A Study of Real-world Use and Effectiveness of Cytoreductive Strategies for the Treatment of Second-line Polycythemia Vera in France

Proportion of Patients per Type of First-line Cytoreductive Treatment

Time frame: Baseline

Proportion of Patients per Type of Third-line Cytoreductive Treatment

Time frame: Up to approximately 12 months

Initial Dose of Second-line Cytoreductive Treatment Received for Each Type of Treatment

Time frame: Day 1 (first dose of second-line cytoreductive treatment)

Duration of Each Line of Treatment

Time frame: Baseline up to approximately 12 months

Duration Between PV Diagnosis and Second-line Cytoreductive Treatment Initiation

Time frame: Baseline

Proportion of Patients With Treatment Interruptions and Dose Modification During Second-line Treatment

Time frame: Up to approximately 12 months

Proportion of Patients by Number of Dose Modifications During Second-line Cytoreductive Treatment

Dose modifications were categorized as an increase or decrease in dose.

Time frame: Up to approximately 12 months

Proportion of Patients Who Permanently Discontinued Second-line Cytoreductive Treatment

Time frame: Up to approximately 12 months

Proportion of Patients by Reasons for Switching to Second-line Cytoreductive Treatment

Time frame: Baseline

Proportion of Patients by Reasons for Switching to Third-line Cytoreductive Treatment

Time frame: Up to approximately 12 months

Proportion of Patients per Type of Concomitant Treatment/Procedure During Second-line Cytoreductive Treatment

Time frame: Up to approximately 12 months

Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to First-line Cytoreductive Treatment

Timing of bone marrow biopsy was categorized as: * Prior to first-line treatment * Prior to second-line treatment

Time frame: Baseline

Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to Second-line Cytoreductive Treatment

Timing of bone marrow biopsy was categorized as: * During second-line treatment * After second-line treatment

Time frame: Baseline

Proportion of Patients Achieving Hematocrit Control

Hematocrit control was defined as hematocrit \< 45% with the absence of phlebotomy eligibility during the last 3 months.

Time frame: Approximately 6 months

Proportion of Patients Achieving Clinicohematologic Response

Proportion of patients achieving clinicohematologic response according to the European LeukemiaNet (ELN) criteria (complete or partial). Complete clinicohematologic response was defined by: * Hematocrit \< 45% without phlebotomies during the last 3 months, and * Platelet count ≤ 400 x 10\^9/L, and * White blood cell count ≤ 10 x 10\^9/L, and * Normal spleen size evaluated by physical examination and/or by imaging. Partial clinicohematologic response was defined by: In patients who do not fulfill the criteria for complete response, hematocrit \< 45% without phlebotomy for 3 months OR response in 3 of the other criteria.

Time frame: Approximately 6 months

Proportion of Patients Achieving Symptom Response

Proportion of patients achieving symptom response according to the ELN criteria. Symptom response is defined as an absolute 10-point improvement in the Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS). The MPN-SAF TSS (or MPN-10) is a validated patient-reported questionnaire that measures symptom burden in patients with myeloproliferative neoplasms. The instrument assesses 10 key disease-related symptoms, each scored from 0 (absent) to 10 (worst imaginable), generating a total score ranging from 0 to 100. Higher scores indicate greater symptom burden, and changes in the score are commonly used to evaluate clinical benefit and treatment response in both clinical practice and clinical trials

Time frame: Approximately 6 months

Proportion of Patients Achieving Molecular Response

Proportion of patients achieving molecular response according to the ELN criteria (complete or partial). Complete molecular response was defined by the reduction of any specific molecular abnormality to undetectable levels. Partial molecular response was defined by: * A reduction of ≥ 50% from baseline value in patients with \< 50% mutant allele burden at baseline OR * A reduction of ≥ 25% from baseline value in patients with ≥ 50% mutant allele burden at baseline.

Time frame: Approximately 6 months

Proportion of Patients With Occurrence of Disease Progression Events

Disease progression events include acute myeloid leukemia, myelofibrosis, and PV related death.

Time frame: Up to 6 approximately months

Proportion of Patients With Occurrence of Thromboembolic or Hemorrhagic Events

Thromboembolic and hemorrhagic events include arterial thrombotic, venous thrombotic, and hemorrhage.

Time frame: Up to 6 approximately months

Proportion of Patients by Sex

Time frame: Day 1 (first dose of second-line cytoreductive treatment)

Age

Time frame: Day 1 (first dose of second-line cytoreductive treatment)

Proportion of Patients With Cardiovascular and Thromboembolic Risk Factors

Time frame: Baseline

Proportion of Patients With a History of Medical Conditions

Medical conditions include cancer, autoimmune disease, and opportunistic infection.

Time frame: Baseline

Proportion of Patients With Other Ongoing Comorbidities

Time frame: Baseline

Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Prior to First-line Treatment

Time frame: Baseline

Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Between First- and Second-line Cytoreductive Treatment

Time frame: Baseline

Duration Between Most Recent Thromboembolic or Hemorrhagic Event and Initiation of First and Second-line Cytoreductive Treatment

Time frame: Baseline

Proportion of Patients by Reason for Initiating First-line Cytoreductive Treatment

Time frame: Baseline

Proportion of Patients per Type of Pre-specified Emergency Treatment/Procedure Administered Prior to Second-line Cytoreductive Treatment Initiation

Emergency treatments/procedures include antiplatelet drugs, anticoagulants, and phlebotomies.

Time frame: Baseline

Proportion of Patients by Number of Phlebotomies Required in the 3 Months Prior to Second-line Cytoreductive Treatment

Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

Proportion of Patients by PV Symptoms

PV symptoms include splenomegaly, pruritus, fatigue, and bone pain.

Time frame: Day 1 (first dose of second-line cytoreductive treatment)

MPN-SAF TSS Score

The MPN-SAF TSS (or MPN-10) is a validated patient-reported questionnaire that measures symptom burden in patients with myeloproliferative neoplasms. The instrument assesses 10 key disease-related symptoms, each scored from 0 (absent) to 10 (worst imaginable), generating a total score ranging from 0 to 100. Higher scores indicate greater symptom burden, and changes in the score are commonly used to evaluate clinical benefit and treatment response in both clinical practice and clinical trials.

Time frame: Day 1 (first dose of second-line cytoreductive treatment)

Hemoglobin Level

Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

Hematocrit Level

Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

Leukocyte Count

Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

Platelet Count

Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)

Proportion of Patients by Type of Mutation

Time frame: Baseline

Mutant Allele Burden

Mutant allele burden is a molecular measure that quantifies the proportion of cells harboring a specific disease-associated mutation (e.g., JAK2 V617F, CALR, or MPL) within a patient sample. It is usually reported as the variant allele frequency (VAF), representing the percentage of mutant alleles among all alleles analyzed, and serves as an indicator of the size of the malignant clone in myeloproliferative neoplasms (MPNs). Changes in mutant allele burden may provide insight into the biological activity of the disease and the molecular effects of therapy. Mutant allele burden was categorized as ≥ 50% or \< 50%.

Time frame: Baseline

Proportion of Patients With Pre-specified Adverse Events of Special Interest Occurring After Initiation of the Second-line Cytoreductive Treatment

Pre-specified adverse events of special interest include thrombocytopenia, anemia, neutropenia, infection, weight gain, psychological disorders, nonmelanoma skin cancer, skin disorders, and autoimmune disorders.

Time frame: Up to 12 months