25 ORAL A randomized clinical trial on sentinel node biopsy versus axillary lymph node dissection in breast cancer: early results of the Sentinella/GIVOM trial

Zavagno, G.; Bianco, Paola Del; Scalco, G.; Barutta, L.; Burelli, Paolo; Carraro, Paolo; Tacchetti, G; Mencarelli, Roberto; Salvo, Gian Luca De; Nitti, Donato

doi:10.1016/s0748-7983(06)70460-7

Cited by 69 publications

(132 citation statements)

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“…Seven trials were thus eligible, as shown in Table 1 [3,4,[7][8][9][10][11]. A total of 9,608 patients were randomly assigned to treatment (658 in the SNB only arm, 5,084 in the ALND only arm and 4,406 who had SNB and then went onto have ALND), and data was available for analysis from 8,853 of them (636, 4,389 and 3,828 in the three arms, respectively).…”

Section: Eligible Studiesmentioning

confidence: 99%

“…There was little variability among studies in the menopausal status, eligible stages of breast cancer and tumour size of participants. All seven trials enroled patients between 1998 and 2005, and six of the seven studies were multicentre trials [4,[7][8][9][10][11].…”

Section: Eligible Studiesmentioning

confidence: 99%

“…Five trials [3,4,7,9,11] described the method of power calculation, six trials [4,[7][8][9][10][11] described in detail the mode of randomization and five trials [4,[7][8][9]11] described the mode of allocation concealment in detail. Withdrawals were described in detail in six trials [3,4,[8][9][10][11].…”

Section: Eligible Studiesmentioning

confidence: 99%

“…Withdrawals were described in detail in six trials [3,4,[8][9][10][11]. None of the seven studies were blinded.…”

Section: Eligible Studiesmentioning

confidence: 99%

“…None of the seven studies were blinded. One trial was terminated early due to clear loss of equipoise in relation to morbidity [4] and one ended due to increasing patient withdrawal prerandomization [9], and one was stopped due to slow accrual and a lower than anticipated event rate [7].…”

Section: Eligible Studiesmentioning

confidence: 99%

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Outcome of axillary staging in early breast cancer: a meta-analysis

Kell

Burke

Barry

et al. 2010

Breast Cancer Res Treat

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Axillary lymph node dissection (ALND) is associated with significant morbidity, whilst sentinel node biopsy (SNB) has the potential to minimize complications in the management of breast cancer. The aim of this study was to systematically appraise the outcome of SNB when compared to ALND. A comprehensive search for published trials examining outcomes after SNB for breast cancer was performed using medline and cross-referencing available data. Each study was reviewed and data extracted. Primary outcomes were nodal positivity and surgery-related morbidity. A total of 9,608 patients were identified from trials comparing ALND and SNB. The overall rate of axillary lymph node positivity for those with no clinically palpable nodes was 28.8% for ALND and 27.6% for SNB (OR = 1.00, 95% CI = 0.86-1.17, P = 0.956), though there was a trend for superior detection of metastatic disease with SNB when this was compared with ALND alone (OR = 1.22, 95% CI = 0.95-1.57, P = 0.122). Patients who undergo SNB are significantly less likely to suffer post-operative morbidity relative to ALND: risk of infection (OR = 0.58, 95% CI = 0.42-0.80, P = 0.0011), seroma (OR = 0.40, 95% CI = 0.31-0.51, P = 0.0071), arm swelling (OR = 0.30, 95% CI = 0.14-0.66, P = 0.0028) and numbness (OR = 0.25, 95% CI = 0.1-0.59, P = 0.0018).SNB is at least equivalent to ALND in detecting metastatic disease in the axilla. SNB is the optimum approach in terms of morbidity for the assessment of axillary metastasis in clinically node negative breast cancer.

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Section: Eligible Studiesmentioning

confidence: 99%

Section: Eligible Studiesmentioning

confidence: 99%

Section: Eligible Studiesmentioning

confidence: 99%

“…Withdrawals were described in detail in six trials [3,4,[8][9][10][11]. None of the seven studies were blinded.…”

Section: Eligible Studiesmentioning

confidence: 99%

Section: Eligible Studiesmentioning

confidence: 99%

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Outcome of axillary staging in early breast cancer: a meta-analysis

Kell

Burke

Barry

et al. 2010

Breast Cancer Res Treat

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Use of Axillary Staging in the Management of Ductal Carcinoma In Situ

Zee

2015

JAMA Oncol

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45. Pernas S, Gil M, Benítez A, et al. Avoiding axillary treatment in sentinel lymph node micrometastases of breast cancer: a prospective analysis of axillary or distant recurrence. Ann Surg Oncol. 2010;17(3):772-777. 46. Lucci A, McCall LM, Beitsch PD, et al; American College of Surgeons Oncology Group. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol. 2007;25(24):3657-3663. 47. Fleissig A, Fallowfield LJ, Langridge CI, et al. 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. Breast Cancer Res Treat. 2006;95(3):279-293. 48. Veronesi U, Paganelli G, Viale G, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003;349(6):546-553. 49. McMasters KM, Chao C, Wong SL, Martin RC III, Edwards MJ. Sentinel lymph node biopsy in patients with ductal carcinoma in situ: a proposal. Cancer. 2002;95(1):15-20. 50. Miller CL, Specht MC, Skolny MN, et al. Sentinel lymph node biopsy at the time of mastectomy does not increase the risk of lymphedema: implications for prophylactic surgery. Breast Cancer Res Treat. 2012;135(3):781-789. 51. Osako T, Iwase T, Ushijima M, et al. Incidence and prediction of invasive disease and nodal metastasis in preoperatively diagnosed ductal carcinoma in situ. Cancer Sci. 2014;105(5):576-582. 52. Khuri SF, Daley J, Henderson W, et al. Relation of surgical volume to outcome in eight common operations: results from the VA National Surgical Quality Improvement Program. Ann Surg. 1999;230 (3):414-429. 53. Hershman DL, Richards CA, Kalinsky K, et al. Influence of health insurance, hospital factors and physician volume on receipt of immediate post-mastectomy reconstruction in women with invasive and noninvasive breast cancer. Breast Cancer Res Treat. 2012;136(2):535-545.Owing to the widespread adoption of screening for breast cancer and improvements in the sensitivity of mammography, the diagnosis of ductal carcinoma in situ (DCIS) has increased dramatically over the past few decades. Historically, DCIS accounted for only 1% to 2% of all breast cancer diagnoses, but now it accounts for over 20%.Until the early 1990s, mastectomy was the standard surgical treatment for DCIS, and axillary lymph node dissection (ALND) was routine. Simultaneously with the rapid increase in diagnosis of DCIS in the 1980s and early 1990s, the use of breast-conserving surgery (BCS) for DCIS became more widely used. The use of axillary staging decreased as DCIS became more frequently diagnosed and more commonly treated with BCS.Sentinel lymph node biopsy (SLNB) for invasive breast cancer was first reported in 1993 by Krag et al, 1 and was validated in dozens of institutions in the late 1990s. Because validation studies demonstrated low false-ne...

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