The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc(99) and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies.
The aim of the study is to compare the efficacy of SPIO as a tracer in sentinel node biopsy (SNB) in breast cancer with Tc and patent blue in a multicentre prospective study and perform a meta-analysis of all published studies. It also aims to follow skin discoloration after SPIO injection and describe when and how it resolves. Totally 206 patients with early breast cancer were recruited. Tc and patent blue were administered in standard fashion. Patients were injected with SPIO (Sienna+) preoperatively. SNB was performed and detection rates were recorded for both methods. Skin discoloration was followed and documented postoperatively. Data extraction and subsequent meta-analysis of all previous studies were also performed. SN detection rates were similar between standard technique succeeded and SPIO both per patient (97.1 vs. 97.6 %, p = 0.76) as well as per node (91.3 vs. 93.3 %, p = 0.34), something which was not affected by the presence of malignancy. Concordance rates were also consistently high (98.0 % per patient and 95.9 % per node). Discoloring was present in 35.5 % of patients postoperatively, almost exclusively in breast conservation. It fades slowly and is still detectable in 8.6 % of patients after 15 months. Meta-analysis depicted similar detection rates (p = 0.71) and concordance rates (p = 0.82) per patient. However, it seems that SPIO is characterized by higher nodal retrieval (p < 0.001). SPIO is an effective method for the detection of SN in patients with breast cancer. It is comparable to the standard technique and seems to simplify logistics. Potential skin discoloration is something of consideration in patients planned for breast conservation.
Section for Endocrine and Breast Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden. andreas.karakatsanis@akademiska.se.
Andreas
A
Karakatsanis
Breast Unit, Department of Surgery, Aarhus University Hospital/Randers Regional Hospital, Aarhus, Denmark.
Peer Michael
PM
Christiansen
Breast Unit, Department of Surgery, Aarhus University Hospital/Randers Regional Hospital, Aarhus, Denmark.
Lone
L
Fischer
Breast Unit, Department of Surgery, Linköping University Hospital, Linköping, Sweden.
Christina
C
Hedin
Breast Unit, Department of Surgery, Linköping University Hospital, Linköping, Sweden.
Lida
L
Pistioli
Department of Surgical and Perioperative Sciences, Umeå, Sweden.
Malin
M
Sund
Breast Unit, Department of Surgery, SVS, Esbjerg, Denmark.
Nils Ryegaard
NR
Rasmussen
Breast Unit, Department of Surgery, SVS, Esbjerg, Denmark.
Hjørdis
H
Jørnsgård
Breast Unit, Department of Surgery, Örebro University Hospital, Örebro, Sweden.
Daniel
D
Tegnelius
Department of Surgery, Västmanland County Hospital, Västerås, Sweden.
Staffan
S
Eriksson
Section for Endocrine and Breast Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Kosmas
K
Daskalakis
Section for Endocrine and Breast Surgery, Department of Surgical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Fredrik
F
Wärnberg
Medical School, National and Kapodistrian University, Athens, Greece.
Christos J
CJ
Markopoulos
Center for Clinical Research Uppsala University and Department of Surgery, Västmanland County Hospital, Västerås, Sweden.
Leif
L
Bergkvist
D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology*; D004396:Coloring Agents / Q000008:administration & dosage*; D003718:Denmark; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D006801:Humans; D058185:Magnetite Nanoparticles; D008875:Middle Aged; D011446:Prospective Studies; D019275:Radiopharmaceuticals / Q000008:administration & dosage*; D012394:Rosaniline Dyes / Q000008:administration & dosage*; D000071036:Sentinel Lymph Node / Q000000981:diagnostic imaging*; D021701:Sentinel Lymph Node Biopsy / Q000379:methods; D013548:Sweden; D013668:Technetium Tc 99m Aggregated Albumin / Q000008:administration & dosage*
D004396:Coloring Agents; D005290:Ferric Compounds; D058185:Magnetite Nanoparticles; D019275:Radiopharmaceuticals; D012394:Rosaniline Dyes; D013668:Technetium Tc 99m Aggregated Albumin; C000499:ferric oxide; C008769:sulfan blue
Breast cancer; Sentinel node; Super paramagnetic iron oxide