Prognostic Impact of Clostridium butyricum MIYAIRI (CBM588) in Combination With Pembrolizumab for Advanced Urothelial Carcinoma: A Retrospective Cohort Study

IF 1.9 Q4 ONCOLOGY

Cancer reports Pub Date : 2025-08-05 DOI:10.1002/cnr2.70308

Junya Arima, Hirofumi Yoshino, Shuichi Tatarano, Akihiko Mitsuke, Yoichi Osako, Takashi Sakaguchi, Ryosuke Matsushita, Satoru Inoguchi, Yasutoshi Yamada, Hideki Enokida

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Abstract

Background

Combining the probiotic product CBM588 with immune checkpoint inhibitors (ICIs) has shown improved prognosis in several cancers. Pembrolizumab alone as a second-line treatment for urothelial cancer (UC) extends prognosis by only 3 months.

Aims

This is a retrospective study that examined the effects of CBM588 combined with pembrolizumab in advanced UC.

Methods and Results

The study included 44 patients who had recurrence or progression after first-line chemotherapy with cisplatin or carboplatin. The study compared 33 patients treated with pembrolizumab alone and 11 patients treated with CBM588 plus pembrolizumab over a median observation period of 12 months. The combination of CBM588 and pembrolizumab significantly improved progression-free survival (PFS; p = 0.004) and overall survival (OS; p = 0.02). Multivariate analysis identified CBM588 as a significant prognostic factor for both PFS (hazard ratio: 0.074, p = 0.0008) and OS (hazard ratio: 0.105, p = 0.0056).

Conclusion

These results suggest the effectiveness of the CBM588 combination with ICI treatment in UC.

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丁酸梭菌MIYAIRI （CBM588）联合派姆单抗治疗晚期尿路上皮癌的预后影响：一项回顾性队列研究

背景益生菌产品CBM588与免疫检查点抑制剂（ICIs）联合使用可改善几种癌症的预后。单独使用派姆单抗作为尿路上皮癌（UC）的二线治疗，预后仅延长3个月。这是一项回顾性研究，旨在研究CBM588联合派姆单抗治疗晚期UC的疗效。方法与结果本研究纳入44例一线顺铂或卡铂化疗后出现复发或进展的患者。该研究比较了33例单独使用派姆单抗治疗的患者和11例使用CBM588加派姆单抗治疗的患者，中位观察期为12个月。CBM588联合派姆单抗显著改善无进展生存期(PFS；p = 0.004)和总生存期(OS；P = 0.02)。多因素分析发现CBM588是PFS（风险比：0.074,p = 0.0008）和OS（风险比：0.105,p = 0.0056）的重要预后因素。结论CBM588联合ICI治疗UC疗效确切。

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