Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan.
Department of Surgery, Osaka Prefectural General Medical Center, Osaka-shi, Japan.
Int J Clin Oncol. 2020 Sep;25(9):1635-1643. doi: 10.1007/s10147-020-01711-z. Epub 2020 Jun 3.
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 were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m twice daily for 14 days) plus cisplatin (80 mg/m 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.
我们之前报道了 HERBIS-4A 期 II 临床试验，该试验比较了 S-1 加顺铂（SP）与卡培他滨加顺铂（XP）在 HER2 阴性晚期胃癌（GC）化疗初治患者中的疗效。我们对 HERBIS-4A 和 HERBIS-2 进行了汇总分析，HERBIS-2 是一项比较 SP 与 XP 在 S-1 辅助治疗后无复发生存期≥6 个月的 HER2 阴性复发性 GC 患者中的疗效的期 II 临床试验。
患者被随机分配接受 SP [S-1（40-60mg 每日两次，连用 21 天）加顺铂（60mg/m 第 8 天），每 5 周]或 XP [卡培他滨（1000mg/m 每日两次，连用 14 天）加顺铂（80mg/m 第 1 天），每 3 周]。
在汇总分析中，SP（n=44-50）组无进展生存期更长[6.4 个月比 5.1 个月；风险比（HR），0.666；P=0.062]，总生存期更长[14.8 个月比 10.6 个月；HR，0.695；P=0.099]，治疗失败时间更长[4.6 个月比 3.6 个月；HR，0.668；P=0.045]，疾病控制率更高[86.4%比 68.1%，P=0.149]，而 XP（n=47-51）组。SP 组的生存优势明显优于 XP 组，在表现状态为 0、分化型肿瘤组织学或原发肿瘤位于胃上部的患者中更为明显。
我们的汇总分析支持将 SP 用于无复发生存期≥6 个月的 HER2 阴性晚期或复发性 GC 患者的一线治疗。
HERBIS-2 试验在 UMIN-CTR 上以 UMIN000006105 注册。
