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Randomized Controlled Trial
. 2019 Apr;8(4):1401-1405.
doi: 10.1002/cam4.1980. Epub 2019 Mar 19.

Rituximab maintenance overcomes the negative prognostic factor of obesity in CLL: Subgroup analysis of the international randomized AGMT CLL-8a mabtenance trial

Alexander Egle  1   2   3 , Thomas Melchardt  1   2   3 , Petra Obrtlíková  4 , Lukáš Smolej  5 , Tomáš Kozák  6 , Michael Steurer  7 , Johannes Andel  8 , Sonja Burgstaller  9 , Eva Mikušková  10 , Liana Gercheva  11 , Thomas Nösslinger  12 , Tomáš Papajík  13 , Miriam Ladická  14 , Michael Girschikofsky  15 , Mikuláš Hrubiško  16 , Ulrich Jäger  17 , Daniela Voskova  18 , Martin Pecherstorfer  19 , Eva Králiková  20 , Christina Burcoveanu  21 , Emil Spasov  22 , Andreas Petzer  23 , Georgi Mihaylov  24 , Julian Raynov  25 , Horst Oexle  26 , August Zabernigg  27 , Emília Flochová  28 , Stanislav Palášthy  29 , Olga Stehlíková  30 , Michael Doubek  30 , Petra Altenhofer  1   2   3 , Lukas Weiss  1   2   3 , Teresa Magnes  1   2   3 , Lisa Pleyer  1   2   3 , Anton Klingler  31 , Jiří Mayer  30 , Richard Greil  1   2   3
Affiliations
Randomized Controlled Trial

Rituximab maintenance overcomes the negative prognostic factor of obesity in CLL: Subgroup analysis of the international randomized AGMT CLL-8a mabtenance trial

Alexander Egle et al. Cancer Med. 2019 Apr.

Abstract

No data are available regarding obesity and outcome in Chronic Lymphocytic Leukemia (CLL). We analyzed 263 patients from the AGMT CLL-8a Mabtenance trial for the impact of obesity. The trial included patients after rituximab-containing induction treatment in first or second line that had achieved at least a PR. A randomization to rituximab maintenance treatment (375 mg/m2 q3 months for 2 years) vs observation was performed. In this cohort 22% of the patients (58/263) were classified as obese. The baseline response to induction treatment was inferior in obese patients with a lower CR rate (43.1% vs 60.5% in obese vs non-obese, P = 0.018) and with a lower rate of patients achieving MRD negativity after chemoimmunotherapy induction treatment (19.6% vs 35.8%, P = 0.02). The PFS outcome of obese patients was significantly worse in the observation group of the trial (24 vs 39 months median PFS, P = 0.03). However, in the rituximab maintenance group the outcome for obese vs non-obese was not different (P = 0.4). In summary, obesity was overall associated with a worse outcome of chemoimmunotherapy induction. However, rituximab maintenance treatment seems to be able to overcome this negative effect.

Keywords: BMI; CLL; maintenance; obesity; rituximab.

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Conflict of interest statement

SB receives support from Roche. AE receives grants and personal fees from Roche. RG receives grants and personal fees from Roche and Takeda, grants from Celgene and Novartis and personal fees from BMS and Amgen. MH receives personal fees from the Czech Lymphoma Study Group, and other support from Roche. TK receives other support from Roche. UJ receives grants and personal fees from Roche. AK receives personal fees from AGMT, Hoffmann‐La Roche, the Central European Society for Anticancer Drug Research and Arbeitsgemeinschaft Internistische Onkologie. JM receives other support from Roche, GlaxoSmithKline and Novartis. HO receives personal fees from Sanofi‐Aventis, Amgen and Celgene. PO receives grants from Roche, nonfinancial support from Janssen and Roche, and personal fees from GlaxoSmithKline and Gilead. AP receives personal fees from Roche. TP receives personal fees from Roche. LS receives personal fees from Abbvie, and personal fees and nonfinancial support from Gilead, Janssen and Roche. MS receives grants and personal fees from Roche. JA, PA, CB, MD, EF, LG, MG, EK, ML, EM, GM, Te.M., Th.M., TN, LP, MP, SP, JR, ES, OS, DV, LW and AZ declare no competing interests.

Figures

Figure 1
Figure 1
Progression‐free survival in the ITT population according to treatment and BMI. The median progression‐free survival was not influenced by obesity in patients treated with rituximab maintenance (median PFS 35.5 months vs not reached, HR: 0.75, CI: 0.38‐1.47, P = 0.41). In patients randomized to observation, obesity was associated with a worse median progression‐free survival (median PFS 23.6 vs 38.4 months, HR: 0.55, CI: 0.31‐0.97, P = 0.042)
See this image and copyright information in PMC

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