Efficacy and Safety of Polatuzumab-Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin and Prednisone (Pola-R-CHP) for Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): A Real-World, Multi-Center, Retrospective Cohort Study
Year: 2024
Type: conference-abstract
Abstract: Introduction In the POLARIX study, Pola-R-CHP showed significant improvement in progression free survival (PFS) in previously untreated DLBCL compared to R-CHOP. Pola-R-CHP was approved for previously untreated DLBCL in China, However, there are still few reports about the efficacy and safety of Pola-R-CHP in real-world setting, leaving some questions about the optimal patient population for Pola-R-CHP. Therefore, we conducted this retrospective observational study to compare the efficacy and safety of Pola-R-CHP with R-CHOP in clinical practice. Methods The Pola-R-CHP group included previously untreated DLBCL patients who received Pola-R-CHP therapy from April 2023 to May 2024 across 5 medical centers in China. The control group included previously untreated DLBCL patients treated with R-CHOP from January 2022 to May 2024. Patients treated with Pola-R-CHP were matched by propensity scores with those treated with R-CHOP. The primary endpoint was the overall response rate (ORR) and complete response rate (CRR) at the end of treatment, and secondary endpoints were 6-month and 12-month PFS, 6-month and 12-month overall survival (OS), and severity and frequency of adverse events (AE). Results A total of 600 patients were identified, of whom 131 patients received Pola-R-CHP and 469 patients received R-CHOP. The baseline features were well balanced using a 1:2 propensity score matching method, and a total of 115 patient pairs were obtained for further survival and prognosis analysis. The ORR was 91.3% and CRR was 82.6% for patients treated with Pola-R-CHP, while 76.1% and 66.5% for patients treated with R-CHOP, respectively (P＜0.005 for both ORR and CRR comparisons). For patients treated with Pola-R-CHP, different gene mutation subgroup has different results: for double-expresser group, the CRR was 89.1% and the ORR was 93.5% ; for EZB group, the CRR was 93.3% and the ORR was 93.3%; for MCD group, the CRR was 77.3% and the ORR was 86.4%; for Non-GCB group, the CRR was 86.3% and the ORR was 94.5%；for TP53 mutation group, the CRR was 66.7% and the ORR was 85.2%. After a median follow-up of 8.53 months, the 6-month PFS was 91.3% for Pola-R-CHP and 73.4% for R-CHOP (hazard ratio (HR) = 0.305; 95% confidence interval (Cl), 0.157-0.596; P= 0.0005), the 12-month PFS was 90.1% for Pola-R-CHP and 68.1% for R-CHOP (HR= 0.297; 95% CI, 0.157-0.560; P= 0.0002). Kaplan-Meier analysis showed statistically significant improvements in PFS and OS in patients with Pola-R-CHP compared to R-CHOP (log-rank test, P= 0.0005 and P＜0.0001 for 6-month and 12-month PFS; P= 0.0002 and P＜0.0001 for 6-month and 12-month OS, respectively). Notably, subgroups analysis indicated that patients with age >= 60 yrs, males, Ann Arbor stage of III-IV, without B symptoms, International Prognostic Index (IPI) of 4-5, elevated β2-microglobulin levels, extranodal involvement＞2, elevated lactate dehydrogenase (LDH) levels and Ki67 expression >= 80%, had a significantly higher ORR, CRR, 6-month and 12-month PFS in the Pola-R-CHP group compared to R-CHOP group. Safety was comparable between Pola-R-CHP and R-CHOP, including rates of grade 3 to 4 AE. The most common AE was hematological toxicity. Lymphopenia, anemia, neutropenia, and thrombocytopenia at grade 3-4 was observed in 66.41% vs 69.08%, 6.11% vs 6.18%, 7.63% vs 6.82%, and 7.63% vs 9.38% respectively in Pola-R-CHP and R-CHOP with no significant difference. In terms of non-hematologic toxicity, many cases were complicated with constipation (32.82% vs 29.42%), fatigue (22.90% vs 26.44%), ALT/AST elevation (22.14% vs 26.65%), diarrhea (19.85% vs 22.60%) and peripheral neuropathy (15.27% vs 14.29%), but only a few were grade 3-4. Prophylactic PEG-G-CSF administration was given in most of the cases. No deaths due to AE were observed. Unexpected adverse events were not observed. Conclusion In this study, patients treated with Pola-R-CHP had better treatment response, PFS, OS and controlled toxicity compared with those received R-CHOP in the real-world setting. And safety profiles were similar to POLARIX study. These findings demonstrate that Pola-R-CHP is well tolerated and the efficacy can be promising compared to R-CHOP.
Source: Blood
Institutions: Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, Fourth Hospital of Hebei Medical University, Fujian Provincial Cancer Hospital, Qingdao University, Yuhuangding Hospital, Fujian Medical University
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4405041666