Prevention of lymphoedema after axillary clearance by external compression sleeves PLACE randomised trial results. Effects of high BMI.

ABSTRACT

Around 25% of women undergoing Axillary Clearance (ANC) develop lymphedema (LE). Intervention with a compression garment is recommended to prevent LE but no randomised evidence exists to support this strategy. METHODS: A randomised trial tested standard management versus application of graduated compression garments (20-24 mmHg) to affected arm, for 1 year. Women with node positive breast cancer (n = 1300) undergoing ANC consented to arm volume measurements and those developing a 4-9% relative arm volume increase (RAVI) (subclinical LE) within 9 months post-surgery were randomised. Primary outcome was proportion of patients developing LE (RAVI > 10%) by 24-months in each group. Secondary endpoints included Quality of life in each group. RESULTS: In total 143 patients were randomised (74 no sleeve 69 compression sleeve) between October 2010 and November 2015. The lymphoedema rate at 24 months in the 'no sleeve' group was at 41%, similar to the 'sleeve' group (30% p = 0.32). Thirtytwo patients randomised to the 'no sleeve' group had a sleeve applied within 24 months. Body Mass Index (BMI) at randomisation predicted LE at any time point HR 1.04 (CI 1.01-1.08; p = 0.01). Patients with obesity (BMI > 30) had higher rates of LE in both groups (46%) compared to those with BMI < 30 (24%). No difference between patients was found in either group in changes in QoL. Compression sleeves applied after development of LE improved QoL scores (FACT-B p = 0.007TOI p = 0.042). CONCLUSION: Early intervention with External Compression garments does not prevent clinical LE, particularly in women with a high BMI > 30. The use of prophylactic garments in subclinical LE (RAVI < 9%) is unwarranted.