R-CHOP 14 with or without radiotherapy in non-bulky limited-stage diffuse large B-cell lymphoma (DLBCL)

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1 R-CHOP 14 with or without radiotherapy in non-bulky limited-stage diffuse large B-cell lymphoma (DLBCL) Thierry Lamy, Gandhi Damaj, Pierre Soubeyran, Emmanuel Gyan, Guillaume Cartron, Krimo Bouabdallah, Rémy Gressin, Jérôme Cornillon, Anne Banos, Katell Le Du, et al. To cite this version: Thierry Lamy, Gandhi Damaj, Pierre Soubeyran, Emmanuel Gyan, Guillaume Cartron, et al.. R- CHOP 14 with or without radiotherapy in non-bulky limited-stage diffuse large B-cell lymphoma (DLBCL). Blood, American Society of Hematology, 2018, 131 (2), pp < /blood >. <hal > HAL Id: hal Submitted on 16 Mar 2018 HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.

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23 Figure 1: Consort Diagram 334 patients randomized 6 excluded - Misdiagnosis n=2 - Protocol violation n = 1 - Lost of follow-up n=3 Partial responders N=22 mipi 0 N=76 No further treatment 165 assigned to R-CHOP 169 assigned to R-CHOP + RT 4 R-CHOP cycles completed N=159 Assigned to R-CHOP N=137 CR reached N=137 Total CR cycles of R-CHOP N=281 4 R-CHOP cycles completed N=160 CR reached N=144 According to initial randomization Assigned to R-CHOP+RT N=144 9 excluded - Misdiagnosis n=2 - Consent withdrawal n = 1 - Evolutive solid tumor n=1 -Lost of follow-up n=5 Partial responders N=16 mipi 0 N=82 Assigned to RT mipi >1 N=61 2 additional R-CHOP mipi >1 N=62 2 additional R-CHOP + RT Toxic death n=1 Relapses n=13 Non toxic deaths n=13 Relapses n=10 Non toxic deaths n=8

24 Figure 2a: Kaplan-Meier Analysis of Event-free survival calculated from time of inclusion. Solid line R-CHOP, dotted line R-CHOP+RT 100 EFS Survival probability (%) Time in months Number at risk Group: R-CHOP Group: R-CHOP + RT Figure 2b: Kaplan-Meier Analysis of Overall Survival calculated from time of inclusion. Solid line R-CHOP, dotted line R-CHOP+RT Survival probability (%) line R-CHOP, dotted line R-CHOP+RT OS Time in months Number at risk Group: R-CHOP Group: R-CHOP + RT

25 Figure 3: Kaplan-Meier Analysis of overall survival for patients in complete remission at C4 according to randomization. Solid line: R-CHOP, dotted line R-CHOP+RT OS Time in months Number at risk Group: R-CHOP Group: R-CHOP + RT

26 Figure 4: Incidence of relapse according to treatment arm. Solid line: R-CHOP, dotted line R-CHOP+RT. Cumulative incidence of relapse %

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