Impact of prior intravesical bacillus Calmette-Guerin therapy on the effectiveness of pembrolizumab for patients with metastatic urothelial carcinoma,Urologic Oncology: Seminars and Original Investigations

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Impact of prior intravesical bacillus Calmette-Guerin therapy on the effectiveness of pembrolizumab for patients with metastatic urothelial carcinoma
Urologic Oncology: Seminars and Original Investigations ( IF 2.4 ) Pub Date : 2021-08-26 , DOI: 10.1016/j.urolonc.2021.08.002
Rikiya Taoka ₁ , Takashi Kobayashi ₂ , Yu Hidaka ₃ , Hiroyasu Abe ₃ , Katsuhiro Ito ₄ , Takahiro Kojima ₅ , Minoru Kato ₆ , Souhei Kanda ₇ , Shingo Hatakeyama ₈ , Yoshiyuki Matsui ₉ , Yuto Matsushita ₁₀ , Sei Naito ₁₁ , Masanobu Shiga ₅ , Makito Miyake ₁₂ , Yusuke Muro ₁₃ , Shotaro Nakanishi ₁₄ , Yoichiro Kato ₁₅ , Tadamasa Shibuya ₁₆ , Tetsutaro Hayashi ₁₇ , Hiroaki Yasumoto ₁₈ , Takashi Yoshida ₁₉ , Motohide Uemura ₂₀ , Manabu Kamiyama ₂₁ , Satoshi Morita ₃ , Osamu Ogawa ₂ , Hiroyuki Nishiyama ₅ , Hiroshi Kitamura ₂₂ , Mikio Sugimoto ₁ ,

Affiliation

Department of Urology, Kagawa University, Kita, Japan.
Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Department of Urology, Ijinkai Takeda General Hospital, Kyoto, Japan.
Department of Urology, University of Tsukuba, Tsukuba, Japan.
Department of Urology, Osaka City University, Osaka, Japan.
Department of Urology, Akita University, Akita, Japan.
Department of Urology, Hirosaki University, Hirosaki, Japan.
Department of Urology, National Cancer Center Hospital, Tokyo, Japan.
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan.
Department of Urology, Nara Medical University, Kashihara, Japan.
Department of Urology, Shizuoka General Hospital, Shizuoka, Japan.
Department of Urology, University of the Ryukyus, Nishihara, Japan.
Department of Urology, Iwate Medical University, Morioka, Japan.
Department of Urology, Oita University, Yufu, Japan.
Department of Urology, Hiroshima University, Hiroshima, Japan.
Department of Urology, Shimane University, Izumo, Japan.
Department of Urology, Kansai Medical University, Hirakata, Japan.
Department of Urology, Osaka University, Suita, Japan.
Department of Urology, University of Yamanashi, Chuo, Japan.
Department of Urology, University of Toyama, Toyama, Japan.

Objective

The aim of this study was to determine whether a history of treatment for non-muscle invasive bladder cancer (NMIBC), including intravesical bacillus Calmette-Guerin (BCG) therapy, affects the treatment outcomes of pembrolizumab in patients with metastatic, chemo-resistant urothelial carcinoma (UC).

Materials and methods

The clinicopathological data of 755 patients with metastatic, chemo-resistant UC who received pembrolizumab were retrospectively reviewed. Best overall response and overall survival (OS) from the initiation of pembrolizumab were analyzed with regard to the history of NMIBC treatment and BCG usage using propensity score matching (PSM).

Results

A total of 155 (20.5%) patients had a history of NMIBC treatment, of which 97 (12.8%) had received intravesical BCG therapy. When compared to patients without a NMIBC history (median 10.0 months), the OS from the initiation of pembrolizumab for patients with a NMIBC history (13.3 months, HR [95% CI] 0.79 [0.62–1.02], P = 0.073), those with a NMIBC history and BCG (12.1 months, HR 0.87 [0.64–1.17], P = 0.356), or those with a NMIBC history but not BCG (14.5 months, HR 0.68 [0.45–1.12], P = 0.061) were not significantly different. This tendency was robust after 1:1 or 1:2 PSMs. The objective response rate (ORR, 24.5% vs. 31.0%, P = 0.222) and disease control rate (DCR, 56.1% vs. 52.1%, P = 0.501) of the 155 patients with an NMIBC history did not differ from those of 155 matched patients without an NMIBC history. Among those with an NMIBC history, the prior use of BCG did not affect OS (with vs. without BCG, 12.1 vs. 14.5 months, HR 1.29 [0.80–2.09], P = 0.295), ORR (24.5% vs. 34.0%, P = 0.298) or DCR (57.1% vs. 56.0%, P = 0.908). The ORR in BCG-treated patients was significantly lower than that in those without a NMIBC history (19.8% vs. 33.3%, P = 0.042), whereas DCR between the 2 groups did not differ significantly (55.8% vs. 54.4%, P = 0.855).

Conclusions

Our risk-adjusted analyses revealed that a history of prior NMIBC treatment, including intravesical BCG therapy, did not affect the treatment outcomes of pembrolizumab in metastatic UC patients.

中文翻译：

既往膀胱内卡介苗治疗对帕博利珠单抗治疗转移性尿路上皮癌患者疗效的影响

客观的

本研究的目的是确定非肌层浸润性膀胱癌 (NMIBC) 的治疗史，包括膀胱内卡介苗 (BCG) 治疗，是否会影响 pembrolizumab 在转移性、化疗耐药性尿路上皮癌患者中的治疗结果癌（UC）。

材料和方法

回顾性分析了 755 例接受帕博利珠单抗治疗的转移性、耐药性 UC 患者的临床病理资料。使用倾向评分匹配 (PSM) 就 NMIBC 治疗历史和 BCG 使用情况分析了从 pembrolizumab 开始的最佳总体反应和总体生存期 (OS)。

结果

共有155名（20.5%）患者有NMIBC治疗史，其中97名（12.8%）接受过膀胱内卡介苗治疗。与没有 NMIBC 病史的患者（中位 10.0 个月）相比，有 NMIBC 病史的患者从开始使用派姆单抗开始的 OS（13.3 个月，HR [95% CI] 0.79 [0.62–1.02]，P  = 0.073），那些有 NMIBC 病史和 BCG（12.1 个月，HR 0.87 [0.64–1.17]，P  = 0.356），或有 NMIBC 病史但没有 BCG 的患者（14.5 个月，HR 0.68 [0.45–1.12]，P  = 0.061）没有明显不同。这种趋势在 1:1 或 1:2 PSM 后表现强劲。客观缓解率 (ORR, 24.5% vs. 31.0%, P  = 0.222) 和疾病控制率 (DCR, 56.1% vs. 52.1%, P = 0.501) 的 155 名有 NMIBC 病史的患者与 155 名没有 NMIBC 病史的匹配患者没有差异。在有 NMIBC 病史的患者中，先前使用 BCG 不影响 OS（有与无 BCG，12.1 与 14.5 个月，HR 1.29 [0.80-2.09]，P  = 0.295），ORR（24.5% 与 34.0% , P  = 0.298) 或 DCR (57.1% 对 56.0%, P  = 0.908)。BCG 治疗患者的 ORR 显着低于没有 NMIBC 病史的患者（19.8% vs. 33.3%，P  = 0.042），而两组之间的 DCR 没有显着差异（55.8% vs. 54.4%，P  = 0.855)。