Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Cancer Med. 2020 Apr;9(8):2812-2819. doi: 10.1002/cam4.2933. Epub 2020 Feb 26.
This prospective phase II study aimed to determine the efficacy and tolerability of sequential boost of intensity-modulated radiation therapy (IMRT) with chemotherapy for patients with inoperable esophageal squamous cell carcinoma (ESCC).
Patients with histologically or cytologically proven inoperable ESCC were enrolled in this study (ChiCTR-OIC-17010485). A larger target volume for subclinical lesion was irradiated with 50 Gy, and then, a smaller target volume only including gross tumor was boosted to 66 Gy. The fraction dose was 2 Gy, and no elective node was irradiated. Concurrent and consolidation chemotherapy of fluorouracil (600 mg/m , days 1-3) plus cisplatin (25 mg/m , days 1-3) was administered every 4 weeks, for 4 cycles in total. The primary endpoint was 2-year progression-free survival (PFS).
Eighty-eight patients were enrolled in this study. The median age was 65 years (range: 45-75 years), and 69 patients (78.4%) were men. With the median follow-up of 26 (range: 3-95) months, the 2- and 5-year PFS were 39.3% and 36.9%, respectively, and overall survival (OS) were 57.1% and 39.2%, respectively. Tumor stage and concurrent chemotherapy were independent OS predictors. Major acute adverse events were myelosuppression and esophagitis, most of which were grades 1-2. Nine percent and 2.3% of patients had grade 3 acute esophagitis and late esophageal strictures, respectively.
Sequential boost to 66 Gy by IMRT with chemotherapy was safe and effective for inoperable ESCC. A randomized phase III study to compare with standard dose of 50 Gy is warranted.
本前瞻性 II 期研究旨在确定化疗序贯调强放疗（IMRT）递增强度治疗不可切除食管鳞癌（ESCC）患者的疗效和耐受性。
本研究纳入了经组织学或细胞学证实为不可切除的 ESCC 患者（ChiCTR-OIC-17010485）。采用 50Gy 照射较大的亚临床病变靶区，然后对仅包括大体肿瘤的较小靶区进行 66Gy boost。分次剂量为 2Gy，不进行选择性淋巴结照射。每 4 周给予氟尿嘧啶（600mg/m ，第 1-3 天）联合顺铂（25mg/m ，第 1-3 天）的同步和巩固化疗，共 4 个周期。主要终点为 2 年无进展生存期（PFS）。
本研究共纳入 88 例患者。中位年龄为 65 岁（范围：45-75 岁），69 例（78.4%）为男性。中位随访 26（范围：3-95）个月后，2 年和 5 年 PFS 分别为 39.3%和 36.9%，总生存期（OS）分别为 57.1%和 39.2%。肿瘤分期和同步化疗是 OS 的独立预测因素。主要急性不良反应为骨髓抑制和食管炎，大多数为 1-2 级。分别有 9%和 2.3%的患者发生 3 级急性食管炎和晚期食管狭窄。
化疗序贯调强放疗递增至 66Gy 对不可切除的 ESCC 是安全有效的。需要进行随机 III 期研究以比较与 50Gy 标准剂量的疗效。
