TY - JOUR
T1 - Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma
AU - Al-Mamgani, Abrahim
AU - Kessels, Rob
AU - Verhoef, Cornelia G.
AU - Navran, Arash
AU - Hamming-Vrieze, Olga
AU - Kaanders, Johannes H. A. M.
AU - Steenbakkers, Roel J. H. M.
AU - Tans, Lisa
AU - Hoebers, Frank
AU - Ong, Francisca
AU - van Werkhoven, Erik
AU - Langendijk, Johannes A.
N1 - Funding Information:
The authors would like to thank all participating patients, and all colleagues who contributed to data collection. We are also very grateful for the support of the Dutch Cancer Society. AA was principal investigator and conceived and designed the study with the other principal investigators of the participating centers (all co-authors). RK, EW, and AA contributed to data collection, analyzed and interpreted the data. AA drafted the manuscript, in cooperation with all co-authors. All authors revised the manuscript and approved the submission. The trial is sponsored by the Dutch Cancer Society (Grant reference TDM-H1-8054). 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 NCT02421458) 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: NL 52512.031.15). 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.
Funding Information:
The trial is sponsored by the Dutch Cancer Society (Grant reference TDM-H1-8054 ). The funding source had no role in study design, collection, analysis and interpretation of data, decision to publish, or preparation of the manuscript.
Publisher Copyright:
© 2020 Elsevier B.V.
PY - 2020/8
Y1 - 2020/8
N2 - Background: No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).Materials and methods: Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).Results: The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade >= 3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.Conclusion: No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power. (C) 2020 Elsevier B.V. All rights reserved.
AB - Background: No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).Materials and methods: Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).Results: The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade >= 3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.Conclusion: No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power. (C) 2020 Elsevier B.V. All rights reserved.
KW - COHORT
KW - Head and neck cancer
KW - Incurable cancer
KW - Palliative radiotherapy
KW - Randomized controlled trial
KW - Squamous cell carcinoma
KW - SURVIVAL
KW - NOMOGRAM
KW - PREDICTION
U2 - 10.1016/j.radonc.2020.05.020
DO - 10.1016/j.radonc.2020.05.020
M3 - Article
C2 - 32417345
SN - 0167-8140
VL - 149
SP - 181
EP - 188
JO - Radiotherapy and Oncology
JF - Radiotherapy and Oncology
ER -