目的:为了评估可行性,同步综合增强调强放疗(SIB-IMRT)联合尼妥珠单抗治疗局部晚期食管鳞状细胞癌(ESCC)的安全性和有效性.
方法:符合条件的患者经组织学证实为局部晚期ESCC,无法耐受或拒绝同步放化疗(CCRT)。纳入患者同时接受SIB-IMRT联合尼妥珠单抗。
■对于临床目标体积(PTV-C)的计划目标体积,处方剂量为50.4Gy/28fractions,1.8Gy/分数,5分/周,同时,大体肿瘤的计划目标体积(PTV-G)经过综合加强治疗,处方剂量为63Gy/28fracts,2.25Gy/分数,5分/周。尼妥珠单抗与放疗同时给药,200毫克/次,在D1、8、15、22、29和36上,通过静脉输注的总累积量为1200mg。研究的主要终点是联合治疗方案的安全性和有效性,次要终点是1年,2年,和3年局部控制和生存结果。
结果:(1)从2018年12月至2021年8月,纳入了35例II-IVAESCC患者,34例患者完成了全程放疗和全剂量尼妥珠单抗静脉输注。方案的总体完成率为97.1%。(2)全组无4~5级不良事件发生。最常见的治疗相关毒性是急性放射性食管炎,总发病率为68.6%(24/35)。2、3级急性食管炎的发生率分别为25.7%(9/35)和17.1%(6/35),分别。急性放射性肺炎的发病率为8.6%(3/35),包括1、2和3级肺炎各1例。其他系统的不良事件包括血细胞减少,低蛋白血症,电解质干扰,还有皮疹.在这些患者中,治疗期间有5人出现3级电解质紊乱(3人出现3级低钠血症,2人出现3级低钾血症).(3)疗效:总CR率为22.8%,PR率为71.4%,ORR率为94.2%,DCR率为97.1%。(4)局部控制和生存:1-,2-,和3年本地控制(LC)利率,无进展生存率(PFS),全组总生存率(OS)为85.5%,75.4%,和64.9%;65.7%,54.1%,和49.6%;和77.1%,62.9%,和54.5%,分别。
结论:SIB-IMRT联合尼妥珠单抗治疗局部晚期食管癌具有良好的可行性。安全性和有效性。它为当地控制和生存提供了潜在的好处。急性放射性食管炎是主要的治疗相关毒性,这是临床上可控的。这种综合治疗方法值得临床进一步探索(ChiCTR1900027936)。
OBJECTIVE: 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).
METHODS: 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.
UNASSIGNED: 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.
RESULTS: (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%. (2) No grade 4-5 adverse events occurred in the entire group. The most common treatment-related toxicity was acute radiation esophagitis, with a total incidence of 68.6% (24/35). The incidence of grade 2 and 3 acute esophagitis was 25.7% (9/35) and 17.1% (6/35), respectively. The incidence of acute radiation pneumonitis was 8.6% (3/35), including one case each of Grades 1, 2, and 3 pneumonitis. Adverse events in other systems included decreased blood cells, hypoalbuminemia, electrolyte disturbances, and skin rash. Among these patients, five experienced grade 3 electrolyte disturbances during the treatment period (three with grade 3 hyponatremia and two with grade 3 hypokalemia). (3) Efficacy: The overall CR rate was 22.8%, PR rate was 71.4%, ORR rate was 94.2%, and DCR rate was 97.1%.(4) Local control and survival: The 1-, 2-, and 3-year local control (LC) rate, progression-free survival(PFS) rate, and overall survival(OS) rate for the entire group were 85.5%, 75.4%, and 64.9%; 65.7%, 54.1%, and 49.6%; and 77.1%, 62.9%, and 54.5%, respectively.
CONCLUSIONS: The combination of SIB-IMRT and nimotuzumab for locally advanced esophageal cancer demonstrated good feasibility, safety and efficacy. It offered potential benefits in local control and survival. Acute radiation esophagitis was the primary treatment-related toxicity, which is clinically manageable. This comprehensive treatment approach is worthy of further clinical exploration (ChiCTR1900027936).