Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer

A subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study

Akira Sawaki, Yasuo Ohashi, Yasushi Omuro, Taroh Satoh, Yasuo Hamamoto, Narikazu Boku, Yoshinori Miyata, Hiroya Takiuchi, Kensei Yamaguchi, Yasutsuna Sasaki, Tomohiro Nishina, Atsushi Satoh, Eishi Baba, Takao Tamura, Takashi Abe, Kiyohiko Hatake, Atsushi Ohtsu

Research output: Contribution to journalArticle

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Abstract

Background The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (HER2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5-fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. Methods We performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). Results Median overall survival in the Japanese subgroup was 15.9 months (95% confidence interval 12-25) for trastuzumab plus chemotherapy and 17.7 months (95% confidence interval 12-24) for chemotherapy (hazard ratio 1.00; 95% confidence interval 0.59-1.69). After adjusting Presented in part at the American Society of Clinical Oncology for prespecified covariates, the estimated hazard ratio for overall survival was 0.68 (95% confidence interval 0.36-1.27). Further post hoc and exploratory examinations supported the robustness of the adjusted hazard ratios. Conclusions After adjusting for imbalanced patient backgrounds between arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advanced/metastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone.

Original languageEnglish
Pages (from-to)313-322
Number of pages10
JournalGastric Cancer
Volume15
Issue number3
DOIs
Publication statusPublished - 2012 Jul 1
Externally publishedYes

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Esophagogastric Junction
Epidermal Growth Factor
Stomach Neoplasms
Stomach
Drug Therapy
Neoplasms
Confidence Intervals
Survival
Cisplatin
Trastuzumab
Fluorouracil
Population

Keywords

  • Drug therapy
  • Randomized controlled trial
  • Stomach neoplasms
  • Trastuzumab

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer : A subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study. / Sawaki, Akira; Ohashi, Yasuo; Omuro, Yasushi; Satoh, Taroh; Hamamoto, Yasuo; Boku, Narikazu; Miyata, Yoshinori; Takiuchi, Hiroya; Yamaguchi, Kensei; Sasaki, Yasutsuna; Nishina, Tomohiro; Satoh, Atsushi; Baba, Eishi; Tamura, Takao; Abe, Takashi; Hatake, Kiyohiko; Ohtsu, Atsushi.

In: Gastric Cancer, Vol. 15, No. 3, 01.07.2012, p. 313-322.

Research output: Contribution to journalArticle

Sawaki, A, Ohashi, Y, Omuro, Y, Satoh, T, Hamamoto, Y, Boku, N, Miyata, Y, Takiuchi, H, Yamaguchi, K, Sasaki, Y, Nishina, T, Satoh, A, Baba, E, Tamura, T, Abe, T, Hatake, K & Ohtsu, A 2012, 'Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer: A subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study', Gastric Cancer, vol. 15, no. 3, pp. 313-322. https://doi.org/10.1007/s10120-011-0118-1
Sawaki, Akira ; Ohashi, Yasuo ; Omuro, Yasushi ; Satoh, Taroh ; Hamamoto, Yasuo ; Boku, Narikazu ; Miyata, Yoshinori ; Takiuchi, Hiroya ; Yamaguchi, Kensei ; Sasaki, Yasutsuna ; Nishina, Tomohiro ; Satoh, Atsushi ; Baba, Eishi ; Tamura, Takao ; Abe, Takashi ; Hatake, Kiyohiko ; Ohtsu, Atsushi. / Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer : A subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study. In: Gastric Cancer. 2012 ; Vol. 15, No. 3. pp. 313-322.
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abstract = "Background The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (HER2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5-fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. Methods We performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). Results Median overall survival in the Japanese subgroup was 15.9 months (95{\%} confidence interval 12-25) for trastuzumab plus chemotherapy and 17.7 months (95{\%} confidence interval 12-24) for chemotherapy (hazard ratio 1.00; 95{\%} confidence interval 0.59-1.69). After adjusting Presented in part at the American Society of Clinical Oncology for prespecified covariates, the estimated hazard ratio for overall survival was 0.68 (95{\%} confidence interval 0.36-1.27). Further post hoc and exploratory examinations supported the robustness of the adjusted hazard ratios. Conclusions After adjusting for imbalanced patient backgrounds between arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advanced/metastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone.",
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T1 - Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer

T2 - A subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study

AU - Sawaki, Akira

AU - Ohashi, Yasuo

AU - Omuro, Yasushi

AU - Satoh, Taroh

AU - Hamamoto, Yasuo

AU - Boku, Narikazu

AU - Miyata, Yoshinori

AU - Takiuchi, Hiroya

AU - Yamaguchi, Kensei

AU - Sasaki, Yasutsuna

AU - Nishina, Tomohiro

AU - Satoh, Atsushi

AU - Baba, Eishi

AU - Tamura, Takao

AU - Abe, Takashi

AU - Hatake, Kiyohiko

AU - Ohtsu, Atsushi

PY - 2012/7/1

Y1 - 2012/7/1

N2 - Background The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (HER2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5-fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. Methods We performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). Results Median overall survival in the Japanese subgroup was 15.9 months (95% confidence interval 12-25) for trastuzumab plus chemotherapy and 17.7 months (95% confidence interval 12-24) for chemotherapy (hazard ratio 1.00; 95% confidence interval 0.59-1.69). After adjusting Presented in part at the American Society of Clinical Oncology for prespecified covariates, the estimated hazard ratio for overall survival was 0.68 (95% confidence interval 0.36-1.27). Further post hoc and exploratory examinations supported the robustness of the adjusted hazard ratios. Conclusions After adjusting for imbalanced patient backgrounds between arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advanced/metastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone.

AB - Background The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (HER2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5-fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. Methods We performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). Results Median overall survival in the Japanese subgroup was 15.9 months (95% confidence interval 12-25) for trastuzumab plus chemotherapy and 17.7 months (95% confidence interval 12-24) for chemotherapy (hazard ratio 1.00; 95% confidence interval 0.59-1.69). After adjusting Presented in part at the American Society of Clinical Oncology for prespecified covariates, the estimated hazard ratio for overall survival was 0.68 (95% confidence interval 0.36-1.27). Further post hoc and exploratory examinations supported the robustness of the adjusted hazard ratios. Conclusions After adjusting for imbalanced patient backgrounds between arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advanced/metastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone.

KW - Drug therapy

KW - Randomized controlled trial

KW - Stomach neoplasms

KW - Trastuzumab

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