Polivy▼ and Use of Methotrexate for Central Nervous System Prophylaxis in Patients with Previously Untreated Diffuse Large B-cell Lymphoma
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This article responds to your request for information on the use of methotrexate for CNS prophylaxis in patients with previously untreated DLBCL receiving treatment with Polivy® (polatuzumab vedotin). This response was developed according to the principles of evidence-based medicine and contains data from clinical trials.
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Last updated September 08, 2023
Summary
- There is no recommendation on treatment for CNS prophylaxis for patients on Polivy.
- In the Phase 3 POLARIX study patients in both arms could receive IT CNS prophylaxis, but high-dose IV MTX was not allowed and was considered a new anti-lymphoma therapy.
- There is no real world evidence of use of high-dose MTX for CNS prophylaxis in patients receiving Polivy.
Abbreviations
CNS=central nervous system
DLBCL=diffuse large B-cell lymphomaIT=intrathecal
IV=intravenous
MTX=methotrexate
R-CHP=rituximab, cyclophosphamide, doxorubicin, and prednisone
R-CHOP = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
CNS prophylaxis for patients on Polivy
There is no recommendation on treatment for CNS prophylaxis for patients on Polivy.[1]
CNS prophylaxis in the POLARIX study in patients with previously untreated DLBCL
The Phase 3 POLARIX study compared Polivy-R-CHP versus R-CHOP in patients with previously untreated DLBCL.[2]
In this study, patients in both arms could receive IT CNS prophylaxis, per institutional practice. High-dose IV MTX (e.g. 1 g/m² per cycle) was not allowed and was considered a new anti-lymphoma therapy.[3]
Patients who received CNS prophylaxis
In the Polivy-R-CHP group, 72 patients (16.4%) and in the R-CHOP group 86 patients (19.6%) received CNS prophylaxis.[4] CNS prophylaxis included any IT administration of MTX, cytarabine, or corticosteroid.[4]
Some patients in the Polivy-R-CHP arm received MTX as a concomitant treatment during the study treatment period or during the follow-up period. It was not specified how many of these patients received IT MTX for CNS prophylaxis.[5]
Case reports of high-dose MTX for CNS prophylaxis
There is no real world evidence of use of high-dose MTX for CNS prophylaxis in patients receiving Polivy.
References
- Roche Internal Regulatory Document (Accessed on July 25, 2023).
- Tilly H, Morschhauser F, Sehn L, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med 2022;386:351-363. https://www.ncbi.nlm.nih.gov/pubmed/34904799
- Protocol for Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. Available at https://www.nejm.org/doi/suppl/10.1056/NEJMoa2115304/suppl_file/nejmoa2115304_protocol.pdf. Accessed on July 25, 2023.
- The New England Journal of Medicine. Table S2 in Supplementary Appendix of Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. January 27, 2023. Available at https://www.nejm.org/doi/suppl/10.1056/NEJMoa2115304/suppl_file/nejmoa2115304_appendix.pdf. Accessed on July 25, 2023.
- Roche Internal Clinical Study Report (Accessed on July 25, 2023).
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