Cost-Effectiveness of Radioguided Occult Lesion Localization (ROLL) Versus Wire-Guided Localization (WGL) in Breast Conserving Surgery for Nonpalpable Breast Cancer: Results from a Randomized Controlled Multicenter Trial

Abstract

Accurate preoperative localization of nonpalpable breast cancer is essential to achieve complete resection. Radioguided occult lesion localization (ROLL) has been introduced as an alternative for wire-guided localization (WGL). Although efficacy of ROLL has been established in a randomized controlled trial, cost-effectiveness of ROLL compared with WGL is not yet known. The objective of this study was to determine whether ROLL has acceptable cost-effectiveness compared with WGL. An economic evaluation was performed along with a randomized controlled trial (ClinicalTrials.gov, No. NCT00539474). Women (>18 years) with histologically proven nonpalpable breast cancer and eligible for breast conserving treatment with sentinel node procedure were randomized to ROLL (n = 162) or WGL (n = 152). Empirical data on direct medical costs were collected, and changes in quality of life were measured over a 6-month period. Bootstrapping was used to assess uncertainty in cost-effectiveness estimates, and sensitivity of the results to the missing data approach was investigated. In total, 314 patients with 316 invasive breast cancers were enrolled. On average ROLL required the same time as WGL for the surgical procedure (119 vs 118 min), resulted in a 7 % higher reinterventions risk, and 13 % more complications. Quality of life effects were similar (difference 0.00 QALYs 95 % CI (-0.04-0.05). Total costs were also similar for ROLL and WGL (+<euro>26 per patient 95 % CI <euro>-250-311). ROLL is comparable to WGL with respect to both costs and quality of life effects as measured with the EQ5D and will therefore not lead to more cost-effective medical care.