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Allocation and validation of the second revision of the International Staging System in the ICARIA-MM and IKEMA studies

PG. Richardson, A. Perrot, J. Mikhael, T. Martin, M. Beksac, I. Spicka, M. Capra, M. D'Agostino, P. Sonneveld, K. Bisht, T. Fukao, R. Zhang, K. Tada, C. Tekle, S. Macé, Z. Klippel, H. van de Velde, P. Moreau

. 2024 ; 14 (1) : 209. [pub] 20241128

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, klinické zkoušky, fáze III, validační studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc25003368

The International Staging System for multiple myeloma recently underwent a second revision (R2-ISS) to include gain/amplification of 1q21 and account for the additive prognostic significance of multiple high-risk features. The phase 3 ICARIA-MM (isatuximab-pomalidomide-dexamethasone vs. pomalidomide-dexamethasone) and IKEMA (isatuximab-carfilzomib-dexamethasone vs. carfilzomib-dexamethasone) studies provide large datasets for retrospectively validating the prognostic value of the R2-ISS in relapsed/refractory multiple myeloma. Of 609 pooled patients, 68 (11.2%) were reclassified as R2-ISS stage I, 136 (22.3%) as R2-ISS stage II, 204 (33.5%) as R2-ISS stage III, 55 (9.0%) as stage IV, and 146 (24.0%) "Not classified". Median progression-free survival was shorter among those reclassified as R2-ISS stage II (HR 1.52, 95% CI 0.979-2.358), stage III (HR 2.59, 95% CI 1.709-3.923), and stage IV (HR 3.51, 95% CI 2.124-5.784) versus stage I. Adding isatuximab led to longer progression-free survival versus doublet therapy (adjusted HR 0.544 [95% CI 0.436-0.680]), with a consistent treatment effect observed across all R2-ISS stages. This is the first study to validate the R2-ISS with novel agents, including anti-CD38 monoclonal antibodies, and to show that R2-ISS, as a prognostic scoring system, can be applied to patients with relapsed/refractory multiple myeloma.

Citace poskytuje Crossref.org

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