一项关于笔形束扫描质子放射治疗作为食管癌三联疗法组成部分的前瞻性初步研究。
A Prospective Pilot Study of Pencil Beam Scanning Proton Radiation Therapy as a Component of Trimodality Therapy for Esophageal Cancer.
作者信息
Hallemeier Christopher L, Merrell Kenneth W, Neben-Wittich Michelle A, Jethwa Krishan R, Yoon Harry H, Pitot Henry C, Blackmon Shanda, Shen K Robert, Tryggestad Erik J, Giffey Broc, Kazemba Bret D, Viehman Jason K, Harmsen William S, Haddock Michael G
机构信息
Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.
Department of Oncology, Mayo Clinic, Rochester, Minnesota.
出版信息
Adv Radiat Oncol. 2024 Jun 6;9(8):101547. doi: 10.1016/j.adro.2024.101547. eCollection 2024 Aug.
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/m). 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 ( = .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.
目的
评估笔形束扫描（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
这项前瞻性试点研究计划纳入30例局部晚期食管癌或食管胃交界癌患者，这些患者在医学上适合进行放化疗（CRT），随后进行食管切除术。PBS质子RT包括25次分割，肿瘤+1 cm处剂量为50 Gy，3.5 cm黏膜扩展及区域淋巴结处剂量为45 Gy。化疗包括每周使用卡铂（曲线下面积，2 mg/mL/min）和紫杉醇（50 mg/m²）。在CRT后4至8周，患者接受重新分期及可能的食管切除术。主要终点是归因于CRT的3级及以上急性不良事件（AE）。采用Kaplan-Meier方法评估总生存期和无进展生存期；采用累积发病率方法评估局部区域复发率和远处转移率。使用癌症治疗功能评估-食管量表评估生活质量。
结果
2015年6月至2017年4月共纳入30例符合条件的患者。中位年龄为68岁。组织学类型腺癌占87%，病变部位位于食管远端/食管胃交界占90%。87%的患者分期为T3至T4，80%为N1至N3。所有患者均完成了计划的放疗剂量。3级及以上急性AE发生率为30%，最常见的是白细胞减少和中性粒细胞减少。3级及以上急性非血液学AE发生率为3%。90%的患者接受了食管切除术（R0切除率为93%）。病理完全缓解率为40%。主要术后并发症（Clavien-Dindo评分≥3）发生率为34%。30天术后死亡率为3.7%。中位随访时间为5.2年。5年预后估计为总生存率46%，无进展生存率39%，局部区域复发率17%，远处转移率40%。癌症治疗功能评估-食管量表评分（中位数）在基线、CRT结束时、食管切除术前、12个月和24个月时分别为145、与基线相比为136（P = 0.0002）, 144, 146和157。
结论
PBS质子RT作为食管癌三联疗法的一部分是可行且安全的。
Zotero 插件