Five-weekly S-1 plus cisplatin therapy combined with trastuzumab therapy in HER2-positive gastric cancer: a phase II trial and biomarker study (WJOG7212G)
| Autor: | K. Nishikawa, Naotoshi Sugimoto, Miki Ito, Ichinosuke Hyodo, Misuzu Mori, Kenichi Yoshimura, Shuichi Hironaka, Keita Uchino, Hirotsugu Yoshiyama, Katsunori Shinozaki, Tsuyoshi Shirakawa, Takeshi Sakamoto, Kazuhiro Nishikawa, Yasutaka Sukawa, Yutaka Kimura, Hiroharu Shinozaki, Shinya Tokunaga, Yoshinori Miyata, Yuji Negoro, Hiroyuki Okuda, Kimio Yonesaka, Toshikazu Moriwaki, Narikazu Boku, Keisei Taku, Nobuyuki Musha, Katsuhiko Nosho, Toshimi Takano, Yuji Miura, Takashi Tsuda |
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| Rok vydání: | 2016 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Receptor ErbB-2 Neutropenia Adenocarcinoma Disease-Free Survival 03 medical and health sciences 0302 clinical medicine Trastuzumab Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Biomarkers Tumor Humans Adverse effect Aged Tegafur Cisplatin business.industry Gastroenterology Cancer General Medicine Middle Aged medicine.disease Drug Combinations Oxonic Acid 030220 oncology & carcinogenesis Toxicity Biomarker (medicine) 030211 gastroenterology & hepatology Female business medicine.drug |
| Zdroj: | Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association. 21(1) |
| ISSN: | 1436-3305 |
| Popis: | Five-weekly S-1 plus cisplatin (SP) therapy is the standard care for advanced gastric or esophagogastric junction cancer (GC/EGJC) in East Asia. However, its efficacy and safety when combined with trastuzumab therapy for human epidermal growth factor receptor 2 (HER2)-positive advanced GC/EGJC remains unclear. Patients received 5-weekly SP therapy (S-1 at 40–60 mg twice daily for 21 days plus cisplatin at 60 mg/m2 on day 8, every 5 weeks) plus trastuzumab therapy (first dose of 8 mg/kg, then 6 mg/kg every 3 weeks). The primary end point was the response rate, and the secondary end points included progression-free survival, overall survival, safety, and serum biomarker levels. Forty-four patients were enrolled. The response rate, progression-free survival, and overall survival were 61% (95% confidence interval 46–76%), 5.9 months, and 16.5 months respectively. The commonest grade 3 or grade 4 adverse events were neutropenia (30%) and anorexia (25%). A significantly higher response rate (92% vs 43%; P = 0.008) and longer progression-free survival (median 14.5 months vs 4.2 months; P = 0.028) were observed in patients with high (n = 14) compared with low (n = 17) pretreatment serum neuregulin 1 levels. Five-weekly SP therapy combined with trastuzumab therapy showed a good antitumor response and acceptable toxicity in HER2-positive advanced GC/EGJC. Serum neuregulin 1 might be associated with the efficacy of this treatment regimen. |
| Databáze: | OpenAIRE |
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