Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab

Narikazu Boku; Taroh Satoh; Min Hee Ryu; Yee Chao; Ken Kato; Hyun Cheol Chung; Jen Shi Chen; Kei Muro; Won Ki Kang; Kun Huei Yeh; Takaki Yoshikawa; Sang Cheul Oh; Li Yuan Bai; Takao Tamura; Keun Wook Lee; Yasuo Hamamoto; Jong Gwang Kim; Keisho Chin; Do Youn Oh; Keiko Minashi; Jae Yong Cho; Masahiro Tsuda; Taihei Nishiyama; Li Tzong Chen; Yoon Koo Kang

doi:10.1007/s10120-021-01173-w

Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab

Narikazu Boku, Taroh Satoh, Min Hee Ryu, Yee Chao, Ken Kato, Hyun Cheol Chung, Jen Shi Chen, Kei Muro, Won Ki Kang, Kun Huei Yeh, Takaki Yoshikawa, Sang Cheul Oh, Li Yuan Bai, Takao Tamura, Keun Wook Lee, Yasuo Hamamoto, Jong Gwang Kim, Keisho Chin, Do Youn Oh, Keiko MinashiJae Yong Cho, Masahiro Tsuda, Taihei Nishiyama, Li Tzong Chen, Yoon Koo Kang

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

38 Citations (Scopus)

Abstract

Background: ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified. Methods: The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression. Results: Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42). Conclusions: Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.

Original language	English
Pages (from-to)	946-958
Number of pages	13
Journal	Gastric Cancer
Volume	24
Issue number	4
DOIs	https://doi.org/10.1007/s10120-021-01173-w
Publication status	Published - 2021 Jul

Bibliographical note

Funding Information:
We thank the patients, their families, and the investigators. Editorial support, in the form of medical writing, assembling tables and creating high-resolution images based on the authors’ detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Annirudha Chillar, MD, PhD, of Cactus Life Sciences (part of Cactus Communications) and was funded by Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb, Princeton, NJ, USA.

Publisher Copyright:
© 2021, The Author(s).

All Science Journal Classification (ASJC) codes

Oncology
Gastroenterology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s10120-021-01173-w

Cite this

Boku, N., Satoh, T., Ryu, M. H., Chao, Y., Kato, K., Chung, H. C., Chen, J. S., Muro, K., Kang, W. K., Yeh, K. H., Yoshikawa, T., Oh, S. C., Bai, L. Y., Tamura, T., Lee, K. W., Hamamoto, Y., Kim, J. G., Chin, K., Oh, D. Y., ... Kang, Y. K. (2021). Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab. Gastric Cancer, 24(4), 946-958. https://doi.org/10.1007/s10120-021-01173-w

@article{d6ab44735dc54b118979b9402f671a91,

title = "Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab",

abstract = "Background: ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified. Methods: The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression. Results: Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42). Conclusions: Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.",

author = "Narikazu Boku and Taroh Satoh and Ryu, {Min Hee} and Yee Chao and Ken Kato and Chung, {Hyun Cheol} and Chen, {Jen Shi} and Kei Muro and Kang, {Won Ki} and Yeh, {Kun Huei} and Takaki Yoshikawa and Oh, {Sang Cheul} and Bai, {Li Yuan} and Takao Tamura and Lee, {Keun Wook} and Yasuo Hamamoto and Kim, {Jong Gwang} and Keisho Chin and Oh, {Do Youn} and Keiko Minashi and Cho, {Jae Yong} and Masahiro Tsuda and Taihei Nishiyama and Chen, {Li Tzong} and Kang, {Yoon Koo}",

note = "Funding Information: We thank the patients, their families, and the investigators. Editorial support, in the form of medical writing, assembling tables and creating high-resolution images based on the authors{\textquoteright} detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Annirudha Chillar, MD, PhD, of Cactus Life Sciences (part of Cactus Communications) and was funded by Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb, Princeton, NJ, USA. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = jul,

doi = "10.1007/s10120-021-01173-w",

language = "English",

volume = "24",

pages = "946--958",

journal = "Gastric Cancer",

issn = "1436-3291",

publisher = "Springer Japan",

number = "4",

}

Boku, N, Satoh, T, Ryu, MH, Chao, Y, Kato, K, Chung, HC, Chen, JS, Muro, K, Kang, WK, Yeh, KH, Yoshikawa, T, Oh, SC, Bai, LY, Tamura, T, Lee, KW, Hamamoto, Y, Kim, JG, Chin, K, Oh, DY, Minashi, K, Cho, JY, Tsuda, M, Nishiyama, T, Chen, LT & Kang, YK 2021, 'Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab', Gastric Cancer, vol. 24, no. 4, pp. 946-958. https://doi.org/10.1007/s10120-021-01173-w

TY - JOUR

T1 - Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2)

T2 - 3-year update and outcome of treatment beyond progression with nivolumab

AU - Boku, Narikazu

AU - Satoh, Taroh

AU - Ryu, Min Hee

AU - Chao, Yee

AU - Kato, Ken

AU - Chung, Hyun Cheol

AU - Chen, Jen Shi

AU - Muro, Kei

AU - Kang, Won Ki

AU - Yeh, Kun Huei

AU - Yoshikawa, Takaki

AU - Oh, Sang Cheul

AU - Bai, Li Yuan

AU - Tamura, Takao

AU - Lee, Keun Wook

AU - Hamamoto, Yasuo

AU - Kim, Jong Gwang

AU - Chin, Keisho

AU - Oh, Do Youn

AU - Minashi, Keiko

AU - Cho, Jae Yong

AU - Tsuda, Masahiro

AU - Nishiyama, Taihei

AU - Chen, Li Tzong

AU - Kang, Yoon Koo

N1 - Funding Information: We thank the patients, their families, and the investigators. Editorial support, in the form of medical writing, assembling tables and creating high-resolution images based on the authors’ detailed directions, collating author comments, copyediting, fact checking, and referencing, was provided by Annirudha Chillar, MD, PhD, of Cactus Life Sciences (part of Cactus Communications) and was funded by Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb, Princeton, NJ, USA. Publisher Copyright: © 2021, The Author(s).

PY - 2021/7

Y1 - 2021/7

N2 - Background: ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified. Methods: The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression. Results: Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42). Conclusions: Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.

AB - Background: ATTRACTION-2 demonstrated that nivolumab improved overall survival (OS) vs placebo in patients with advanced gastric cancer treated with ≥ 2 chemotherapy regimens. However, its long-term efficacy and outcome of treatment beyond progression (TBP) with nivolumab have not been clarified. Methods: The 3-year follow-up data were collected. A subset analysis was performed to explore the efficacy of TBP by assessing postprogression survival (PPS) after the first event of disease progression. Results: Overall, 493 patients were randomized (2:1) to receive nivolumab (n = 330) or placebo (n = 163). With a median follow-up of 38.5 (range 36.1–47.5) months, OS of the nivolumab group was significantly longer compared to the placebo group (median 5.3 vs 4.1 months; 3-year survival rate, 5.6% vs 1.9%; hazard ratio [HR], 0.62 [95% confidence interval (CI) 0.50–0.75], P < 0.0001). The median OS of responders (n = 32) who achieved complete response or partial response was 26.7 months and the 3-year survival rate was 35.5% in the nivolumab group. Overall, 109 patients in the nivolumab group and 37 patients in the placebo group received TBP. PPS tended to be longer in the nivolumab group vs placebo group (median 5.8 vs 4.5 months; HR [95% CI], 0.69 [0.47–1.01], P = 0.057). In contrast, PPS was similar between both treatment groups in non-TBP patients (median 2.3 vs 2.2 months; HR 0.90, P = 0.42). Conclusions: Long-term efficacy of nivolumab was confirmed at the 3-year follow-up, and a survival benefit of TBP with nivolumab was suggested. Biomarkers for selecting patients suitable for TBP with nivolumab should be identified in the future.

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JO - Gastric Cancer

JF - Gastric Cancer

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ER -

Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

UN SDGs

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