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Radiation dose escalation by simultaneous modulated accelerated radiotherapy combined with chemotherapy for esophageal cancer: a phase II study

机译:同步调制加速放疗联合化疗治疗食管癌的放射剂量增加:II期研究

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摘要

The outcomes for patients with esophageal cancer (EC) underwent standard-dose radical radiotherapy were still disappointing. This phase II study investigated the feasibility, safety and efficacy of radiation dose escalation using simultaneous modulated accelerated radiotherapy (SMART) combined with chemotherapy in 60 EC patients. Radiotherapy consisted of 66Gy at 2.2 Gy/fraction to the gross tumor and 54Gy at 1.8 Gy/fraction to subclinical diseases simultaneously. Chemotherapy including cisplatin and 5fluorouracil were administered to all patients during and after radiotherapy. The data showed that the majority of patients (98.3%) completed the whole course of radiotherapy and concurrent chemotherapy. The most common ≥ grade 3 acute toxicities were neutropenia (16.7%), followed by esophagitis (6.7%) and thrombopenia (5.0%). With a median follow-up of 24 months (5-38) for all patients and 30 months (18-38) for those still alive, 11 patients (18.3%) developed ≥ Grade 3 late toxicities and 2 (3.3%) of them died subsequently due to esophageal hemorrhage. The 1- and 2-year local-regional control, distant metastasis-free survival, disease-free survival and overall survival rates were 87.6% and 78.6%, 86.0% and 80.5%, 75.6% and 64.4%, 86.7% and 72.7%, respectively. SMART combined with concurrent chemotherapy is feasible in EC patients with tolerable acute toxicities. They showed a trend of significant improvements in local-regional control and overall survival. Further follow-up is needed to evaluate the late toxicities.
机译:接受标准剂量根治性放射治疗的食管癌(EC)患者的治疗效果仍然令人失望。这项II期研究调查了60例EC患者使用同步调制加速放疗(SMART)联合化学疗法提高放射剂量的可行性,安全性和有效性。放射治疗同时包括对大体肿瘤2.2 Gy /次的66Gy和对次临床疾病的1.8 Gy /次的54Gy。在放疗期间和放疗后,对所有患者均进行了包括顺铂和5-氟尿嘧啶在内的化学治疗。数据显示,大多数患者(98.3%)完成了放疗和同步化疗的整个过程。 ≥3级最常见的急性毒性是中性粒细胞减少症(16.7%),其次是食管炎(6.7%)和血小板减少症(5.0%)。所有患者的中位随访时间为24个月(5-38),仍存活的患者为30个月(18-38),其中11例(18.3%)发生了≥3级晚期毒性,其中2例(3.3%)随后因食道出血死亡。 1年和2年局部控制,远处无转移生存,无病生存和总生存率分别为87.6%和78.6%,86.0%和80.5%,75.6%和64.4%,86.7%和72.7% , 分别。 SMART联合同步化疗对于耐受急性毒性的EC患者是可行的。他们显示出在局部区域控制和总体生存方面有重大改善的趋势。需要进一步的随访以评估晚期毒性。

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