Phase II trial of a novel chemotherapy regimen CVEP (cyclophosphamide, vinblastine, etoposide and prednisolone) for acquired immunodeficiency syndrome (AIDS)-associated lymphomas.

Abstract

Management of acquired immunodeficiency syndrome (AIDS)-related diffuse large B-cell (DLBCL) and plasmablastic lymphomas (PBL) poses significant challenges. The evidence supports use of dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin) with or without rituximab as first-line therapy. The need for central venous access, growth factors and significant toxicities limits its use in resource-constrained settings. To address these challenges, we have developed a novel regimen, CVEP (cyclophosphamide, vinblastine, etoposide, and prednisolone) based on the pharmacodynamic principles of dose-adjusted EPOCH. This single-centre phase II study evaluated the efficacy and safety of CVEP regimen in patients with de novo systemic AIDS-related DLBCL and PBL. The primary objective was complete response (CR) rates as assessed by positron emission tomography-computed tomography. The secondary objectives were incidence of Grade 3/4 toxicities, toxicities requiring hospitalisation, and disease-free survival. From May 2011 to February 2017, 42 patients were enrolled. At the end of therapy the CR rates were 69% (29/42) in the intention-to-treat population and 80.5% (29/36) in evaluable patients. At a median follow-up of 69 months, the 5-year disease-free survival was 65.3%. Out of 217 cycles administered, febrile neutropenia occurred in 19.3% and hospitalisation was required in 18.3% of cycles. There were two treatment-related deaths. The CVEP regimen is an active and safe regimen for AIDS-related DLBCL and PBL.

• Authors: Manju Sengar, Hasmukh Jain, Tanuja Shet, Epari Sridhar, Vikram Gota, Venkatesh Rangarajan, Siddhartha S Laskar, Aruna Alahari, Jayashree Thorat, Archi Agarwal, Neha Sharma, Himanshi Gupta, Sadhana Kannan, Shikhar Kumar, Lingaraj Nayak, Hari Menon, Sumeet Gujral, Bhausaheb Bagal
• Journal: British journal of haematology (Br J Haematol) Vol. 200 Issue 4 Pg. 429-439 (02 2023) ISSN: 1365-2141 [Electronic] England
• PMID: 36323643 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2022 British Society for Haematology and John Wiley & Sons Ltd.

Chemical References

• Etoposide
• Vinblastine
• Prednisolone
• Cyclophosphamide
• Prednisone
• Vincristine
• Doxorubicin

Topics

• Humans
• Etoposide (adverse effects)
• Vinblastine (adverse effects)
• Acquired Immunodeficiency Syndrome (drug therapy)
• Prednisolone (adverse effects)
• Lymphoma, Large B-Cell, Diffuse
• Cyclophosphamide (adverse effects)
• Prednisone (therapeutic use)
• Vincristine (adverse effects)
• Doxorubicin (adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)