Three-Dimensionally-Precise Breast Conformal Device for IMRT in Breast Cancer Patients Treated With Breast-Conserving Surgery—A Pilot Randomized Controlled Trial

OBJECTIVE: To examine the accuracy and efficiency of breast radiotherapy after breast-conserving surgery of a novel 3-dimensional (3D) printing tissue compensator technology, the 3D-precise breast conformer, compared with a usual compensator and an unstructured compensator. METHODS: This novel device is patented in China (patent No.: ZL2015 2 0259472.9). Thirty patients with breast cancer after breast-conserving surgery were randomly divided into 2 control groups (no compensator, NST group, and usual compensator, ST group) and 1 study group (3D-precise breast conformer, 3D-BCT group) (n = 10/group). Before radiotherapy, all patients were scanned in the same CT positioning conditions to prepare the treatment plans. RESULTS: The 3D-BCT showed the best homogeneity index (HI) (0.08 ± 0.03) and conformity index (CI) (0.95 ± 0.03), while the NST group showed the worst HI (0.34 ± 0.07) and CI (0.78 ± 0.06), with the ST group between the 2 (HI: 0.15 ± 0.05; CI: 0.87 ± 0.04) (all P < 0.01). The common tissue compensation membrane could lead to 95-100% of the prescription dose covering 85-95% of the target volume, and the uniformity and conformability of the target dose were improved overall compared with the NST group. In the 3D-BCT group, 100% of the prescription dose covered the target volume of 95-100%. CONCLUSION: The 3D-precision breast conformal device had the highest individualization, uniformity, and conformity. The V(95), V(98), CI, and HI of PTV were optimal in the 3D-BCT group, and an ideal isodose curve distribution of the breast and clavicle upper and lower target areas was achieved. This device could improve the surface dose and the efficacy of radiotherapy after breast-conserving surgery.