TY - JOUR
T1 - Mapping of sentinel lymph node drainage using SPECT/CT to tailor elective nodal irradiation in head and neck cancer patients (SUSPECT-2)
T2 - a single-center prospective trial
AU - De Veij Mestdagh, Pieter D.
AU - Schreuder, Willem H.
AU - Vogel, Wouter V.
AU - Donswijk, Maarten L.
AU - Van Werkhoven, Eric
AU - Van Der Wal, Jacqueline E.
AU - Dirven, Richard
AU - Karakullukcu, Baris
AU - Sonke, Jan Jakob
AU - Van Den Brekel, Michiel W.M.
AU - Marijnen, Corrie A.M.
AU - Al-Mamgani, Abrahim
N1 - Funding Information: The PhD position of one of the authors involved in this manuscript was partially funded by a public-private partnership grant (LSHM15036) in collaboration with Elekta (SE), provided by the Dutch Ministry of Economic Affairs, through the Top Consortium Knowledge and Innovation of the sector Life Sciences & Health (LSH-TKI Foundation). The funding source had no role in study design, decision to publish, or preparation of the manuscript. Publisher Copyright: © 2019 The Author(s).
PY - 2019/11/14
Y1 - 2019/11/14
N2 - Background: The majority of patients with head and neck squamous cell carcinoma (HNSCC) receive bilateral elective nodal irradiation (ENI), in order to reduce the risk of regional failure. Bilateral ENI, as compared to unilateral ENI, is associated with higher incidence of acute and late radiation-induced toxicity with subsequent deterioration of quality of life. Increasing evidence that the incidence of contralateral regional failure (cRF) in lateralized HNSCC is very low (< 10%) suggests that it can be justified to treat selected patients unilaterally. This trial aims to minimize the proportion of patients that undergo bilateral ENI, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. Methods: In this one-armed, single-center prospective trial, patients with primary T1-4 N0-2b HNSCC of the oral cavity, oropharynx, larynx (except T1 glottic) or hypopharynx, not extending beyond the midline and planned for primary (chemo) radiotherapy, are eligible. After 99mTc-nanocolloid tracer injection in and around the tumor, lymphatic drainage is visualized using SPECT/CT. In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed on the same day. Patients without contralateral lymph drainage, and patients with contralateral drainage but without pathologic involvement of any removed contralateral sentinel nodes, receive unilateral ENI. Only when tumor cells are found in a contralateral sentinel node the patient will be treated with bilateral ENI. The primary endpoint is cumulative incidence of cRF at 1 and 2 years after treatment. Secondary endpoints are radiation-related toxicity and quality of life. The removed lymph nodes will be studied to determine the prevalence of occult metastatic disease in contralateral sentinel nodes. Discussion: This single-center prospective trial aims to reduce the incidence and duration of radiation-related toxicities and improve quality of life of HNSCC patients, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. Trial registration: ClinicalTrials.gov Identifier: NCT03968679, date of registration: May 30, 2019.
AB - Background: The majority of patients with head and neck squamous cell carcinoma (HNSCC) receive bilateral elective nodal irradiation (ENI), in order to reduce the risk of regional failure. Bilateral ENI, as compared to unilateral ENI, is associated with higher incidence of acute and late radiation-induced toxicity with subsequent deterioration of quality of life. Increasing evidence that the incidence of contralateral regional failure (cRF) in lateralized HNSCC is very low (< 10%) suggests that it can be justified to treat selected patients unilaterally. This trial aims to minimize the proportion of patients that undergo bilateral ENI, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. Methods: In this one-armed, single-center prospective trial, patients with primary T1-4 N0-2b HNSCC of the oral cavity, oropharynx, larynx (except T1 glottic) or hypopharynx, not extending beyond the midline and planned for primary (chemo) radiotherapy, are eligible. After 99mTc-nanocolloid tracer injection in and around the tumor, lymphatic drainage is visualized using SPECT/CT. In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed on the same day. Patients without contralateral lymph drainage, and patients with contralateral drainage but without pathologic involvement of any removed contralateral sentinel nodes, receive unilateral ENI. Only when tumor cells are found in a contralateral sentinel node the patient will be treated with bilateral ENI. The primary endpoint is cumulative incidence of cRF at 1 and 2 years after treatment. Secondary endpoints are radiation-related toxicity and quality of life. The removed lymph nodes will be studied to determine the prevalence of occult metastatic disease in contralateral sentinel nodes. Discussion: This single-center prospective trial aims to reduce the incidence and duration of radiation-related toxicities and improve quality of life of HNSCC patients, by using lymph drainage mapping by SPECT/CT to select patients with a minimal risk of contralateral nodal failure for unilateral elective nodal irradiation. Trial registration: ClinicalTrials.gov Identifier: NCT03968679, date of registration: May 30, 2019.
KW - Bilateral elective irradiation
KW - Head and neck cancer
KW - Lymph drainage mapping
KW - Sentinel node
KW - Unilateral elective irradiation
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85075114622&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/31727019
UR - http://www.scopus.com/inward/record.url?scp=85075114622&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12885-019-6331-8
DO - https://doi.org/10.1186/s12885-019-6331-8
M3 - Article
C2 - 31727019
SN - 1471-2407
VL - 19
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 1110
ER -
