Quality assurance analysis of participating centres' protocol compliance to a UK multicentre hypofractionated breast (FAST) trial.

OBJECTIVES: The FAST (FASTer radiotherapy for breast radiotherapy) trial is a UK Phase 2 multicentre randomised clinical trial evaluating a five-fraction schedule of whole-breast radiotherapy following local excision of early breast cancer. The purpose of this quality assurance study was to analyse the radiotherapy planning data in order to confirm compliance with the trial protocol.
METHODS: 915 patients were recruited between 2004 and 2007 from 18 centres. The protocol required that all centres should use three-dimensional dose compensations to optimise radiotherapy plans. Planning techniques, maximum dose (D(max)) and dose-volume histograms from treatment plans were evaluated and compared between centres. The homogeneity of plans was tested by creating a cut-off value of 5% for the percentage of breast volume receiving >105% of the prescribed dose.
RESULTS: 672 data sets from 15 centres were available. 93% (624/672) of plans were treated using forward-planned multileaf collimator (MLC) segments, 6% with breast compensators and 1% with inverse-planned MLC segments. 94% (635/672) of patients had a D(max)≤107% of the prescribed dose. 11% (74/672) of plans delivered >105% of the prescribed dose to >5% of the breast volume.
CONCLUSION: Reviewing the data in this study, 95% of plans submitted by centres complied with the protocol. With the improved breast radiotherapy standards shown in FAST centres, the following recommendations were suggested for future UK breast radiotherapy trials: (i) the minimum, mean and maximum dose to the whole-breast planning target volume (PTV) should be recorded and assessed; (ii) apart from having a D(max)≤107% of the prescribed dose, ≤5% of PTV should a receive dose >105% of the prescription dose.