Effect of atorvastatin versus placebo on efficacy in patients with diffuse large B-cell lymphoma receiving R-CHOP

Abstract

STOP-CA was a multicenter, double-blind, randomized, placebo-controlled trial comparing atorvastatin to placebo in treatment-naïve lymphoma patients receiving anthracycline-based chemotherapy. We performed a preplanned subgroup to analyze the impact of atorvastatin on efficacy in patients with diffuse large B-cell lymphoma (DLBCL). Patients received rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) at standard doses for six 21-day cycles and were randomly assigned to receive atorvastatin 40 mg daily (n = 55) or placebo (n = 47) for 12 months. The complete response (CR) rate was numerically higher in the atorvastatin arm (95% [52/55] vs. 85% [40/47], p = .18), but this was not statistically significant. Adverse event rates were similar between the atorvastatin and placebo arms. In summary, atorvastatin did not result in a statistically significant improvement in the CR rate or progression-free survival, but both were numerically improved in the atorvastatin arm. These data warrant further investigation into the potential therapeutic role of atorvastatin added to anthracycline-based chemotherapies.

Keywords:

• Atorvastatin
• R-CHOP
• anthracycline
• diffuse large B-cell lymphoma

Acknowledgements

The authors are grateful to the patients who participated in the STOP-CA trial. This trial was registered at www.clinicaltrials.gov as #NCT02943590. Dr. Soumerai is supported by the National Cancer Institute of the National Institutes of Health [K08CA270202].

Disclosure statement

Ronald Nemec, Robert Redd, Hannah K. Gilman, Terry Ho, Jessica Wu, Julius Heemelaar, Marielle Scherrer-Crosbie, Ephraim P. Hochberg, Jeffrey A. Barnes, Eric D. Jacobsen, and Austin I. Kim report no relevant conflicts of interest. Donna Neuberg Reports stock ownership in Madrigal Pharmaceuticals. Philippe Armand reports receiving consulting fees from Merck, BMS, ADC Therapeutics, GenMab, Enterome, Genentech/Roche, ATB Therapeutics, Foresight, and Regeneron, and research funding from Kite, and research funding paid to institution from Merck, BMS, Adaptive, Genentech, IGM, and Astra Zeneca. Caron Jacobson reports receiving consulting fees from Kite/Gilead, Novartis, BMS/Celgene, ImmPACT Bio, Instill Bio, Caribou Bio, Abintus Bio, Ipsen, Miltenyi, Morphosys, ADC Therapeutics, Abbvie, AstraZeneca, Sana, and Synthekine, and research funding paid to institution from Kite/Gilead and Pfizer. Robb S. Friedman reports receiving consulting fees from AbbVie and Beigene. Ann S. LaCasce reports receiving consulting or personal fees from Research to Practice, Kite Pharma, and Seagen. Tomas G. Neilan reports consulting or personal fees from Bristol Myers Squibb, Genentech, Roche, Sanofi, C4 Therapeutics, CardiolRx, RACE, and CRC Oncology, and receiving grant support from Bristol Myers Squibb, Abbott, and AstraZeneca. Jeremy S. Abramson reports consulting fees from AbbVie, Astra-Zeneca, BeiGene, BMS, Caribou Biosciences, Cellectar, Century Therapeutics, Epizyme, Genentech, Genmab, Incyte, Interius, Janssen, Kite Pharma, Lilly, and Takeda, and research support paid to institution from BMS, Cellectis, Merck, Mustang Bio, and Seagen. Jacob D. Soumerai reports consulting fees from Abbvie, AstraZeneca, Beigene, Bristol Myers Squibb, Roche, Seattle Genetics, and TG Therapeutics, and research funding paid to institution from Adaptive Biotechnologies, Beigene, BostonGene, Genentech/Roche, GlaxoSmithKline, Moderna, Takeda, and TG Therapeutics.

Additional information

Funding

This study was supported by a grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health [R01HL130539] to Drs. Neilan and Scherrer-Crosbie