Abstract
Background and purpose: Bilateral elective nodal irradiation (ENI) remains the standard treatment for head and neck squamous cell carcinoma (HNSCC). Unilateral ENI could reduce treatment toxicity and improve health-related quality-of-life (HRQOL). This prospective proof-of-principle trial (NCT02572661) investigated the feasibility, safety and clinical benefits of SPECT/CT-guided ENI of the node-negative contralateral neck. Materials and methods: Patients with lateralized T1-3N0-2bM0 HNSCC of the oropharynx, oral cavity, larynx and hypopharynx underwent SPECT/CT after peritumoral 99mTc-nanocolloid injection. Patients without contralateral lymph drainage received ipsilateral ENI only. If lymph drainage to only one contralateral hot spot was visible, ENI to the contralateral neck would be limited to only the level containing the hot spot. The primary endpoint was the incidence of contralateral regional failure (CRF) at 2 years. Toxicity and HRQOL were compared with a 1:1 matched historical cohort that received standard bilateral ENI (B-ENI) with identical planning and treatment techniques. Results: Fifty patients were treated with SPECT/CT-guided ENI. After a median follow-up of 33 months (range 18–45), CRF was observed in one patient (2%; 95% confidence interval: 0–6%). Compared to the matched B-ENI group, patients treated with SPECT/CT-guided ENI had significantly lower incidences of grade ≥2 dysphagia (54% vs. 82%; p < 0.001), tube feeding (10% vs. 50%; p < 0.001) and late grade ≥2 xerostomia (9% vs. 54%; p < 0.001). Significant and clinically relevant HRQOL benefits of SPECT/CT-guided ENI were observed on the EORTC QLQ-C30 summary score, and QLQ-HN35 swallowing and dry mouth subscales. Conclusion: SPECT/CT-guided ENI is associated with a low risk of contralateral regional failure. Compared to B-ENI, SPECT/CT-guided ENI significantly reduces dysphagia, feeding tube placement, and late xerostomia and improves HRQOL.
| Original language | English |
|---|---|
| Pages (from-to) | 56-63 |
| Number of pages | 8 |
| Journal | Radiotherapy and Oncology |
| Volume | 147 |
| DOIs | |
| Publication status | Published - Jun 2020 |
Bibliographical note
Funding Information:The PhD position of the first author was partially funded by a grant received by the Department of Radiation Oncology : 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, collection, analysis and interpretation of data, decision to publish, or preparation of the manuscript.
Funding Information:
The authors would like to thank all participating patients, and all colleagues who contributed to data collection. AA conceived the study and was principal investigator. AA, EW, WV and MB designed the study. PV, WV, WS, CC, MD and AA contributed to data collection. PV, IW, EW and AA analyzed and interpreted the data and drafted the manuscript. All authors revised the manuscript and approved the submission. Pieter de Veij Mestdagh has nothing to disclose. Iris Walraven has nothing to disclose. Wouter Vogel has nothing to disclose. Willem Schreuder has nothing to disclose. Erik van Werkhoven has nothing to disclose. Casper Carbaat has nothing to disclose. Maarten Donswijk has nothing to disclose. Michiel van den Brekel has nothing to disclose. Abrahim Al-Mamgani has nothing to disclose. The PhD position of the first author was partially funded by a grant received by the Department of Radiation Oncology: 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, collection, analysis and interpretation of data, decision to publish, or preparation of the manuscript. The study (ClinicalTrials.gov Identifier NCT02572661) was conducted in accordance with the Declaration of Helsinki. The study was approved by the local research ethics committee (Medical Research Ethics Committee of the Netherlands Cancer Institute/Antoni van Leeuwenhoek, protocol ID: NL68958.031.19). All patients were given oral and written information about the study, and were given sufficient time to consider participating. Written informed consent was obtained from each patient before inclusion.
Publisher Copyright:
© 2020 Elsevier B.V.
Funding
The PhD position of the first author was partially funded by a grant received by the Department of Radiation Oncology : 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, collection, analysis and interpretation of data, decision to publish, or preparation of the manuscript. The authors would like to thank all participating patients, and all colleagues who contributed to data collection. AA conceived the study and was principal investigator. AA, EW, WV and MB designed the study. PV, WV, WS, CC, MD and AA contributed to data collection. PV, IW, EW and AA analyzed and interpreted the data and drafted the manuscript. All authors revised the manuscript and approved the submission. Pieter de Veij Mestdagh has nothing to disclose. Iris Walraven has nothing to disclose. Wouter Vogel has nothing to disclose. Willem Schreuder has nothing to disclose. Erik van Werkhoven has nothing to disclose. Casper Carbaat has nothing to disclose. Maarten Donswijk has nothing to disclose. Michiel van den Brekel has nothing to disclose. Abrahim Al-Mamgani has nothing to disclose. The PhD position of the first author was partially funded by a grant received by the Department of Radiation Oncology: 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, collection, analysis and interpretation of data, decision to publish, or preparation of the manuscript. The study (ClinicalTrials.gov Identifier NCT02572661) was conducted in accordance with the Declaration of Helsinki. The study was approved by the local research ethics committee (Medical Research Ethics Committee of the Netherlands Cancer Institute/Antoni van Leeuwenhoek, protocol ID: NL68958.031.19). All patients were given oral and written information about the study, and were given sufficient time to consider participating. Written informed consent was obtained from each patient before inclusion.
| Funders | Funder number |
|---|---|
| Dutch Ministry of Economic Affairs | |
| LSH-TKI Foundation | NCT02572661 |
| Netherlands Cancer Institute/Antoni van Leeuwenhoek | NL68958.031.19 |
