Diagnosis and Management of Castleman Disease Blastic

Total Page:16

File Type:pdf, Size:1020Kb

Diagnosis and Management of Castleman Disease Blastic cancercontroljournal.org Vol. 21, No. 4, October 2014 H. LEE MOFFITT CANCER CENTER & RESEARCH INSTITUTE, AN NCI COMPREHENSIVE CANCER CENTER Diagnosis and Management of Castleman Disease Jacob D. Soumerai, MD, Aliyah R. Sohani, MD, and Jeremy S. Abramson, MD Blastic Plasmacytoid Dendritic Cell Neoplasm: Update on Molecular Biology, Diagnosis, and Therapy Wasif Riaz, MD, Ling Zhang, MD, Pedro Horna, MD, et al Dendritic Cell and Histiocytic Neoplasms: Biology, Diagnosis, and Treatment Samir Dalia, MD, Haipeng Shao, MD, PhD, Elizabeth Sagatys, MD, et al Hereditary and Acquired Hemophagocytic Lymphohistiocytosis Ling Zhang, MD, Jun Zhou, MD, and Lubomir Sokol, MD, PhD Pathogenesis, Diagnosis, and Management of Kikuchi–Fujimoto Disease Darcie Deaver, PhD, Pedro Horna, MD, Hernani Cualing, MD, et al Rosai–Dorfman Disease: Tumor Biology, Clinical Features, Pathology, and Treatment Samir Dalia, MD, Elizabeth Sagatys, MD, Lubomir Sokol, MD, PhD, et al Langerhans Cell Histiocytosis Nanette Grana, MD Transplantation in Rare Lymphoproliferative and Histiocytic Disorders Alexis Cruz-Chacon, MD, John Mathews, MD, and Ernesto Ayala, MD Cancer Control is included in Index Medicus/MEDLINE Permit No. 4390 No. Permit Tampa FL 33612-9416 FL Tampa Jacksonville, FL Jacksonville, 12902 Magnolia Drive Magnolia 12902 PAID & RESEARCH INSTITUTE INC INSTITUTE RESEARCH & Nonprofit Org. Nonprofit CENTER CANCER MOFFITT LEE H advances in the management of multiple Save the Date! presents Advances in the Management of Multiple Myeloma March 6–7, 2015 Loews Don Cesar Hotel St. Petersburg Beach, Florida Course Directors: Melissa Alsina, MD, Rachid Baz, MD, and Kenneth H. Shain, MD, PhD Moffitt Cancer Center, Tampa, Florida Conference Overview: Advances in the Management of Multiple Myeloma conference is designed to foster the exchange of the most recent advances in the biology and treatment of multiple myeloma. National and international leading experts in the field will present in a format promoting discussion and interaction with participants. Target Audience: This educational program is directed toward hematologists, medical and surgical oncologists, and BMT physicians who diagnose, treat, and manage multiple myeloma. Other health care professionals who are interested in the diagnosis, treatment, and care of patients with multiple myeloma are also invited to attend. To be added to the conference mailing list, contact: Moffitt Cancer Center | Marsha Moyer, MBA | 813-745-2286 | [email protected] Editorial Board Members Editor: Rami Komrokji, MD Production Staff: Associate Member Lodovico Balducci, MD Veronica Nemeth Malignant Hematology Senior Member Editorial Coordinator Conor C. Lynch, PhD Program Leader, Senior Adult Oncology Program Don Buchanan Assistant Member Moffitt Cancer Center Graphic Designer Tumor Biology Deputy Editor: Amit Mahipal, MD, MPH Consultant: Julio M. Pow-Sang, MD Assistant Member Clinical Research Unit Sherri Damlo Senior Member Medical Copy Editor Chair, Department of Genitourinary Oncology Gastrointestinal Oncology Director of Moffitt Robotics Program Kristen J. Otto, MD Associate Editor of Moffitt Cancer Center Assistant Member Head & Neck Oncology Educational Projects Editor Emeritus: Michael A. Poch, MD John M. York, PharmD Akita Biomedical Consulting John Horton, MB, ChB Assistant Member 1111 Bailey Drive Professor Emeritus of Medicine & Oncology Genitourinary Oncology Paso Robles, CA 93446 Jeffery S. Russell, MD, PhD Phone: 805-238-2485 Moffitt Cancer Center Assistant Member Fax: 949-203-6115 Journal Advisory Committee: Endocrine Tumor Oncology E-mail: [email protected] Aliyah Baluch, MD Elizabeth M. Sagatys, MD Assistant Member Assistant Member For Consumer and Infectious Diseases Pathology - Clinical General Advertising Dung-Tsa Chen, PhD Jose E. Sarria, MD Information: Associate Member Assistant Member Veronica Nemeth Biostatistics Anesthesiology Editorial Coordinator Hey Sook Chon, MD Saïd M. Sebti, PhD Cancer Control: Assistant Member Senior Member Journal of the Moffitt Cancer Center Gynecological Oncology Drug Discovery 12902 Magnolia Drive – MBC-JRNL Tampa, FL 33612 Jasreman Dhillon, MD Bijal D. Shah, MD Phone: 813-745-1348 Assistant Member Assistant Member Fax: 813-449-8680 Pathology - Anatomic Malignant Hematology E-mail: [email protected] Jennifer S. Drukteinis, MD Lubomir Sokol, MD, PhD Associate Member Senior Member Diagnostic Radiology Hematology/Oncology Timothy J. George, PharmD Hatem H. Soliman, MD Pharmacy Residency Director Assistant Member Clinical Pharmacist - Malignant Hematology Breast Oncology Clement K. Gwede, PhD Jonathan R. Strosberg, MD Associate Member Assistant Member Health Outcomes & Behavior Gastrointestinal Oncology Sarah E. Hoffe, MD Sarah W. Thirlwell, RN Associate Member Nurse Director Radiation Oncology Supportive Care Medicine Program Cancer Control is a member of John V. Kiluk, MD Eric M. Toloza, MD, PhD the Medscape Publishers’ Circle®, Associate Member Assistant Member an alliance of leading medical Breast Oncology Thoracic Oncology publishers whose content is Richard D. Kim, MD Nam D. Tran, MD featured on Medscape Associate Member Assistant Member (www.medscape.com). Gastrointestinal Oncology Neuro-Oncology Bela Kis, MD, PhD Jonathan S. Zager, MD Most issues and supplements of Assistant Member Associate Member Cancer Control are available at Diagnostic Radiology Sarcoma and Cutaneous Oncology cancercontroljournal.org CANCER CONTROL: JOURNAL OF THE MOFFITT CANCER CENTER (ISSN 1073-2748) is published by H. Lee Moffitt Cancer Center & Research Institute, 12902 Magnolia Drive, Tampa, FL 33612. Telephone: 813-745-1348. Fax: 813-449-8680. E-mail: [email protected]. Internet address: cancercontroljournal.org. Cancer Control is included in Index Medicus ®/MEDLINE® and EM- BASE®/Excerpta Medica, Thomson Reuters Science Citation Index Expanded (SciSearch®) and Journal Citation Reports/Science Edition. Send subscription requests to the publisher. Single copy: $10 US, $15 Canada and foreign. Subscription rates: nonqualified individuals $60 per year US, $75 per year outside US, institutions/libraries $120 per year US ($135 per year foreign). Send change of address to the publisher with old address label and new address. Publisher is not responsible for undelivered copies. Copyright 2014 by H. Lee Moffitt Cancer Center & Research Institute. All rights reserved. Printed on acid-free paper. Cancer Control: Journal of the Moffitt Cancer Center is a peer-reviewed journal that is published to enhance the knowledge needed by professionals in oncology to help them minimize the impact of human malignancy. Each issue emphasizes a specific theme relating to the detection or management of cancer. The objectives of Cancer Control are to define the current state of cancer care, to integrate recently generated information with historical practice patterns, and to enlighten readers through critical reviews, commentaries, and analyses of recent research studies. DISCLAIMER: All articles published in this journal, including editorials and letters, represent the opinions of the author(s) and do not necessarily reflect the opinions of the editorial board, the H. Lee Moffitt Cancer Center & Research Institute, Inc, or the institutions with which the authors are affiliated unless clearly specified. The reader is advised to independently verify the effectiveness of all methods of treatment and the accuracy of all drug names, dosages, and schedules. Dosages and methods of administration of pharmaceutical products may not be those listed in the package insert and solely reflect the experience of the author(s) and/or clinical investigator(s). October 2014, Vol. 21, No. 4 Cancer Control 257 Table of Contents Editorial Hope for Orphan Lymphoproliferative and Histocytic Diseases on the Horizon? 260 Lubomir Sokol, MD, PhD Articles Diagnosis and Management of Castleman Disease 266 Jacob D. Soumerai, MD, Aliyah R. Sohani, MD, and Jeremy S. Abramson, MD Blastic Plasmacytoid Dendritic Cell Neoplasm: 279 Update on Molecular Biology, Diagnosis, and Therapy Wasif Riaz, MD, Ling Zhang, MD, Pedro Horna, MD, and Lubomir Sokol, MD, PhD Dendritic Cell and Histiocytic Neoplasms: 290 Biology, Diagnosis, and Treatment Samir Dalia, MD, Haipeng Shao, MD, PhD, Elizabeth Sagatys, MD, Hernani Cualing, MD, and Lubomir Sokol, MD, PhD Hereditary and Acquired Hemophagocytic Lymphohistiocytosis 301 Ling Zhang, MD, Jun Zhou, MD, and Lubomir Sokol, MD, PhD Pathogenesis, Diagnosis, and Management of 313 Kikuchi–Fujimoto Disease Darcie Deaver, PhD, Pedro Horna, MD, Hernani Cualing, MD, and Lubomir Sokol, MD, PhD Rosai–Dorfman Disease: Tumor Biology, Clinical Features, 322 Pathology, and Treatment Samir Dalia, MD, Elizabeth Sagatys, MD, Lubomir Sokol, MD, PhD, and Timothy Kubal, MD 258 Cancer Control October 2014, Vol. 21, No. 4 Table of Contents Langerhans Cell Histiocytosis 328 Nanette Grana, MD Transplantation in Rare Lymphoproliferative and 335 Histiocytic Disorders Alexis Cruz-Chacon, MD, John Mathews, MD, and Ernesto Ayala, MD Departments Special Report: Social Determinants of Racial and Ethnic Disparities in 343 Cutaneous Melanoma Outcomes Valerie M. Harvey, MD, Hitesh Patel, MS, MBA, Sophia Sandhu, MD, Sherrie Flynt Wallington, PhD, and Ginette Hinds, MD Special Report: Fruit and Vegetable Intake Among Jordanians: 350 Results From a Case-Control Study of Colorectal Cancer Reema F. Tayyem, PhD, Ihab Shehadah, MD, Suhad S. Abu-Mweis, PhD, Hiba A. Bawadi, PhD, Kamal E. Bani-Hani, MD, PhD, Tareq Al-Jaberi, MD, PhD,
Recommended publications
  • Kikuchi Disease with Generalized Lymph Node, Spleen And
    Case Report Mol Imaging Radionucl Ther 2016;25:102-106 DOI:10.4274/mirt.25338 Kikuchi Disease with Generalized Lymph Node, Spleen and Subcutaneous Involvement Detected by Fluorine-18-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Flor-18-Florodeoksiglukoz Pozitron Emisyon Tomografisi/Bilgisayarlı Tomografi ile Saptanan Yaygın Lenf Nodu, Dalak ve Deri Altı Tutulumu Olan Kikuchi Hastalığı Alshaima Alshammari1, Evangelia Skoura2, Nafisa Kazem1, Rasha Ashkanani1 1Mubarak Al Kabeer Hospital, Clinic of Nuclear Medicine, Jabriya, Kuwait 2University College London Hospital, Clinic of Nuclear Medicine, London, United Kingdom Abstract Kikuchi-Fujimoto disease, known as Kikuchi disease, is a rare benign and self-limiting disorder that typically affects the regional cervical lymph nodes. Generalized lymphadenopathy and extranodal involvement are rare. We report a rare case of a 19-year- old female with a history of persistent fever, nausea, and debilitating malaise. Fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) revealed multiple hypermetabolic generalized lymph nodes in the cervical, mediastinum, axillary, abdomen and pelvic regions with diffuse spleen, diffuse thyroid gland, and focal parotid involvement, bilaterally. In addition, subcutaneous lesions were noted in the left upper paraspinal and occipital regions. An excisional lymph node biopsy guided by 18F-FDG PET/CT revealed the patient’s diagnosis as Kikuchi syndrome. Keywords: Kikuchi-Fujimoto disease, histiocytic necrotizing lymphadenitis, fluorine-18-fluorodeoxyglucose Öz Kikuchi hastalığı olarak bilinen Kikuchi-Fujimoto hastalığı, genellikle bölgesel servikal lenf düğümlerini etkileyen, nadir görülen benign ve kendini sınırlayıcı bir hastalıktır. Yaygın lenfadenopati ve ekstranodal tutulum nadirdir. Bu yazıda sürekli ateş, bulantı ve halsizlik şikayetleri olan 19 yaşında bir kadın hasta sunulmaktadır.
    [Show full text]
  • Advances in the Treatment of Hematologic Malignancies a Review of Newly Approved Drugs
    Advances in the Treatment of Hematologic Malignancies A Review of Newly Approved Drugs Katherine Shah, PharmD, BCOP Clinical Pharmacy Specialist, Hematology/Oncology Emory University Hospital / Winship Cancer Institute Disclosures • I do not (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity or any affiliation with an organization whose philosophy could potentially bias my presentation • There was no financial support obtained for this CPE activity 1 Objectives • Discuss the pharmacologic principles of several new agents approved for use in hematologic malignancies – Drug class – Mechanism of action – Clinical trial highlights • Review approved dosing and recommend appropriate clinical monitoring and management of toxicities of new agents covered – Dosing recommendations for new agents – Side effect profile – Clinical management Approvals 1980‐2014 http://innovation.org/images/dmImage/SourceImage/lg_FDA_Approval.jpg 2 2014 Novel Drug Approvals Nature Reviews Drug Discovery 14, 77–81(2015) doi:10.1038/nrd4545 Select 2014 Novel Oncology Drugs Drug Indication Approval Date Siltuximab (Sylvant) Multicentric Castleman’s April 2014 Disease Belinostat (Beleodaq) Peripheral T‐cell Lymphoma July 2014 Idelalisib (Zydelig) CLL, Follicular NHL, SLL July 2014 Netupitant and Nausea/vomiting October 2014 palonosetron (Akynzeo) Blinatumomab Acute Lymphoblastic December 2014 (Blincyto) Leukemia, Ph‐ Ph-= Philadelphia
    [Show full text]
  • SYLVANT (Siltuximab) for Injection, for Intravenous Infusion Institute Prompt Anti-Infective Therapy and Do Not Administer Initial U.S
    ------------------------WARNINGS AND PRECAUTIONS----------------------- HIGHLIGHTS OF PRESCRIBING INFORMATION • Concurrent Active Severe Infections These highlights do not include all the information needed to use o Do not administer SYLVANT to patients with severe infections SYLVANT™ safely and effectively. See full prescribing information for until the infection resolves. (2) SYLVANT. o Monitor patients receiving SYLVANT closely for infections. SYLVANT (siltuximab) for Injection, for Intravenous infusion Institute prompt anti-infective therapy and do not administer Initial U.S. Approval: [yyyy] SYLVANT until the infection resolves. (2) ----------------------------INDICATIONS AND USAGE---------------------------- • Vaccinations: Do not administer live vaccines because IL-6 inhibition SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of may interfere with the normal immune response to new antigens. (5.2) patients with multicentric Castleman’s disease (MCD) who are human • Infusion Related Reactions: Administer SYLVANT in a setting that immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) provides resuscitation equipment, medication, and personnel trained to negative. (1) provide resuscitation. (6.1) • Gastrointestinal (GI) perforation: Use with caution in patients who may Limitation of Use be at increased risk. Promptly evaluate patients presenting with SYLVANT was not studied in patients with MCD who are HIV positive or symptoms that may be associated or suggestive of GI perforation. (5.4) HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. ------------------------------ADVERSE REACTIONS------------------------------- The most common adverse reactions (>10% compared to placebo) during -----------------------DOSAGE AND ADMINISTRATION----------------------- treatment with SYLVANT in the MCD clinical trial were pruritus, increased For intravenous infusion only. weight, rash, hyperuricemia, and upper respiratory tract infection.
    [Show full text]
  • Focus: Blood Cancer
    JAN-MAR 17 www.singhealth.com.sg A SingHealth Newsletter for Medical Practitioners MCI (P) 027/11/2016 FOCUS: BLOOD CANCER Haematologic Emergencies An Overview of in the General Practice Myeloproliferative Neoplasms When to Suspect Approach to an Adult with Myeloma in Primary Care Lymphadenopathy in Primary Care SingHealth Duke-NUS Academic Medical Centre • Singapore General Hospital • KK Women’s and Children’s Hospital • Sengkang Health • National Cancer Centre Singapore • National Dental Centre of Singapore • National Heart Centre Singapore • National Neuroscience Institute • Singapore National Eye Centre • SingHealth Polyclinics • Bright Vision Hospital Medical Appointments: 6321 4402 (SGH) Focus: Update Blood Cancer 6436 8288 (NCCS) Haematologic Emergencies in the General Practice Adj Assoc Prof Wong Gee Chuan, Senior Consultant, Department of Haematology, Singapore General Hospital; SingHealth Duke-NUS Blood Cancer Centre Patients with malignant haematological diseases may present with dramatic and life-threaten- ing complications. General physicians must be able to recognise these conditions as prompt treatment can be life-saving. Hyperleukocytosis and leukostasis and febrile neutropaenia in patients with haematologic malignancies are two such conditions highlighted in this article. mental state and unsteadiness in gait. patient presents with a high white cell HYPERLEUKOCYTOSIS AND There is also increased risk of intracra- count and symptoms suggestive of tis- LEUKOSTASIS IN HAEMATOLOGIC nial haemorrhage. sue hypoxia. MALIGNANCIES Besides affecting the central nervous Hyperleukocytosis has been variably system, eyes and lungs, other manifes- Leukostasis constitutes a medi- defined as a total white cell count tations include myocardial ischaemia, cal emergency. Prompt treatment (WBC) of 50 x 109/L or 100 x 109/L. Leu- limb ischaemia or bowel infarction.
    [Show full text]
  • SYLVANT® (Siltuximab): a Targeted Therapy That's PREFERRED for The
    SYLVANT® (siltuximab): A Targeted Therapy That’s PREFERRED for the Treatment of iMCD NCCN CDCN Guidelines®1 Treatment Guidelines2 To access the clinical To access the treatment guidelines, scan the QR guidelines, scan the QR code or visit: code or visit: http://promail.nicelines.com/ https://ashpublications. v5fmsnet/OeCart/OEFrame. org/blood/article- asp?Action=NEWORDER&cme lookup/doi/10.1182/ nunodseq=&FromFav=&PmSe blood-2018-07-862334 ss1=3512&pos=NCCN01&v=9 The only FDA-approved therapy for the treatment of patients with MCD who are negative for HIV and HHV-8.3 Limitations of use: SYLVANT® was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.3 Please see Important Safety Information on back and accompanying Full Prescribing Information. Abbreviations: CDCN, Castleman Disease Collaborative Network; FDA, US Food and Drug Administration; HHV-8, human herpesvirus 8; HIV, human immunodeficiency virus; IL-6, interleukin-6; iMCD, idiopathic multicentric Castleman disease; MCD, multicentric Castleman disease; NCCN, National Comprehensive Cancer Network. NCCN Guidelines® Updates in Version 1.2020 of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas include new recommendations for the management of patients with iMCD.1 Primary Treatment Relapsed Disease HIV-1(-) PREFERRED MCD d HHV-8(-) Response If siltuximab, (criteria for Siltuximab (for Treat with alternate (idiopathic MCD)b continue until active disease
    [Show full text]
  • Federal Register/Vol. 83, No. 31/Wednesday, February 14, 2018
    Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices 6563 Wireless Telecommunications Bureau Signed: DEPARTMENT OF HEALTH AND and Wireline Competition Bureau (the Dayna C. Brown, HUMAN SERVICES Bureaus) may implement, and (3) certify Secretary and Clerk of the Commission. Centers for Disease Control and its challenge. The USAC system will [FR Doc. 2018–03166 Filed 2–12–18; 4:15 pm] validate a challenger’s evidence using Prevention BILLING CODE 6715–01–P an automated challenge validation [CDC–2018–0004; NIOSH–233–B] process. Once all valid challenges have been identified, a challenged party that NIOSH List of Antineoplastic and Other chooses to respond to any valid FEDERAL RESERVE SYSTEM Hazardous Drugs in Healthcare challenge(s) may submit additional data Settings: Proposed Additions to the via the online USAC portal during the Change in Bank Control Notices; NIOSH Hazardous Drug List 2018 established response window. A Acquisitions of Shares of a Bank or AGENCY: Centers for Disease Control and challenged party may submit technical Bank Holding Company information that is probative regarding Prevention, HHS. ACTION: Notice of draft document the validity of a challenger’s speed tests, The notificants listed below have available for public comment. including speed test data and other applied under the Change in Bank device-specific data collected from Control Act (12 U.S.C. 1817(j)) and transmitter monitoring software or, SUMMARY: The National Institute for § 225.41 of the Board’s Regulation Y (12 alternatively, may submit its own speed Occupational Safety and Health test data that conforms to the same CFR 225.41) to acquire shares of a bank (NIOSH) of the Centers for Disease standards and requirements specified by or bank holding company.
    [Show full text]
  • Kikuchi–Fujimoto Disease: Lymphadenopathy in Siblings
    Practice CMAJ Cases Kikuchi–Fujimoto disease: lymphadenopathy in siblings Allison Stasiuk BSc Pharm, Susan Teschke MD, Gaynor J. Williams MD MPhil, Matthew D. Seftel MD MPH Patient 1 Key points • Kikuchi–Fujimoto disease is an uncommon and sometimes A 19-year-old Aboriginal woman presented with a three-week familial disorder that should be considered in the history of swollen neck glands, nausea, vomiting, chills and differential diagnosis of cervical lymphadenopathy. weight loss. On examination, she had bilateral, nontender, dif- • Typical presentation includes fever, leukopenia and fuse cervical lymphadenopathy. Oral examination revealed cervical lymphadenopathy. extensive dental caries and periodontal disease. The results of • Although Kikuchi–Fujimoto disease is self-limiting and no her laboratory workup are shown in Table 1. Both a lymph definitive treatment exists, lymph node biopsy is required node aspiration and a bone marrow biopsy were nondiagnostic. to rule out malignancy. The patient was scheduled for a surgical lymph node biopsy, • Patients should be followed closely because of increased but when she was seen one month later, the lymphadenopathy risk for recurrence and for systemic lupus erythematosus. had resolved spontaneously. Based on these findings, she was diagnosed with Kikuchi–Fujimoto disease. At follow-up a year and a half later, she had no evidence of recurrence. of a cervical lymph node in the first sister was nondiagnostic. In the second sister, an excisional biopsy showed geographic areas Patient 2 of necrosis containing apoptotic bodies and a striking degree of karyorrhexis with nuclear debris (Figure 1). Cells within the Two years after the initial presentation of the first patient, her 19- areas of necrosis were highly proliferative; more than 60% of year-old younger sister was assessed for a three-week history of the cells tested positive for the Ki-67 proliferation marker.
    [Show full text]
  • Monitoring Multiple Myeloma Patients Treated with Daratumumab: Teasing out Monoclonal Antibody Interference
    Clin Chem Lab Med 2016; 54(6): 1095–1104 Open Access Christopher McCuddena, Amy E. Axela, Dominique Slaets, Thomas Dejoie, Pamela L. Clemens, Sandy Frans, Jaime Bald, Torben Plesner, Joannes F.M. Jacobs, Niels W.C.J. van de Donk, Philippe Moreau, Jordan M. Schecter, Tahamtan Ahmadi and A. Kate Sasser* Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference DOI 10.1515/cclm-2015-1031 developed using a mouse anti-daratumumab antibody. To Received October 21, 2015; accepted February 10, 2016; previously evaluate whether anti-daratumumab bound to and shifted published online March 30, 2016 the migration pattern of daratumumab, it was spiked into Abstract daratumumab-containing serum and resolved by IFE/SPE. The presence (DIRA positive) or absence (DIRA negative) Background: Monoclonal antibodies are promising anti- of residual M-protein in daratumumab-treated patient myeloma treatments. As immunoglobulins, monoclonal samples was evaluated using predetermined assessment antibodies have the potential to be identified by serum criteria. DIRA was evaluated for specificity, limit of sensi- protein electrophoresis (SPE) and immunofixation elec- tivity, and reproducibility. trophoresis (IFE). Therapeutic antibody interference with Results: In all of the tested samples, DIRA distinguished standard clinical SPE and IFE can confound the use of between daratumumab and residual M-protein in com- these tests for response assessment in clinical trials and mercial serum samples spiked with daratumumab and disease monitoring. in daratumumab-treated patient samples. The DIRA Methods: To discriminate between endogenous myeloma limit of sensitivity was 0.2 g/L daratumumab, using protein and daratumumab, a daratumumab-specific spiking experiments. Results from DIRA were repro- immunofixation electrophoresis reflex assay (DIRA) was ducible over multiple days, operators, and assays.
    [Show full text]
  • Medical Drug Benefit Clinical Criteria Updates
    UniCare Health Plan of West Virginia, Inc. Medicaid Managed Care Provider Bulletin April 2020 Medical drug benefit Clinical Criteria updates On November 15, 2019, and February 21, 2020, the Pharmacy and Therapeutics (P&T) Committee approved the following Clinical Criteria applicable to the medical drug benefit for UniCare Health Plan of West Virginia, Inc. These policies were developed, revised or reviewed to support clinical coding edits. Visit Clinical Criteria to search for specific policies. For questions or additional information, use this email. Please see the explanation/definition for each category of Clinical Criteria below: New: newly published criteria Revised: addition or removal of medical necessity requirements, new document number Annual Review: minor wording and formatting updates, new document number Updates marked with an asterisk (*): criteria may be perceived as more restrictive Please share this notice with other members of your practice and office staff. Please note: The clinical criteria listed below applies only to the medical drug benefits contained within the member’s medical policy. This does not apply to pharmacy services. Effective date Document number Clinical Criteria title New, revised, annual review 06/01/2020 ING-CC-0002* Colony Stimulating Factor Agents Revised 06/01/2020 ING-CC-0124 Keytruda (pembrolizumab) Revised 06/01/2020 ING-CC-0125* Opdivo (nivolumab) Revised 06/01/2020 ING-CC-0119* Yervoy (ipilimumab) Revised 06/01/2020 Abraxane (paclitaxel, protein ING-CC-0099* Revised bound) 06/01/2020
    [Show full text]
  • Effectiveness of Rituximab-Containing Treatment Regimens in Idiopathic Multicentric Castleman Disease
    Annals of Hematology https://doi.org/10.1007/s00277-018-3347-0 ORIGINAL ARTICLE Effectiveness of rituximab-containing treatment regimens in idiopathic multicentric Castleman disease Yujun Dong1 & Lu Zhang2 & Lin Nong 3 & Lihong Wang1 & Zeyin Liang1 & Daobin Zhou2 & David C. Fajgenbaum4 & Hanyun Ren1 & Jian Li2 Received: 27 February 2018 /Accepted: 23 April 2018 # Springer-Verlag GmbH Germany, part of Springer Nature 2018 Abstract Human herpes virus type 8 (HHV-8)-negative, idiopathic multicentric Castleman disease (iMCD) is a rare lymphoproliferative disease often involving constitutional symptoms, cytopenias, and multiple organ system dysfunction. In China, the majority of MCD cases are HHV-8 negative. Given that siltuximab, the only FDA-approved treatment for iMCD is not available in China; rituximab- and cyclophosphamide-containing regimens are often used in the treatment of Chinese iMCD patients. To evaluate the efficacy of rituximab in this rare and heterogeneous disease, clinical and pathological data from 27 cases of iMCD were retrospectively analyzed from two large medical centers in China. The novel diagnostic criteria for iMCD were applied, and POEMS syndrome, IgG4-related diseases, and follicular dendritic cell sarcomas cases were excluded from analyses. Total response rate of rituximab- and cyclophosphamide-containing regimens was 55.5%, with 33.3% (9/27) of the cases reaching CR and 22.2% (6/27) PR. In the 14 cases of R-R iMCD, total response rate was only 42.9% (CR 14.3% [2/14], PR 28.6% [4/14]). The 5-year OS of these 27 iMCD cases was 81% (95% CI 64–98; 27 total patients, 4 events, 23 censored) after receiving these regimens, but the 5-year PFS was 43% (95% CI 19–66; 25 total patients, 11 events, 14 censored).
    [Show full text]
  • Kikuchi's Disease with Multisystemic Involvement and Adverse Reaction to Drugs Maria L
    Kikuchi’s Disease With Multisystemic Involvement and Adverse Reaction to Drugs Maria L. Murga Sierra, MD*; Eva Vegas, MD*; Javier E. Blanco-Gonza´lez, MD*; Almudena Gonza´lez, MD‡; Pilar Martı´nez, MD‡; and Maria A. Calero, MD§ ABSTRACT. Kikuchi’s disease (KD), or histiocytic ne- 163 mg/dL. Biochemical analysis, coagulation, hepatic and renal crotizing lymphadenitis, was initially described in Japan functions, immunoglobulins, and complement count were normal in 1972. In the following years, several series of cases (Tables 1, 2). Rheumatoid factor, antinuclear antibodies, direct involving patients of different ages, races, and geo- Coombs test, and two Mantoux test results proved to be negative. graphic origins were reported, but pediatric reports have Multiple blood, urine, feces, sputum, and tissue culture results been rare. also were negative. Antibody titers against Epstein–Barr, cyto- megalovirus, hepatitis, HIV, and Parvovirus B19, and serum poly- The etiology of KD is unknown, although a viral or merase chain reaction for herpesvirus type 6 were negative as autoimmune hypothesis has been suggested. The most well, as were results of serologic tests for syphilis, Brucella, toxo- frequent clinical manifestation consists of local or gen- plasmosis, Leishmania, Rickettsia, Borrelia, and Bartonella henselae eralized adenopathy, although in some cases, it is asso- and quintana. ciated with more general symptoms, multiorganic in- Results of chest roentgenography, echocardiography, and bone volvement, and diverse analytic changes (leukopenia, scan were normal; an abdominal ultrasound examination detected elevated erythrocyte sedimentation rate, and C-reactive hepatosplenomegaly with uniform density and nephromegaly protein, as well as an increase of transaminases and se- with increased cortical echogenicity.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2010/0210567 A1 Bevec (43) Pub
    US 2010O2.10567A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0210567 A1 Bevec (43) Pub. Date: Aug. 19, 2010 (54) USE OF ATUFTSINASATHERAPEUTIC Publication Classification AGENT (51) Int. Cl. A638/07 (2006.01) (76) Inventor: Dorian Bevec, Germering (DE) C07K 5/103 (2006.01) A6IP35/00 (2006.01) Correspondence Address: A6IPL/I6 (2006.01) WINSTEAD PC A6IP3L/20 (2006.01) i. 2O1 US (52) U.S. Cl. ........................................... 514/18: 530/330 9 (US) (57) ABSTRACT (21) Appl. No.: 12/677,311 The present invention is directed to the use of the peptide compound Thr-Lys-Pro-Arg-OH as a therapeutic agent for (22) PCT Filed: Sep. 9, 2008 the prophylaxis and/or treatment of cancer, autoimmune dis eases, fibrotic diseases, inflammatory diseases, neurodegen (86). PCT No.: PCT/EP2008/007470 erative diseases, infectious diseases, lung diseases, heart and vascular diseases and metabolic diseases. Moreover the S371 (c)(1), present invention relates to pharmaceutical compositions (2), (4) Date: Mar. 10, 2010 preferably inform of a lyophilisate or liquid buffersolution or artificial mother milk formulation or mother milk substitute (30) Foreign Application Priority Data containing the peptide Thr-Lys-Pro-Arg-OH optionally together with at least one pharmaceutically acceptable car Sep. 11, 2007 (EP) .................................. O7017754.8 rier, cryoprotectant, lyoprotectant, excipient and/or diluent. US 2010/0210567 A1 Aug. 19, 2010 USE OF ATUFTSNASATHERAPEUTIC ment of Hepatitis BVirus infection, diseases caused by Hepa AGENT titis B Virus infection, acute hepatitis, chronic hepatitis, full minant liver failure, liver cirrhosis, cancer associated with Hepatitis B Virus infection. 0001. The present invention is directed to the use of the Cancer, Tumors, Proliferative Diseases, Malignancies and peptide compound Thr-Lys-Pro-Arg-OH (Tuftsin) as a thera their Metastases peutic agent for the prophylaxis and/or treatment of cancer, 0008.
    [Show full text]