The UK Almanac Trial (MRC) - Early Results
Professor RE Mansel-Principal Investigator on behalf of the ALMANAC Trialists Group

Sentinel Node Biopsy (SNB) is rapidly becoming the surgical staging procedure of choice to determine the status of the axillary nodes in the management of breast cancer. Whilst there have been a large number of audit studies confirming the validity of SNB in breast cancer, there are no published randomized, controlled trials to validate this new surgical technique. The ALMANAC trial (Axillary Lymphatic Mapping Against Nodal Axillary Clearance) is a two-phased, multi-centre, randomized trial being run in the United Kingdom comparing SNB with standard axillary treatment in the management of breast cancer.

The randomization phase of the trial started in August, 2000 and as of January, 2000, 243 patients were recruited. The target for recruitment is 1,260 patients by the end of 2001.

We present our early data of the audit phase of the above trial, which has been funded by the Medical Research Council and has been completed in 9 centers.

In the audit phase each of the 11 surgeons, whose results are presented here, performed a SNB followed by a standard axillary procedure (clearance or sampling) in 40 consecutive patients. All patients with breast cancer in whom an axillary procedure was indicated were included in the study. Following informed consent, the sentinel node was localized using a protocol of a combination of a radiopharmaceutical and blue dye (Patent blue V). The radiopharmaceutical used was Nanocoll (Nycomed Amersham), 40 MBq if injected the day before surgery or 20 MBq if injected on the day of surgery. This was injected around the tumour and was followed by a static lymphoscintiscan performed around 3 hours after the injection. 16 patients did not have a lymphoscintiscan due to logistical problems. Patent blue V was injected pre-operatively around the tumour and the sentinel node was localized using a combination of the blue dye and a hand held gamma probe. The SNB was followed by the standard axillary procedure and all nodes including the sentinel node were assessed by standard haematoxylin and eosin staining from paraffin blocks.

The objective of the audit phase was to standardize the surgical technique of localizing the sentinel node in breast cancer and to assess the learning curve involved in the introduction of a new surgical technique. To facilitate these objectives, all surgeons in the trial attended a course on SNB and in addition were proctored in the procedure by the Principal Investigator of the trial.

The data presented is from 440 patients (436 female, 4 male), of these 365 had palpable lesions and 150 (34%) were screen detected. The mean tumour size was 21 mms (range 1.7 - 100mms). Tumours were localized for injection by palpation (88.2%), ultrasound (9.3%) and mammogram (2.5%) (Fig:1). On the scintiscan, axillary drainage was seen in 68% of the cases and internal mammary drainage in 8%. A sentinel node was successfully identified in 425 patients (96.6%, Fig:2) and the mean number of sentinel nodes removed was 2.2 per patient (range 1 - 8). The mean time for completing a sentinel node biopsy was 17 minutes (range 2 - 90 minutes). There were 153 (34.8%) patients with a positive axillae, 9 of these patients had a false negative sentinel node, giving a false negative rate of 5.9% (Fig:3).

This study shows that after detailed instruction on the theory and a session of proctoring by an experienced surgeon all the surgeons were able to achieve a high success rate of locating the sentinel node with a low false negative rate. These data represent the whole learning phase for all the surgeons except the PI and one other who had performed some 80 procedures prior to undertaking the 40 case audit series. We conclude that with adequate training sentinel node biopsy can be performed to a high standard.

ALMANAC centres: Bangor, N.Wales; Cardiff*; Charing Cross, London*; Derby; Edinburgh*; Guildford*; Huddersfield*; Hull; Leeds*; Manchester*; Nottingham*; Portsmouth*; Rhyl, N.Wales; Swansea *Centres that contributed data for this poster Trial Steering Committee: Professor R Haward (Chairman), Professor D Cohen, Professor P Ell, Dr I Ellis, Professor L Fallowfield, Professor R Mansel, Dr R Newcombe, Dr E Rutgers, Professor C Woodman

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