In Reply As Drs Jani and Horowitz state, both major and minor deviations in radiation therapy from the planned protocol occurred in our study. However the majority of patients (82%) either received radiation therapy per protocol or had only minor deviations. They ask whether adherence to all quality assessment factors was associated with outcomes.
The LAP07 protocol included detailed, published radiation therapy guidelines.1 All clinicians undertook an initial benchmark case to check adherence to protocol radiation therapy guidelines. Centers with major deviations were not allowed to include patients until they improved. On-trial radiation therapy quality assessment consisted of a central review of treatment plan with dose-volume histograms for each patient. Radiation therapy quality assessment included 8 criteria: gross tumor volume delineation, planning target volume delineation, homogeneity of the dose distribution to the planning target volume, maximal dose to the spinal cord, dose to the kidneys, dose to the liver, number of fields, and treatment of every field every day. Adherence to radiation therapy guidelines was graded as per protocol, acceptable minor deviation, or major unacceptable deviation.
Huguet F, Goldstein D, Hammel P. Radiation Therapy Deviations in Trial of Locally Advanced Pancreatic Cancer—Reply. JAMA. 2016;316(13):1409. doi:10.1001/jama.2016.9781