R-Cmop in Elderly Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: A Multicenter, Prospective Study

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Backgroud: The R-CHOP regimen is considered standard of care for patients (pts) with Diffuse Large B-cell Lymphoma (DLBCL). Older pts with DLBCL have a worse outcome than corresponding younger pts. In particular, the elderly population often exhibit an intolerance to the cardiac toxicities caused by anthracycline drugs. For this reason, alternative effective treatment modalities with less toxicity are required in the elderly population. A previous study (DOI:10.1007/s10637-021-01182-7.) found that the incidence of cTnT elevation was much lower in the mitoxantrone hydrochloride liposome (Lipo-MIT) group than in the mitoxantrone group (3.3% vs. 36.7%), indicating better cardiac safety with Lipo-MIT. Therefore, we investigate the clinical outcomes of using Lipo-MIT instead of traditional anthracycline drugs in elderly population. This exploratory study was designed to evaluate the effectiveness and safety of combining Lipo-MIT with rituximab, cyclophosphamide, vincristine and prednisone (R-CMOP) in newly diagnosed DLBCL pts aged 60 years or older (ChiCTR2300078813). Methods: The study enrolled pts (≥60 years old) newly diagnosed with DLBCL. Pts were required to have at least one evaluable or measurable lesion that met the Lugano 2014 criteria. Eligible patients received the R-CMOP regimen every 21 days for up to 6-8 cycles, consisting of rituximab (375mg/m2 on day 0), cyclophosphamide (750mg/m2 on day 1), Lipo-MIT (18mg/m2 on day 1), vincristine (1.4mg/m2, maximum dose 2 mg on day 1) and prednisone (100mg on days 1-5) for pts aged 60-80 years, while rituximab (375mg/m2 on day 0), cyclophosphamide (400mg/m2 on day 1), Lipo-MIT 12mg/m2 on day 1), vincristine (1mg on day 1) and prednisone (40 mg/m2 on days 1-5) for pts aged 80 years or older. The primary endpoint was the objective response rate (ORR), and secondary endpoints included complete response (CR) rate, progression-free survival (PFS), overall survival rate (OS), and safety assessment according to the NCI-CTCAE v5.0. Results: From May 20, 2022 to July 13, 2024, a total of 17 pts with newly diagnosed DLBCL were enrolled in the study. The median age of all pts was 71 years (range 61-80), with 5 (29.4%) being male. Among these pts, 11 (64.7%) were nGCB subtype and 5 (29.4%) were GCB subtype. 12 pts (70.6%) were classified as stage disease III-IV, and 14 pts (82.4%) had an IPI score of 3-5. All pts showed normal cardiac function and were classified as fit according to their CGA results. Additionally, two pts (11.8%) had B symptoms at diagnosis and none of the pts had central nervous system invasion. By the end of the statistical analysis, 14 pts were assessed for efficacy with a median of 4 cycles (range 1-8), all of whom achieved an objective response, leading to an ORR of 100%. Futhermore, 9 pts (64.3%) achieved a complete response after treatments. PFS and OS data are still too early and will be reported after a long-term follow-up. Common grade 3/4 treatment-related adverse events (TRAEs) included leucopenia (41.2%), lymphocyte count decreased (35.3%), neutropenia (29.4%), anemia (11.8%), pulmonary infection (11.8%), and upper respiratory tract infection (11.8%). Importantly, no cardiac toxicities were reported during this study. Conclusion: The R-CMOP regimen has demonstrated inspiring efficacy in newly diagnosed DLBCL pts aged 60 years or older with a manageable safety profile. Subsequent research will focus on expanding the clinical cohort and confirming its clinical significance.

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