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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Randomized trials of axillary lymph node management in early breast cancer

Randomized trials of axillary lymph node management in early breast cancer
Study name Study population Mean follow-up Comparison Primary outcome Additional outcomes Morbidity
RCTs comparing SLNB with ALND
NSABP B32 (2010)[1,2] 5611 women with mostly <4 cm invasive breast cancer 96 months SLNB + ALND SLNB alone (if negative) OS: no difference

DFS: no difference

Axillary recurrence: no difference		 ALND caused fewer shoulder abduction deficits, less arm volume difference (lymphedema), and less patient-reported arm numbness or tingling throughout a three-year follow-up period.
ALMANAC (2006)[3] 1031 women with clinically node-negative breast cancer 12 months ALND

SLNB alone (if negative)

SLNB + ALND or axillary RT (if positive)		 Arm/shoulder morbidity and Quality of Life (QOL)  

SLNB causes less lymphedema and sensory loss than ALND (relative risk 0.37 and 0.37).

Drain use, length of hospital stay, and time to normal activity were all lower in SLNB group.

Patient-recorded QOL and arm functioning scores were better in SLNB group.
Veronesi (2010)[4,5] 516 women with <2 cm breast cancer 102 months SLNB + ALND SLNB alone (if negative) DFS: no difference

OS: no difference

Breast cancer related events or death: no difference		 NR
Cambridge/East Anglia study group (2005)[6] 298 patients with <3 cm breast cancer 12 months ALND SLNB alone (if negative) Postoperative morbidity  

SLNB caused a reduction in postoperative arm swelling, subjective lymphedema, seroma formation, numbness, loss of sensitivity to light touch and pinprick, and paresthesia.

SLNB was associated with less impairment in shoulder mobility.

Scores reflecting QOL and psychological morbidity were better in SLNB group.
RACS/SNAC (2004)[7] 1088 women with clinically node-negative breast cancer 36 months ALND SLNB alone (if negative) Upper limb volume, symptoms, and function  

Upper limb volume increased in both groups over first two years but was less likely to stay increased in SLNB group after the first month.

Reduction in upper limb movement was greater in ALND group up to six months but similar between groups from one to three years.

Subjective ratings of upper limb swelling, symptoms, dysfunction, and disability over three years were worse in ALND group.
Sentinella/GIVOM (2008)[8] 697 women with <3 cm breast cancer 56 months ALND SLNB alone (if negative) DFS: no difference OS: no difference SLNB group had less lymphedema, restriction of shoulder mobility, and numbness.
Canavese (2009)[9] 225 patients with <3 cm primary invasive cancer clinically node-negative 66 months ALND SLNB alone (if negative)

OS: no difference

Axillary recurrence: none in SLNB group		 DFS: no difference NR
RCTs comparing ALND with no further axillary treatment for patients with positive sentinel nodes
Z0011 (2011)[10]

856 women with T1-2 breast cancer, and 1-2 metastatic nodes by SLNB

All underwent lumpectomy and whole-breast irradiation

76 months[10]

111 months[11] 		ALND No further axillary treatment OS: no difference[10]

DFS: no difference[10,11]

Nodal recurrence: no difference[11]

Local regional recurrence: no difference[11]

Wound infections, axillary seromas, and paresthesias were more common in ALND group.[10]

Lymphedema was more common by self-reporting and by arm circumference measurement in ALND group.[10]
IBCSG 23-01 (2013)[12] 931 women with <5 cm breast cancer and 1 or more micrometastatic sentinel nodes 60 months ALND No further axillary treatment DFS: no difference

OS: no difference

Breast cancer events: no difference		 ALND caused more lymphedema, sensory neuropathy, and motor neuropathy than the no further treatment group.
RCT comparing ALND with axillary radiotherapy for patients with positive sentinel nodes
AMAROS (2014)[13]

4805 patients randomized, 1425 patients had positive sentinel node(s)

744 assigned to ALND, 681 to axillary radiotherapy		 73 months ALND Axillary radiation Axillary recurrence: 0.43 percent ALND versus 1.19 percent axillary radiation

OS: no difference

DFS: no difference		 ALND caused more lymphedema at one, three, and five years.
RCT: randomized controlled trial; SLNB: sentinel lymph node biopsy; ALND: axillary lymph node dissection; OS: overall survival; DFS: disease-free survival; NR: not reported.
References:
  1. Krag DN, Anderson SJ, JulianTB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol 2010; 11:927.
  2. Ashikaga, T, Krag, DN, Land, SR, et al. Morbidity results from the NSABP B-32 trial comparing sentinel lymph node dissection versus axillary dissection. J Surg Oncol 2010; 102:111.
  3. Mansel, RE, Fallowfield, L, Kissin, M, et al. Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst 2006;98:599.
  4. Veronesi, U, Viale, G, Paganelli, G, et al. Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study. Ann Surg 2010; 251:595.
  5. Veronesi, U, Paganelli, G, Viale, G, et al. Sentinel-lymph-node biopsy as a staging procedure in breast cancer: update of a randomised controlled study. Lancet Oncol 2006; 7:983.
  6. Purushotham AD, Upponi S, Klevesath MB, et al. Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial. J Clin Oncol 2005; 23:4312.
  7. Wetzig N, Gill PG, Zannino D, et al. Sentinel lymph node based management or routine axillary clearance? Three-year outcomes of the RACS sentinel node biopsy versus axillary clearance (SNAC) 1 trial. Ann Surg Oncol 2015; 22:17.
  8. Zavagno G, De Salvo GL, Scalco G, et al. A randomized clinical trial on sentinel lymph node biopsy versus axillary lymph node dissection in breast cancer: results of the Sentinella/GIVOM trial. Ann Surg 2008; 247:207.
  9. Canavese G, Catturich A, Vecchio C, et al. Sentinel node biopsy compared with complete axillary dissection for staging early breast cancer with clinically negative lymph nodes: results of randomized trial. Ann Oncol 2009; 20:1001.
  10. Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA 2011; 305:569.
  11. Giuliano AE, Ballman K, McCall L, et al. Locoregional Recurrence After Sentinel Lymph Node Dissection With or Without Axillary Dissection in Patients With Sentinel Lymph Node Metastases: Long-term Follow-up From the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 Randomized Trial. Ann Surg 2016; 264:413.
  12. Galimberti V, Cole BF, Zurrida S, et al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol 2013; 14:297.
  13. Donker M, van Tienhoven G, Straver ME, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol 2014; 15:1303.
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