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Neoadjuvant gemcitabine-cisplatin plus tislelizumab in persons with resectable muscle-invasive bladder cancer: a multicenter, single-arm, phase 2 trial.
Li, Kaiwen; Zhong, Wenlong; Fan, Jinhai; Wang, Shaogang; Yu, Dexin; Xu, Tao; Lyu, Jiaju; Wu, Shaoxu; Qin, Tao; Wu, Zhuo; Xu, Longhao; Wu, Kaijie; Liu, Zheng; Hu, Zhiquan; Li, Fan; Wang, Jinyou; Wang, Qi; Min, Jie; Zhang, Zhiqiang; Yu, Luping; Ding, Sentai; Huang, Longfei; Zhao, Tingting; Huang, Jian; Lin, Tianxin.
Afiliación
  • Li K; Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • Zhong W; Guangdong Provincial Clinical Research Center for Urological Diseases, Guangzhou, China.
  • Fan J; Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • Wang S; Guangdong Provincial Clinical Research Center for Urological Diseases, Guangzhou, China.
  • Yu D; Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
  • Xu T; Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • Lyu J; Department of Urology, The Second Hospital of Anhui Medical University, Hefei, China.
  • Wu S; Department of Urology, Peking University People's Hospital, Beijing, China.
  • Qin T; Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Ji'nan, China.
  • Wu Z; Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • Xu L; Guangdong Provincial Clinical Research Center for Urological Diseases, Guangzhou, China.
  • Wu K; Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • Liu Z; Department of Radiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • Hu Z; Department of Urology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
  • Li F; Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
  • Wang J; Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • Wang Q; Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • Min J; Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • Zhang Z; Department of Urology, The Second Hospital of Anhui Medical University, Hefei, China.
  • Yu L; Department of Urology, The Second Hospital of Anhui Medical University, Hefei, China.
  • Ding S; Department of Urology, The Second Hospital of Anhui Medical University, Hefei, China.
  • Huang L; Department of Urology, The Second Hospital of Anhui Medical University, Hefei, China.
  • Zhao T; Department of Urology, Peking University People's Hospital, Beijing, China.
  • Huang J; Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Ji'nan, China.
  • Lin T; Research Institute, GloriousMed Clinical Laboratory Co., Ltd., Shanghai, China.
Nat Cancer ; 5(10): 1465-1478, 2024 Oct.
Article en En | MEDLINE | ID: mdl-39256488
ABSTRACT
Programmed death 1 blockade (tislelizumab) has been approved for metastatic urothelial carcinoma but not as part of neoadjuvant therapy for muscle-invasive bladder cancer (MIBC). In this multicenter single-arm trial (ChiCTR2000037670), 65 participants with cT2-4aN0M0 MIBC received neoadjuvant gemcitabine-cisplatin plus tislelizumab; 57 of them underwent radical cystectomy (RC). The primary endpoint of pathologic complete response (pCR) rate was 50.9% (29/57, 95% confidence interval (CI) 37.3-64.4%) and the pathologic downstaging (secondary endpoint) rate was 75.4% (43/57, 95% CI 62.2-85.9%) in participants undergoing RC. Genomic and transcriptomic analyses revealed three MIBC molecular subtypes (S) S1 (immune-desert) with activated cell-cycle pathway, S2 (immune-excluded) with activated transforming growth factor-ß pathway and S3 (immune-inflamed) with upregulated interferon-α and interferon-γ response. Post hoc analysis showed pCR rates of 16% (3/19, S1), 77% (10/13, S2) and 80% (12/15, S3) (P = 0.006). In conclusion, neoadjuvant gemcitabine-cisplatin plus tislelizumab for MIBC was compatible with an enhanced pCR rate.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Vejiga Urinaria / Protocolos de Quimioterapia Combinada Antineoplásica / Cisplatino / Terapia Neoadyuvante / Desoxicitidina / Anticuerpos Monoclonales Humanizados / Gemcitabina Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Nat Cancer Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Vejiga Urinaria / Protocolos de Quimioterapia Combinada Antineoplásica / Cisplatino / Terapia Neoadyuvante / Desoxicitidina / Anticuerpos Monoclonales Humanizados / Gemcitabina Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Nat Cancer Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido