Regional differences in advanced gastric cancer: exploratory analyses of the AVAGAST placebo arm

Akira Sawaki, Yasuhide Yamada, Kensei Yamaguchi, Tomohiro Nishina, Toshihiko Doi, Taroh Satoh, Keisho Chin, Narikazu Boku, Yasushi Omuro, Yoshito Komatsu, Yasuo Hamamoto, Wasaburo Koizumi, Shigehira Saji, Manish A. Shah, Eric van Cutsem, Yoon Koo Kang, Junko Iwasaki, Hiroshi Kuriki, Wataru Ohtsuka, Atsushi Ohtsu

Research output: Contribution to journalArticle

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Abstract

Background: AVAGAST was an international, randomized, placebo-controlled phase III study of chemotherapy with or without bevacizumab as first-line therapy for patients with advanced gastric cancer. We performed exploratory analyses to evaluate regional differences observed in the trial. Methods: Analyses were performed in the placebo plus chemotherapy arm (intention-to-treat population). Chemotherapy was cisplatin 80 mg/m2 for six cycles plus capecitabine (1000 mg/m2 orally bid days 1–14) or 5-fluorouracil (800 mg/m2/day continuous IV infusion days 1–5) every 3 weeks until disease progression or unacceptable toxicity. Results: Overall, 387 patients were assigned to placebo plus chemotherapy (eastern Europe/South America, n = 118; USA/western Europe, n = 81; Korea/other Asia, n = 94; Japan, n = 94). At baseline, poor performance status, liver metastases, and larger tumors were most frequent in eastern Europe/South America and least frequent in Japan. Patients received subsequent chemotherapy after disease progression as follows: eastern Europe/South America (14%); USA/western Europe (37%); Korea/other Asia (61%); and Japan (77%). Hazard ratios for overall survival versus USA/western Europe were 1.47 (95% CI, 1.09–1.99) for eastern Europe/South America, 0.91 (95% CI, 0.67–1.25) for Korea/other Asia, and 0.87 (95% CI, 0.64–1.19) for Japan. Conclusions: Regional differences in the healthcare environment may have contributed to the differences in overall survival observed in the AVAGAST study.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalGastric Cancer
DOIs
Publication statusAccepted/In press - 2017 Oct 20

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Eastern Europe
South America
Stomach Neoplasms
Placebos
Japan
Drug Therapy
Korea
Disease Progression
Survival
Fluorouracil
Cisplatin
Neoplasm Metastasis
Delivery of Health Care
Liver
Population
Neoplasms
Therapeutics

Keywords

  • Geographic locations
  • Stomach neoplasms
  • Survival analysis

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

Sawaki, A., Yamada, Y., Yamaguchi, K., Nishina, T., Doi, T., Satoh, T., ... Ohtsu, A. (Accepted/In press). Regional differences in advanced gastric cancer: exploratory analyses of the AVAGAST placebo arm. Gastric Cancer, 1-10. https://doi.org/10.1007/s10120-017-0773-y

Regional differences in advanced gastric cancer : exploratory analyses of the AVAGAST placebo arm. / Sawaki, Akira; Yamada, Yasuhide; Yamaguchi, Kensei; Nishina, Tomohiro; Doi, Toshihiko; Satoh, Taroh; Chin, Keisho; Boku, Narikazu; Omuro, Yasushi; Komatsu, Yoshito; Hamamoto, Yasuo; Koizumi, Wasaburo; Saji, Shigehira; Shah, Manish A.; van Cutsem, Eric; Kang, Yoon Koo; Iwasaki, Junko; Kuriki, Hiroshi; Ohtsuka, Wataru; Ohtsu, Atsushi.

In: Gastric Cancer, 20.10.2017, p. 1-10.

Research output: Contribution to journalArticle

Sawaki, A, Yamada, Y, Yamaguchi, K, Nishina, T, Doi, T, Satoh, T, Chin, K, Boku, N, Omuro, Y, Komatsu, Y, Hamamoto, Y, Koizumi, W, Saji, S, Shah, MA, van Cutsem, E, Kang, YK, Iwasaki, J, Kuriki, H, Ohtsuka, W & Ohtsu, A 2017, 'Regional differences in advanced gastric cancer: exploratory analyses of the AVAGAST placebo arm', Gastric Cancer, pp. 1-10. https://doi.org/10.1007/s10120-017-0773-y
Sawaki, Akira ; Yamada, Yasuhide ; Yamaguchi, Kensei ; Nishina, Tomohiro ; Doi, Toshihiko ; Satoh, Taroh ; Chin, Keisho ; Boku, Narikazu ; Omuro, Yasushi ; Komatsu, Yoshito ; Hamamoto, Yasuo ; Koizumi, Wasaburo ; Saji, Shigehira ; Shah, Manish A. ; van Cutsem, Eric ; Kang, Yoon Koo ; Iwasaki, Junko ; Kuriki, Hiroshi ; Ohtsuka, Wataru ; Ohtsu, Atsushi. / Regional differences in advanced gastric cancer : exploratory analyses of the AVAGAST placebo arm. In: Gastric Cancer. 2017 ; pp. 1-10.
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abstract = "Background: AVAGAST was an international, randomized, placebo-controlled phase III study of chemotherapy with or without bevacizumab as first-line therapy for patients with advanced gastric cancer. We performed exploratory analyses to evaluate regional differences observed in the trial. Methods: Analyses were performed in the placebo plus chemotherapy arm (intention-to-treat population). Chemotherapy was cisplatin 80 mg/m2 for six cycles plus capecitabine (1000 mg/m2 orally bid days 1–14) or 5-fluorouracil (800 mg/m2/day continuous IV infusion days 1–5) every 3 weeks until disease progression or unacceptable toxicity. Results: Overall, 387 patients were assigned to placebo plus chemotherapy (eastern Europe/South America, n = 118; USA/western Europe, n = 81; Korea/other Asia, n = 94; Japan, n = 94). At baseline, poor performance status, liver metastases, and larger tumors were most frequent in eastern Europe/South America and least frequent in Japan. Patients received subsequent chemotherapy after disease progression as follows: eastern Europe/South America (14{\%}); USA/western Europe (37{\%}); Korea/other Asia (61{\%}); and Japan (77{\%}). Hazard ratios for overall survival versus USA/western Europe were 1.47 (95{\%} CI, 1.09–1.99) for eastern Europe/South America, 0.91 (95{\%} CI, 0.67–1.25) for Korea/other Asia, and 0.87 (95{\%} CI, 0.64–1.19) for Japan. Conclusions: Regional differences in the healthcare environment may have contributed to the differences in overall survival observed in the AVAGAST study.",
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T1 - Regional differences in advanced gastric cancer

T2 - exploratory analyses of the AVAGAST placebo arm

AU - Sawaki, Akira

AU - Yamada, Yasuhide

AU - Yamaguchi, Kensei

AU - Nishina, Tomohiro

AU - Doi, Toshihiko

AU - Satoh, Taroh

AU - Chin, Keisho

AU - Boku, Narikazu

AU - Omuro, Yasushi

AU - Komatsu, Yoshito

AU - Hamamoto, Yasuo

AU - Koizumi, Wasaburo

AU - Saji, Shigehira

AU - Shah, Manish A.

AU - van Cutsem, Eric

AU - Kang, Yoon Koo

AU - Iwasaki, Junko

AU - Kuriki, Hiroshi

AU - Ohtsuka, Wataru

AU - Ohtsu, Atsushi

PY - 2017/10/20

Y1 - 2017/10/20

N2 - Background: AVAGAST was an international, randomized, placebo-controlled phase III study of chemotherapy with or without bevacizumab as first-line therapy for patients with advanced gastric cancer. We performed exploratory analyses to evaluate regional differences observed in the trial. Methods: Analyses were performed in the placebo plus chemotherapy arm (intention-to-treat population). Chemotherapy was cisplatin 80 mg/m2 for six cycles plus capecitabine (1000 mg/m2 orally bid days 1–14) or 5-fluorouracil (800 mg/m2/day continuous IV infusion days 1–5) every 3 weeks until disease progression or unacceptable toxicity. Results: Overall, 387 patients were assigned to placebo plus chemotherapy (eastern Europe/South America, n = 118; USA/western Europe, n = 81; Korea/other Asia, n = 94; Japan, n = 94). At baseline, poor performance status, liver metastases, and larger tumors were most frequent in eastern Europe/South America and least frequent in Japan. Patients received subsequent chemotherapy after disease progression as follows: eastern Europe/South America (14%); USA/western Europe (37%); Korea/other Asia (61%); and Japan (77%). Hazard ratios for overall survival versus USA/western Europe were 1.47 (95% CI, 1.09–1.99) for eastern Europe/South America, 0.91 (95% CI, 0.67–1.25) for Korea/other Asia, and 0.87 (95% CI, 0.64–1.19) for Japan. Conclusions: Regional differences in the healthcare environment may have contributed to the differences in overall survival observed in the AVAGAST study.

AB - Background: AVAGAST was an international, randomized, placebo-controlled phase III study of chemotherapy with or without bevacizumab as first-line therapy for patients with advanced gastric cancer. We performed exploratory analyses to evaluate regional differences observed in the trial. Methods: Analyses were performed in the placebo plus chemotherapy arm (intention-to-treat population). Chemotherapy was cisplatin 80 mg/m2 for six cycles plus capecitabine (1000 mg/m2 orally bid days 1–14) or 5-fluorouracil (800 mg/m2/day continuous IV infusion days 1–5) every 3 weeks until disease progression or unacceptable toxicity. Results: Overall, 387 patients were assigned to placebo plus chemotherapy (eastern Europe/South America, n = 118; USA/western Europe, n = 81; Korea/other Asia, n = 94; Japan, n = 94). At baseline, poor performance status, liver metastases, and larger tumors were most frequent in eastern Europe/South America and least frequent in Japan. Patients received subsequent chemotherapy after disease progression as follows: eastern Europe/South America (14%); USA/western Europe (37%); Korea/other Asia (61%); and Japan (77%). Hazard ratios for overall survival versus USA/western Europe were 1.47 (95% CI, 1.09–1.99) for eastern Europe/South America, 0.91 (95% CI, 0.67–1.25) for Korea/other Asia, and 0.87 (95% CI, 0.64–1.19) for Japan. Conclusions: Regional differences in the healthcare environment may have contributed to the differences in overall survival observed in the AVAGAST study.

KW - Geographic locations

KW - Stomach neoplasms

KW - Survival analysis

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