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The Need for Randomized Controlled Trials to Evaluate Radioguided Occult Lesion Localization (ROLL) for Breast Cancer

Dear Sir, We read with great interest the article by Sajid et al. [1] entitled, “Comparison of Radioguided Occult Lesion Localization (ROLL) and Wire Localization for Non‐Palpable Breast Cancers: A Meta‐Analysis” in Journal of Surgical Oncology 2012;105:852–858. The effort made by the authors to perform a meta‐analysis on a rapidly emerging topic is greatly commendable and brings forward important points of discussion. However, one cannot help but feel that this recently published article is left somewhat redundant by the publication of the randomized controlled trial (RCT) for ROLL by Postma et al. [2] which is not included in the analysis. Of the six RCT’s [2–7] performed on ROLL to date, Postma et al. [2] is the only RCT to have had a sample size calculation performed on the basis of a pre‐specified statistical power analysis, greater than 100 patients in each arm and to only consider invasive breast cancers. As a result of their thorough work the only statistically significant difference they found between ROLL and wire‐guided localization (WGL) was increased volumes of excised specimens in the ROLL group (P< 0.017). This is in contrast to the benefits found in favor of ROLL by the meta‐ analysis of Sajid et al. [1], which included reduced involved surgical margins, localization and operative time. The RCT by Postma et al. [2] had a total of 314 patients (162 randomized to ROLL and 152 to WGL). If we consider the four RCTs [4–7] included by Sajid et al. [1], we find that only the RCT by Martinez et al. [7] exclusively evaluated invasive breast cancers. The remaining three RCTs [4–6] had very high numbers of benign disease. Indeed if we consider the numbers of invasive breast cancers in these studies they only amount to 123 in the ROLL group and 157 in theWGL group. This total of 280 does not even make up the total study size of Postma et al. [2]. The gross lack of adequate numbers of invasive disease mean an accurate assessment of the key surgical outcome of involved surgical margins cannot be assessed and the statistically significant difference of volume of excisions found by Postma et al. [2] is very likely to be underplayed by a high number of benign cases in any evaluation by Sajid et al. [1] and hence no significant difference was found in their analysis. The effort of Sajid et al. [1] is commendable in raising debate, but unfortunately the lack of cases of invasive breast cancers in their analysis mean that their findings cannot be taken with confidence as representative of ROLL. Indeed, the study by Postma et al. [2] is more likely to represent the true relationship between ROLL and WGL. We suggest that further adequately powered, multicenter RCTs are needed to validate ROLL as an alternative toWGL as the current available RCTs are severely lacking in numbers of invasive disease and complete outcome measures to allow confidence from the outcomes of any meta‐analysis.