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Fast-Track Schedule for Vitamin D3 Substitution in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

2020; Elsevier BV; Volume: 136; Issue: Supplement 1 Linguagem: Inglês

10.1182/blood-2020-134944

1528-0020

Jonas Matthias Jabs, Viola Poeschel, Martin Sökler, Kerstin Habersang, Rolf Mahlberg, Ulrich Keller, Heinz‐Gert Hoeffkes, Andreas Rank, Andreas Viardot, Andreas Neubauer, Marita Ziepert, Bettina Altmann, Stephan Stilgenbauer, Michael Pfreundschuh, Gerhard Held, Joerg Thomas Bittenbring,

Vitamin D Research Studies

Vitamin D deficient patients suffering from diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP have lower overall survival. This especially applies for patients with vitamin D levels ≤8 ng/ml (Bittenbring et al. J Clin Oncol. 2014; 32:3242-8). Vitamin D up to 65 ng/ml may be necessary for optimal efficacy of R-CHOP (Neumann et al. Cancer Immunol Immunother. 2018; 67:1709-18). To study the clinical benefit of vitamin D substitution, we established a fast-track schedule to appropriately substitute patients to these vitamin D levels. The pre-treatment baseline vitamin D level was determined in 99 patients included in the ongoing, randomized, multicenter, phase-III, open-label OPTIMAL>60 trial (NCT01478542) from November 2014 to July 2015. It was intended that patients reach a vitamin D level of 65 ng/ml. We calculated the dose needed using patient weight and baseline vitamin D: IU = 100 x ΔVitD3 x kg body weight (Van Groningen et al. Eur J Endocrinol. 2010; 162:805-11) and substitution started before treatment. Patients received 20.000 IU capsules of vitamin D, split over several days, with a daily maximum of 200.000 IU. Vitamin D level was checked again after substitution and at all restagings. Patients, who did not reach the intended vitamin D level of 65 ng/ml, received a second or third cycle of substitution. Baseline vitamin D level was 17.8±12.7 ng/ml. 14.3% of the patients reached the target value of up to 65 ng/ml after one substitution cycle with a mean dose of 386.000±137.000 IU. The average increase was 27.8 ng/ml, to a mean of 45.6±18.7 ng/ml. After the second substitution cycle with a median dose of 188.000±102.000 IU patients had vitamin D serum levels of 52.6±13.8 ng/ml. After a third substitution with 91.000±56.000 IU mean level of vitamin D was 56.0±9.6 ng/ml. By administering vitamin D in a dosage calculated by the van Groningen formula, we were able to increase the vitamin D level of our patients reliably after 2-3 cycles of substitution. After second and third substitution, a saturation effect was seen. The clinical effect of vitamin D substitution is the subject of the current study and the results are presently pending. The OPTIMAL>60 trial is supported by Amgen, Roche, Acrotech. Disclosures Poeschel: Roche:Other: Travel, Accommodations, Expenses;Amgen:Other: Travel, Accommodations, Expenses;Abbvie:Other: Travel, Accommodations, Expenses.Habersang:Rheinlandklinikum Neuss:Current Employment.Mahlberg:Janssen:Other: Travel, Accommodations, Expenses;Mutterhaus der Borromaeerinnen, Trier:Current Employment;Novartis:Honoraria, Other: Travel, Accommodations, Expenses;Labor Synlab:Ended employment in the past 24 months;Abbvie:Other: Travel, Accommodations, Expenses;Roche:Honoraria;Amgen:Honoraria, Other: Travel, Accommodations, Expenses;Merck:Honoraria, Other: Travel, Accommodations, Expenses.Keller:Janssen-Cilag:Consultancy, Other: Travel, Accommodations, Expenses;Takeda:Consultancy, Other: Travel, Accommodations, Expenses;Celgene:Consultancy, Other: Travel, Accommodations, Expenses;BMS:Consultancy, Other: Travel, Accommodations, Expenses;Roche:Consultancy, Other: Travel, Accommodations, Expenses;Hexal:Consultancy;Novartis:Consultancy;MSD:Consultancy;Pfizer:Consultancy;Astra-Zeneca:Consultancy;Pentixapharm:Consultancy.Viardot:Kite/Gilead:Honoraria, Other: advisory board;Roche:Honoraria, Other: advisory board;Amgen:Honoraria, Other: advisory board;Novartis:Honoraria, Other: advisory board.Stilgenbauer:Novartis:Consultancy, Honoraria, Other, Research Funding;Pharmacyclics:Consultancy, Honoraria, Other, Research Funding;GlaxoSmithKline:Consultancy, Honoraria, Other: travel support, Research Funding;Janssen-Cilag:Consultancy, Honoraria, Other: travel support, Research Funding;Mundipharma:Consultancy, Honoraria, Other, Research Funding;Genzyme:Consultancy, Honoraria, Other: travel support, Research Funding;Genentech:Consultancy, Honoraria, Other: travel support, Research Funding;F. Hoffmann-LaRoche:Consultancy, Honoraria, Other: travel support, Research Funding;Celgene:Consultancy, Honoraria, Other: travel support, Research Funding;Gilead:Consultancy, Honoraria, Other: travel support, Research Funding;AbbVie:Consultancy, Honoraria, Other: travel support, Research Funding;Boehringer-Ingelheim:Consultancy, Honoraria, Other: travel support, Research Funding;Amgen:Consultancy, Honoraria, Other: travel support, Research Funding.Held:Roche:Consultancy, Other: Travel, Accommodations, Expenses, Research Funding;BMS:Consultancy, Other: Travel, Accommodations, Expenses, Research Funding;MSD:Consultancy;Acrotech:Research Funding;Spectrum:Research Funding;Amgen:Research Funding.Bittenbring:Gilead:Honoraria, Other: Travel, Accommodations, Expenses;Bluebird Bio:Honoraria, Other: Travel, Accommodations, Expenses;Roche:Honoraria, Other: Travel, Accommodations, Expenses, Advisory board;Celgene:Honoraria, Other: Travel, Accommodations, Expenses, Advisory Board;Pfizer:Honoraria, Other: Travel, Accommodations, Expenses.