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Letters to the Editor
AB
C
P<0.001 P=0.0015
Lymph-nodes < 5 cm Lymph-nodes ≥ 5 cm
P=0.0558
Figure 2. Prognostic impact of baseline biologic factors and response on overall survival (OS). CR: complete response; TP53+: TP53 disruption present; TP53-: TP53 disruption absent; MRD: minimal residual disease; Flow-pos MRD: positive MRD by flow- cytometry; Flow-uMRD: undetectable MRD by flow-cytometry. (A) OS by TP53 disruption. 24-month OS, TP53 disruption, absent versus present, 98.3% versus 62.5% (hazard ratio [HR]: 31.19; 95% confidence interval [CI]: 31.21-303.15); P<0.001. (B) OS by the size of enlarged nodes. 24-month OS, nodes ≥5 cm, absent versus present, 97% versus 71.4% (HR: 12.095; 95%CI: 1.693- 86.418); P=0.0015. (C) OS in CR patients by MRD. 36-month OS, Flow-uMRD-CR versus Flow-MRD-pos-CR, 100% versus 90%; (HR 0.289, 95%CI: 0.03-2.60); P=0.0558.
patients with CLL. IGHV-M patients without TP53 dis- ruption had the highest benefit from the FCO2 chemoimmunotherapy; about two-thirds of them achieved a Flow-uMRD-CR and were progression-free at 32 months. These findings confirm the favorable out- comes of M-IGHV patients treated with the FCR regi- men3-5 and the survival benefit of patients who obtain an uMRD at response.3-5,13 Direct cross-comparisons between the results of this study and those of other trials with the FCR regimen,1-3 or with the FC schedule com- bined with obinutuzumab,14 or a single dose of ofatu- mumab,10 are methodologically incorrect. These studies differ on many points: the number and age of treated patients, inclusion criteria, selection of patients who had an MRD assessment, and supportive measures. In the absence of a randomized study, the FCR regimen remains the standard chemoimmunotherapy approach for fit and young patients with CLL and no deletion 17p. However, recent studies highlight the superiority of front-line chemo-free regimens over conventional chemoimmunotherapy. In the randomized ECOG E1912 study,15 young and fit patients with CLL who received front-line treatment with ibrutinib and rituximab
showed a significantly higher PFS and OS than those treated with FCR. A superior PFS than that observed with FCR was seen in UM-IGHV patients, while it was less evident in M-IGHV patients. Given the favorable outcomes with front-line chemoimmunotherapy in young and fit patients, IGHV mutated and without TP53 disruption, the role of novel agents in this subset of patients should be better defined.
Francesca R. Mauro,1 Stefano Molica,2 Stefano Soddu,3 Fiorella Ilariucci,4 Marta Coscia,5 Francesco Zaja,6
Emanuele Angelucci,7 Francesca Re,8 Anna Marina Liberati,9 Alessandra Tedeschi,10 Gianluigi Reda,11 Daniela Pietrasanta,12 Alessandro Gozzetti,13 Roberta Battistini,14 Giovanni Del Poeta,15 Caterina Musolino,16 Mauro Nanni,1 Alfonso Piciocchi,3 Marco Vignetti,3 Antonino Neri,11 Francesco Albano,17
Antonio Cuneo,18 Ilaria Del Giudice,1 Irene Della Starza,1 Maria Stefania De Propris,1 Sara Raponi,1 Anna R Guarini1 and Robin Foà1
1Department of Hematology and Department of Translational and Precision Medicine, 'Sapienza' University, Rome; 2Department of Hematology, Pugliese Ciaccio Hospital, Catanzaro; 3Italian Group for Adult Hematologic Diseases (GIMEMA) Foundation, Rome;
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