JAKAFI® for steroid-refractory acute Graft-Versus-Host Disease (GVHD) in adult and pediatric patients 12 years and older. JAKAFI® is a product of Incyte Corporation.
AACR Late-Breaking Research Predicting Response to Anti-PD1/PDL1 Therapy beyond Tumor Mutational Burden
SUMMARY: Immunotherapy with checkpoint inhibitors such as anti-PD1/PDL1 antibodies, is rapidly moving to the forefront of cancer treatment. These agents include PD1 targeted therapies such as KEYTRUDA® (Pembrolizumab), OPDIVO® (Nivolumab) and LIBTAYO® (Cemiplimab-rwlc) and PDL1 targeted therapies such as TECENTRIQ® (Atezolizumab), IMFINZI® (Durvalumab) and BAVENCIO® (Avelumab). Treatment with checkpoint inhibitors given as a single agent or in combination with chemotherapy has resulted in significant survival benefit in a variety of solid tumors, as well as hematologic malignancies. The efficacy of checkpoint inhibitors however varies considerably across different cancer types. Understanding tumors and their microenvironment and identifying the underlying variables that predict response to anti-PD1/PDL1 antibodies, has been challenging.
Tumor Mutational Burden (TMB) has recently emerged as a potential biomarker for immunotherapy with anti PD-1/PDL1 antibodies. TMB can be measured using Next-Generation Sequencing (NGS) and is defined as the number of somatic coding base substitutions and short insertions and deletions (indels), per megabase of genome examined. Several studies have incorporated Tumor Mutational Burden (TMB) as a biomarker, using the validated cutoff of TMB of 10 or more mutations/megabase as High, and less than 10 mutations/megabase, as Low. Drawbacks with TMB include sample consumption, higher attrition rate due to sample quality and quantity, and lack of standardization for the different TMB testing assays, with the definition of High TMB varying across studies from 7.4 or more to 20 mutations/megabase.
The Cancer Genome Atlas (TCGA), a landmark cancer genomics program, is a joint effort between the National Cancer Institute and the National Human Genome Research Institute. This program began in 2006 and has molecularly characterized over 20,000 primary cancers and matched normal samples, across 33 different cancer types. After 12 years and contributions from over 11,000 patients, TCGA has deepened our understanding of the molecular basis of cancer, changed the way cancer patients are managed in the clinic, established a rich genomics data resource for the research community and helped advance health and science technologies.
The authors in this study systematically analyzed Whole Exome Sequencing (WES) and RNA sequencing (RNAseq) data of 10,000 patients from the Cancer Genome Atlas, and the Overall Response Rate (ORR) to anti-PD1/PDL1 therapy of 21 different cancer types obtained from previous clinical trials. The researchers took into consideration more than 30 different variables belonging to three distinct classes: a) those associated with tumor neoantigen landscape (Tumor Mutational Burden-TMB) b) tumor microenvironment and inflammation, and c) the checkpoint inhibitor targets (PD1/PDL1). The performance of each of these variables and their combinations was then evaluated in predicting the ORR to anti-PD1/PDL1 therapy.
It was noted that the most important predictor of response to anti-PD1/PDL1 therapy across cancer types was CD8+ T-cell abundance in the tumor microenvironment, followed by the Tumor Mutational Burden, and a high PD1 gene expression in each cancer type in a fraction of samples. These three top predictors encompassed the three distinct classes considered in this analysis, and their combination was highly predictive of the ORR to anti-PD1/PDL1 therapy, and was able to explain more than 80% of the variance observed across different tumor types.
The authors concluded that in this first systemic evaluation of the different variables associated with PD1/PDL1 therapy response across different tumor types, the three top predictors mentioned above can explain most of the observed cross-cancer response variability. Combining tumor mutational burden, CD8+ T-cell abundance and PD1 mRNA expression accurately predicts response to anti-PD1/PDL1 therapy across cancers. Lee JS and Ruppin E. Presented at: 2019 AACR Annual Meeting; March 29 to April 3, 2019; Atlanta, GA.LB-017/9
Antimicrobial Prophylaxis for Adult Patients with Cancer-Related Immunosuppression ASCO and IDSA Clinical Practice Guideline Update
SUMMARY: Patients undergoing cytotoxic chemotherapy and Hematopoietic Stem Cell Transplantation (HSCT), when neutropenic, are at risk for infection. The risk of infection increases with the depth and duration of neutropenia. The greatest infection risk is among those who experience profound, prolonged neutropenia after chemotherapy. Neutropenia is defined as an absolute neutrophil count of less than 1,000/µL, severe neutropenia as absolute neutrophil count less than 500/µL and profound neutropenia as less than 100/µL. Neutropenia is considered protracted if it lasts for 7 days or more. Fever in neutropenic patients is defined as a single oral temperature of 38.3°C (101°F) or more or a sustained temperature of 38.0°C (100.4°F) or more over a period of 1 hour.
The ASCO in partnership with Infectious Diseases Society of America (IDSA) convened an Expert Panel and updated the 2013 ASCO guideline on antimicrobial prophylaxis for immunosuppressed adult patients undergoing treatment of malignancy. The expert panel conducted a systematic review of relevant studies which included six new or updated meta-analyses and six new primary studies, from May 2011 to November 2016. The guideline recommendations were based on the review of evidence by the Expert Panel.
KEY RECOMMENDATIONS
CLINICAL QUESTION 1 – Antibacterial Prophylaxis: Does antibacterial prophylaxis with a Fluoroquinolone, compared with placebo, no intervention, or another class of antibiotic, reduce the incidence of and mortality as a result of febrile episodes in patients with cancer?
Recommendation: Antibiotic prophylaxis with a Fluoroquinolone is recommended for patients who are at high risk for Febrile Neutropenia or profound, protracted neutropenia, such as those patients with Acute Myeloid Leukemia/Myelodysplastic syndromes (AML/MDS) or Hematopoietic Stem Cell Transplantation (HSCT) treated with myeloablative conditioning regimens. Antibiotic prophylaxis is not routinely recommended for patients with solid tumors, for patients who are at low risk of profound, protracted neutropenia and when CSF prophylaxis effectively reduces the severity and duration of neutropenia.
CLINICAL QUESTION 2 – Antifungal Prophylaxis: Does antifungal prophylaxis with an oral triazole or parenteral Echinocandin, compared with no prophylaxis, or another treatment option, reduce the incidence of and mortality, as a result of febrile episodes in patients with cancer?
Recommendation 2.1: Antifungal prophylaxis with an oral triazole or parenteral echinocandin is recommended for patients who are at risk for profound, protracted neutropenia and mucositis, such as most patients with AML/MDS or HSCT. Antifungal prophylaxis is not routinely recommended for patients with solid tumors. Clinicians should be able to differentiate the risks for invasive candidiasis from the risks for invasive mold infection. This is because Fluconazole is active against yeast but not mold whereas Echinocandins and other azole antifungals, such as Posaconozole, Voriconozole, or Isavuconazole are mold-active agents. A mold-active triazole is recommended where the risk of invasive Aspergillosis is more than 6%, such as in patients with AML/MDS during the neutropenic period associated with chemotherapy, in the late stage postallogeneic SCT and/or in the context of GVHD. Antifungal prophylaxis is not routinely recommended for patients who are at low risk of profound, protracted neutropenia and when CSF prophylaxis effectively reduces the severity and duration of neutropenia.
Recommendation 2.2: Prophylaxis is recommended with Trimethoprim-Sulfamethoxazole (TMP-SMX), for patients receiving chemotherapy regimens associated with more than 3.5% risk for pneumonia from Pneumocystis jirovecii (eg, for those on 20 mg or more of prednisone daily for more than 4 weeks). For those hypersensitive to Sulfonamides or unable to tolerate TMP-SMX, alternative options include Dapsone, aerosolized Pentamidine, or Atovaquone.
CLINICAL QUESTION 3 – Antiviral Prophylaxis: Does antiviral prophylaxis reduce the incidence of immunosuppression-related viral infections in patients with cancer compared with no prophylaxis or another treatment option?
Recommendation 3.1: Herpes Simplex Virus-seropositive patients undergoing allogeneic HSCT or leukemia induction therapy should receive prophylaxis with a nucleoside analog such as Acyclovir.
Recommendation 3.2: For patients who are at high risk of Hepatitis B Virus reactivation, treatment with a nucleoside reverse transcription inhibitor (eg, Entecavir or Tenofovir) is recommended.
Recommendation 3.3: Yearly influenza vaccination with inactivated quadrivalent vaccine is recommended for all patients receiving chemotherapy for malignancy and all family and household contacts and health care providers. It is best administered more than 1 week after the last treatment or more than 2 weeks before chemotherapy administration. Individuals older than 65 years should receive the high-dose vaccine.
Recommendation 3.4: The Expert Panel also supports other vaccination recommendations for immunosuppressed adult oncology patients that are contained within the IDSA guideline for vaccination of the immunosuppressed patients.
CLINICAL QUESTION 4 – Do additional precautions, such as hand hygiene, air filtration, or a neutropenic diet, reduce the risk of infection in neutropenic patients with cancer compared with no or other additional precautions?
Recommendation 4.1: All health care workers should comply with hand hygiene and respiratory hygiene/cough etiquette guidelines to reduce the risk for aerosol- and direct or indirect contact-based transmission of pathogenic microorganisms in the health care setting.
Recommendation 4.2: Outpatients with neutropenia from cancer therapy should avoid prolonged contact with environments that have high concentrations of airborne fungal spores (eg, construction and demolition sites, intensive exposure to soil through gardening or digging, or household renovation).
Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update. Taplitz RA, Kennedy EB, Bow EJ, et al. J Clin Oncol 2018;36:3043-3054
ELZONRIS® (Tagraxofusp-erzs)
The FDA on December 21, 2018 approved ELZONRIS®, a CD123-directed cytotoxin, for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS® is a product of Stemline Therapeutics.