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Guidelines

Guidelines Summary

The following organizations have published guidelines for the diagnosis and treatment of primary myelofibrosis:

National Comprehensive Cancer Network (NCCN)
European Society for Medical Oncology (ESMO)

Diagnosis

In addition to the history and physical examination, NCCN guidelines recommend the following workup for patients with suspected myeloproliferative neoplasms^[25]:

Complete blood cell count (CBC) with differential
Comprehensive metabolic panel with uric acid, lactate dehydrogenase (LDH), and liver function tests (LFTs)
Multiplex real time polymerase chain reaction (RT-PCR) (preferred) or fluorescence in situ hybridization (FISH) (if RT-PCR is not available) for BCR-ABL1to exclude the diagnosis of chronic myeloid leukemia
Examination of blood smear
Bone marrow aspirate and biopsy with trichrome and reticulin stain
Bone marrow cytogenetics (blood, if bone marrow is inaspirable) (karyotype ± FISH)
Molecular testing of blood for JAK2 V617F mutation; if negative, test for CALR and MPL mutations; or molecular testing using multigene next-generation sequencing (NGS) panel that includes JAK2, CALR, and MPL
Assessment of symptom burden using MPN Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; MPN-10; MPN-E 2 of 2)
Human leukocyte antigen (HLA) testing, if allogeneic hematopoietic cell transplant (HCT) is being considered
Serum erythropoietin (EPO) level
Serum iron studies
Coagulation tests to evaluate for acquired von Willebrand disease (VWD) and/or other coagulopathies in selected patients

Both guidelines recommend use of the World Health Organization (WHO) diagnostic criteria for the most accurate diagnosis and grading of primary myelofibrosis.^{[25, 59]}

Risk Stratification

The NCCN prefers use of the Mutation-Enhanced International Prognostic Scoring System (MIPSS) for the initial stratification of risk at diagnosis. The Dynamic International Prognostic Scoring System (DIPSS)-Plus is recommended if molecular testing is unavailable. The DIPSS is used if karyotyping is not available. The DIPSS-Plus is preferred for assessing risk during treatment.^[25] The ESMO guidelines are in concurrence with NCCN.^[59]

Treatment

All patients should be evaluated for allogeneic hematopoietic cell transplantation (HCT). Enrollment in clinical trials is also recommended for all patients with primary myelofibrosis.^{[25, 59]}

The NCCN guidelines recommend administering the MPN-SAF Total Symptom Score (MPN-10) to assess symptom burden at baseline and during the course of treatment. Changes in symptom status can be an indication of disease progression and should trigger evaluation of current treatment efficacy and/or disease risk stratification.^[25]

Lower-risk myelofibrosis

NCCN guidelines recommend monitoring asymptomatic patients for signs and symptoms of disease progression every 3-6 months. For symptomatic patients, NCCN recommends the following treatments in selected patients^[25]:

Ruxolitinib
Peginterferon alfa-2A
Hydroxyurea, if cytoreduction would be beneficial

Higher-risk myelofibrosis

The NCCN and ESMO recommend allogeneic HCT.^{[25, 59]}In patients who are not candidates, NCCN-recommended treatments include the following^[25]:

Ruxolitinib
Fedratinib
Enrollment in clinical trials

Advanced myelofibrosis/acute myeloid leukemia

NCCN treatment recommendations include clinical trial enrollment or, for transplant candidates, inducement of remission with azacitidine or decitabine or intensive induction chemotherapy followed by HCT; for non-candidates for HCT, azacitidine or decitabine or low-intensity induction chemotherapy.^[25]

Supportive Care

NCCN recommendations for supportive care include the following^[25]:

Red blood cell (RBC) transfusions for symptomatic anemia
Platelet transfusions for thrombocytopenic bleeding or a platelet count < 10,000 m ³
Antifibrinolytic agents for bleeding that is refractory to transfusions
Iron chelation can be considered in patients receiving more than 20 transfusions, but NCCN cautions that the role of iron chelation is unclear ^[25]
Erythropoietin-stimulating agents (ESAs) for myelofibrosis-associated anemia ^{[25, 59]}
Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) for recurrent infections in patients with neutropenia; however, these agents are associated with splenic rupture and should be used with caution in patients with enlarged spleens ^[25]
Antibiotic prophylaxis for recurrent infections
Vaccinations
Hydroxyurea should be considered for treatment of thrombocytosis or leukocytosis
Tumor lysis syndrome (TLS) prophylaxis should be considered for patients undergoing induction therapy
Ruxolitinib may stabilize bone/muscle pain and improve pruritus

Medication

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[Guideline] NCCN Clinical Practice Guidelines in Oncology: Myeloproliferative Neoplasms. National Comprehensive Cancer Network. Available at https://www.nccn.org/professionals/physician_gls/pdf/mpn.pdf. Version 3.2022 — August 11, 2022; Accessed: September 21, 2022.
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Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, et al. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug. 1 (5):643-51. [QxMD MEDLINE Link].
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Media Gallery

Primary myelofibrosis. Peripheral smear shows teardrop red blood cells (RBCs) and a leukoerythroblastic picture with nucleated RBC precursors and immature myeloid cells. Courtesy of Wei Wang, MD, and John Lazarchick, MD, Department of Pathology, Medical University of South Carolina.
Bone marrow biopsy from a patient with primary myelofibrosis shows extensive fibrosis. Courtesy of Wei Wang, MD, and John Lazarchick, MD, Department of Pathology, Medical University of South Carolina.
Reticulin stain on a bone marrow biopsy from a patient with primary myelofibrosis shows extensive fibrosis. Courtesy of Wei Wang, MD, and John Lazarchick, MD, Department of Pathology, Medical University of South Carolina.
Extramedullary hematopoiesis in the spleen of a patient with primary myelofibrosis. Courtesy of Wei Wang, MD, and John Lazarchick, MD, Department of Pathology, Medical University of South Carolina.

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Author

Asheesh Lal, MBBS, MD Physician, Department of Internal Medicine, Lexington Medical Center

Asheesh Lal, MBBS, MD is a member of the following medical societies: American Society of Clinical Oncology, American Society of Hematology

Disclosure: Nothing to disclose.

Specialty Editor Board

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Received salary from Medscape for employment. for: Medscape.

Chief Editor

Emmanuel C Besa, MD Professor Emeritus, Department of Medicine, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Kimmel Cancer Center, Jefferson Medical College of Thomas Jefferson University

Emmanuel C Besa, MD is a member of the following medical societies: American Association for Cancer Education, American Society of Clinical Oncology, American College of Clinical Pharmacology, American Federation for Medical Research, American Society of Hematology, New York Academy of Sciences

Disclosure: Nothing to disclose.

Additional Contributors

Karen Seiter, MD Professor, Department of Internal Medicine, Division of Oncology/Hematology, New York Medical College

Karen Seiter, MD is a member of the following medical societies: American Association for Cancer Research, American College of Physicians, American Society of Hematology

Disclosure: Received honoraria from Novartis for speaking and teaching; Received consulting fee from Novartis for speaking and teaching; Received honoraria from Celgene for speaking and teaching.

Acknowledgements

Author: Asheesh Lal, MBBS, MD, Physician, Department of Internal Medicine, Lexington Medical Center.

Asheesh Lal is a member of the following medical societies: American Society of Clinical Oncology and American Society of Hematology.

Editors: Karen Seiter, MD, Professor, Department of Internal Medicine, Division of Oncology/Hematology, New York Medical College; Francisco Talavera, PharmD, PhD, Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference; Emmanuel C Besa, MD, Professor Emeritus, Department of Medicine, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Kimmel Cancer Center, Jefferson Medical College of Thomas Jefferson University.

Primary Myelofibrosis Guidelines

Guidelines Summary

Diagnosis

Risk Stratification

Treatment

Supportive Care

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