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Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial.
European Journal of Cancer ( IF 8.4 ) Pub Date : 2020-03-11 , DOI: 10.1016/j.ejca.2020.02.013 Yanan Zheng 1 , Xiao Yang 1 , Chao Yan 1 , Runhua Feng 1 , Birendra Kumar Sah 1 , Zhongyin Yang 1 , Zhenglun Zhu 1 , Wentao Liu 1 , Wei Xu 1 , Zhentian Ni 1 , Maneesh Kumarsing Beeharry 1 , Zichen Hua 1 , Min Yan 1 , Zhenggang Zhu 1 , Chen Li 1
European Journal of Cancer ( IF 8.4 ) Pub Date : 2020-03-11 , DOI: 10.1016/j.ejca.2020.02.013 Yanan Zheng 1 , Xiao Yang 1 , Chao Yan 1 , Runhua Feng 1 , Birendra Kumar Sah 1 , Zhongyin Yang 1 , Zhenglun Zhu 1 , Wentao Liu 1 , Wei Xu 1 , Zhentian Ni 1 , Maneesh Kumarsing Beeharry 1 , Zichen Hua 1 , Min Yan 1 , Zhenggang Zhu 1 , Chen Li 1
Affiliation
BACKGROUND
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.
METHODS
Treatment-naïve patients received three preoperative cycles of S-1 (80-120 mg/day on days 1-14) and oxaliplatin (130 mg/m2 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.
RESULTS
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.
CONCLUSION
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).
中文翻译：
阿帕替尼联合新辅助化疗后切除对局部晚期胃腺癌患者病理反应的影响：一项单臂，开放标签，II期试验。
背景技术对于局部晚期胃癌患者，将新辅助化疗与靶向治疗相结合的证据不足。我们进行了单臂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。方法初治患者接受3个术前S-1（第1-14天为每天80-120 mg /天）和奥沙利铂（第1天为130 mg / m2）和两个周期的阿帕替尼（500 mg /天，共21天） ），间隔3周，然后进行手术。主要终点是病理反应率（pRR）。该试验已在ChiCTR.gov.cn上注册：ChiCTR-OPC-16010061。结果纳入的29例患者的中位年龄为60岁（范围43-73）。20名（69.0％）是男性。pRR为89.7％（95％置信区间[CI]，72.7％-97.8％； 29位患者中的26位；P <0.001），其中28例接受了手术治疗。所有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％）。无切缘切除率为96.6％（95％CI，82.2％-99.9％）。病理完全缓解率为13.8％（95％CI，1.2％-26.3％）。在16名（55.2％）患者中观察到整体TNM分期的降低。在新辅助治疗期间，有10名（34.5％）患者发生了≥III级不良事件。没有发生与治疗有关的死亡。28名患者中有12名（42.9％）观察到了与手术相关的并发症。结论SOXA手术治疗局部晚期胃腺癌表现出良好的活动性和可控的安全性。
更新日期：2020-03-12
中文翻译：
阿帕替尼联合新辅助化疗后切除对局部晚期胃腺癌患者病理反应的影响：一项单臂，开放标签，II期试验。
背景技术对于局部晚期胃癌患者，将新辅助化疗与靶向治疗相结合的证据不足。我们进行了单臂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。方法初治患者接受3个术前S-1（第1-14天为每天80-120 mg /天）和奥沙利铂（第1天为130 mg / m2）和两个周期的阿帕替尼（500 mg /天，共21天） ），间隔3周，然后进行手术。主要终点是病理反应率（pRR）。该试验已在ChiCTR.gov.cn上注册：ChiCTR-OPC-16010061。结果纳入的29例患者的中位年龄为60岁（范围43-73）。20名（69.0％）是男性。pRR为89.7％（95％置信区间[CI]，72.7％-97.8％； 29位患者中的26位；P <0.001），其中28例接受了手术治疗。所有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％）。无切缘切除率为96.6％（95％CI，82.2％-99.9％）。病理完全缓解率为13.8％（95％CI，1.2％-26.3％）。在16名（55.2％）患者中观察到整体TNM分期的降低。在新辅助治疗期间，有10名（34.5％）患者发生了≥III级不良事件。没有发生与治疗有关的死亡。28名患者中有12名（42.9％）观察到了与手术相关的并发症。结论SOXA手术治疗局部晚期胃腺癌表现出良好的活动性和可控的安全性。
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