Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer

doi:10.19401/j.cnki.1007-3639.2023.02.005

Abstract

Abstract:

Background and purpose: Both domestic and foreign guidelines recommend the use of radionuclide as sentinel lymph node (SLN) biopsy (SLNB) tracer, however this technique has not been popularized in China for a variety of reasons. Mitoxantrone hydrochloride injection for tracing (MHI), a new strategy to identify lymph nodes, has not been tested for axillary node staging in breast cancer. This multicenter, self-controlled, non-inferiority trial aimed to evaluate the differences between MHI and radionuclide in SLNB tracing. Methods: The trial was conducted across 7 hospitals from December 2019 to December 2020. Patients with early-stage breast cancer received MHI and radionuclide (technetium 99 labeled sulfur colloid, ^99mTc-Sc) as SLN tracers during the surgery. The number of SLNs detected and sentinel node detection rates of MHI and radionuclide were counted to evaluate differences in the tracing effects between the two tracers. Results: SLN detection rates of MHI and radionuclide were 96.9% (370/382) and 97.4% (372/382), respectively, with no significant difference (P>0.05). SLNs were co-detected by both tracers in 362 (94.7%) patients; 16 (4.1%) had adverse events possibly related to the trial drugs. Conclusion: In this study, it was found that the lymphatic tracing ability of MHI was not inferior to that of radionuclide. Meanwhile, the use of MHI does not require special instrument/equipment assistance.

Key words: Breast cancer, Sentinel lymph node biopsy, Mitoxantrone hydrochloride injection for tracing, Lymphatic tracer, Radionuclide, Axillary lymph node

CLC Number:

R737.9

YANG Benlong, JIAO Dechuang, CHEN Jiajian, WANG Chunjian, JIN Lidan, ZHAO Wenhe, GAO Xueqiang, WANG Haibo, LI Jun, ZHAO Haidong, WU Di, FAN Zhimin, WANG Shujun, LIU Zhenzhen, WANG Yongsheng, WU Jiong. Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer[J]. China Oncology, 2023, 33(2): 126-133.

Figures/Tables 5

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References 21

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Item	Patients in MHI and ^99mTc-Sc group (n=382)	Item	Patients in MHI and ^99mTc-Sc group (n=382)
Age/year [mean (range)]	53 (26-70)	Tumor site n (%)
Body mass index [mean (range)]	23.8 (16.6-38.8)	Outer	175 (45.8)
Tumor type n (%)		Outer bottom	30 (7.8)
Invasive breast cancer	308 (80.6)	Inner top	96 (25.1)
Carcinoma in situ	47 (12.3)	Inferior	20 (5.2)
Other	27 (7.1)	Central area	61 (16.0)
Pathological diagnosis n (%)		Procedure n (%)
T_1a	4 (1.0)	Breast conservation	161 (42.1)
T_1b	2 (8.4)	Total mastectomy	221 (57.9)
T_1c	184 (48.2)
T₂	157 (41.1)
T₃	5 (1.3)

^99mTc-Sc	MHI
^99mTc-Sc	Blue staining	No blue staining	Total
Positive SLN
Hot spots	102 (70.8)	12 (8.3)	114 (79.2)
No hot spot	15 (10.4)	15 (10.4)	30 (20.8)
Total	117 (81.2)	27 (18.8)	144 (100.0)
Positive patients
Hot spots	75 (79.8)	5 (5.3)	80 (85.1)
No hot spot	9 (9.6)	5 (5.3)	14 (14.9)
Total	84 (89.4)	10 (10.6)	94 (100.0)

System organ class preferred term	Number of patients (n = 387)
All adverse events	16 (4.1)
Infections and infestations	1 (0.3)
Pustular rash	1 (0.3)
Investigations	16 (4.1)
Alanine aminotransferase increased	16 (4.1)
Aspartate aminotransferase increased	15 (3.9)
Gamma-glutamyltransferase increased	5 (1.3)
Blood alkaline phosphatase increased	2 (0.5)