Post-operative arm morbidity and quality of life. Results of the ALMANAC randomised trial comparing sentinel node biopsy with standard axillary treatment in the management of patients with early breast cancer

Anne Fleissig, Lesley J Fallowfield, Carolyn I Langridge, Leigh Johnson, Robert G Newcombe, Mark Kissin, Robert E Mansel

Research output: Contribution to journalArticle (Academic Journal)peer-review

362 Citations (Scopus)

Abstract

This study is the first large prospective RCT of sentinel node biopsy (SNB) compared with standard axillary treatment (level I-III axillary lymph node dissection or four node sampling), which includes comprehensive and repeated quality of life (QOL) assessments over 18 months. Patients (n = 829) completed the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the Spielberger State/Trait Anxiety Inventory (STAI) at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months post-surgery. There were significant differences between treatment groups favouring the SNB group throughout the 18 months assessment. Patients in the standard treatment group showed a greater decline in Trial Outcome Index (TOI) scores (physical well-being, functional well-being and breast cancer concerns subscales in FACT-B+4) and recovered more slowly than patients in the SNB group (p < 0.01). The change in total FACT-B+4 scores (measuring global QOL) closely resembled the TOI results. 18 months post-surgery approximately twice as many patients in the standard group compared with the SNB group reported substantial arm swelling (14% versus 7%) (p = 0.002) or numbness (19% versus 8.7%) (p < 0.001). Despite the uncertainty about undergoing a relatively new procedure and the possible need for further surgery, there was no evidence of increased anxiety amongst patients randomised to SNB (p > 0.05). For 6 months post-surgery younger patients reported less favourable QOL scores (p < 0.001) and greater levels of anxiety (p < 0.01). In view of the benefits regarding arm functioning and quality of life, the data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.

Original languageEnglish
Pages (from-to)279-93
Number of pages15
JournalBreast Cancer Research and Treatment
Volume95
Issue number3
DOIs
Publication statusPublished - Feb 2006

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Arm/physiopathology
  • Axilla
  • Breast Neoplasms/pathology
  • Female
  • Humans
  • Lymph Node Excision
  • Lymphatic Metastasis
  • Middle Aged
  • Morbidity
  • Postoperative Period
  • Quality of Life
  • Sentinel Lymph Node Biopsy
  • Surveys and Questionnaires
  • Treatment Outcome

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