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Nivolumab in Relapsed or Refractory Primary Central Nervous System Lymphoma: Multicenter, Retrospective Study
Jun Ho Yi, Seok Jin Kim, Sang-A Kim, Jongheon Jung, Dok Hyun Yoon
Received June 5, 2024  Accepted August 14, 2024  Published online August 16, 2024  
DOI: https://doi.org/10.4143/crt.2024.531    [Epub ahead of print]
AbstractAbstract PDFPubReaderePub
Purpose
Given that 40%-50% of primary central nervous system lymphoma (PCNSL) tissues exhibit aberrancy on 9p24.1, immune checkpoint inhibitors (ICI) may work for the disease.
Materials and Methods
To define the role of ICIs in PCNSL, we carried out a nationwide retrospect analysis for 22 patients who had been treated with nivolumab monotherapy for relapsed or refractory PCNSL.
Results
The median age at diagnosis was 66, and male: female ratio was 1:1. Patients received nivolumab after a median of 3 lines (range, 2 to 6) of therapy and at the median age of 67 years (range, 37 to 82 years). Eleven patients (50%) were refractory to the last treatment prior to nivolumab. With a median follow-up duration of 22.3 months (95% confidence interval [CI], 13.1 to 31.5), nine patients (41%) had an objective response (6 complete responses, 3 partial responses), and the median duration of response was 20.9 months (95% CI, 1.7 to 40.0). The median progression-free survival and overall survival were 2.1 months (95% CI, 0.2 to 4.0) and 18.9 months (95% CI, 5.0 to 32.8), respectively. Nivolumab was generally well-tolerated as no patients required dose reduction and only two patients required delay of treatment.
Conclusion
Our study suggests that nivolumab can be a reasonable option with the durable response for RR PCNSL.
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Gastrointestinal cancer
Neoadjuvant Nivolumab Therapy for Esophageal Squamous Cell Carcinoma: A Single-Arm, Phase II Study
Sehhoon Park, Yurimi Lee, Jiyun Lee, Yang Won Min, Hong Kwan Kim, Joon Young Choi, Hyun Ae Jung, Yong Soo Choi, Yoon-La Choi, Young Mog Shim, Jong-Mu Sun
Cancer Res Treat. 2024;56(2):567-579.   Published online October 16, 2023
DOI: https://doi.org/10.4143/crt.2023.897
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Programmed death-1/programmed death-ligand 1 (PD-L1) inhibitors have shown efficacy in metastatic esophageal squamous cell carcinoma (ESCC) therapy. However, data is still limited regarding neoadjuvant immunotherapy for operable ESCC.
Materials and Methods
Patients with clinical stage T2 or T3 and N0 ESCC received three cycles of nivolumab therapy every two weeks before surgical resection. The primary endpoint is major pathologic responses (MPR) rate (≤ 10% of residual viable tumor [RVT]).
Results
Total 20 patients completed the planned nivolumab therapy. Among them, 17 patients underwent surgery as protocol, showing MPR in two patients (MPR rate, 11.8%), including one pathologic complete response, on conventional pathologic response evaluation. Pathologic response was re-evaluated using the immune-related pathologic response criteria based on immune-related RVT (irRVT). Three patients were classified as immunologic major pathologic response (iMPR; ≤ 10% irRVT, iMPR rate: 17.6%), five as pathologic partial response (> 10% and < 90% irRVT), and nine as pathologic nonresponse (≥ 90% irRVT). The combined positive score (CPS) for PD-L1 in the baseline samples was predictable for iMPR, with the probability as 37.5% in CPS ≥ 10 (3/8) and 0% in CPS < 10 (0/9).
Conclusion
Although the efficacy of neoadjuvant nivolumab therapy was modest in unselected ESCC patients, further researches on neoadjuvant immunotherapy are necessary in patients with PD-L1 expressed ESCC.
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Genitourinary cancer
Neoadjuvant Nivolumab Plus Gemcitabine/Cisplatin Chemotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder
Hongsik Kim, Byong Chang Jeong, Joohyun Hong, Ghee Young Kwon, Chan Kyo Kim, Won Park, Hongryull Pyo, Wan Song, Hyun Hwan Sung, Jung Yong Hong, Se Hoon Park
Cancer Res Treat. 2023;55(2):636-642.   Published online October 6, 2022
DOI: https://doi.org/10.4143/crt.2022.343
AbstractAbstract PDFPubReaderePub
Purpose
The activity and safety of neoadjuvant nivolumab plus gemcitabine/cisplatin (N+GC) were tested in patients with muscle-invasive bladder urothelial carcinoma (MIBC).
Materials and Methods
In a prospective phase II trial, patients with cT2-T4a N0 MIBC who were eligible for cisplatin and medically appropriate to undergo radical cystectomy (RC) were enrolled. Treatment with nivolumab 3 mg/kg on days 1 and 15 plus GC (cisplatin 70 mg/m2 on day 1, and gemcitabine 1,000 mg/m2 on days 1, 8, and 15) was repeated every 28 days up to 3 or 4 cycles, depending on the surgery schedules. The primary endpoint was pathologic complete response (pCR, ypT0). Secondary endpoints included pathologic downstaging (≤ ypT1), disease-free survival (DFS), and safety.
Results
Between September 2019 and October 2020, 51 patients were enrolled. Neoadjuvant N+GC was well tolerated. Among 49 patients who completed neoadjuvant N+GC, clinical complete response (cCR) was achieved in 59% of intent-to-treat (ITT) population. RC was performed in 34 (69%) patients. pCR was achieved in 24% (12/49) of ITT population and 35% (12/34) of RC patients. Median DFS was not reached. Over a median follow-up of 24 months, 12 patients experienced disease recurrence and were treated with palliative therapy or surgery. Although 12 patients declined surgery and were treated with concurrent chemoradiotherapy, DFS was longer in patients with cCR after neoadjuvant therapy than those without. Preoperative programmed death-ligand 1 (PD-L1) did not correlate with pCR or pathologic downstaging rates.
Conclusion
Neoadjuvant N+GC was feasible and provided meaningful pathologic responses in patients with MIBC, regardless of baseline PD-L1 expression (ONO-4538-X41; CRIS.nih.go.kr, KCT0003804).

Citations

Citations to this article as recorded by  
  • Evaluating Neoadjuvant Immunochemotherapeutic Response for Bladder Carcinoma Using Amide Proton Transfer-Weighted MRI
    Lingmin Kong, Bei Weng, Qian Cai, Ling Ma, Wenxin Cao, Yanling Chen, Long Qian, Yan Guo, Junxing Chen, Huanjun Wang
    Academic Radiology.2025;[Epub]     CrossRef
  • Current and Future Role of Circulating DNA in the Diagnosis and Management of Urothelial Carcinoma
    Joaquim Bellmunt, Brian M. Russell, Bernadett Szabados, Begoña P. Valderrama, Rosa Nadal
    American Society of Clinical Oncology Educational Book.2025;[Epub]     CrossRef
  • Efficacy and safety of neoadjuvant PD-1 inhibitors or PD-L1 inhibitors for muscle invasive bladder cancer: a systematic review and meta-analysis
    Shibo Huang, Yanping Huang, Chunyan Li, Yiwen Liang, Miaoyan Huang, Raoshan Luo, Weiming Liang
    Frontiers in Immunology.2024;[Epub]     CrossRef
  • What’s new about the tumor microenvironment of urothelial carcinoma?
    João Queirós Coelho, Maria João Ramos, Ridhi Ranchor, Rita Pichel, Laura Guerra, Hugo Miranda, Joana Simões, Sérgio Xavier Azevedo, Joana Febra, António Araújo
    Clinical and Translational Oncology.2024; 26(7): 1549.     CrossRef
  • A bibliometric insight into neoadjuvant chemotherapy in bladder cancer: trends, collaborations, and future avenues
    Yi Huang, Chengxiao Liao, Zefeng Shen, Yitong Zou, Weibin Xie, Qinghua Gan, Yuhui Yao, JunJiong Zheng, Jianqiu Kong
    Frontiers in Immunology.2024;[Epub]     CrossRef
  • Bladder-sparing treatment using tislelizumab combined with gemcitabine/cisplatin in selected patients with muscle-invasive bladder cancer: a real-world study
    Cheng Luo, Shuhang Luo, Wumier Wusimanjiang, Zongren Wang, Ping Liu, Bin Wang, Dan Yuan, Hao Lin, Abai Xu, Nan Deng, Kaihui Wu, Xuejin Zhu, Peng Xu, Junxing Chen, Bin Huang
    Clinical and Translational Oncology.2024; 26(7): 1759.     CrossRef
  • Neoadjuvant Cisplatin-Based Chemotherapy Followed by Selective Bladder Preservation Chemoradiotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder: Post Hoc Analysis of Two Prospective Studies
    Sung Wook Cho, Sung Hee Lim, Ghee Young Kwon, Chan Kyo Kim, Won Park, Hongryull Pyo, Jae Hoon Chung, Wan Song, Hyun Hwan Sung, Byong Chang Jeong, Se Hoon Park
    Cancer Research and Treatment.2024; 56(3): 893.     CrossRef
  • Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer
    Thomas Powles, James W.F. Catto, Matthew D. Galsky, Hikmat Al-Ahmadie, Joshua J. Meeks, Hiroyuki Nishiyama, Toan Quang Vu, Lorenzo Antonuzzo, Pawel Wiechno, Vagif Atduev, Ariel G. Kann, Tae-Hwan Kim, Cristina Suárez, Chao-Hsiang Chang, Florian Roghmann, M
    New England Journal of Medicine.2024; 391(19): 1773.     CrossRef
  • Klassische Chemotherapie, Immuntherapie oder adjuvante Strahlentherapie – Wie können wir die onkologischen Ergebnisse der radikalen Zystektomie verbessern?
    Pia Paffenholz, Stefanie Zschäbitz
    Die Urologie.2024; 63(10): 994.     CrossRef
  • Recent developments in perioperative combination therapy in muscle-invasive bladder cancer
    Jan-Jaap J. Mellema, Bas W.G. van Rhijn, Michiel S. van der Heijden
    Current Opinion in Urology.2023; 33(5): 404.     CrossRef
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  • 7 Web of Science
  • 10 Crossref
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Gastrointestinal cancer
Real-World Efficacy Data and Predictive Clinical Parameters for Treatment Outcomes in Advanced Esophageal Squamous Cell Carcinoma Treated with Immune Checkpoint Inhibitors
Jwa Hoon Kim, Bokyung Ahn, Seung-Mo Hong, Hwoon-Yong Jung, Do Hoon Kim, Kee Don Choi, Ji Yong Ahn, Jeong Hoon Lee, Hee Kyoung Na, Jong Hoon Kim, Yong-Hee Kim, Hyeong Ryul Kim, Hyun Joo Lee, Sung-Bae Kim, Sook Ryun Park
Cancer Res Treat. 2022;54(2):505-516.   Published online June 23, 2021
DOI: https://doi.org/10.4143/crt.2020.1198
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
This study aimed to evaluate the real-world efficacy of immune checkpoint inhibitors (ICIs), and to identify clinicolaboratory factors to predict treatment outcomes in patients with advanced esophageal squamous cell carcinoma (ESCC) receiving ICIs.
Materials and Methods
Sixty patients with metastatic or unresectable ESCC treated with nivolumab (n=48) or pembrolizumab (n=12) as ≥ second-line treatment between 2016 and 2019 at Asan Medical Center were included.
Results
The median age of the patients was 68 years (range, 52 to 76 years), and 93.3% were male. Most patients had metastatic disease (81.7%) and had been previously treated with fluoropyrimidines, platinum, and taxane. In 53 patients with measurable disease, the overall response rate and disease control rate were 15.1% and 35.8%, respectively. With a median follow-up duration of 16.0 months, the median progression-free survival (PFS) and overall survival (OS) were 1.9 months (95% confidence interval [CI], 1.54 to 2.19) and 6.4 months (95% CI, 4.77 to 8.11), respectively. After multivariate analysis, recent use of antibiotics, low prognostic nutrition index (< 35.93), high Glasgow Prognosis Score (≥ 1) at baseline, and ≥ 1.4-fold increase in neutrophil-to-lymphocyte ratio after one cycle from baseline were significantly unfavorable factors for both PFS and OS. Younger age (< 65 years) was a significant factor for unfavorable PFS and hyponatremia (< 135 mmol/L) for unfavorable OS.
Conclusion
The use of ICIs after the failure of chemotherapy showed comparable efficacy in patients with advanced ESCC in real practice; this may be associated with host immune-nutritional status, which could be predicted by clinical and routine laboratory factors.

Citations

Citations to this article as recorded by  
  • Pretreatment neutrophil-to-lymphocyte ratio is associated with immunotherapy efficacy in patients with advanced cancer: a systematic review and meta-analysis
    Jialin Su, Yuning Li, Shuhua Tan, Tianli Cheng, Yongzhong Luo, Lemeng Zhang
    Scientific Reports.2025;[Epub]     CrossRef
  • Prognostic value of liver metastasis in patients with esophageal squamous cell carcinoma treated with nivolumab
    Ryuichi Morita, Takeshi Ishikawa, Toshifumi Doi, Junichiro Itani, Daiki Sone, Naoto Iwai, Ken Inoue, Hirotaka Konishi, Osamu Dohi, Naohisa Yoshida, Atsushi Shiozaki, Kazuhiko Uchiyama, Tomohisa Takagi, Hitoshi Fujiwara, Hideyuki Konishi, Yoshito Itoh
    Oncology Letters.2025;[Epub]     CrossRef
  • Clinical features and treatment outcomes of PD-1 inhibitor therapy in elderly patients (≥ 65 years) with advanced esophageal squamous cell carcinoma: a real-world study
    Yi Yu, Tao Wu, Wei Gan, Can Liu, Ran Zhang, Jinxiu Zheng, Jianping Xiong, Jun Chen, Junhe Li
    Clinical and Translational Oncology.2024; 26(9): 2360.     CrossRef
  • Pembrolizumab for recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus: a drug safety evaluation
    Kazumasa Yamamoto, Shun Yamamoto, Ken Kato
    Expert Opinion on Drug Safety.2024; 23(6): 667.     CrossRef
  • Efficacy and survival of nivolumab treatment for recurrent/unresectable esophageal squamous-cell carcinoma: real-world clinical data from a large multi-institutional cohort
    Tomoki Makino, Shigeto Nakai, Kota Momose, Kotaro Yamashita, Koji Tanaka, Hiroshi Miyata, Sachiko Yamamoto, Masaaki Motoori, Yutaka Kimura, Yuki Ushimaru, Motohiro Hirao, Jin Matsuyama, Yusuke Akamaru, Yukinori Kurokawa, Hidetoshi Eguchi, Yuichiro Doki
    Esophagus.2024; 21(3): 319.     CrossRef
  • The impact of antibiotic use in gastrointestinal tumors treated with immune checkpoint inhibitors: systematic review and meta-analysis
    Faizah M. Alotaibi, Ibrahim Abdullah S. Albalawi, Amna M. Anis, Hawazin Alotaibi, Seham Khashwayn, Kanan Alshammari, Jaffar A. Al-Tawfiq
    Frontiers in Medicine.2024;[Epub]     CrossRef
  • Prognostic factors of second-line nivolumab monotherapy for unresectable or metastatic esophageal cancer: a multi-institutional cohort study for 184 cases
    Sho Sato, Takashi Suzuki, Takashi Chinen, Hironori Yamaguchi, Yusuke Suzuki, Nobukazu Hokamura, Zenichiro Saze, Koji Kono, Keita Takahashi, Fumiaki Yano, Tsutomu Sato, Takashi Kosaka, Itaru Endo, Yasushi Ichikawa, Yutaka Miyawaki, Hiroshi Sato, Hideaki Sh
    Journal of Gastroenterology.2024; 59(11): 979.     CrossRef
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    Frontiers in Immunology.2024;[Epub]     CrossRef
  • Prognostic nutritional index as a prognostic biomarker for gastrointestinal cancer patients treated with immune checkpoint inhibitors
    Lilong Zhang, Wangbin Ma, Zhendong Qiu, Tianrui Kuang, Kunpeng Wang, Baohong Hu, Weixing Wang
    Frontiers in Immunology.2023;[Epub]     CrossRef
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    Hyejee Ohm, Omar Abdel-Rahman
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  • Prognostic and predictive impact of neutrophil‐to‐lymphocyte ratio and HLA‐I genotyping in advanced esophageal squamous cell carcinoma patients receiving immune checkpoint inhibitor monotherapy
    Lin Wang, Yanrong Zhu, Bo Zhang, Xi Wang, Hongnan Mo, Yuchen Jiao, Jiachen Xu, Jing Huang
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  • Prognostic Nutritional Index Predicts Response and Prognosis in Cancer Patients Treated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis
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    Jiaxin Zhou, Guowei Huang, Wan-Ching Wong, Da-hai Hu, Jie-wen Zhu, Ruiman Li, Hong Zhou
    Frontiers in Immunology.2022;[Epub]     CrossRef
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    Pengfei Li, Yutian Lai, Long Tian, Qinghua Zhou
    Cancer Medicine.2022; 11(16): 3048.     CrossRef
  • Intratumoral immunotherapy using a TLR2/3 agonist, L-pampo, induces robust antitumor immune responses and enhances immune checkpoint blockade
    Won Suk Lee, Dong Sung Kim, Jeong Hun Kim, Yoonki Heo, Hannah Yang, Eun-Jin Go, Jin Hyoung Kim, Seung Joon Lee, Byung Cheol Ahn, Jung Sun Yum, Hong Jae Chon, Chan Kim
    Journal for ImmunoTherapy of Cancer.2022; 10(6): e004799.     CrossRef
  • Focus on the Dynamics of Neutrophil-to-Lymphocyte Ratio in Cancer Patients Treated with Immune Checkpoint Inhibitors: A Meta-Analysis and Systematic Review
    Yusheng Guo, Dongqiao Xiang, Jiayu Wan, Lian Yang, Chuansheng Zheng
    Cancers.2022; 14(21): 5297.     CrossRef
  • The association between albumin levels and survival in patients treated with immune checkpoint inhibitors: A systematic review and meta-analysis
    Deniz Can Guven, Taha Koray Sahin, Enes Erul, Alessandro Rizzo, Angela Dalia Ricci, Sercan Aksoy, Suayib Yalcin
    Frontiers in Molecular Biosciences.2022;[Epub]     CrossRef
  • Nomogram Based on Monocyte-to-Lymphocyte Ratio to Predict Survival of Unresectable Esophageal Squamous Cell Carcinoma Who Receive First-Line PD-1/PD-L1 Inhibitors Combined with Chemotherapy
    Xiaolu Ma, Yongfeng Ding, Jiong Qian, Mingyu Wan, Ning Li, Chenyu Mao, Cheng Xiao, Haiping Jiang, Yulong Zheng, Luntao Wu, Xiaoyu Chen, Nong Xu
    Current Oncology.2022; 29(11): 8937.     CrossRef
  • 8,669 View
  • 303 Download
  • 23 Web of Science
  • 23 Crossref
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