Preliminary analysis of a multicenter study of Pola-R-CHP in untreated Japanese patients with DLBCL (POLASTAR)

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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Journal
International Journal of Hematology
Published
2025-12-03
DOI
https://doi.org/10.1007/s12185-025-04122-w
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00

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article

Preliminary analysis of a multicenter study of Pola-R-CHP in untreated Japanese patients with DLBCL (POLASTAR)

Ritsuro Suzuki, Shinya Rai, Hideki Goto, Itaru Matsumura et al.
International Journal of Hematology
Lymphoma Diagnosis and Treatment
article

Preliminary analysis of a multicenter study of Pola-R-CHP in untreated Japanese patients with DLBCL (POLASTAR)

Ritsuro Suzuki, Shinya Rai, Hideki Goto, Itaru Matsumura, Shuichi Ota, Tsuyoshi Muta, Koji Izutsu, Hisashi Tsurumi, Kohta Miyawaki, Takayuki Shimose, Koji Kato, Takahiro Kumode, Noriko Fukuhara, Hirohiko Shibayama, Momoko Nishikori, Daisuke Ennishi, Atsushi� Satake, Yuki Fujiwara, Yasuhiro Nagate, Mamiko Sakata-Yanagimoto, Naoki Inubashiri, Akashi Koichi, Takaaki Miyake
article en

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).

International Journal of HematologyVol. 123(3)
Kansai Medical University (JP), Kyushu University (JP), University of Tsukuba (JP), Tohoku University (JP), Japanese Red Cross Hiroshima College of Nursing (JP), Kyushu Economic Research Center (JP), Osaka National Hospital (JP), Okayama University Hospital (JP), Matsunami General Hospital (JP), Sapporo Hokuyu Hospital (JP), Shimane Prefectural Central Hospital (JP), Himeji Red Cross Hospital (JP), Hokkaido University Hospital (JP), Shimane University Hospital (JP), Kyoto University Hospital (JP), Tokyo National Hospital (JP), Kindai University (JP)
Chugai Pharmaceutical
Openalex Percentile: Top 48%
Lymphoma Diagnosis and Treatment
DOIOpen Access PDFOpenAlex
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