Abstract
Background: Data on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients. Methods: In ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed. Results: Of 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab−. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3–12.9] vs 3.1 [1.9–5.3] months, hazard ratio, 0.38 [0.22–0.66]; P = 0.0006; Tmab−, 4.8 [4.1–6.0] vs 4.2 [3.6–4.9] months, 0.71 [0.57–0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5–4.0] vs 1.5 [1.3–2.9] months, 0.49 [0.29–0.85]; P = 0.0111; Tmab−, 1.6 [1.5–2.4] vs 1.5 [1.5–1.5] months, 0.64 [0.51–0.80]; P = 0.0001). Conclusions: Nivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer.
| Original language | English |
|---|---|
| Journal | Gastric Cancer |
| DOIs | |
| Publication status | Published - 2019 Jan 1 |
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Keywords
- Gastric cancer
- Gastroesophageal junction cancer
- Nivolumab
- Trastuzumab
ASJC Scopus subject areas
- Oncology
- Gastroenterology
- Cancer Research
Cite this
Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial : a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer. / Satoh, Taroh; Kang, Yoon Koo; Chao, Yee; Ryu, Min Hee; Kato, Ken; Cheol Chung, Hyun; Chen, Jen Shi; Muro, Kei; Ki Kang, Won; Yeh, Kun Huei; Yoshikawa, Takaki; Oh, Sang Cheul; Bai, Li Yuan; Tamura, Takao; Lee, Keun Wook; Hamamoto, Yasuo; Kim, Jong Gwang; Chin, Keisho; Oh, Do Youn; Minashi, Keiko; Cho, Jae Yong; Tsuda, Masahiro; Tanimoto, Mitsunobu; Chen, Li Tzong; Boku, Narikazu.
In: Gastric Cancer, 01.01.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Exploratory subgroup analysis of patients with prior trastuzumab use in the ATTRACTION-2 trial
T2 - a randomized phase III clinical trial investigating the efficacy and safety of nivolumab in patients with advanced gastric/gastroesophageal junction cancer
AU - Satoh, Taroh
AU - Kang, Yoon Koo
AU - Chao, Yee
AU - Ryu, Min Hee
AU - Kato, Ken
AU - Cheol Chung, Hyun
AU - Chen, Jen Shi
AU - Muro, Kei
AU - Ki Kang, Won
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 - Tanimoto, Mitsunobu
AU - Chen, Li Tzong
AU - Boku, Narikazu
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Background: Data on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients. Methods: In ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed. Results: Of 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab−. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3–12.9] vs 3.1 [1.9–5.3] months, hazard ratio, 0.38 [0.22–0.66]; P = 0.0006; Tmab−, 4.8 [4.1–6.0] vs 4.2 [3.6–4.9] months, 0.71 [0.57–0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5–4.0] vs 1.5 [1.3–2.9] months, 0.49 [0.29–0.85]; P = 0.0111; Tmab−, 1.6 [1.5–2.4] vs 1.5 [1.5–1.5] months, 0.64 [0.51–0.80]; P = 0.0001). Conclusions: Nivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer.
AB - Background: Data on immune checkpoint inhibitor efficacy in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced gastric/gastroesophageal junction (G/GEJ) cancer are lacking. Because HER2 status was not captured in the ATTRACTION-2 trial, we used patients with prior trastuzumab use (Tmab+) as surrogate for HER2 expression status to evaluate the efficacy and safety of nivolumab as third- or later-line therapy in these patients. Methods: In ATTRACTION-2, a randomized, double-blind, placebo-controlled, phase 3 multicenter trial, patients were randomized (2:1) to receive nivolumab (3 mg/kg) or placebo every 2 weeks until disease progression or toxicity requiring study discontinuation. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were assessed. Results: Of 493 enrolled patients, 81 (nivolumab, n = 59; placebo, n = 22) were Tmab+ and 412 (nivolumab, n = 271; placebo, n = 141) were Tmab−. In both groups, patients receiving nivolumab showed a longer median OS vs placebo (Tmab+, 8.3 [95% confidence interval, 5.3–12.9] vs 3.1 [1.9–5.3] months, hazard ratio, 0.38 [0.22–0.66]; P = 0.0006; Tmab−, 4.8 [4.1–6.0] vs 4.2 [3.6–4.9] months, 0.71 [0.57–0.88]; P = 0.0022). PFS was longer in both groups receiving nivolumab vs placebo (Tmab+, 1.6 [1.5–4.0] vs 1.5 [1.3–2.9] months, 0.49 [0.29–0.85]; P = 0.0111; Tmab−, 1.6 [1.5–2.4] vs 1.5 [1.5–1.5] months, 0.64 [0.51–0.80]; P = 0.0001). Conclusions: Nivolumab was efficacious and safe as third- or later-line therapy regardless of prior trastuzumab use in patients with advanced G/GEJ cancer.
KW - Gastric cancer
KW - Gastroesophageal junction cancer
KW - Nivolumab
KW - Trastuzumab
UR - http://www.scopus.com/inward/record.url?scp=85065787461&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85065787461&partnerID=8YFLogxK
U2 - 10.1007/s10120-019-00970-8
DO - 10.1007/s10120-019-00970-8
M3 - Article
AN - SCOPUS:85065787461
JO - Gastric Cancer
JF - Gastric Cancer
SN - 1436-3291
ER -