Neoadjuvant therapy with camrelizumab plus gemcitabine and cisplatin for patients with muscle-invasive bladder cancer: A multi-center, single-arm, phase 2 study
机构:[1]Chinese Acad Med Sci, Canc Hosp, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China[2]Peking Union Med Coll Hosp, Beijing, Peoples R China[3]Ningbo First Hosp, Ningbo, Peoples R China[4]Canc Hosp Huanxing, Beijing, Peoples R China[5]Beijing Tongren Hosp, Beijing, Peoples R China首都医科大学附属北京同仁医院首都医科大学附属同仁医院[6]Kunming Med Univ, Affiliated Hosp 2, Kunming, Peoples R China[7]Harbin Med Univ, Affiliated Hosp 4, Harbin, Peoples R China[8]Shandong Univ, Qilu Hosp, Jinan, Peoples R China[9]Tianjin Med Univ, Hosp 2, Tianjin, Peoples R China[10]Zhongshan Hosp, Shanghai, Peoples R China
Background: Neoadjuvant chemotherapy followed by radical cystectomy (RC) is the standard of care for patients with muscle--invasive bladder cancer (MIBC). However, treatment outcomes are suboptimal. Camrelizumab, a PD--1 blockade, has shown benefits in several tumors. This study aimed to investigate the efficacy and safety of neoadjuvant camrelizumab in combination with gemcitabine plus cisplatin (GC) followed by RC for MIBC patients. Methods: This was a multi-center, single--arm study that enrolled MIBC patients with a clinical stage of T2-4aN0-1M0, and scheduled for RC. Patients received three 21-day cycles of camrelizumab 200 mg on day 1, gemcitabine 1000 mg/m(2) on day 1 and 8, and cisplatin 70 mg/m(2) on day 2, followed by RC. The primary endpoint was pathologic complete response (pCR, pT0N0). Results: From May 2020 to July 2021, 43 patients were enrolled and received study medications at nine centers in China. Three of them were deemed ineligible and excluded from efficacy analysis but included in safety analysis. In total 10 patients were unevaluable as they declined RC (two due to adverse events [AEs] and eight due to patient's willingness). Among 30 evaluable patients, 13 patients (43.3%) achieved pCR, and 16 patients (53.3%) achieved pathologic downstaging. No AEs leading to death were observed. The most common AEs were anemia (69.8%), decreased white blood cell count (65.1%), and nausea (65.1%). Immune-related AEs were all grade 1 or 2. Pathologic response was not correlated with PD-L1 expression status or tumor mutation burden. Individual genes as a biomarker for pathologic response were not identified. Conclusions: Neoadjuvant treatment with camrelizumab and GC regimen demonstrated preliminary anti--tumor activity for MIBC patients with manageable
基金:
Capital Health Research and Development of Special Funding [2022-1-4021]
第一作者机构:[1]Chinese Acad Med Sci, Canc Hosp, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Chinese Acad Med Sci, Canc Hosp, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China[*1]Cancer Hospital Chinese Academy of Medical Sciences, No.17, Panjiayuan Nanli, Chaoyang, Beijing 100021, China.
推荐引用方式(GB/T 7714):
Han Sujun,Ji Zhigang,Jiang Junhui,et al.Neoadjuvant therapy with camrelizumab plus gemcitabine and cisplatin for patients with muscle-invasive bladder cancer: A multi-center, single-arm, phase 2 study[J].CANCER MEDICINE.2023,12(11):12106-12117.doi:10.1002/cam4.5900.
APA:
Han, Sujun,Ji, Zhigang,Jiang, Junhui,Fan, Xinrong,Ma, Qi...&Xing, Nianzeng.(2023).Neoadjuvant therapy with camrelizumab plus gemcitabine and cisplatin for patients with muscle-invasive bladder cancer: A multi-center, single-arm, phase 2 study.CANCER MEDICINE,12,(11)
MLA:
Han, Sujun,et al."Neoadjuvant therapy with camrelizumab plus gemcitabine and cisplatin for patients with muscle-invasive bladder cancer: A multi-center, single-arm, phase 2 study".CANCER MEDICINE 12..11(2023):12106-12117