联盟 A021501 的放射治疗质量保证分析：术前 mFOLFIRINOX 或 mFOLFIRINOX 联合低分割放射治疗局部可切除胰腺腺癌。

Radiation Therapy Quality Assurance Analysis of Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Pancreas.

机构信息

Northwell, New Hyde Park, New York.

Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, Minnesota.

出版信息

Int J Radiat Oncol Biol Phys. 2024 Sep 1;120(1):111-119. doi: 10.1016/j.ijrobp.2024.03.013. Epub 2024 Mar 15.

DOI:10.1016/j.ijrobp.2024.03.013

PMID:38492812

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11329353/

Abstract

PURPOSE

Alliance A021501 is the first randomized trial to evaluate stereotactic body radiation therapy (SBRT) for borderline resectable pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant chemotherapy. In this post hoc study, we reviewed the quality of radiation therapy (RT) delivered.

METHODS AND MATERIALS

SBRT (6.6 Gy × 5) was intended but hypofractionated RT (5 Gy × 5) was permitted if SBRT specifications could not be met. Institutional credentialing through the National Cancer Institute-funded Imaging and Radiation Oncology Core (IROC) was required. Rigorous RT quality assurance (RT QA) was mandated, including pretreatment review by a radiation oncologist. Revisions were required for unacceptable deviations. Additionally, we performed a post hoc RT QA analysis in which contours and plans were reviewed by 3 radiation oncologists and assigned a score (1, 2, or 3) based on adequacy. A score of 1 indicated no deviation, 2 indicated minor deviation, and 3 indicated a major deviation that could be clinically significant. Clinical outcomes were compared by treatment modality and by case score.

RESULTS

Forty patients were registered to receive RT (1 planned but not treated) at 27 centers (18 academic and 9 community). Twenty-three centers were appropriately credentialed for moving lung/liver targets and 4 for static head and neck only. Thirty-two of 39 patients (82.1%) were treated with SBRT and 7 (17.9%) with hypofractionated RT. Five cases (13%) required revision before treatment. On post hoc review, 23 patients (59.0%) were noted to have suboptimal contours or plan coverage, 12 (30.8%) were scored a 2, and 11 (28.2%) were scored a 3. There were no apparent differences in failure patterns or surgical outcomes based on treatment technique or post hoc case score. Details related to on-treatment imaging were not recorded.

CONCLUSIONS

Despite rigorous QA, we encountered variability in simulation, contouring, plan coverage, and dose on trial. Although clinical outcomes did not appear to have been affected, findings from this analysis serve to inform subsequent PDAC SBRT trial designs and QA requirements.

摘要

目的

A021501 联盟是第一项评估新辅助化疗后边界可切除胰腺导管腺癌（PDAC）立体定向体放射治疗（SBRT）的随机试验。在这项事后研究中，我们回顾了放射治疗（RT）的质量。

方法和材料

SBRT（6.6 Gy×5）是预期的，但如果不能满足 SBRT 规范，则允许进行 hypofractionated RT（5 Gy×5）。需要通过国家癌症研究所资助的成像和放射肿瘤学核心（IROC）进行机构认证。强制性进行严格的 RT 质量保证（RT QA），包括放射肿瘤学家进行的治疗前审查。对于不可接受的偏差，需要进行修订。此外，我们进行了事后 RT QA 分析，其中由 3 名放射肿瘤学家对轮廓和计划进行了审查，并根据充分性分配了分数（1、2 或 3）。分数为 1 表示没有偏差，分数为 2 表示有轻微偏差，分数为 3 表示有临床意义的重大偏差。通过治疗方式和病例评分比较临床结果。

结果

在 27 个中心（18 个学术中心和 9 个社区中心）登记了 40 名接受 RT 治疗的患者（1 例计划但未治疗）。23 个中心适当地认证了移动肺/肝靶区，4 个中心仅认证了静态头颈部。39 名患者中的 32 名（82.1%）接受了 SBRT 治疗，7 名（17.9%）接受了 hypofractionated RT 治疗。有 5 例（13%）在治疗前需要修订。事后审查发现，23 例（59.0%）患者的轮廓或计划覆盖不佳，12 例（30.8%）评分为 2，11 例（28.2%）评分为 3。基于治疗技术或事后病例评分，失败模式或手术结果没有明显差异。关于治疗期间影像学的详细信息没有记录。