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25.11.2019 | Clinical Trial Report

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

verfasst von: 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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 1/2020

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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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Titel: Multicenter phase II study of SOX plus trastuzumab for patients with HER2+ metastatic or recurrent gastric cancer: KSCC/HGCSG/CCOG/PerSeUS 1501B
verfasst von: 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
Publikationsdatum: 25.11.2019
Verlag: Springer Berlin Heidelberg
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 1/2020
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-019-03991-3

Springer Medizin

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