Tislelizumab versus chemotherapy as second-line treatment for European and North American patients with advanced or metastatic esophageal squamous cell carcinoma: a subgroup analysis of the randomized phase III RATIONALE-302 study

被引：3

作者：

Ajani, J. ^{[1
]}

El Hajbi, F. ^{[2
]}

Cunningham, D. ^{[3
]}

Alsina, M. ^{[4
]}

Thuss-Patience, P. ^{[5
]}

Scagliotti, G. V. ^{[6
]}

Van den Eynde, M. ^{[7
]}

Kim, S-b. ^{[8
]}

Kato, K. ^{[9
]}

Shen, L. ^{[10
]}

Li, L. ^{[11
]}

Ding, N. ^{[11
]}

Shi, J.

Barnes, G. ^{[12
]}

Van Cutsem, E. ^{[13
,14
,15
,16
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Gastrointestinal Med Oncol, Houston, TX USA

[2] Oscar Lambert Ctr, Dept Gastro Intestinal Oncol, Lille, France

[3] Royal Marsden NHS Fdn Trust, Dept Oncol, London, England

[4] Vall dHebron Inst Oncol VHIO, Dept Med Oncol, Barcelona, Spain

[5] Charite Univ Med Berlin, Dept Hematol Oncol & Tumor Immunol, Campus Virchow Klinikum, Berlin, Germany

[6] Univ Torino, Dept Oncol, Orbassano, Torino, Italy

[7] Univ Catholique Louvain Uclouvain, Inst Roi Albert II, Dept Med Oncol & Hepatogastroenterol, Clin Univ St Luc, Brussels, Belgium

[8] Univ Ulsan, Asan Med Ctr, Dept Oncol, Coll Med, Seoul, South Korea

[9] Natl Canc Ctr, Dept Gastrointestinal Med Oncol, Tokyo, Japan

[10] Peking Univ Canc Hosp & Inst, Key Lab Carcinogenesis & Translat Res, Dept Gastrointestinal Oncol Key Lab Carcinogenesis, Dept Gastrointestinal Oncol, Beijing, Peoples R China

[11] BeiGene Ltd, Zhongguancun Life Sci Pk, Beijing, Peoples R China

[12] BeiGene Ltd, Emeryville, CA USA

[13] Univ Hosp Gasthuisberg Leuven, Digest Oncol, Leuven, Belgium

[14] KULeuven, Leuven, Belgium

[15] Univ Hosp Gasthuisberg Leuven, Digest Oncol, Herestr 49, B-3000 Leuven, Belgium

[16] KULeuven, Herestr 49, B-3000 Leuven, Belgium

来源：

ESMO OPEN | 2024年 / 9卷 / 01期

关键词：

tislelizumab; esophageal squamous cell carcinoma; anti-programmed cell death protein 1 antibody; QUALITY-OF-LIFE; EPIDEMIOLOGY; NIVOLUMAB; SURVIVAL; THERAPY; EORTC;

D O I：

10.1016/j.esmoop.2023.102202

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: The phase III RATIONALE-302 study evaluated tislelizumab, an anti-programmed cell death protein 1 antibody, as second-line (2L) treatment for advanced/metastatic esophageal squamous cell carcinoma (ESCC). This prespecified exploratory analysis investigated outcomes in patients from Europe and North America (Europe/North America subgroup).Patients and methods: Patients with tumor progression during/after first-line systemic treatment were randomized 1 : 1 to open-label tislelizumab or investigator's choice of chemotherapy (paclitaxel, docetaxel, or irinotecan).Results: The Europe/North America subgroup comprised 108 patients (tislelizumab: n = 55; chemotherapy: n = 53). Overall survival (OS) was prolonged with tislelizumab versus chemotherapy (median: 11.2 versus 6.3 months), with a hazard ratio (HR) of 0.55 [95% confidence interval (CI) 0.35-0.87]; HR was similar irrespective of programmed death-ligand 1 score [>= 10%: 0.47 (95% CI 0.18-1.21); <10%: 0.55 (95% CI 0.30-1.01)]. Median progression-free survival was 2.3 versus 2.7 months with tislelizumab versus chemotherapy [HR: 0.97 (95% CI 0.64-1.47)]. Overall response rate was greater with tislelizumab (20.0%) versus chemotherapy (11.3%), with more durable response (median duration of response: 5.1 versus 2.1 months). Tislelizumab had a favorable safety profile versus chemotherapy, with fewer patients experiencing >grade 3 treatment-related adverse events (13.0% versus 51.0%). Those on tislelizumab experienced less deterioration in health-related quality of life, physical functioning, and/or disease-and treatment-related symptoms (i.e. fatigue, pain, and eating problems) as compared to those on chemotherapy, per the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and QLQ-OES18 scores.Conclusions: As a 2L therapy for advanced/metastatic ESCC, tislelizumab improved OS and had a favorable safety profile as compared to chemotherapy in European/North American ESCC patients in the randomized phase III RATIONALE-302 study.

引用

页数：9

共 30 条

[1] Epidemiology of Esophageal Squamous Cell Carcinoma [J].

Abnet, Christian C. ;

Arnold, Melina ;

Wei, Wen-Qiang .

GASTROENTEROLOGY, 2018, 154 (02) :360-373

[2] Chinese guidelines for diagnosis and treatment of esophageal carcinoma 2018 [J].

不详 .

CHINESE JOURNAL OF CANCER RESEARCH, 2019, 31 (02) :223-258

[3] Global burden of oesophageal and gastric cancer by histology and subsite in 2018 [J].

Arnold, Melina ;

Ferlay, Jacques ;

Henegouwen, Mark I. van Berge ;

Soerjomataram, Isabelle .

GUT, 2020, 69 (09) :1564-1571

[4] Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer [J].

Blazeby, JM ;

Conroy, T ;

Hammerlid, E ;

Fayers, P ;

Sezer, O ;

Koller, M ;

Arraras, J ;

Bottomley, A ;

Vickery, CW ;

Etienne, PL ;

Alderson, D .

EUROPEAN JOURNAL OF CANCER, 2003, 39 (10) :1384-1394

[5] Pembrolizumab versus chemotherapy for patients with esophageal squamous cell carcinoma enrolled in the randomized KEYNOTE-181 trial in Asia [J].

Cao, Y. ;

Qin, S. ;

Luo, S. ;

Li, Z. ;

Cheng, Y. ;

Fan, Y. ;

Sun, Y. ;

Yin, X. ;

Yuan, X. ;

Li, W. ;

Liu, T. ;

Hsu, C-H ;

Lin, X. ;

Kim, S-B ;

Kojima, T. ;

Zhang, J. ;

Lee, S-H ;

Bai, Y. ;

Muro, K. ;

Doi, T. ;

Bai, C. ;

Gu, K. ;

Pan, H-M ;

Bai, L. ;

Yang, J-W ;

Cui, Y. ;

Lu, W. ;

Chen, J. .

ESMO OPEN, 2022, 7 (01)

[6] Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma [J].

Doki, Y. ;

Ajani, J. A. ;

Kato, K. ;

Xu, J. ;

Wyrwicz, L. ;

Motoyama, S. ;

Ogata, T. ;

Kawakami, H. ;

Hsu, C. -H. ;

Adenis, A. ;

El Hajbi, F. ;

Di Bartolomeo, M. ;

Braghiroli, M. I. ;

Holtved, E. ;

Ostoich, S. A. ;

Kim, H. R. ;

Ueno, M. ;

Mansoor, W. ;

Yang, W. -C. ;

Liu, T. ;

Bridgewater, J. ;

Makino, T. ;

Xynos, I. ;

Liu, X. ;

Lei, M. ;

Kondo, K. ;

Patel, A. ;

Gricar, J. ;

Chau, I. ;

Kitagawa, Y. .

NEW ENGLAND JOURNAL OF MEDICINE, 2022, 386 (05) :449-462

[7]

Fayers P, 2002, EUR J CANCER, V38, pS125

[8] Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study [J].

Huang, Jing ;

Xu, Jianming ;

Chen, Yun ;

Zhuang, Wu ;

Zhang, Yiping ;

Chen, Zhendong ;

Chen, Jia ;

Zhang, Helong ;

Niu, Zuoxing ;

Fan, Qingxia ;

Lin, Lizhu ;

Gu, Kangsheng ;

Liu, Ying ;

Ba, Yi ;

Miao, Zhanhui ;

Jiang, Xiaodong ;

Zeng, Ming ;

Chen, Jianhua ;

Fu, Zhichao ;

Gan, Lu ;

Wang, Jun ;

Zhan, Xianbao ;

Liu, Tianshu ;

Li, Zhiping ;

Shen, Lin ;

Shu, Yongqian ;

Zhang, Tao ;

Yang, Qing ;

Zou, Jianjun .

LANCET ONCOLOGY, 2020, 21 (06) :832-842

[9] A global perspective in second-line treatment patterns for patients with advanced esophageal squamous cell carcinoma [J].

Jaffe, Dena H. ;

Gricar, Joseph ;

DeCongelio, Marc ;

Mackie, DeMauri S. .

THORACIC CANCER, 2022, 13 (09) :1240-1257

[10] Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial [J].

Kato, Ken ;

Cho, Byoung Chul ;

Takahashi, Masanobu ;

Okada, Morihito ;

Lin, Chen-Yuan ;

Chin, Keisho ;

Kadowaki, Shigenori ;

Ahn, Myung-Ju ;

Hamamoto, Yasuo ;

Doki, Yuichiro ;

Yen, Chueh-Chuan ;

Kubota, Yutaro ;

Kim, Sung-Bae ;

Hsu, Chih-Hung ;

Holtved, Eva ;

Xynos, Ioannis ;

Kodani, Mamoru ;

Kitagawa, Yuko .

LANCET ONCOLOGY, 2019, 20 (11) :1506-1517

← 1 2 3 →