Radiotherapy Quality Assurance (RTQA) of Concurrent Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial

Publication date: Available online 12 April 2018
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Anthony M. Brade, Frederik Wenz, Friederike Koppe, Yolande Lievens, Belen San Antonio, Neill Allan Iscoe, Anwar Hossain, Nadia Chouaki, Suresh Senan
PurposeChemoradiotherapy trials in 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 chemoradiotherapy regimens. The RTQA results were evaluated from PROCLAIM study, and the impact of radiation deviations on efficacy outcomes was investigated.Methods and MaterialsThe study was conducted from 2008 to 2014. Review of the radiation plan was mandated for all patients. Real-time review was performed prior to radiation 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 (PTV) coverage, dose homogeneity, volume of lung receiving ≥20 Gy, and maximum point dose to spinal cord.ResultsForty of 554 patients, treated at 28 sites, had major RTQA violations. Seven sites treated 2 or more patients with major violations. Stage IIIB disease and larger PTV were observed more frequently in patients with major violations. Major violations were more prevalent in sites treating either less than 6 or more than 15 patients. Patients treated at sites enrolling 2 or more patients with major violations (n=86) had lower median overall survival (OS) (21.1 vs 29.8 months; hazard ratio [HR] =1.442) and progression-free survival (7.3 vs 11.3 months; HR=1.345) than patients treated at sites without major violations. These findings remained significant for OS on multivariate analysis.ConclusionsMajor 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 chemoradiotherapy plans. Poorer observed outcomes at centers with multiple major violations are hypothesis generating.Trial Registration Numberclinicaltrials.gov identifier: NCT00686959.

Teaser

Results from PROCLAIM study, the largest global randomized study using RTQA in Stage III NSCLC, showed poorer outcomes at centers with multiple major violations. Those findings are hypothesis-generating and support the importance of real-time RTQA in future randomized trials. Real-time RTQA can play an important role in improving overall RT quality for patients entered and treated on studies.


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