Radiation Oncology Division, Trillium Health Partners, Mississauga, Ontario, Canada.
Department of Radiation Oncology, University Hospital Mannheim, Mannheim, Germany.
Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.
Chemoradiation therapy trials of different tumors, including lung cancer, have shown a correlation between protocol deviations and adverse outcomes. Radiation therapy quality assurance (RTQA) was mandated for all patients treated in the PROCLAIM trial evaluating 2 different chemoradiation therapy regimens. The RTQA results were evaluated from the PROCLAIM study, and the impact of irradiation deviations on efficacy outcomes was investigated.
The study was conducted from 2008 to 2014. Review of the irradiation plan was mandated for all patients. Real-time review was performed prior to irradiation start for the first enrolled patient at each site and randomly in 20% of additional patients, with non-real-time review in the remainder. The RTQA criteria evaluated included planning target volume coverage, dose homogeneity, volume of lung receiving ≥20 Gy, and maximum point dose to spinal cord.
Major RTQA violations occurred in 40 of 554 patients, treated at 28 sites. Seven sites treated ≥2 patients with major violations. Stage IIIB disease and larger planning target volume were observed more frequently in patients with major violations. Major violations were more prevalent in sites treating either <6 patients or >15 patients. Patients treated at sites enrolling ≥2 patients with major violations (n = 86) had lower median overall survival (21.1 months vs 29.8 months; hazard ratio, 1.442) and progression-free survival (7.3 months vs 11.3 months; hazard ratio, 1.345) than patients treated at sites without major violations. These findings remained significant for overall survival on multivariate analysis.
Major violations in treatment plans were uncommon in the PROCLAIM study, possibly reflecting mandatory RTQA. The RTQA violations were more frequent in patients requiring more complex chemoradiation therapy plans. Poorer observed outcomes at centers with multiple major violations are hypothesis generating.
包括肺癌在内的不同肿瘤的放化疗试验表明，方案偏离与不良结果之间存在相关性。为了评估两种不同放化疗方案的疗效，在 PROCLAIM 试验中对所有接受治疗的患者都进行了强制性的放射治疗质量保证（RTQA）。从 PROCLAIM 研究中评估了 RTQA 结果，并研究了照射偏差对疗效结果的影响。
该研究于 2008 年至 2014 年进行。所有患者的放疗计划都需要进行审查。对于每个入组患者，在开始放疗前，每个站点都要进行实时审查，在 20%的额外患者中随机进行实时审查，其余患者进行非实时审查。RTQA 评估标准包括计划靶区覆盖、剂量均匀性、接受≥20Gy 剂量的肺体积和脊髓最大点剂量。
在 28 个站点治疗的 554 名患者中，有 40 名患者发生了主要的 RTQA 违规。有 7 个站点治疗了≥2 名存在重大违规的患者。存在重大违规的患者中，III 期 B 疾病和更大的计划靶区更为常见。在治疗<6 名或>15 名患者的站点中，重大违规更为常见。在治疗存在≥2 名存在重大违规患者的站点（n=86）的患者中，中位总生存期（21.1 个月比 29.8 个月；风险比，1.442）和无进展生存期（7.3 个月比 11.3 个月；风险比，1.345）均低于治疗无重大违规患者的站点。这些发现经多变量分析后对总生存期仍有显著意义。
在 PROCLAIM 研究中，治疗计划中的重大违规情况并不常见，这可能反映了强制性的 RTQA。在需要更复杂放化疗方案的患者中，RTQA 违规更为常见。在存在多个重大违规的中心观察到的较差结果是产生假说的基础。
