Francesco Merli1, Stefano Luminari1,2, Alessandra Tucci3, Annalisa Arcari4, Luigi Rigacci5, Eliza Hawkes6, Carlos S Chiattone7,8, Federica Cavallo9, Giuseppina Cabras10, Isabel Alvarez1, Alberto Fabbri11, Alessandro Re3, Benedetta Puccini5, Allison Barraclough12, Marcia Torresan Delamain13, Simone Ferrero9, Sara Veronica Usai10, Angela Ferrari1, Emanuele Cencini11, Elsa Pennese14, Vittorio Ruggero Zilioli15, Dario Marino16, Monica Balzarotti17, Maria Christina Cox18, Manuela Zanni19, Alice Di Rocco20, Arben Lleshi21, Barbara Botto22, Stefan Hohaus23, Michele Merli24, Roberto Sartori25, Guido Gini26, Luca Nassi27, Gerardo Musuraca28, Monica Tani29, Chiara Bottelli3, Sofia Kovalchuk5, Francesca Re30, Leonardo Flenghi31, Annalia Molinari32, Giuseppe Tarantini33, Emanuela Chimienti21, Luigi Marcheselli34, Caterina Mammi35, Michele Spina21. 1. Hematology Unit, Azienda Unità Sanitaria Locale-IRCCS, Reggio Emilia, Italy. 2. Department CHIMOMO, University of Modena and Reggio Emilia, Reggio Emilia, Italy. 3. Hematology Division, ASST Spedali Civili Brescia, Brescia, Italy. 4. Hematology Unit, Ospedale Guglielmo da Saliceto, Piacenza, Italy. 5. Haematology Unit, Careggi University Hospital, Firenze, Italy. 6. Department of Oncology and Clinical Haematology, Olivia Newton-John Cancer Research Institute at Austin Health, Heidelberg, Melbourne, Australia. 7. Santa Casa Medical School, Sao Paulo, Brazil. 8. Samaritano Hospital, Sao Paulo, Brazil. 9. Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino/AOU "Città della Salute e della Scienza di Torino," Torino, Italy. 10. Division of Hematology, Ospedale Oncologico Armando Businco, Cagliari, Italy. 11. Unit of Hematology, Azienda Ospedaliera Universitaria Senese and University of Siena, Siena, Italy. 12. Department of Haematology, Austin Health, Heidelberg, Melbourne, Australia. 13. Hemocentro-Unicamp, University of Campinas, Campinas, Brazil. 14. Lymphoma Unit, Department of Hematology, Ospedale Spirito Santo, Pescara, Italy. 15. Division of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy. 16. Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy. 17. Department of Medical Oncology and Hematology, Humanitas Clinical Research Hospital-IRCCS, Rozzano (MI), Italy. 18. Hematology Unit, Azienda Ospedaliera Universitaria Sant'Andrea, Roma, Italy. 19. Hematology Unit, Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. 20. Institute of Hematology, Department of Translational and Precision Medicine "Sapienza," University of Roma, Roma, Italy. 21. Division of Medical Oncology and Immune-related Tumors, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano (PN), Italy. 22. Division of Hematology, Città della Salute e della Scienza Hospital and University, Torino, Italy. 23. University Policlinico Gemelli Foundation-IRCCS, Catholic University of the Sacred Heart, Roma, Italy. 24. Division of Hematology, Ospedale di Circolo e Fondazione Macchi-ASST Sette Laghi, University of Insubria, Varese, Italy. 25. Department of Clinical and Experimental Oncology, Oncohematology Unit, Veneto Institute of Oncology, IOV-IRCCS, Castelfranco Veneto (TV), Italy. 26. Division of Hematology, Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona, Italy. 27. Hematology, AOU Maggiore della Carità and University of Eastern Piedmont, Novara, Italy. 28. Hematology Unit, IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) SRL, Meldola (FC), Italy. 29. Hematology Unit, Santa Maria delle Croci Hospital, Ravenna, Italy. 30. Hematology and BMT Center, Azienda Ospedaliera Universitaria, Parma, Italy. 31. Hematology, Santa Maria della Misericordia Hospital, Perugia, Italy. 32. Hematology Unit, Ospedale degli Infermi, Rimini, Italy. 33. Haematology and BMT Unit, Ospedale Monsignor R. Dimiccoli, Barletta, Italy. 34. Fondazione Italiana Linfomi Onlus, Modena, Italy. 35. Gruppo Amici dell'Ematologia GRADE-Onlus Foundation, Reggio Emilia, Italy.
Abstract
PURPOSE: To prospectively validate the use of a simplified geriatric assessment (sGA) at diagnosis and to integrate it into a prognostic score for older patients with diffuse large B-cell lymphoma (DLBCL). METHODS: We conducted the prospective Elderly Project study on patients with DLBCL older than 64 years who underwent our Fondazione Italiana Linfomi original geriatric assessment (oGA) (age, Cumulative Illness Rating Scale for Geriatrics, activities of daily living, and instrumental activities of daily living) before treatment. Treatment choice was left to the physician's discretion. The primary end point was overall survival (OS) (ClinicalTrials.gov identifier: NCT02364050). RESULTS: We analyzed 1,163 patients (median age 76 years), with a 3-year OS of 65% (95% CI, 62 to 68). Because at multivariate analysis on oGA, age > 80 years retained an independent correlation with OS, we also developed a new, simplified version of the GA (sGA) that classifies patients as fit (55%), unfit (28%), and frail (18%) with significantly different 3-year OS of 75%, 58%, and 43%, respectively. The sGA groups, International Prognostic Index, and hemoglobin levels were independent predictors of OS and were used to build the Elderly Prognostic Index (EPI). Three risk groups were identified: low (23%), intermediate (48%), and high (29%), with an estimated 3-year OS of 87% (95% CI, 81 to 91), 69% (95% CI, 63 to 73), and 42% (95% CI, 36 to 49), respectively. The EPI was validated using an independent external series of 328 cases. CONCLUSION: The Elderly Project validates sGA as an objective tool to assess fitness status and defines the new EPI to predict OS of older patients with DLBCL.
PURPOSE: To prospectively validate the use of a simplified geriatric assessment (sGA) at diagnosis and to integrate it into a prognostic score for older patients with diffuse large B-cell lymphoma (DLBCL). METHODS: We conducted the prospective Elderly Project study on patients with DLBCL older than 64 years who underwent our Fondazione Italiana Linfomi original geriatric assessment (oGA) (age, Cumulative Illness Rating Scale for Geriatrics, activities of daily living, and instrumental activities of daily living) before treatment. Treatment choice was left to the physician's discretion. The primary end point was overall survival (OS) (ClinicalTrials.gov identifier: NCT02364050). RESULTS: We analyzed 1,163 patients (median age 76 years), with a 3-year OS of 65% (95% CI, 62 to 68). Because at multivariate analysis on oGA, age > 80 years retained an independent correlation with OS, we also developed a new, simplified version of the GA (sGA) that classifies patients as fit (55%), unfit (28%), and frail (18%) with significantly different 3-year OS of 75%, 58%, and 43%, respectively. The sGA groups, International Prognostic Index, and hemoglobin levels were independent predictors of OS and were used to build the Elderly Prognostic Index (EPI). Three risk groups were identified: low (23%), intermediate (48%), and high (29%), with an estimated 3-year OS of 87% (95% CI, 81 to 91), 69% (95% CI, 63 to 73), and 42% (95% CI, 36 to 49), respectively. The EPI was validated using an independent external series of 328 cases. CONCLUSION: The Elderly Project validates sGA as an objective tool to assess fitness status and defines the new EPI to predict OS of older patients with DLBCL.
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