Originally published as JCO Early Release 10.1200/JCO.2005.04.242 on April 4 2005

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International Staging System for Multiple Myeloma

From the Mayo Clinic College of Medicine and Eastern Cooperative Oncology Group, Rochester, MN; Grupo Espanol di Mieloma and Program de Estudio y Tratamiento de las Hemapatias Malignas, University of Salamanca, Salamanca; PETHEMA, Hospital Clinic, Barcelona; Grupo Espanol di Mieloma, Hospital Universitario, Madrid, Spain; Southwest Oncology Group, International Myeloma Foundation and Cedars Sinai Comprehensive Cancer Center, Los Angeles, CA; University of Arkansas for Medical Sciences, Little Rock, AR; Cancer Research and Biostatistics, Seattle, WA; Italian Cooperative Group, University of Torino, Torino; Italian Cooperative Group, Istituto di Ematologia Seragnoli, Bologna, Italy; Medical Research Council, The General Infirmary at Leeds, Leeds; Medical Research Council, Royal Mardsen Hospital, Sutton; Myeloma Unit, Parkside Oncology Clinic, Wimbledon, United Kingdom; Intergroup Francais Myelome, Institut de Biologie, Nantes, France; Wilhelminenspital Der Stat Wien, Vienna, Austria; Japan Myeloma Study Group, Nagoya City Higashi General Hospital, Nagoya, Japan; National Cancer Institute of Canada, and McGill University, Montreal, Quebec, Canada; Dutch-Belgìan Haematology-Oncology Cooperative Group Data Center, Erasmus MC Hospital, Rotterdam, the Netherlands; Nordic Myeloma Study Group, Malm, Sweden; and Lund University Hospital, Lund, Sweden

Address reprint requests to International Myeloma Foundation, International Headquarters, 12650 Riverside Dr, Suite 206, North Hollywood, CA 91607; e-mail: lpaik{at}myeloma.org

PURPOSE: There is a need for a simple, reliable staging system for multiple myeloma that can be applied internationally for patient classification and stratification.

PATIENTS AND METHODS: Clinical and laboratory data were gathered on 10,750 previously untreated symptomatic myeloma patients from 17 institutions, including sites in North America, Europe, and Asia. Potential prognostic factors were evaluated by univariate and multivariate techniques. Three modeling approaches were then explored to develop a staging system including two nontree and one tree survival assessment methodologies.

RESULTS: Serum beta₂-microglobulin (Sß₂M), serum albumin, platelet count, serum creatinine, and age emerged as powerful predictors of survival and were then used in the tree analysis approach. A combination of Sß₂M and serum albumin provided the simplest, most powerful and reproducible three-stage classification. This new International Staging System (ISS) was validated in the remaining patients and consists of the following stages: stage I, Sß₂M less than 3.5 mg/L plus serum albumin 3.5 g/dL (median survival, 62 months); stage II, neither stage I nor III (median survival, 44 months); and stage III, Sß₂M 5.5 mg/L (median survival, 29 months). The ISS system was further validated by demonstrating effectiveness in patients in North America, Europe, and Asia; in patients less than and 65 years of age; in patients with standard therapy or autotransplantation; and in comparison with the Durie/Salmon staging system.

CONCLUSION: The new ISS is simple, based on easy to use variables (Sß₂M and serum albumin), and recommended for early adoption and widespread use.

Supported by the International Myeloma Foundation, Los Angeles, CA.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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