Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial.
نویسندگان
چکیده
BACKGROUND Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment. METHODS The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided. RESULTS The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval [CI] = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P < .001), and axillary operative time was reduced (P = .055). Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout (all P < or = .003). These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group (P > .05). CONCLUSION Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.
منابع مشابه
Sentinel node biopsy after primary chemotherapy in breast cancer: a note of caution from results of ABCSG-14.
Over the past years, experience has been increasing with lymphatic mapping and sentinel node biopsy (SNB) after preoperative chemotherapy for breast cancer, with a wide range of results reported in the literature and final conclusions on the diagnostic value and clinical consequences of this sequential approach still missing. Between 1999 and 2002, the Austrian Breast and Colorectal Cancer Stud...
متن کاملAxillary recurrence rate in breast cancer patients with negative sentinel lymph node.
AIM To assess the axillary recurrence rate in operable breast cancer patients with clinically negative axilla after negative sentinel lymph node in whom axillary lymph node dissection had not been performed. METHODS Fifty consecutive female operable breast cancer patients with negative sentinel lymph node biopsy in whom axillary lymph node dissection had not been performed were included in th...
متن کاملIt Is Not Always Necessary to Do Axillary Dissection for T1 and T2 Breast Cancer
Axillary lymph node dissection (ALND) has been a part of breast cancer management since the 1900s. The idea that axillary metastases do not require surgical removal is a repudiation of the Halstedian concept of breast cancer biology, yet multiple prospective randomized studies show that the incidence of nodal recurrence in patients not having ALND is substantially lower than expected, based on ...
متن کاملPoint–Counterpoint Review Point It Is Not Always Necessary to Do Axillary Dissection for T1 and T2 Breast Cancer
Axillary lymph node dissection (ALND) has been a part of breast cancer management since the 1900s. The idea that axillary metastases do not require surgical removal is a repudiation of the Halstedian concept of breast cancer biology, yet multiple prospective randomized studies show that the incidence of nodal recurrence in patients not having ALND is substantially lower than expected, based on ...
متن کاملIs sentinel lymph node biopsy enough for axillary macrometastasis?
Although the omission of further treatment of the axilla in early stage clinical N0 breast cancer patients with conserved breast and one or two positive micrometastatic sentinel lymph node(s) is relatively well established, the optimal management of the axilla in macrometastatic disease is still controversial. There are three randomized studies, which shed light on this issue (Table 1). The ver...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Journal of the National Cancer Institute
دوره 98 9 شماره
صفحات -
تاریخ انتشار 2006