TY - JOUR
T1 - Morbidity comparison of sentinel lymph node biopsy versus conventional axillary lymph node dissection for breast cancer patients
T2 - Results of the sentinella-GIVOM Italian randomised clinical trial
AU - Del Bianco, P.
AU - Zavagno, G.
AU - Burelli, P.
AU - Scalco, G.
AU - Barutta, L.
AU - Carraro, P.
AU - Pietrarota, P.
AU - Meneghini, G.
AU - Morbin, T.
AU - Tacchetti, G.
AU - Pecoraro, P.
AU - Belardinelli, V.
AU - De Salvo, G. L.
PY - 2008/5
Y1 - 2008/5
N2 - Aims: To compare physical morbidity and health-related quality of life (HRQOL) in breast cancer patients who received standard axillary dissection (ALND) or sentinel lymph node biopsy (SLNB), followed by axillary dissection only in the case of sentinel-node positivity, within a randomised clinical trial. Patients and methods: Patients with early breast cancer ≤ 3 cm and clinically negative axilla were randomly allocated to ALND or SLNB. All patients underwent physical examination every 6 months in order to assess any arm-related symptoms. A subset of patients completed the SF-36 quality of life questionnaire and the Psychological General Well Being Index (PGWBI) before randomisation, at 6 and 12 months after surgery and yearly thereafter. Results of the first 24 months are reported. Results: Six-hundred and seventy-seven patients were available for analysis: 341 patients randomised to the ALND group and 336 to the SLNB group. Six months after surgery, the SLNB group had significantly less lymph-oedema, movement restrictions, pain and numbness with respect to the ALND group. Lymph-oedema was also significantly reduced at 12 months and numbness remained significantly less frequent in the SLNB arm at all time points. Three-hundred and ten patients participated in the HRQOL assessment. The mean scores of the PGWB questionnaire general index and anxiety domain were significantly better in the SLNB group than in the ALND group but the difference ceased to be significant at 24 months. Conclusions: The SLNB is associated with reduced arm morbidity without evidence of a negative impact on psychological well being. While waiting for long-term results of ongoing randomised clinical trials, the SLNB may be proposed for early stage breast cancer patients after adequate information on the expected advantages and the possible risks.
AB - Aims: To compare physical morbidity and health-related quality of life (HRQOL) in breast cancer patients who received standard axillary dissection (ALND) or sentinel lymph node biopsy (SLNB), followed by axillary dissection only in the case of sentinel-node positivity, within a randomised clinical trial. Patients and methods: Patients with early breast cancer ≤ 3 cm and clinically negative axilla were randomly allocated to ALND or SLNB. All patients underwent physical examination every 6 months in order to assess any arm-related symptoms. A subset of patients completed the SF-36 quality of life questionnaire and the Psychological General Well Being Index (PGWBI) before randomisation, at 6 and 12 months after surgery and yearly thereafter. Results of the first 24 months are reported. Results: Six-hundred and seventy-seven patients were available for analysis: 341 patients randomised to the ALND group and 336 to the SLNB group. Six months after surgery, the SLNB group had significantly less lymph-oedema, movement restrictions, pain and numbness with respect to the ALND group. Lymph-oedema was also significantly reduced at 12 months and numbness remained significantly less frequent in the SLNB arm at all time points. Three-hundred and ten patients participated in the HRQOL assessment. The mean scores of the PGWB questionnaire general index and anxiety domain were significantly better in the SLNB group than in the ALND group but the difference ceased to be significant at 24 months. Conclusions: The SLNB is associated with reduced arm morbidity without evidence of a negative impact on psychological well being. While waiting for long-term results of ongoing randomised clinical trials, the SLNB may be proposed for early stage breast cancer patients after adequate information on the expected advantages and the possible risks.
KW - Axillary surgery
KW - Breast cancer
KW - Morbidity
KW - Quality of life
KW - Sentinel lymph node biopsy
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U2 - 10.1016/j.ejso.2007.05.017
DO - 10.1016/j.ejso.2007.05.017
M3 - Article
C2 - 17614245
AN - SCOPUS:41949107482
VL - 34
SP - 508
EP - 513
JO - European Journal of Surgical Oncology
JF - European Journal of Surgical Oncology
SN - 0748-7983
IS - 5
ER -