将铅笔束扫描质子放疗作为食管癌三联疗法组成部分的前瞻性试点研究

IF 2.2 Q3 ONCOLOGY

Advances in Radiation Oncology Pub Date : 2024-06-06 DOI:10.1016/j.adro.2024.101547

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引用次数: 0

摘要

目的评估铅笔束扫描（PBS）质子放射治疗（RT）在食管癌三联疗法中的安全性和有效性。方法和材料这项前瞻性试验研究计划招募 30 名局部晚期食管癌或胃食管交界处癌患者，这些患者在医学上适合化放疗（CRT），然后进行食管切除术。PBS质子 RT包括25个分段，肿瘤+1厘米处50 Gy，3.5厘米粘膜扩张处和区域淋巴结45 Gy。化疗包括每周一次的卡铂（曲线下面积为 2 毫克/毫升/分钟）和紫杉醇（50 毫克/平方米）。CRT 4-8 周后，患者接受重新分期和可能的食管切除术。主要终点是CRT导致的急性3级以上不良事件（AE）。采用Kaplan-Meier方法评估总生存期和无进展生存期；采用累积发生率方法评估局部区域复发率和远处转移率。癌症治疗功能评估-食道评估生活质量。结果2015年6月至2017年4月，30名符合条件的患者入组。中位年龄为68岁。87%的患者组织学为腺癌，90%的患者病变部位为食管远端/胃食管交界处。87%的患者分期为T3至T4，80%的患者分期为N1至N3。所有患者都完成了计划的 RT 剂量。30%的患者出现急性3+级AE，最常见的是白细胞减少和中性粒细胞减少。急性3+级非血液学AEs发生率为3%。90%的患者进行了食管切除术（93%为R0）。病理完全反应率为40%。主要术后并发症（Clavien-Dindo评分≥3）发生率为34%。术后30天死亡率为3.7%。中位随访时间为 5.2 年。五年生存率为46%，无进展生存率为39%，局部复发率为17%，远处转移率为40%。癌症治疗功能评估-食管评分（中位数）在基线、CRT 结束时、食管切除术前、12 个月时和 24 个月时分别为 145、136（与基线相比 p = 0.0002）、144、146 和 157。

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A Prospective Pilot Study of Pencil Beam Scanning Proton Radiation Therapy as a Component of Trimodality Therapy for Esophageal Cancer

Purpose

To evaluate the safety and efficacy of pencil beam scanning (PBS) proton radiation therapy (RT) in trimodality therapy for esophageal cancer.

Methods and Materials

This prospective pilot study was planned to accrue 30 patients with locally advanced esophageal or gastroesophageal junction carcinoma medically suitable for chemoradiation therapy (CRT) followed by esophagectomy. PBS proton RT consisted of 25 fractions, 50 Gy to tumor + 1 cm and 45 Gy to a 3.5 cm mucosal expansion and regional lymph nodes. Chemotherapy included weekly carboplatin (area under the curve, 2 mg/mL/min) and paclitaxel (50 mg/m²). At 4 to 8 weeks after CRT, patients underwent restaging and potential esophagectomy. The primary endpoint was acute grade 3+ adverse events (AEs) attributed to CRT. Overall survival and progression-free survival were assessed using the Kaplan-Meier methodology; local-regional recurrence and distant metastases rates were assessed using the cumulative incidence methodology. The Functional Assessment of Cancer Therapy–Esophagus assessed quality of life.

Results

Thirty eligible patients were enrolled from June 2015 to April 2017. Median age was 68 years. Histology was adenocarcinoma in 87%, and location was distal esophagus/gastroesophageal junction in 90%. Stage was T3 to T4 in 87% and N1 to N3 in 80%. All patients completed the planned RT dose. Acute grade 3+ AEs occurred in 30%, most commonly leukopenia and neutropenia. Acute grade 3+ nonhematologic AEs occurred in 3%. Esophagectomy was performed in 90% of patients (R0 in 93%). Pathologic complete response rate was 40%. Major postoperative complications (Clavien-Dindo score, ≥3) occurred in 34%. Postoperative mortality at 30 days was 3.7%. Median follow-up was 5.2 years. Five-year outcome estimates were overall survival at 46%, progression-free survival at 39%, local-regional recurrence at 17%, and distant metastases at 40%. Functional Assessment of Cancer Therapy–Esophagus scores (medians) at baseline, at the end of CRT, before esophagectomy, at 12 months, and at 24 months were 145, 136 (p = .0002 vs baseline), 144, 146 and 157, respectively.

Conclusions

PBS proton RT is feasible and safe as a component of trimodality therapy for esophageal cancer.

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来源期刊

Advances in Radiation Oncology Medicine-Radiology, Nuclear Medicine and Imaging

CiteScore

4.60

自引率

4.30%

发文量

208

审稿时长

98 days

期刊介绍： The purpose of Advances is to provide information for clinicians who use radiation therapy by publishing: Clinical trial reports and reanalyses. Basic science original reports. Manuscripts examining health services research, comparative and cost effectiveness research, and systematic reviews. Case reports documenting unusual problems and solutions. High quality multi and single institutional series, as well as other novel retrospective hypothesis generating series. Timely critical reviews on important topics in radiation oncology, such as side effects. Articles reporting the natural history of disease and patterns of failure, particularly as they relate to treatment volume delineation. Articles on safety and quality in radiation therapy. Essays on clinical experience. Articles on practice transformation in radiation oncology, in particular: Aspects of health policy that may impact the future practice of radiation oncology. How information technology, such as data analytics and systems innovations, will change radiation oncology practice. Articles on imaging as they relate to radiation therapy treatment.