Multiple Myeloma R-ISS Prognostic Stratification System in Real Life Population

Author:

Radocha Jakub112,Maisnar Vladimír34,Pour Ludek35,Adam Zdenek35,Spicka Ivan36,Straub Jan36,Scudla Vlastimil37,Minarik Jiri38,Gregora Evzen39,Pavlicek Petr310,Frankova Hana311,Zahradova Lenka312,Jungova Alexandra313,Sykora Michal314,Kessler Petr315,Adamova Dagmar316,Wrobel Marek317,Sedlarikova Lenka318,Sevcikova Sabina319,Horinek Daniel3,Pelcova Jana3,Jarkovsky Jiri320,Hájek Roman312

Affiliation:

1. 4th Department of Medicince - Haematology, University Hospital Hradec Kralove, Charles University, Hradec Kralove, CZE

2. 4th Department of Internal Medicine-Haematology, Charles University Hospital, Hradec Kralove, Hradec Kralove, Czech Republic

3. Czech Myeloma Group, Brno, Czech Republic

4. 4th Department of Medicince - Haematology, University Hospital Hradec Kralove, Charles University, Hradec Králové, Czech Republic

5. Masaryk University, Brno, Czech Republic

6. Vseobecna Fakultni Nemocnice V Praze, I. Interni Klinika, Klinika Hematologie, Praha 2, Prague, Czech Republic

7. Department of Hematooncology, University Hospital and Palacky University Olomouc, Olomouc, Czech Republic

8. Department of Hemato-Oncology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Olomouc, Czech Republic

9. Department of Internal Medicine and Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic

10. Department for Internal Medicine and Haematology, 3rd Faculty of Medicine,Charles Universitiy in Prague and Faculty Hospital Kralovske Vinohrady, Prague, Czech Republic

11. Department of Hematology, General Hospital Liberec,, Liberec, Czech Republic

12. Dept. of Hematooncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic

13. Department of Hemato-Oncology, Charles University Hospital Pilsen, Pilsen, Czech Republic

14. Department of Clinical Hematology, Hospital Ceske Budejovice, Ceske Budejovice, Czech Republic

15. Department of Hematology and Transfusion Medicine, Pelhrimov Hospital, Pelhrimov, Czech Republic

16. Department of Clinical Hematology, Silesian Hospital Opava, Opava, Czech Republic

17. Department of Hematology, Hospital Novy Jicin, Novy Jicin, Czech Republic

18. Babak Myeloma Group, Department of Pathological Physiology, Faculty of Medicine, Masaryk University, Brno, Brno, Czech Republic

19. Babak Myeloma Group, Department of Pathological Physiology, Faculty of Medicine, Masaryk University, Brno, Czech Republic

20. Institute of Biostatistics and Analyses, Faculty of Medicine and Faculty of Science, Masaryk University, Brno, Czech Republic

Abstract

Abstract Introduction: Revised prognostic scoring system R-ISS (standard ISS plus cytogenetic changes) has been introduced as a possible tool for evaluation of patients with multiple myeloma. This system is based on pooled data from various clinical trials but has not been validated in patients´ population outside the clinical trial setting. Aim: To evaluate clinical relevance of R-ISS in real life population of multiple myeloma patients. Methods: Registry of monoclonal gammopathies (RMG) was established in 2007 and has become one of the flagship projects of the Czech Myeloma Group. The registry collects prospective data from patients with myeloma and other gammopathies (https://trials.cba.muni.cz/trialdb2/interface_forms/login_rmg.asp). Registry is regularly monitored and data are validated by an external monitor. Data from registry were retrieved to identify patients in whom all above mentioned parameters were available. These patients were then stratified according to R-ISS and TTP and OS were calculated as primary endpoints. Results: 555 patients (260 females, 295 males, median age 66 years) with multiple myeloma who had full set of necessary data available were identified. Median follow-up of this cohort was 22.2 months. 97 17.5% (97/555) patients were R-ISS stage I, 55.7% 309/555 were R-ISS stage II and 26.8% (149/555) patients were R-ISS III. Median overall survival was not reached for stage I, 3.9 years for stage II and 2.5 years for stage III. The differences were statistically significant (p<0.001, log-rank test). Median time to progression was 3.3 years for stage I, 1.9 years for stage II and 1.3 years for stage III. The differences were statistically significant (p<0.001, log-rank test). Stage I versus II showed HR (95% CI): 2.84 (1.66-4.87), p<0.001 and stage I versus III HR (95% CI): 5.20 (2.99-9.03), p<0.001 for overall survival and HR (95% CI): 2.02 (1.37-2.96), p<0.001 and (95% CI): 2.49 (1.64-3.77), p< 0.001 for time to progression. Similar survival pattern can be seen in a subgroup of patients treated with autologous stem cell transplantation, without autologous stem cell transplantation and the system provides valuable information even in a subgroup of patients who were never treated with novel agents. Figure 1 shows overall survival and figure 2 time to progression of the cohort. Conclusion: Revised ISS provides valuable information about the long term prognosis in a mixed cohort of real life multiple myeloma patients. This system enables to estimate the prognostic category of each specific patient in a horizon of several years ahead. Supported by PRVOUK P37. Table 1 Table 1. Figure 1 Overall survival for R-ISS stages Figure 1. Overall survival for R-ISS stages Figure 2 Time to progression for R-ISS stages Figure 2. Time to progression for R-ISS stages Disclosures Spicka: BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria; Millenium: Honoraria. Hájek:Janssen: Honoraria; Celgene: Consultancy, Research Funding; BMS: Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

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