Статья

Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma: A European Myeloma Network (EMN) Report Within the HARMONY Project

Mattia D’AgostinoSSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, ItalyDavid A. CairnsMundipharma (Inst)Juan José LahuertaInstituto de Investigación del Hospital Universitario 12 de Octubre, Madrid, SpainRuth WesterMundipharma (Germany)Uta BertschUniversity Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT), Heidelberg, GermanyAnders WaageInstitute of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, NorwayElena ZamagniDipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, ItalyMaría‐Victoria MateosComplejo Asistencial Universitario de Salamanca/IBSAL/CIC/Ciberonc, Salamanca, SpainDaniele Dall’OlioDipartimento di Fisica e Astronomia, Università di Bologna, Bologna, ItalyNiels W.C.J. van de DonkDepartment of Hematology, Amsterdam UMC, Cancer Center Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, the NetherlandsGraham JacksonUniversity of Newcastle upon Tyne, Newcastle upon Tyne, United KingdomSerena RocchiDipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, ItalyHans SalwenderAsklepios Tumorzentrum Hamburg, AK Altona and AK St Georg, Hamburg, GermanyJoan Bladé CreixentiHospital Clinic, IDIBAPS, Barcelona, SpainBronno van der HoltHOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsGastone CastellaniDipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, ItalyFrancesca BonelloSSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, ItalyAndréa CapraSSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, ItalyK. EliasUniversity Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT), Heidelberg, GermanyJan DürigDepartment of Hematology, University Clinic Essen, Essen, GermanyFrancesca GaySSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, ItalySonja ZweegmanDepartment of Hematology, Amsterdam UMC, Cancer Center Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, the NetherlandsMichèle CavoDipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, ItalyMartin KaiserThe Institute of Cancer Research, London, United Kingdom and The Royal Marsden Hospital, London, United KingdomHartmut GoldschmidtMundipharma (Germany)Jesús María Hernández‐RivasDepartment of Medicine, University of Salamanca, Institute of Biomedical Research of Salamanca (IBSAL), University of Salamanca—Cancer Research Center of Salamanca (IBMCC, USAL-CSIG). Hematology Department, Hospital Universitario de Salamanca (CAUSA/IBSAL), Salamanca, SpainAlessandra LaroccaSSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, ItalyGordon CookLeeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United KingdomJesús F. San MiguelClínica Universidad de Navarra, CIMA, IDISNA, CIBER-ONC (CB16/12/00369), Pamplona, SpainMario BoccadoroSSD Clinical Trial in Oncoematologia e Mieloma Multiplo, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, ItalyPieter SonneveldDepartment of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands

2022en

ABI

Аннотация

PURPOSE: Patients with newly diagnosed multiple myeloma (NDMM) show heterogeneous outcomes, and approximately 60% of them are at intermediate-risk according to the Revised International Staging system (R-ISS), the standard-of-care risk stratification model. Moreover, chromosome 1q gain/amplification (1q+) recently proved to be a poor prognostic factor. In this study, we revised the R-ISS by analyzing the additive value of each single risk feature, including 1q+. PATIENTS AND METHODS: The European Myeloma Network, within the HARMONY project, collected individual data from 10,843 patients with NDMM enrolled in 16 clinical trials. An additive scoring system on the basis of top features predicting progression-free survival (PFS) and overall survival (OS) was developed and validated. RESULTS: In the training set (N = 7,072), at a median follow-up of 75 months, ISS, del(17p), lactate dehydrogenase, t(4;14), and 1q+ had the highest impact on PFS and OS. These variables were all simultaneously present in 2,226 patients. A value was assigned to each risk feature according to their OS impact (ISS-III 1.5, ISS-II 1, del(17p) 1, high lactate dehydrogenase 1, and 1q+ 0.5 points). Patients were stratified into four risk groups according to the total additive score: low (Second Revision of the International Staging System [R2-ISS]-I, 19.2%, 0 points), low-intermediate (II, 30.8%, 0.5-1 points), intermediate-high (III, 41.2%, 1.5-2.5 points), high (IV, 8.8%, 3-5 points). Median OS was not reached versus 109.2 versus 68.5 versus 37.9 months, and median PFS was 68 versus 45.5 versus 30.2 versus 19.9 months, respectively. The score was validated in an independent validation set (N = 3,771, of whom 1,214 were with complete data to calculate R2-ISS) maintaining its prognostic value. CONCLUSION: The R2-ISS is a simple prognostic staging system allowing a better stratification of patients with intermediate-risk NDMM. The additive nature of this score fosters its future implementation with new prognostic variables.

Перевод пока недоступен

Идентификаторы

DOI: 10.1200/jco.21.02614

Цитирования и источники

Цитирований: 2Использованных источников: 0

Показатели — AkademScholar