Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.
Department of Gastrointestinal Surgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai, China.
Eur J Cancer. 2020 May;130:12-19. doi: 10.1016/j.ejca.2020.02.013. Epub 2020 Mar 11.
The evidence of combining neoadjuvant chemotherapy with targeted therapy for patients with locally advanced gastric cancer is inadequate. We conducted a single-arm phase II trial to evaluate the efficacy and safety of S-1, oxaliplatin and apatinib (SOXA) in patients with locally advanced gastric adenocarcinoma.
Treatment-naïve patients received three preoperative cycles of S-1 (80-120 mg/day on days 1-14) and oxaliplatin (130 mg/m on day 1) and two cycles of apatinib (500 mg/day for 21 days) at 3-week intervals, followed by surgery. The primary end-point was pathologic response rate (pRR). This trial is registered at ChiCTR.gov.cn: ChiCTR-OPC-16010061.
Of 29 patients included, median age was 60 (range, 43-73) years; 20 (69.0%) were male. The pRR was 89.7% (95% confidence interval [CI], 72.7%-97.8%; 26 of 29 patients; P < 0.001) with 28 patients treated with surgery. All 29 patients were available for preoperative response evaluation, achieving an objective response rate of 79.3% (95% CI, 60.3%-92.0%) and a disease control rate of 96.6% (95% CI, 82.2%-99.9%). The margin-free resection rate was 96.6% (95% CI, 82.2%-99.9%). The pathologic complete response rate was 13.8% (95%CI, 1.2%-26.3%). Downstaging of overall TNM stage was observed in 16 (55.2%) patients. During neoadjuvant therapy, 10 (34.5%) patients had grade ≥III adverse events. No treatment-related death occurred. Surgery-related complications were observed in 12 of 28 (42.9%) patients.
SOXA followed by surgery in patients with locally advanced gastric adenocarcinoma showed favourable activity and manageable safety. A randomised controlled trial in locally advanced gastric or oesophagogastric junction adenocarcinoma is ongoing (ClinicalTrials.gov: NCT04208347).
联合新辅助化疗和靶向治疗局部晚期胃癌的证据不足。我们进行了一项单臂 II 期试验，以评估 S-1、奥沙利铂和阿帕替尼（SOXA）在局部晚期胃腺癌患者中的疗效和安全性。
未经治疗的患者接受三个术前周期的 S-1（第 1-14 天每天 80-120mg）和奥沙利铂（第 1 天 130mg/m）和两个周期的阿帕替尼（21 天每天 500mg），每 3 周一次，然后进行手术。主要终点是病理缓解率（pRR）。该试验在中国临床试验注册中心注册：ChiCTR-OPC-16010061。
29 例患者中，中位年龄为 60 岁（范围，43-73 岁）；20 例（69.0%）为男性。pRR 为 89.7%（95%置信区间[CI]，72.7%-97.8%；26/29 例；P<0.001），28 例患者接受了手术。29 例患者均可进行术前反应评估，客观缓解率为 79.3%（95%CI，60.3%-92.0%），疾病控制率为 96.6%（95%CI，82.2%-99.9%）。无切缘残留率为 96.6%（95%CI，82.2%-99.9%）。病理完全缓解率为 13.8%（95%CI，1.2%-26.3%）。总体 TNM 分期降期见于 16 例（55.2%）患者。新辅助治疗期间，10 例（34.5%）患者出现≥III 级不良事件。无治疗相关死亡。28 例患者中有 12 例（42.9%）发生手术相关并发症。
SOXA 联合局部晚期胃腺癌患者手术治疗显示出良好的活性和可管理的安全性。一项针对局部晚期胃或食管胃交界腺癌的随机对照试验正在进行中（ClinicalTrials.gov：NCT04208347）。
