Evidence map›Paper›PMID 38191615›Full record

Trial reportNature medicine2024

Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial.

Zefei Jiang, Quchang Ouyang, Tao Sun, Qingyuan Zhang, Yuee Teng, Jiuwei Cui, Haibo Wang, Yongmei Yin, Xiaojia Wang, Xin Zhou and 48 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03777579 (A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001), which is not on this map. Cited by 90 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 8 pooled it
27.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03777579 phase3suspendednot on this map

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer

TypeinterventionalSponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.Ran2018 to 2020Enrolled375ConditionsTriple Negative Breast CancerArmsJS001,an engineered anti-PD-1 antibody, Nab-Paclitaxel, Placebo
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 8 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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30 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

58 authors at 20 institutions in 2 countries.

Zefei Jiang *Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. jiangzefei@csco.org.cn.ORCID 0000-0002-4295-0173
Quchang Ouyang *Breast Internal Medicine Department, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
Tao Sun *Breast Medicine Ward Area I, Liaoning Cancer Hospital, Shenyang, China.ORCID 0000-0001-5931-386X
Qingyuan Zhang *Department of Breast & Lymphoma, Harbin Medical University Cancer Hospital, Harbin, China.
Yuee TengDepartment of Medical Oncology, The First Hospital of China Medical University, Shenyang, China.
Jiuwei CuiOncology Center, Oncology Department, The First Hospital of Jilin University, Changchun, China.
Haibo WangBreast Disease Center, The Affiliated Hospital of Qingdao University, Qingdao, China.ORCID 0000-0002-7514-1719
Yongmei YinDepartment of Oncology, Jiangsu Province Hospital, Nanjing, China.ORCID 0000-0003-3335-369X
Xiaojia WangDepartment of Breast (Mammary Gland) Disease, Zhejiang Cancer Hospital, Hangzhou, China.ORCID 0000-0002-7005-0842
Xin ZhouThe Breast Cancer Center, Chongqing University Cancer Hospital, Chongqing, China.
Yongsheng WangBreast Surgery, Shandong Cancer Hospital, Jinan, China.
Gang SunBreast Medicine Department, Xinjiang Medical University Affiliated Cancer Hospital, Urumqi, China.
Jingfen WangBreast Medicine Department, Linyi Cancer Hospital, Linyi, China.
Lili ZhangDepartment of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
Jin YangDepartment of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Jun QianDepartment of Surgical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
Min YanBreast Surgery, Henan Cancer Hospital, Zhengzhou, China.ORCID 0000-0002-3911-748X
Xinlan LiuDepartment of Medical Oncology, General Hospital of Ningxia Medical University, Yinchuan, China.
Tienan YiDepartment of Oncology, Xiangyang Central Hospital, Xiangyang, China.
Ying ChengDepartment of Medical Oncology, Jilin Cancer Hospital, Changchun, China.ORCID 0000-0001-9908-597X
Man LiDepartment of Medical Oncology, The Second Hospital of Dalian Medical University, Dalian, China.
Aimin ZangDepartment of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China.
Shusen WangInternal Medicine Department, Sun Yat-sen University Cancer Center, Guangzhou, China.ORCID 0000-0003-0139-5780
Chuan WangBreast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
Xinhong WuGalactophore Department, Hubei Cancer Hospital, Wuhuan, China.
Jing ChengGalactophore Department, Union Hospital Tongji Medical College of Hust, Wuhan, China.
Hui LiBreast Surgery, Sichuan Cancer Hospital, Chengdu, China.
Ying LinBreast Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.ORCID 0000-0002-5923-3306
Cuizhi GengDepartment of Breast Cancer, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Kangsheng GuDepartment of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Chunwei XieBreast Surgery, Nanchang People's Hospital, Nanchang, China.
Huihua XiongDepartment of Oncology, Tongji Hospital Tongji Medical College of Hust, Wuhan, China.
Xiaohong WuDepartment of Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.
Junlan YangDepartment of Medical Oncology, The First Medical Center of the General Hospital of the People's Liberation Army of China, Beijing, China.
Qingshan LiDepartment of Oncology, Affiliated Hospital of Chengde Medical University, Chengde, China.
Yiding ChenBreast Surgery, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0002-2263-6275
Fanfan LiDepartment of Oncology, The Second Affiliated Hospital of Anhui University, Hefei, China.ORCID 0000-0003-4116-1604
Anqin ZhangBreast Surgery Department, Guandong Maternal Hospital, Guandong Children's Hospital, Guangzhou, China.
Yongqiang ZhangDepartment of Medical Oncology, Beijing Hospital, Beijing, China.
Yudong WuBreast Surgery, Jiangxi Cancer Hospital, Nanchang, China.
Jianyun NieThird department of Breast surgery, Yunnan Cancer Hospital (The Third Affiliated Hospital of Kunming Medical University), Kuming, China.ORCID 0000-0003-3691-8940
Qiang LiuBreast Surgery Department, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Kun WangDepartment of Breast Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.
Xueli MoBreast Disease Department, Peking University Shougang Hospital, Beijing, China.
Lilin ChenDepartment of Medical Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, China.
Yueyin PanOncology Chemotherapy Department, First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, China.ORCID 0000-0003-0532-5368
Peifen FuBreast Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Helong ZhangDepartment 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.
Danmei PangBreast Oncology Department, The First People's Hospital of Foshan, Foshan, China.
Yuan ShengThyroid and Breast Surgery Department, Changhai Hospital of Shanghai, Shanghai, China.
Yunwei HanDepartment of Oncology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Hongxia WangDepartment of Oncology, Shanghai General Hospital, Shanghai, China.
Shundong CangDepartment of Medical Oncology, Henan Provincial People's Hospital, Zhengzhou, China.
Xianming LuoShanghai Junshi Biosciences, Shanghai, China.
Wenbo YuShanghai Junshi Biosciences, Shanghai, China.
Rong DengShanghai Junshi Biosciences, Shanghai, China.
Chaoqiang YangShanghai Junshi Biosciences, Shanghai, China.
Patricia KeeganTopAlliance Biosciences, Rockville, MD, USA.ORCID 0000-0002-7266-395X
Sun Yat-sen University · CNJiangnan University · CNPeople's Liberation Army No. 150 Hospital · CNQingdao University · CNAffiliated Hospital of Hebei University · CNAffiliated Hospital of Southwest Medical University · CNAnhui Medical University · CNAnhui Provincial Hospital · CNAnhui University · CNBeijing Hospital · CNBioReliance (United States) · USCentral South University · CNChengde Medical University · CNChinese People's Liberation Army · CNChinese PLA General Hospital · CNChongqing University · CNDalian Medical University · CNFirst Affiliated Hospital of Bengbu Medical College · CNFirst Affiliated Hospital of Xiamen University · CNFirst Affiliated Hospital Zhejiang University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 .

Indexed as

AlbuminsAntibodies, Monoclonal, HumanizedTriple Negative Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenFemaleHumansNeoplasm Recurrence, LocalPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedB7-H1 AntigenPaclitaxeltoripalimab

Identifiers

PMID38191615
OpenAlexW4390670334

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.