Dataset Information

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial.

ABSTRACT:

Background/purpose

Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial.

Methods

This is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (BMI) greater than 35 kg/m², those who underwent immediate breast reconstruction, and/or received neoadjuvant chemotherapy were excluded. Patients were randomized in a 1:1 ratio, and were stratified according to their age, BMI, tumor size, and operation type. The primary endpoint was the total seroma volume (the total drained volume and the total aspirated volume after drain removal). Data presented as mean and range when applicable.

Results

111 patients were randomized (Cyanoacrylate 57; control 54). 105 patients were analyzed. Sixty-nine patients underwent breast conserving surgery, and 36 underwent modified radical mastectomy. There was no difference in the total seroma volume between the Cyanoacrylate vs. control arms (1,304 (60-4,950) vs. 1,446 (100-5,223) ml, p=0.458). Wound infection, flap necrosis, number of manual aspirates, and hematoma formation were not statistically different between the two groups. Time to drain removal was shorter in the Cyanoacrylate arm (11.04(3-23) vs. 13.84(3-37) days, p=0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550-748) vs. $29.63 (0-198), p<0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m².

Conclusion

Cyanoacrylate did not reduce seroma formation and its use was not cost effective.

Clinical trial registration

clinicaltrials.gov, identifier NCT02141373.

SUBMITTER: Al-Masri M

PROVIDER: S-EPMC7868378 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial.

Al-Masri Mahmoud M Alawneh Fade F Daoud Faiez F Ebous Ali A Hamdan Basem B Al-Najjar Hani H Al-Masri Rama R Abufara Marwan M

Frontiers in oncology 20210125

<h4>Background/purpose</h4>Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial.<h4>Methods</h4>This is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (B ...[more]

PMID: 33569343

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Project description:ContextSentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer, but it is not clear whether further nodal dissection affects survival.ObjectiveTo determine the effects of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.Design, setting, and patientsThe American College of Surgeons Oncology Group Z0011 trial, a phase 3 noninferiority trial conducted at 115 sites and enrolling patients from May 1999 to December 2004. Patients were women with clinical T1-T2 invasive breast cancer, no palpable adenopathy, and 1 to 2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin-eosin staining on permanent section. Targeted enrollment was 1900 women with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected.InterventionsAll patients underwent lumpectomy and tangential whole-breast irradiation. Those with SLN metastases identified by SLND were randomized to undergo ALND or no further axillary treatment. Those randomized to ALND underwent dissection of 10 or more nodes. Systemic therapy was at the discretion of the treating physician.Main outcome measuresOverall survival was the primary end point, with a noninferiority margin of a 1-sided hazard ratio of less than 1.3 indicating that SLND alone is noninferior to ALND. Disease-free survival was a secondary end point.ResultsClinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up, March 4, 2010), 5-year overall survival was 91.8% (95% confidence interval [CI], 89.1%-94.5%) with ALND and 92.5% (95% CI, 90.0%-95.1%) with SLND alone; 5-year disease-free survival was 82.2% (95% CI, 78.3%-86.3%) with ALND and 83.9% (95% CI, 80.2%-87.9%) with SLND alone. The hazard ratio for treatment-related overall survival was 0.79 (90% CI, 0.56-1.11) without adjustment and 0.87 (90% CI, 0.62-1.23) after adjusting for age and adjuvant therapy.ConclusionAmong patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND alone compared with ALND did not result in inferior survival.Trial registrationclinicaltrials.gov Identifier: NCT00003855.

Project description:For patients with breast cancer and metastases in the sentinel nodes, axillary dissection has been standard treatment. However, for patients with limited sentinel-node involvement, axillary dissection might be overtreatment. We designed IBCSG trial 23-01 to determine whether no axillary dissection was non-inferior to axillary dissection in patients with one or more micrometastatic (≤2 mm) sentinel nodes and tumour of maximum 5 cm.In this multicentre, randomised, non-inferiority, phase 3 trial, patients were eligible if they had clinically non-palpable axillary lymph node(s) and a primary tumour of 5 cm or less and who, after sentinel-node biopsy, had one or more micrometastatic (≤2 mm) sentinel lymph nodes with no extracapsular extension. Patients were randomly assigned (in a 1:1 ratio) to either undergo axillary dissection or not to undergo axillary dissection. Randomisation was stratified by centre and menopausal status. Treatment assignment was not masked. The primary endpoint was disease-free survival. Non-inferiority was defined as a hazard ratio (HR) of less than 1·25 for no axillary dissection versus axillary dissection. The analysis was by intention to treat. Per protocol, disease and survival information continues to be collected yearly. This trial is registered with ClinicalTrials.gov, NCT00072293.Between April 1, 2001, and Feb 28, 2010, 465 patients were randomly assigned to axillary dissection and 469 to no axillary dissection. After the exclusion of three patients, 464 patients were in the axillary dissection group and 467 patients were in the no axillary dissection group. After a median follow-up of 5·0 (IQR 3·6-7·3) years, we recorded 69 disease-free survival events in the axillary dissection group and 55 events in the no axillary dissection group. Breast-cancer-related events were recorded in 48 patients in the axillary dissection group and 47 in the no axillary dissection group (ten local recurrences in the axillary dissection group and eight in the no axillary dissection group; three and nine contralateral breast cancers; one and five [corrected] regional recurrences; and 34 and 25 distant relapses). Other non-breast cancer events were recorded in 21 patients in the axillary dissection group and eight in the no axillary dissection group (20 and six second non-breast malignancies; and one and two deaths not due to a cancer event). 5-year disease-free survival was 87·8% (95% CI 84·4-91·2) in the group without axillary dissection and 84·4% (80·7-88·1) in the group with axillary dissection (log-rank p=0·16; HR for no axillary dissection vs axillary dissection was 0·78, 95% CI 0·55-1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3-4) included one sensory neuropathy (grade 3), three lymphoedema (two grade 3 and one grade 4), and three motor neuropathy (grade 3), all in the group that underwent axillary dissection, and one grade 3 motor neuropathy in the group without axillary dissection. One serious adverse event was reported, a postoperative infection in the axilla in the group with axillary dissection.Axillary dissection could be avoided in patients with early breast cancer and limited sentinel-node involvement, thus eliminating complications of axillary surgery with no adverse effect on survival.None.

Project description:ImportanceThe American College of Surgeons Oncology Group (ACOSOG) Z0011 study demonstrated the safety of sentinel node biopsy alone in clinically node-negative women with metastases in 1 or 2 sentinel nodes treated with breast conservation. Little is known about surgeon perspectives regarding when axillary lymph node dissection (ALND) can be omitted.ObjectivesTo determine surgeon acceptance of ACOSOG Z0011 findings, identify characteristics associated with acceptance of ACOSOG Z0011 results, and examine the association between acceptance of the Society of Surgical Oncology and American Society for Radiation Oncology negative margin of no ink on tumor and surgeon preference for ALND.Design, setting, and participantsA survey was sent to 488 surgeons treating a population-based sample of women with early-stage breast cancer (N = 5080). The study was conducted from July 1, 2013, to August 31, 2015.Main outcomes and measuresSurgeons were categorized as having low, intermediate, or high propensity for ALND according to the outer quartiles of ALND scale distribution. A multivariable linear regression model was used to confirm independent associations.ResultsOf the 488 surgeons invited to participate, 376 (77.0%) responded and 359 provided complete information regarding propensity for ALND derived from 5 clinical scenarios. Mean surgeon age was 53.7 (range, 31-80) years; 277 (73.7%) were male; 142 (37.8%) treated 20 or fewer breast cancers annually and 108 (28.7%) treated more than 50. One hundred seventy-five (49.0%) recommended ALND for 1 macrometastasis. Of low-propensity surgeons who recommended ALND, only 1 (1.1%) approved ALND for any nodal metastases compared with 69 (38.6%) and 85 (95.5%) of selective and high-propensity surgeons (P < .001), respectively. In multivariable analysis, lower ALND propensity was significantly associated with higher breast cancer volume (21-50: -0.19; 95% CI, -0.39 to 0.02; >51: -0.48; 95% CI, -0.71 to -0.24; P < .001), recommendation of a minimal margin width (1-5 mm: -0.10; 95% CI, -0.43 to 0.22; no ink on tumor: -0.53; 95% CI, -0.82 to -0.24; P < .001), participation in a multidisciplinary tumor board (1%-9%: -0.25; 95% CI, -0.55 to 0.05; >9%: -0.37; 95% CI, -0.63 to -0.11; P = .02), and Los Angeles Surveillance, Epidemiology, and End Results site (-0.18; 95% CI, -0.35 to -0.01; P = .04).Conclusions and relevanceThis study shows substantial variation in surgeon acceptance of more limited surgery for breast cancer, which is associated with higher breast cancer volume and multidisciplinary interactions, suggesting the potential for overtreatment of many patients and the need for education targeting lower-volume breast surgeons.

Dataset Information

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial.

Background/purpose

Methods

Results

Conclusion

Clinical trial registration

Publications

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial.

Similar Datasets

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