ROLLIS trial

14 June 2013

Purpose

To investigate an alternative method of marking nonpalpable breast cancers to guide surgery.

Scientific Title

Can the use of low dose radioactive seeds to guide surgical removal of small areas of abnormal breast tissue reduce the rate of second operation compared with standard hook-wire technique? (ROLLIS RCT: Radio-guided Occult Lesion Localisation using Iodine125 Seeds).

Background

The number of non-palpable breast cancers requiring pre-operative image-guided localisation continues to increase due to breast screening and the use of pre-operative chemotherapy. Hook wire localisation (HWL) has been standard of care since the 1970s, but is associated with a high positive margin (20-40%) and re-excision (30-50%) rates. Other disadvantages of HWL include technical difficulties (e.g. wire transection and migration), inefficient use of radiology bookings, and impact on theatre time.

The new method trialed in Australian and New Zealand (Waikato only) is called “ROLLIS”, which stands for Radioguided Occult Lesion Localisation using low activity Iodine 125 Seeds. Instead of using a hook-wire to localise the abnormality, the radiologist inserts a very low dose of radioactive Iodine-125 (I-125) seed into the abnormal area. During the surgery, a handheld detecting “probe” is used by the surgeon to detect the radioactive signal produced by the seed. The seed and the abnormal area is then removed. Other international clinical trials suggest that the ROLLIS method offers benefits to patients that include being able to mark the abnormality as an outpatient procedure up to eight days before surgery. It can also make the surgery easier and faster to perform with a better chance of removing all the abnormality in one operation.

Results:

There were 659 women from Australia and New Zealand who took part in this clinical trial.  Results showed that re-excision rates after breast conserving surgery were significantly lower after radioactive seed localisation (ROLLIS) compared with hookwire localisation. Patients reported lower levels of anxiety and pain with the ROLLIS  compared with the hookwire. The ROLLIS can be carried out up to eight days before surgery, whereas the hookwire can only be inserted on the day of surgery (as the wire protrudes from the breast). The ROLLIS enables flexibility of scheduling of localisation prior to breast conserving surgery.

Both radiologists and surgeons found the low dose radioactive seed easier to use than the hookwire. Some surgeons reported that localising the breast cancer using the seed was faster.

This research based at Waikato Hospital was led by Breast Radiologist Dr Rebecca Hughes and was a massive effort from teams of staff from the Breast Care Centre, Nuclear Medicine, Medical Physics, Theatre and Pathology Departments. Huge thanks go to all the dedicated staff and to the participating women who made this research happen. The results confirm the ROLLIS technique improves care for women undergoing breast conserving surgery for small breast cancers.

Publication:

B. Taylor, A. G. Bourke, E. J. Westcott, M. L. Marinovich, C. Y. L. Chong, R. Liang, R. L. Hughes, E. Elder and C. M. Saunders. Surgical outcomes after radioactive 125 Iodine seed versus hookwire localization of non-palpable breast cancer: a multicentre randomized clinical trial. British Journal of Surgery. 1 January, 2021. 108 (1), 40-48. DOI: 10.1093/bjs/znaa008