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

• Published in: International journal of clinical oncology 2020-09, Vol.25 (9), p.1635-1643
• Main Authors: Kawakami, Hisato, Fujitani, Kazumasa, Matsuyama, Jin, Akamaru, Yusuke, Tamura, Shigeyuki, Endo, Shunji, Kimura, Yutaka, Makari, Youichi, Tamura, Takao, Sugimoto, Naotoshi, Sakai, Daisuke, Tsujinaka, Toshimasa, Goto, Masahiro, Kurokawa, Yukinori, Shimokawa, Toshio, Satoh, Taroh
• Format: Article
• Language: English
• Subjects: Adjuvant therapy; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Capecitabine - administration & dosage; Chemotherapy; Chemotherapy, Adjuvant; Cisplatin; Cisplatin - administration & dosage; Cisplatin - therapeutic use; Clinical trials; Disease control; Drug Combinations; ErbB-2 protein; Female; Gastric cancer; Humans; Localization; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Recurrence, Local; Oncology; Original Article; Oxonic Acid - administration & dosage; Patients; Progression-Free Survival; Receptor, ErbB-2 - metabolism; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Stomach Neoplasms - pathology; Surgical Oncology; Survival; Tegafur - administration & dosage; Treatment Outcome
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-020-01711-z

Background We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve 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 and methods Patients were randomly assigned to receive either SP [S-1 (40–60 mg twice daily for 21 days) plus cisplatin (60 mg/m 2  on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m 2  twice daily for 14 days) plus cisplatin (80 mg/m 2 on day 1), every 3 weeks]. Results 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. Conclusion 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. Clinical trial registration The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.