Consensus for Flow Cytometry Clinical Report on Multiple Myeloma: A Multicenter Harmonization Process Merging Laboratory Experience and Clinical Needs
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Iole Cordone
1,*, 
Rachele Amodeo
2,
Silvia Bellesi
3,
Fiorella Bottan
4,
Francesco Buccisano
5
,
Maria Stefania De Propris
6,
Serena Masi
1,
Valentina Panichi
7,
Maria Cristina Scerpa
8,
Ombretta Annibali
9,
Velia Bongarzoni
10,
Tommaso Caravita di Toritto
11,
Ugo Coppetelli
8,
Luca Cupelli
12,
Paolo de Fabritiis
12,
Luca Franceschini
5,
Mariagrazia Garzia
13,
Alessia Fiorini
14,
Giacinto Laverde
15,
Andrea Mengarelli
16,
Tommaso Za
3 and
Maria Teresa Petrucci
17add
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1
Department of Research, Advanced Diagnostic and Technological Innovation, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy
2
Clinical Pathology and Biochemistry Unit, Sant’Andrea University Hospital, 00189 Rome, Italy
3
Department of Diagnostic Imaging, Oncological Radiotherapy and Haematology, IRCCS Foundation A. Gemelli University Hospital, 00168 Rome, Italy
4
Clinical Pathology Unit, San Giovanni Addolorata Hospital, 00184 Rome, Italy
5
Haematology and Stem Cell Transplant Unit, Department of Biomedicine and Prevention, University of Rome ‘Tor Vergata’, 00133 Rome, Italy
6
Immunophenotype Laboratory, Department of Translational and Precision Medicine, ‘Sapienza’ University, 00185 Rome, Italy
7
Microbiology and Virology Unit, Department of Oncology and Haematology, Belcolle Central Hospital, 01100 Viterbo, Italy
8
Haematology and Stem Cell Unit, Santa Maria Goretti Hospital, ASL Latina, 04100 Latina, Italy
9
Haematology and Stem Cell Transplant Unit, Campus Bio-Medico University, 00128 Rome, Italy
10
Haematology Unit, San Giovanni Addolorata Hospital, 00184 Rome, Italy
11
Haematology Unit, ASL Roma 1, 00193 Rome, Italy
12
Haematology Unit, Sant’Eugenio Hospital, ASL Roma 2, 00144 Rome, Italy
13
Haematology and Stem Cell Transplant Unit, San Camillo Forlanini Hospital, 00152 Rome, Italy
14
Department of Oncology and Haematology, Belcolle Central Hospital, 01100 Viterbo, Italy
15
Haematology Unit, Sant’Andrea University Hospital, 00189 Rome, Italy
16
Department of Research and Clinical Oncology, IRCCS Regina Elena National Cancer Institute, 00144 Rome, Italy
17
Haematology Unit, Department of Translational and Precision Medicine, ‘Sapienza’ University, 00185 Rome, Italy
*
Author to whom correspondence should be addressed.
Cancers 2023, 15(7), 2060; https://doi.org/10.3390/cancers15072060
Submission received: 13 January 2023
/
Revised: 14 March 2023
/
Accepted: 14 March 2023
/
Published: 30 March 2023
(This article belongs to the Section Cancer Causes, Screening and Diagnosis)
Simple Summary
We report an Italian multicentre study with the aim to reach a consensus based on the essential data to be included in the flow cytometry clinical report of patients with MM at diagnosis and after treatment. From the pre-analytical phase, through sample processing, data acquisition, analysis and evaluation of the potential limitations and pitfalls of the entire process, the study reaches a final conclusion shared by laboratories and clinicians according to the most up-to-date principles and recommendations.
Abstract
Flow cytometry is a highly sensitive and specific approach for discriminating between normal and clonal plasma cells in multiple myeloma. Uniform response criteria after treatment have been established by the International Myeloma Working Group and the EuroFlow Group; however, the way in which flow cytometry data are reported has suffered from no collaborative or multicentre efforts. This study, involving 8 expert laboratories and 12 clinical hematology units of the Lazio region in Italy, aims to produce a uniform and shared report among the various Centres. From the pre-analytical phase to sample processing, data acquisition, analysis, and evaluation of the potential limitations and pitfalls of the entire process, the study reaches a final conclusion shared by laboratories and clinicians according to the most updated principles and recommendations. The aim was to identify the necessary data to be included in the clinical report by using multiple-choice questionnaires at every single stage of the process. An agreement of more than 75% of the laboratories was considered mandatory for the data to be included in the report. By ensuring the operational autonomy of each laboratory, this study provides a clear report that limits subjective interpretations and highlights possible bias in the process, better supporting clinical decision-making.
