A prospective randomized trial comparing patent blue and methylene blue for the detection of the sentinel lymph node in breast cancer patients

Paulinelli, Régis Resende; Freitas-Junior, Ruffo; Rahal, Rosemar Macedo de Souza; Oliveira, Luis Fernando de Pádua; Vilela, Maria Helena Tavares; Moreira, Marise Amaral Rebouças; Alves, Katyane Larissa; Peleja, Marina Berquó; Resende, Tatiane Coelho Capel de

doi:10.1590/1806-9282.63.02.118

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ORIGINAL ARTICLES • Rev. Assoc. Med. Bras. 63 (2) • Feb 2017 • https://doi.org/10.1590/1806-9282.63.02.118 copy

A prospective randomized trial comparing patent blue and methylene blue for the detection of the sentinel lymph node in breast cancer patients

Estudo randomizado prospectivo comparando o azul patente ao azul de metileno para a detecção do linfonodo sentinela em pacientes com câncer de mama

Authorship SCIMAGO INSTITUTIONS RANKINGS

Summary

Introduction:

Methylene blue is more widely available and less expensive than patent blue, with an apparently lower risk of anaphylaxis.

Objective:

The two dyes were compared regarding detection of the sentinel lymph node (SLN).

Method:

A prospective, randomized trial involved 142 patients with invasive breast carcinoma. Sixty-nine (49.3%) assigned to patent blue (group A) and 71 (50.70%) to methylene blue (group B). Thirty-five patients (25.0%) were clinical stage III or IV; 55 (38.7%) had axillary lymph nodes affected; and 69 (49.3%) underwent neoadjuvant chemotherapy. Two patients were excluded because the dye type was not recorded.

Results:

Patients and tumor characteristics were similar in both groups. SLNs were identified in 47 women (68.1%) in group A and 43 (60.6%) in group B (p=0.35). SLNs were affected in 22 cases (51.2%) in group A and 21 (48.8%) in group B (p=0.62). The SLN was the only node affected in 12 cases (54.5%) in group A and six (33.3%) in group B (p=0.18). The time and degree of difficulty involved in identifying the SLN were similar in both groups. There were no complications or allergies.

Conclusion:

Methylene blue performed as well as patent blue in identifying the SLN in breast cancer patients.

Keywords:
breast cancer; sentinel lymph node; patent blue; methylene blue; randomized controlled trial

	Patent blue	Methylene blue	p-value
Age (years) ^a a Mean (± standard deviation), Student’s t-test.	51.00 (+11.48)	52.82 (13.44)	0.39
Size of the tumor (mm) ^b b Median (interquartile range), Mann-Whitney U test.	35.00 (25.00-50.00)	33.00 (25.00-50.00)	0.78
Clinical staging ^c c n (%), Mann-Whitney U test.			0.34
I	8 (11.6%)	11 (15.5%)
IIa	28 (40.6%)	30 (42.3%)
IIb	14 (20.3%)	14 (19.7%)
III	17 (24.6%)	15 (21.1%)
IV	2 (2.9%)	1 (1.4%)
Clinical involvement of axillae	32 (46.4%)	22 (31.0%)	0.06
Histological grade ^c c n (%), Mann-Whitney U test.			0.90
I	13 (23.6%)	16 (28.6%)
II	32 (58.2%)	28 (50.0%)
III	10 (18.2%)	11 (19.6%)
Skin color ^d d n (%), Chi-square test, with or without Yates’ correction, or Fisher’s exact test.			0.73
White	27 (39.1%)	32 (45.7%)
Black	7 (10.1%)	6 (8.6%)
Brown	35 (50.7%)	32 (45.7%)
Histological type ^d d n (%), Chi-square test, with or without Yates’ correction, or Fisher’s exact test.			0.56
Invasive ductal carcinoma	61 (88.4%)	60 (84.5%)
Invasive lobular carcinoma	3 (4.3%)	3 (4.2%)
Others	5 (7.3%)	8 (11.3%)
Multicentric tumor ^d d n (%), Chi-square test, with or without Yates’ correction, or Fisher’s exact test.	13 (18.8%)	15 (21.4%)	0.70

	Patent blue	Methylene blue	p-value
Lymph node dissection^a a Mean (± standard deviation), Student’s t-test.	15.2 (±6.8)	15.9 (±8.5)	0.67
Lymph nodes affected^b b Median (interquartile range), Mann-Whitney U test.	1.0 (0.0-2.5)	0.0 (0.0-5.0)	0.93
Previous open biopsy^c c n (%); Chi-square test.	15 (21.7%)	21 (29.6%)	0.29
Neoadjuvant chemotherapy^c c n (%); Chi-square test.	39 (56.5%)	47 (66.2%)	0.24
Conservative surgery^c c n (%); Chi-square test.	37 (53.6%)	35 (49.3%)	0.87

	Patent blue	Methylene blue	p-value
Detection of sentinel lymph node	47 (68.1%)	43 (60.6%)	0.35^a a n (%); Chi-square test for trend (Mann-Whitney U test).
Involvement of sentinel lymph node	22 (51.2%)	21 (48.8%)	0.62
Sentinel lymph node was the only node affected	12 (54.5%)	6 (33.3%)	0.19^a a n (%); Chi-square test for trend (Mann-Whitney U test).
Number of sentinel lymph nodes	1.0 (0.0-2.0)	1.0 (0.0-2.0)	0.43^b b Median (interquartile range); Mann-Whitney U test.
Time until detection of sentinel lymph node (minutes)	14.0 (4.0-45.0)	11.0 (1.0-31.3)	0.34^b b Median (interquartile range); Mann-Whitney U test.

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