The Value of Risk Stratification Tools in Multiple Myeloma (MM) in the Real-World: Validation of the Revised- International Staging System (R-ISS) at Initiation of Treatment and Relevance of the ISS and the R-ISS for Risk Stratification in the Relapsed Setting Using Data from the Czech Registry of Monoclonal Gammopathies (RMG)
The ISS stratifies survival risk in patients with MM based on β2-microglobulin and albumin levels. The R-ISS is an improved stratification tool, which also uses chromosomal abnormalities (CA) and lactate dehydrogenase (LDH). It was developed based on clinical trial data in the first-line setting but...
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| Published in: | Blood 2016-12, Vol.128 (22), p.2418-2418 |
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| Main Authors: | , , , , , , , , , , |
| Format: | Article |
| Language: | eng |
| Online Access: | Get full text |
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| Summary: | The ISS stratifies survival risk in patients with MM based on β2-microglobulin and albumin levels. The R-ISS is an improved stratification tool, which also uses chromosomal abnormalities (CA) and lactate dehydrogenase (LDH). It was developed based on clinical trial data in the first-line setting but, has not been validated outside clinical trials or for use in the relapsed setting. Using data from the RMG, we assessed the real-world validity of the R-ISS at diagnosis. Additionally, as it is standard practice to re-stage patients after first relapse, we explored the value of re-estimating ISS stage in the relapsed setting and exploring the carry on effect of R-ISS from diagnosis. Re-estimation of R-ISS at relapse is not possible as standard practice often does not include CA measurement at first relapse. Assessment of improvement in stratification was based on visual comparison of median OS, hazard ratios (HR) and confidence intervals.
Eligible patients were diagnosed with symptomatic MM between May 2007 and April 2016. A Cox regression model and Kaplan-Meier analyses assessed the performance of the ISS and R-ISS for stratifying patients based on survival both at diagnosis and at first relapse.
Overall, there were 3027 patients at diagnosis however only 493 were included in these analyses due to unavailable CA values (84% of patients). ISS and R-ISS stage distribution at diagnosis was ISS I 31.2%, II 29.1% and III 39.6%; and R-ISS I 12% II 57% and III 31% (Table 1). Median overall survival (OS) in months (95% confidence interval [CI]), from diagnosis was 73.5 (68.0-NE), 40.5 (31.0-50.0) and 29.0 (20.9-37.2) in patients with ISS stage I, II and III, respectively, and not reached (NR), 46.6 (39.2-54.1) and 26.0 (18.2-33.8) in patients with R-ISS stage I, II and III, respectively. Table 2 shows HR, which indicate OS assessed in alternative ways was significantly different among the three stages for both ISS and R-ISS. R-ISS provided refined stratification than ISS alone, since R-ISS stage III classified patients with higher risk than ISS III alone, (shorter median OS, narrower CI, and stronger HR vs. ISS I and II). From the original sample of 493 patients at diagnosis, only 250 went on to receive further treatment after first relapse. The median OS months (95% CI) after first relapse was 46.4 (32.0-60.8), 22.8 (13.4-32.1) and 14.9 months (9.0-20.8) in patients staged as ISS stage I, II and III at diagnosis, respectively. In patients staged as R-ISS stage I, II |
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| ISSN: | 0006-4971 1528-0020 |