Multicenter phase II study of SOX plus trastuzumab for patients with HER2+ metastatic or recurrent gastric cancer: KSCC/HGCSG/CCOG/PerSeUS 1501B

Satoshi Yuki, Katsunori Shinozaki, Tomomi Kashiwada, Tetsuya Kusumoto, Masaaki Iwatsuki, Hironaga Satake, Kazuma Kobayashi, Taito Esaki, Yuichiro Nakashima, Hirofumi Kawanaka, Yasunori Emi, Yoshito Komatsu, Mototsugu Shimokawa, Akitaka Makiyama, Hiroshi Saeki, Eiji Oki, Hideo Baba, Masaki Mori

Research output: Contribution to journalArticle

Abstract

Background: Trastuzumab (T-mab) combined with cisplatin and fluoropyrimidines is a standard first-line treatment for HER2+ advanced gastric cancer (AGC). We conducted the first phase II trial among four Japanese study groups to assess the efficacy and safety of T-mab + S-1 and oxaliplatin (T-SOX130) for HER2+ AGC or recurrent gastric cancer. Methods: Patients with IHC 3+ or IHC 2+/FISH+ tumors received 80 mg/m2 (80–120 mg/day) oral S-1 on days 1–14, 130 mg/m2 intravenous oxaliplatin on day 1, and intravenous T-mab (8 mg/kg loading dose, 6 mg/kg thereafter) on day 1 of a 21-day cycle. The primary endpoint was centrally assessed response rate (RR). Adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE) Ver.4.0. Results: We enrolled 42 patients from June 2015 to May 2016. Efficacy and safety analyses were conducted for 39 patients. The data cutoff was May 31, 2018. The confirmed RR was 82.1% (32/39; 90% CI 70.0–90.0); the disease control rate was 87.2% (34/39; 95% CI 73.3–94.4). Nine patients underwent curative surgery after T-SOX130. Median Time to treatment failure (TTF), Progression-free survival (PFS) and Overall survival (OS) was 5.7 (95% CI 4.6–7.0), 7.0 (95% CI 5.5–14.1), and 27.6 (95% CI 15.6–Not reached) months, respectively. Incidences of grade 3–4 adverse events > 10% were thrombocytopenia (17.9%), anorexia (17.9%), anemia (12.8%), neutropenia (10.3%), and hyponatremia (10.3%). Conclusions: T-SOX130 showed promising response and survival with a favorable safety profile and should be considered for patients with HER2+ AGC.

Original languageEnglish
Pages (from-to)217-223
Number of pages7
JournalCancer chemotherapy and pharmacology
Volume85
Issue number1
DOIs
Publication statusPublished - Jan 1 2020

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oxaliplatin
Stomach Neoplasms
Disease control
Safety
Terminology
Surgery
Cisplatin
Tumors
Survival
Hyponatremia
Anorexia
Neutropenia
Treatment Failure
Thrombocytopenia
Disease-Free Survival
Anemia
Trastuzumab
Incidence
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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Multicenter phase II study of SOX plus trastuzumab for patients with HER2+ metastatic or recurrent gastric cancer : KSCC/HGCSG/CCOG/PerSeUS 1501B. / Yuki, Satoshi; Shinozaki, Katsunori; Kashiwada, Tomomi; Kusumoto, Tetsuya; Iwatsuki, Masaaki; Satake, Hironaga; Kobayashi, Kazuma; Esaki, Taito; Nakashima, Yuichiro; Kawanaka, Hirofumi; Emi, Yasunori; Komatsu, Yoshito; Shimokawa, Mototsugu; Makiyama, Akitaka; Saeki, Hiroshi; Oki, Eiji; Baba, Hideo; Mori, Masaki.

In: Cancer chemotherapy and pharmacology, Vol. 85, No. 1, 01.01.2020, p. 217-223.

Research output: Contribution to journalArticle

Yuki, S, Shinozaki, K, Kashiwada, T, Kusumoto, T, Iwatsuki, M, Satake, H, Kobayashi, K, Esaki, T, Nakashima, Y, Kawanaka, H, Emi, Y, Komatsu, Y, Shimokawa, M, Makiyama, A, Saeki, H, Oki, E, Baba, H & Mori, M 2020, 'Multicenter phase II study of SOX plus trastuzumab for patients with HER2+ metastatic or recurrent gastric cancer: KSCC/HGCSG/CCOG/PerSeUS 1501B', Cancer chemotherapy and pharmacology, vol. 85, no. 1, pp. 217-223. https://doi.org/10.1007/s00280-019-03991-3
Yuki, Satoshi ; Shinozaki, Katsunori ; Kashiwada, Tomomi ; Kusumoto, Tetsuya ; Iwatsuki, Masaaki ; Satake, Hironaga ; Kobayashi, Kazuma ; Esaki, Taito ; Nakashima, Yuichiro ; Kawanaka, Hirofumi ; Emi, Yasunori ; Komatsu, Yoshito ; Shimokawa, Mototsugu ; Makiyama, Akitaka ; Saeki, Hiroshi ; Oki, Eiji ; Baba, Hideo ; Mori, Masaki. / Multicenter phase II study of SOX plus trastuzumab for patients with HER2+ metastatic or recurrent gastric cancer : KSCC/HGCSG/CCOG/PerSeUS 1501B. In: Cancer chemotherapy and pharmacology. 2020 ; Vol. 85, No. 1. pp. 217-223.
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abstract = "Background: Trastuzumab (T-mab) combined with cisplatin and fluoropyrimidines is a standard first-line treatment for HER2+ advanced gastric cancer (AGC). We conducted the first phase II trial among four Japanese study groups to assess the efficacy and safety of T-mab + S-1 and oxaliplatin (T-SOX130) for HER2+ AGC or recurrent gastric cancer. Methods: Patients with IHC 3+ or IHC 2+/FISH+ tumors received 80 mg/m2 (80–120 mg/day) oral S-1 on days 1–14, 130 mg/m2 intravenous oxaliplatin on day 1, and intravenous T-mab (8 mg/kg loading dose, 6 mg/kg thereafter) on day 1 of a 21-day cycle. The primary endpoint was centrally assessed response rate (RR). Adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE) Ver.4.0. Results: We enrolled 42 patients from June 2015 to May 2016. Efficacy and safety analyses were conducted for 39 patients. The data cutoff was May 31, 2018. The confirmed RR was 82.1{\%} (32/39; 90{\%} CI 70.0–90.0); the disease control rate was 87.2{\%} (34/39; 95{\%} CI 73.3–94.4). Nine patients underwent curative surgery after T-SOX130. Median Time to treatment failure (TTF), Progression-free survival (PFS) and Overall survival (OS) was 5.7 (95{\%} CI 4.6–7.0), 7.0 (95{\%} CI 5.5–14.1), and 27.6 (95{\%} CI 15.6–Not reached) months, respectively. Incidences of grade 3–4 adverse events > 10{\%} were thrombocytopenia (17.9{\%}), anorexia (17.9{\%}), anemia (12.8{\%}), neutropenia (10.3{\%}), and hyponatremia (10.3{\%}). Conclusions: T-SOX130 showed promising response and survival with a favorable safety profile and should be considered for patients with HER2+ AGC.",
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TY - JOUR

T1 - Multicenter phase II study of SOX plus trastuzumab for patients with HER2+ metastatic or recurrent gastric cancer

T2 - KSCC/HGCSG/CCOG/PerSeUS 1501B

AU - Yuki, Satoshi

AU - Shinozaki, Katsunori

AU - Kashiwada, Tomomi

AU - Kusumoto, Tetsuya

AU - Iwatsuki, Masaaki

AU - Satake, Hironaga

AU - Kobayashi, Kazuma

AU - Esaki, Taito

AU - Nakashima, Yuichiro

AU - Kawanaka, Hirofumi

AU - Emi, Yasunori

AU - Komatsu, Yoshito

AU - Shimokawa, Mototsugu

AU - Makiyama, Akitaka

AU - Saeki, Hiroshi

AU - Oki, Eiji

AU - Baba, Hideo

AU - Mori, Masaki

PY - 2020/1/1

Y1 - 2020/1/1

N2 - Background: Trastuzumab (T-mab) combined with cisplatin and fluoropyrimidines is a standard first-line treatment for HER2+ advanced gastric cancer (AGC). We conducted the first phase II trial among four Japanese study groups to assess the efficacy and safety of T-mab + S-1 and oxaliplatin (T-SOX130) for HER2+ AGC or recurrent gastric cancer. Methods: Patients with IHC 3+ or IHC 2+/FISH+ tumors received 80 mg/m2 (80–120 mg/day) oral S-1 on days 1–14, 130 mg/m2 intravenous oxaliplatin on day 1, and intravenous T-mab (8 mg/kg loading dose, 6 mg/kg thereafter) on day 1 of a 21-day cycle. The primary endpoint was centrally assessed response rate (RR). Adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE) Ver.4.0. Results: We enrolled 42 patients from June 2015 to May 2016. Efficacy and safety analyses were conducted for 39 patients. The data cutoff was May 31, 2018. The confirmed RR was 82.1% (32/39; 90% CI 70.0–90.0); the disease control rate was 87.2% (34/39; 95% CI 73.3–94.4). Nine patients underwent curative surgery after T-SOX130. Median Time to treatment failure (TTF), Progression-free survival (PFS) and Overall survival (OS) was 5.7 (95% CI 4.6–7.0), 7.0 (95% CI 5.5–14.1), and 27.6 (95% CI 15.6–Not reached) months, respectively. Incidences of grade 3–4 adverse events > 10% were thrombocytopenia (17.9%), anorexia (17.9%), anemia (12.8%), neutropenia (10.3%), and hyponatremia (10.3%). Conclusions: T-SOX130 showed promising response and survival with a favorable safety profile and should be considered for patients with HER2+ AGC.

AB - Background: Trastuzumab (T-mab) combined with cisplatin and fluoropyrimidines is a standard first-line treatment for HER2+ advanced gastric cancer (AGC). We conducted the first phase II trial among four Japanese study groups to assess the efficacy and safety of T-mab + S-1 and oxaliplatin (T-SOX130) for HER2+ AGC or recurrent gastric cancer. Methods: Patients with IHC 3+ or IHC 2+/FISH+ tumors received 80 mg/m2 (80–120 mg/day) oral S-1 on days 1–14, 130 mg/m2 intravenous oxaliplatin on day 1, and intravenous T-mab (8 mg/kg loading dose, 6 mg/kg thereafter) on day 1 of a 21-day cycle. The primary endpoint was centrally assessed response rate (RR). Adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE) Ver.4.0. Results: We enrolled 42 patients from June 2015 to May 2016. Efficacy and safety analyses were conducted for 39 patients. The data cutoff was May 31, 2018. The confirmed RR was 82.1% (32/39; 90% CI 70.0–90.0); the disease control rate was 87.2% (34/39; 95% CI 73.3–94.4). Nine patients underwent curative surgery after T-SOX130. Median Time to treatment failure (TTF), Progression-free survival (PFS) and Overall survival (OS) was 5.7 (95% CI 4.6–7.0), 7.0 (95% CI 5.5–14.1), and 27.6 (95% CI 15.6–Not reached) months, respectively. Incidences of grade 3–4 adverse events > 10% were thrombocytopenia (17.9%), anorexia (17.9%), anemia (12.8%), neutropenia (10.3%), and hyponatremia (10.3%). Conclusions: T-SOX130 showed promising response and survival with a favorable safety profile and should be considered for patients with HER2+ AGC.

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