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Prospective studies on the risk of malignant transformation in patients with monoclonal gammopathy of undetermined significance (MGUS) and factors predictive of survival are lacking. The Dutch Comprehensive Cancer Centre West, comprising 1·6 million inhabitants, initiated a prospective hospital-based cohort study on 1464 patients with newly diagnosed M-proteinaemia, median age 73 (17–103) years. M-protein related diagnoses, patients’ characteristics, laboratory investigations, bone marrow examinations and skeletal X-rays were registered with a yearly follow-up. Main endpoints were death, or new diagnoses of multiple myeloma and non-Hodgkin lymphoma. Kaplan–Meier survival curves were compared with age- and gender-matched survival data from the total Dutch population. Cumulative malignant transformation was corrected for death using a competing risk model. Risk factors for transformation or death were analyzed by univariate and multivariate analyses. In 1007 MGUS-patients, malignant transformation was associated with rising M-protein levels, IgA and IgM isotype and occurred at a yearly rate of 0·4%. All MGUS patients survived less than a matched cohort of the Dutch population, even in the absence of M-protein-associated comorbidity. Serum albumin levels at entry appeared highly predictive for survival. M-proteinaemia is not an innocent symptom. Although malignant transformation occurs rarely, survival is shortened irrespective of comorbidity. [ABSTRACT FROM AUTHOR]

Abstract: This study assesses whether new treatment strategies developed in clinical trials translate into improved survival for multiple myeloma (MM) patients in the Netherlands. All patients diagnosed with MM in the Northern part of the Netherlands between 1989 and 2005 were retrieved from two regional population-based cancer registries. Information on study participation was derived from linkage with trial information systems. The effect of period of diagnosis (1989–1992, 1993–1996, 1997–2000, 2001–2005), age (<50, 50–65, 66–74, ⩾75), gender, Salmon–Durie (SD) stage, trial participation and treatment on relative survival were studied. In total 4985 patients were included. When trial participation was analysed for exact periods in which trials were open, 16% of patients aged ⩽65years with SD-stage I and 38% with SD-stage II or III were enrolled compared to 2% of patients aged >65years with SD-stage I and 5% with SD-stage II or III. Relative survival decreased with age (p <.001), with advanced stage (p <.001) and was better for patients enrolled in trials (p <.001). Five-year relative survival increased from 34% (95% confidence interval (95% CI) 28–39%) in 1989–1992 to 56% (95% CI 50–61%) in 2001–2005 for patients ⩽65years. The excess mortality was 37% lower in 2001–2005 than in 1989–1992 for these patients, adjusted for age, stage, trial participation and gender (p <.001). Survival did not improve for older patients. In conclusion: MM survival improved among younger but not among older patients since the mid-1990s. The improved survival of younger patients coincided with increasing trial participation and increasing use of high-dose chemotherapy and autologous stem-cell transplantation. [Copyright &y& Elsevier]