Simultaneous Integrated Boost Intensity-Modulated Radiotherapy (SIB-IMRT) Combined with Nimotuzumab for Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC): A Phase II Clinical Trial.

Lan Wang,Lihong Liu, Yu Cao,Xiaoxi Chen,Shutang Liu,Xiaoning Li,Jing Han,Qi Wang,Chun Han

BMC Cancer（2024）

The Fourth Hospital of Hebei Medical University

Cited 0|Views25

Abstract

To evaluate the feasibility, safety and efficacy of concurrent simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) combined with nimotuzumab in the treatment of locally advanced esophageal squamous cell cancer (ESCC). Eligible patients were histologically proven to have locally advanced ESCC, and were unable to tolerate or refuse concurrent chemoradiotherapy (CCRT). Enrolled patients underwent concurrent SIB-IMRT in combination with nimotuzumab. SIB-IMRT: For the planning target volume of clinical target volume (PTV-C), the prescription dose was 50.4 Gy/28fractions, 1.8 Gy/fraction, 5fractions/week, concurrently, the planning target volume of gross tumor (PTV-G) undergone an integrated boost therapy, with a prescription dose of 63 Gy/28fractions, 2.25 Gy/fraction, 5 fractions/week. Nimotuzumab was administered concurrently with radiotherapy, 200 mg/time, on D1, 8, 15, 22, 29, and 36, with a total accumulation of 1200 mg through intravenous infusion. The primary endpoint of the study was the safety and efficacy of the combined treatment regimen, and the secondary endpoints were 1-year, 2-year, and 3-year local control and survival outcomes. (1) From December 2018 to August 2021, 35 patients with stage II-IVA ESCC were enrolled and 34 patients completed the full course of radiotherapy and the intravenous infusion of full-dose nimotuzumab. The overall completion rate of the protocol was 97.1

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Key words

Esophageal squamous cell cancer,SIB-IMRT,Nimotuzumab,Safety,Efficacy

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【要点】：该论文探讨了同时集成增量的强度调制放射治疗（SIB-IMRT）联合尼莫珠单抗治疗局部晚期食管鳞状细胞癌（ESCC）的可行性、安全性和有效性。创新点在于结合了SIB-IMRT和尼莫珠单抗的治疗方案在局部控制和生存率方面显示出潜在的好处。

【方法】：本研究纳入了35例II-IVA期食管鳞状细胞癌患者，接受尼莫珠单抗联合SIB-IMRT治疗，评估其安全性和有效性。

【实验】：从2018年12月至2021年8月，35例局部晚期ESCC患者入组，34例完成放疗和尼莫珠单抗全剂量静滴。方案整体完成率为97.1%。未发生整个群体的4-5级不良反应。最常见的研究相关毒性为急性放射性食管炎，总发生率为68.6%。II级和III级急性食管炎的发生率分别为25.7%(9/35)和17.1%(6/35)。急性放射性肺炎的发生率为8.6%(3/35)，包括1例分别为1级、2级和3级的肺炎。其他系统的不良事件包括白细胞减少、低蛋白血症、电解质紊乱和皮肤疹。在治疗期间，有5例出现III级电解质紊乱（3例为III级低钠血症，2例为III级低钾血症）。疗效方面，总的CR率为22.8%，PR率为71.4%，ORR率为94.2%，DCR率为97.1%。局部控制和生存方面，整个群体的1年、2年和3年局部控制率分别为85.5%、75.4%和64.9%；进展自由生存率分别为65.7%、54.1%和49.6%；总生存率分别为77.1%、62.9%和54.5%。

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