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- W2951512389 abstract "Introduction: It is well established that follicular lymphoma (FL) patients who have progression of disease within 24 months (POD24) from frontline immunochemotherapy have worse overall survival (OS) and thus constitute a high-risk population (Casulo et al. J Clin Oncol 33:2516-2522, 2015; Jurinovic et al., Blood 128:1112-1120, 2016). Thus far, however only one report from the Nordic Lymphoma Group (NLG) has shown, without an independent validation cohort, that this endpoint can be useful also to predict the long term survival of patients receiving systemic treatment with chemotherapy-free regimens (Lockmer et al. J Clin Oncol 36:3315-3323, 2018). In the present study, we sought to confirm that early progression after first-line treatment is affecting OS also in patients initially treated with immunotherapy only. Methods: In order to determine whether POD24 is associated with inferior OS, we analyzed a pooled dataset of three randomized trials including FL patients with advanced and symptomatic disease conducted between 1998 and 2016 by the Swiss Group for Clinical Cancer Research (SAKK), namely the SAKK35/98 and 35/03 studies, which evaluated different durations of rituximab therapy, and the SAKK 35/10 study, which compared rituximab monotherapy versus rituximab plus lenalidomide in the front-line therapy. OS was calculated from disease progression in patients with POD24 and from 24 months after the start of treatment in the reference group of those without POD24. Results: A total number of 521 FL patients were enrolled in the three SAKK studies, 333 of them had no prior systemic treatment (64 in the SAKK 35/98, 115 in the SAKK 35/03 and all 154 in the SAKK 35/10 studies, respectively) and received front-line therapy with Rituximab alone (n=256) or in combination with lenalidomide (n=77). We excluded 1 patient from the analysis who died without progression within 24 months and 14 other patients who were lost to follow-up without progression within 24 months from treatment start. Hence, the final cohort of this study comprised 318 evaluable patients. POD24 was observed in 85 of 318 (27% [95%-CI: 22, 32]) patients initially treated without chemotherapy. Patients with POD24 showed a trend towards more advanced disease at presentation than the reference group without POD 24: stage IV (55% vs 43%), B-symptoms (26% vs 17%), bulky disease (44% vs 35%), but the differences did not reach the statistical significance. In patients with early POD, median age was 59 years, 42 patients were male (49%) and 43 female (51%), and 20 had elevated LDH (24%). In the reference group of patients without POD24, median age was also 59 years, 97 patients were male (42%) and 136 female (58%), and 48 had elevated LDH (21%). Figure 1 shows the Kaplan-Meier estimates of survival according to POD24. Median survival was not reached in either of the treatment groups. The patients experiencing POD24 had 5- and 10-year OS rates of 69% and 59%, respectively, while in the reference group the 5- and 10-year OS rates were 92% and 77% (HR = 3.12 [1.73, 5.65]; log-rank P < 0.0001). In a multivariable Cox model POD24 predicted poor survival (P=0.0355) across all studies irrespectively of LDH value, presence of B-symptoms or advanced stage. FLIPI score and beta2-microglobulin values were available only in the SAKK 35/10 study and could not be included in the model. Keywords: follicular lymphoma (FL); rituximab. Disclosures: Moccia, A: Consultant Advisory Role: Takeda, Roche, Janssen. Taverna, C: Consultant Advisory Role: Takeda, Celgene, Janssen, AMGEN; Research Funding: Celgene. Kimby, E: Consultant Advisory Role: Roche, Celgene; Honoraria: Roche, Celgene; Research Funding: Roche." @default.
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- W2951512389 date "2019-06-01" @default.
- W2951512389 modified "2023-10-03" @default.
- W2951512389 title "PREDICTIVE VALUE OF POD24 VALIDATION IN FOLLICULAR LYMPHOMA PATIENTS INITIALLY TREATED WITH CHEMOTHERAPY-FREE REGIMENS IN A POOLED ANALYSIS OF THREE RANDOMIZED TRIALS OF THE SWISS GROUP FOR CLINICAL CANCER RESEARCH (SAKK)." @default.
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