Observational studyInternational journal of hematology2026
Preliminary analysis of a multicenter study of Pola-R-CHP in untreated Japanese patients with DLBCL (POLASTAR).
Observational study in International journal of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03274492 (A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP), which is not on this map. Cited by 1 paper.
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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
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1 citing paper in PubMed.
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Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) was approved in Japan for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) in 2022, based on findings of the POLARIX study (NCT03274492). Reports on real-world usage of Pola-R-CHP are lacking. Here we report safety and response rates at end of treatment (EOT) for Pola-R-CHP in Japan from the real-world observational POLASTAR study (jRCT1071220082). Patients (≥ 18 years) with previously untreated DLBCL who were scheduled to receive Pola-R-CHP were enrolled. The primary endpoint was overall survival. As of December 20, 2023, the full analysis set (FAS) included 192 of the initial 199 patients enrolled. Median age was 71.0 years (range 30-91). In the FAS, 99 (51.6%) patients had Grade ≥ 3 adverse events (AEs), 29 (15.1%) had serious AEs, and 15 (7.8%) discontinued polatuzumab vedotin due to AEs. In the efficacy-evaluable population at EOT (n = 141), the overall response rate was 95.0% [95% confidence interval (CI), 90.1-97.6], and the complete response rate was 87.9% (95% CI, 81.5-92.3). These results are consistent with published data from POLARIX. The POLASTAR study is ongoing; the recruitment target of 500 patients has been reached.Clinical trial registration: Japan Registry of Clinical Trials (jRCT1071220082).
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