PMID- 38191615
OWN - NLM
STAT- MEDLINE
DCOM- 20240124
LR  - 20240201
IS  - 1546-170X (Electronic)
IS  - 1078-8956 (Linking)
VI  - 30
IP  - 1
DP  - 2024 Jan
TI  - Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast 
      cancer: a randomized phase 3 trial.
PG  - 249-256
LID - 10.1038/s41591-023-02677-x [doi]
AB  - The combination of immune-checkpoint blockade with chemotherapy for the 
      first-line treatment of advanced triple-negative breast cancer (TNBC) has 
      generated mixed results. TORCHLIGHT is a randomized, double-blinded phase 3 trial 
      evaluating the efficacy and safety of first-line toripalimab and nab-paclitaxel 
      (nab-P) (n = 353; experimental arm) versus placebo and nab-P (n = 178; control 
      arm) for the treatment of women with metastatic or recurrent TNBC. The primary 
      end point was progression-free survival (PFS) assessed by a blinded independent 
      central review in the PD-L1-positive and intention-to-treat populations. The 
      secondary end points included overall survival and safety. Overall, 200 and 100 
      patients, in the toripalimab and placebo arm respectively had PD-L1-positive 
      TNBC. At the prespecified interim analysis, a statistically significant 
      improvement in PFS assessed by a blinded independent central review was 
      demonstrated in the experimental arm in the PD-L1-positive population (median PFS 
      8.4 versus 5.6 months; hazard ratio (HR) = 0.65, 95% confidence interval (CI) 
      0.470-0.906, P = 0.0102). The median overall survival was 32.8 versus 19.5 months 
      (HR = 0.62, 95% CI 0.414-0.914, P = 0.0148). Similar incidences of 
      treatment-emergent adverse events (AEs) (99.2% versus 98.9%), grade >/=3 
      treatment-emergent AEs (56.4% versus 54.3%) and fatal AEs (0.6% versus 3.4%) 
      occurred in the experimental and control arms. The addition of toripalimab to 
      nab-P provided a significant improvement in PFS for PD-L1-positive patients with 
      metastatic or recurrent TNBC with an acceptable safety profile. ClinicalTrial.gov 
      identifier NCT03777579 .
CI  - (c) 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.
FAU - Jiang, Zefei
AU  - Jiang Z
AUID- ORCID: 0000-0002-4295-0173
AD  - Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. 
      jiangzefei@csco.org.cn.
FAU - Ouyang, Quchang
AU  - Ouyang Q
AD  - Breast Internal Medicine Department, Hunan Cancer Hospital, The Affiliated Cancer 
      Hospital of Xiangya School of Medicine, Central South University, Changsha, 
      China.
FAU - Sun, Tao
AU  - Sun T
AUID- ORCID: 0000-0001-5931-386X
AD  - Breast Medicine Ward Area I, Liaoning Cancer Hospital, Shenyang, China.
FAU - Zhang, Qingyuan
AU  - Zhang Q
AD  - Department of Breast & Lymphoma, Harbin Medical University Cancer Hospital, 
      Harbin, China.
FAU - Teng, Yuee
AU  - Teng Y
AD  - Department of Medical Oncology, The First Hospital of China Medical University, 
      Shenyang, China.
FAU - Cui, Jiuwei
AU  - Cui J
AD  - Oncology Center, Oncology Department, The First Hospital of Jilin University, 
      Changchun, China.
FAU - Wang, Haibo
AU  - Wang H
AUID- ORCID: 0000-0002-7514-1719
AD  - Breast Disease Center, The Affiliated Hospital of Qingdao University, Qingdao, 
      China.
FAU - Yin, Yongmei
AU  - Yin Y
AUID- ORCID: 0000-0003-3335-369X
AD  - Department of Oncology, Jiangsu Province Hospital, Nanjing, China.
FAU - Wang, Xiaojia
AU  - Wang X
AUID- ORCID: 0000-0002-7005-0842
AD  - Department of Breast (Mammary Gland) Disease, Zhejiang Cancer Hospital, Hangzhou, 
      China.
FAU - Zhou, Xin
AU  - Zhou X
AD  - The Breast Cancer Center, Chongqing University Cancer Hospital, Chongqing, China.
FAU - Wang, Yongsheng
AU  - Wang Y
AD  - Breast Surgery, Shandong Cancer Hospital, Jinan, China.
FAU - Sun, Gang
AU  - Sun G
AD  - Breast Medicine Department, Xinjiang Medical University Affiliated Cancer 
      Hospital, Urumqi, China.
FAU - Wang, Jingfen
AU  - Wang J
AD  - Breast Medicine Department, Linyi Cancer Hospital, Linyi, China.
FAU - Zhang, Lili
AU  - Zhang L
AD  - Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
FAU - Yang, Jin
AU  - Yang J
AD  - Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong 
      University, Xi'an, China.
FAU - Qian, Jun
AU  - Qian J
AD  - Department of Surgical Oncology, The First Affiliated Hospital of Bengbu Medical 
      College, Bengbu, China.
FAU - Yan, Min
AU  - Yan M
AUID- ORCID: 0000-0002-3911-748X
AD  - Breast Surgery, Henan Cancer Hospital, Zhengzhou, China.
FAU - Liu, Xinlan
AU  - Liu X
AD  - Department of Medical Oncology, General Hospital of Ningxia Medical University, 
      Yinchuan, China.
FAU - Yi, Tienan
AU  - Yi T
AD  - Department of Oncology, Xiangyang Central Hospital, Xiangyang, China.
FAU - Cheng, Ying
AU  - Cheng Y
AUID- ORCID: 0000-0001-9908-597X
AD  - Department of Medical Oncology, Jilin Cancer Hospital, Changchun, China.
FAU - Li, Man
AU  - Li M
AD  - Department of Medical Oncology, The Second Hospital of Dalian Medical University, 
      Dalian, China.
FAU - Zang, Aimin
AU  - Zang A
AD  - Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, 
      China.
FAU - Wang, Shusen
AU  - Wang S
AUID- ORCID: 0000-0003-0139-5780
AD  - Internal Medicine Department, Sun Yat-sen University Cancer Center, Guangzhou, 
      China.
FAU - Wang, Chuan
AU  - Wang C
AD  - Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
FAU - Wu, Xinhong
AU  - Wu X
AD  - Galactophore Department, Hubei Cancer Hospital, Wuhuan, China.
FAU - Cheng, Jing
AU  - Cheng J
AD  - Galactophore Department, Union Hospital Tongji Medical College of Hust, Wuhan, 
      China.
FAU - Li, Hui
AU  - Li H
AD  - Breast Surgery, Sichuan Cancer Hospital, Chengdu, China.
FAU - Lin, Ying
AU  - Lin Y
AUID- ORCID: 0000-0002-5923-3306
AD  - Breast Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 
      China.
FAU - Geng, Cuizhi
AU  - Geng C
AD  - Department of Breast Cancer, The Fourth Hospital of Hebei Medical University, 
      Shijiazhuang, China.
FAU - Gu, Kangsheng
AU  - Gu K
AD  - Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical 
      University, Hefei, China.
FAU - Xie, Chunwei
AU  - Xie C
AD  - Breast Surgery, Nanchang People's Hospital, Nanchang, China.
FAU - Xiong, Huihua
AU  - Xiong H
AD  - Department of Oncology, Tongji Hospital Tongji Medical College of Hust, Wuhan, 
      China.
FAU - Wu, Xiaohong
AU  - Wu X
AD  - Department of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.
FAU - Yang, Junlan
AU  - Yang J
AD  - Department of Medical Oncology, The First Medical Center of the General Hospital 
      of the People's Liberation Army of China, Beijing, China.
FAU - Li, Qingshan
AU  - Li Q
AD  - Department of Oncology, Affiliated Hospital of Chengde Medical University, 
      Chengde, China.
FAU - Chen, Yiding
AU  - Chen Y
AUID- ORCID: 0000-0002-2263-6275
AD  - Breast Surgery, The Second Affiliated Hospital, Zhejiang University School of 
      Medicine, Hangzhou, China.
FAU - Li, Fanfan
AU  - Li F
AUID- ORCID: 0000-0003-4116-1604
AD  - Department of Oncology, The Second Affiliated Hospital of Anhui University, 
      Hefei, China.
FAU - Zhang, Anqin
AU  - Zhang A
AD  - Breast Surgery Department, Guandong Maternal Hospital, Guandong Children's 
      Hospital, Guangzhou, China.
FAU - Zhang, Yongqiang
AU  - Zhang Y
AD  - Department of Medical Oncology, Beijing Hospital, Beijing, China.
FAU - Wu, Yudong
AU  - Wu Y
AD  - Breast Surgery, Jiangxi Cancer Hospital, Nanchang, China.
FAU - Nie, Jianyun
AU  - Nie J
AUID- ORCID: 0000-0003-3691-8940
AD  - Third department of Breast surgery, Yunnan Cancer Hospital (The Third Affiliated 
      Hospital of Kunming Medical University), Kuming, China.
FAU - Liu, Qiang
AU  - Liu Q
AD  - Breast Surgery Department, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, 
      Guangzhou, China.
FAU - Wang, Kun
AU  - Wang K
AD  - Department of Breast Oncology, Guangdong Provincial People's Hospital, Guangzhou, 
      China.
FAU - Mo, Xueli
AU  - Mo X
AD  - Breast Disease Department, Peking University Shougang Hospital, Beijing, China.
FAU - Chen, Lilin
AU  - Chen L
AD  - Department of Medical Oncology, The First Affiliated Hospital of Xiamen 
      University, Xiamen, China.
FAU - Pan, Yueyin
AU  - Pan Y
AUID- ORCID: 0000-0003-0532-5368
AD  - Oncology Chemotherapy Department, First Affiliated Hospital of USTC (Anhui 
      Provincial Hospital), Hefei, China.
FAU - Fu, Peifen
AU  - Fu P
AD  - Breast Surgery, The First Affiliated Hospital, Zhejiang University School of 
      Medicine, Hangzhou, China.
FAU - Zhang, Helong
AU  - Zhang H
AD  - Department of Medical Oncology, The Second Affiliated Hospital of the Air Force 
      Medical University of the People's Liberation Army Chinese People's Liberation 
      Army, Xi'an, China.
FAU - Pang, Danmei
AU  - Pang D
AD  - Breast Oncology Department, The First People's Hospital of Foshan, Foshan, China.
FAU - Sheng, Yuan
AU  - Sheng Y
AD  - Thyroid and Breast Surgery Department, Changhai Hospital of Shanghai, Shanghai, 
      China.
FAU - Han, Yunwei
AU  - Han Y
AD  - Department of Oncology, The Affiliated Hospital of Southwest Medical University, 
      Luzhou, China.
FAU - Wang, Hongxia
AU  - Wang H
AD  - Department of Oncology, Shanghai General Hospital, Shanghai, China.
AD  - Fudan University Shanghai Cancer Center, Shanghai, China.
FAU - Cang, Shundong
AU  - Cang S
AD  - Department of Medical Oncology, Henan Provincial People's Hospital, Zhengzhou, 
      China.
FAU - Luo, Xianming
AU  - Luo X
AD  - Shanghai Junshi Biosciences, Shanghai, China.
FAU - Yu, Wenbo
AU  - Yu W
AD  - Shanghai Junshi Biosciences, Shanghai, China.
FAU - Deng, Rong
AU  - Deng R
AD  - Shanghai Junshi Biosciences, Shanghai, China.
FAU - Yang, Chaoqiang
AU  - Yang C
AD  - Shanghai Junshi Biosciences, Shanghai, China.
FAU - Keegan, Patricia
AU  - Keegan P
AUID- ORCID: 0000-0002-7266-395X
AD  - TopAlliance Biosciences, Rockville, MD, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03777579
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20240108
PL  - United States
TA  - Nat Med
JT  - Nature medicine
JID - 9502015
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 8JXN261VVA (toripalimab)
RN  - 0 (B7-H1 Antigen)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Albumins)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Triple Negative Breast Neoplasms/drug therapy/pathology
MH  - B7-H1 Antigen/therapeutic use
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Paclitaxel/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Albumins
MH  - *Antibodies, Monoclonal, Humanized
EDAT- 2024/01/09 00:42
MHDA- 2024/01/24 06:43
CRDT- 2024/01/08 23:50
PHST- 2023/06/09 00:00 [received]
PHST- 2023/11/01 00:00 [accepted]
PHST- 2024/01/24 06:43 [medline]
PHST- 2024/01/09 00:42 [pubmed]
PHST- 2024/01/08 23:50 [entrez]
AID - 10.1038/s41591-023-02677-x [pii]
AID - 10.1038/s41591-023-02677-x [doi]
PST - ppublish
SO  - Nat Med. 2024 Jan;30(1):249-256. doi: 10.1038/s41591-023-02677-x. Epub 2024 Jan 
      8.