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Abstract：
OBJECTIVE: Preoperative chemoradiation (CRT) is expected to increase the rate of curative resection and complete histological response. In this trial, we investigated the efficacy of a neoadjuvant CRT regimen in gastric adenocarcinoma (NCT01565109 trial).
METHODS: Patients with stage IB to IIIC gastric adenocarcinoma, endoscopy ultrasound and computed tomography-scan diagnosed, were eligible for this phase II trial. Neoadjuvant treatment consisted of 2 cycles of chemotherapy with DCF (docetaxel, cisplatin, and 5-fluorouracil [5FU]) followed by preoperative CRT with oxaliplatin, continuous 5FU and radiotherapy (45 Gy in 25 fractions of 1.8 Gy, 5 fractions per week for 5 weeks) administered before surgery. R0-resection rate, pathological complete response (pathCR) rate, and survival (progression-free survival [PFS] and overall survival [OS]) were evaluated as primary endpoints.
RESULTS: Among 33 patients included, 32 patients (97%) received CRT and 26 (78.8%) were resected (R0 resection for all patients resected). Among resected patients, we report pathCR in 23,1% and pathologic major response (tumor regression grade 2 according to Mandard\'s classification) in 26,9%. With a median follow-up duration of 5.82 years (range, 0.4 to 9.24 years), the estimated median OS for all 33 patients was not reached; 1-, 3-, and 5-year OS rates were 85%, 61%, and 52%, respectively. Among resected patients, those whose histological response was tumor grade regression (TRG) 1-2 had significantly better OS and PFS rates than those with a TRG 3-4-5 response (p=0.019 and p=0.016, respectively).
CONCLUSIONS: Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a phase III trial.
METHODS: Patients with stage IB to IIIC gastric adenocarcinoma, endoscopy ultrasound and computed tomography-scan diagnosed, were eligible for this phase II trial. Neoadjuvant treatment consisted of 2 cycles of chemotherapy with DCF (docetaxel, cisplatin, and 5-fluorouracil [5FU]) followed by preoperative CRT with oxaliplatin, continuous 5FU and radiotherapy (45 Gy in 25 fractions of 1.8 Gy, 5 fractions per week for 5 weeks) administered before surgery. R0-resection rate, pathological complete response (pathCR) rate, and survival (progression-free survival [PFS] and overall survival [OS]) were evaluated as primary endpoints.
RESULTS: Among 33 patients included, 32 patients (97%) received CRT and 26 (78.8%) were resected (R0 resection for all patients resected). Among resected patients, we report pathCR in 23,1% and pathologic major response (tumor regression grade 2 according to Mandard\'s classification) in 26,9%. With a median follow-up duration of 5.82 years (range, 0.4 to 9.24 years), the estimated median OS for all 33 patients was not reached; 1-, 3-, and 5-year OS rates were 85%, 61%, and 52%, respectively. Among resected patients, those whose histological response was tumor grade regression (TRG) 1-2 had significantly better OS and PFS rates than those with a TRG 3-4-5 response (p=0.019 and p=0.016, respectively).
CONCLUSIONS: Promising results from trials involving preoperative chemoradiation followed by surgery in gastric cancer need to be further evaluated in a phase III trial.
摘要：
■术前放化疗（CRT）有望提高治愈性切除率和完整的组织学反应。在这次审判中,我们研究了新辅助CRT方案在胃腺癌中的疗效(NCT01565109试验).
■IB期至IIIC期胃腺癌患者，内窥镜超声和CT扫描诊断，有资格参加这项II期试验。新辅助治疗包括2个周期的DCF化疗（多西他赛，顺铂,5FU），然后术前放化疗奥沙利铂，连续5FU和放疗（1.8Gy的25个部分中45Gy，每周5份，持续5周）在手术前给药。R0-切除率,病理完全缓解率和生存率(无进展生存率和总生存率)作为主要终点进行评估.
■在包括的33名患者中，32例（97％）接受CRT治疗，26例（78.8％）切除（R0切除所有切除患者）。在切除的患者中，我们报告了23,1%的病理完全缓解（pathCR）和26,9%的病理主要缓解（根据Mandard分类，肿瘤消退2级）。中位随访时间为5.82年(范围，0.4-9.24年），未达到所有33例患者的估计中位总生存期（OS）；1-，3-,5年OS率为85%，61%和52%，分别。在切除的患者中，组织学应答为TRG1-2的患者的OS和无进展生存率(PFS)明显优于TRG3-4-5应答的患者(分别为p=0.019和p=0.016).
■胃癌术前放化疗后手术的试验有希望的结果需要在III期试验中进一步评估。
■IB期至IIIC期胃腺癌患者，内窥镜超声和CT扫描诊断，有资格参加这项II期试验。新辅助治疗包括2个周期的DCF化疗（多西他赛，顺铂,5FU），然后术前放化疗奥沙利铂，连续5FU和放疗（1.8Gy的25个部分中45Gy，每周5份，持续5周）在手术前给药。R0-切除率,病理完全缓解率和生存率(无进展生存率和总生存率)作为主要终点进行评估.
■在包括的33名患者中，32例（97％）接受CRT治疗，26例（78.8％）切除（R0切除所有切除患者）。在切除的患者中，我们报告了23,1%的病理完全缓解（pathCR）和26,9%的病理主要缓解（根据Mandard分类，肿瘤消退2级）。中位随访时间为5.82年(范围，0.4-9.24年），未达到所有33例患者的估计中位总生存期（OS）；1-，3-,5年OS率为85%，61%和52%，分别。在切除的患者中，组织学应答为TRG1-2的患者的OS和无进展生存率(PFS)明显优于TRG3-4-5应答的患者(分别为p=0.019和p=0.016).
■胃癌术前放化疗后手术的试验有希望的结果需要在III期试验中进一步评估。
