1. Phase II Prospective Study of Trastuzumab in Combination with S-1 and Oxaliplatin (SOX100) Therapy for HER2-Positive Advanced Gastric Cancer.
- Author
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Mori Y, Kataoka H, Ebi M, Adachi K, Yamaguchi Y, Hayashi N, Hirata Y, Sobue S, Ishihara R, Suzuki Y, Mizushima T, Inoue Y, Hasegawa I, Ono S, Hirano A, Kimura Y, Seno K, Ozeki K, Shimura T, and Kubota E
- Subjects
- Humans, Oxaliplatin, Prospective Studies, Receptor, ErbB-2 metabolism, Trastuzumab therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Stomach Neoplasms drug therapy
- Abstract
Purpose: The standard first-line treatment for human epidermal growth factor receptor type 2 (HER2)-positive advanced gastric cancer (AGC) is trastuzumab in combination with cisplatin and fluoropyrimidines. We evaluated the efficacy and safety of S-1 and oxaliplatin (100 mg/m
2 ) (SOX100) combined with trastuzumab, a monoclonal antibody against HER2 for HER2-positive AGC., Methods: In this single-arm, multicenter phase II study, patients with HER2-positive AGC received S-1 (80-120 mg per day) orally on days 1-14, oxaliplatin (100 mg/m2 ) intravenously on day 1, and trastuzumab (8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) intravenously. The primary end point was 1-year survival rate. The secondary end points included overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety., Results: A total of 25 patients from six centers were enrolled from December 2015 to March 2020. In the 25 patients evaluable for analysis, the 1-year survival rate was 70.8% [90% confidence interval (CI) = 55.5-86.1%], whereas the median OS, PFS, and ORR were 17.8 (95% CI 10.5-22.9) months, 7.6 (95% CI 5.0-10.9) months, and 75.0% (95% CI 53.3-90.2), respectively. Major grade 3/4 adverse events included anorexia (20%), anemia (16%), peripheral sensory neuropathy (16%), and diarrhea (15%)., Conclusion: SOX100 combined with trastuzumab was effective with a favorable safety profile in patients with HER2-positive AGC., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)- Published
- 2022
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