Comparison of S-1–cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials
| Autor: | Yutaka Kimura, Hisato Kawakami, Masahiro Goto, Youichi Makari, Takao Tamura, Naotoshi Sugimoto, Jin Matsuyama, Yukinori Kurokawa, Toshimasa Tsujinaka, Daisuke Sakai, Shunji Endo, Kazumasa Fujitani, Yusuke Akamaru, Toshio Shimokawa, Shigeyuki Tamura, Taroh Satoh |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Receptor ErbB-2 Gastroenterology Capecitabine 03 medical and health sciences 0302 clinical medicine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Adjuvant therapy Humans Aged Tegafur Cisplatin Performance status business.industry Stomach Hazard ratio Cancer Hematology General Medicine Middle Aged medicine.disease Primary tumor Progression-Free Survival Drug Combinations Oxonic Acid Treatment Outcome 030104 developmental biology medicine.anatomical_structure Oncology Chemotherapy Adjuvant 030220 oncology & carcinogenesis Female Surgery Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | International Journal of Clinical Oncology. 25:1635-1643 |
| ISSN: | 1437-7772 1341-9625 |
| Popis: | We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naive patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months. Patients were randomly assigned to receive either SP [S-1 (40–60 mg twice daily for 21 days) plus cisplatin (60 mg/m2 on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m2 twice daily for 14 days) plus cisplatin (80 mg/m2 on day 1), every 3 weeks]. In the pooled analysis, SP (n = 44–50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47–51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach. Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months. The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105. |
| Databáze: | OpenAIRE |
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