Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer.
Adult
Aged
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Cetuximab
/ administration & dosage
Cisplatin
/ administration & dosage
Combined Modality Therapy
Disease-Free Survival
Female
Humans
Male
Middle Aged
Neoplasm Metastasis
Neoplasm Recurrence, Local
/ drug therapy
Platinum
/ administration & dosage
Progression-Free Survival
Proportional Hazards Models
Prospective Studies
Squamous Cell Carcinoma of Head and Neck
/ drug therapy
Cetuximab
Chemotherapy
HNSCC
Response
Symptom
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
29 Sep 2020
29 Sep 2020
Historique:
received:
30
05
2020
accepted:
21
09
2020
entrez:
30
9
2020
pubmed:
1
10
2020
medline:
15
4
2021
Statut:
epublish
Résumé
Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC. In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score. Fourhundred seventy patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (- 2.13 vs. non-responders + 1.15, p = 0.048), and even more for the best post-baseline assessment (- 7.82 vs. non-responders - 1.97, p = 0.0005). The VAS for pain (- 16.37 vs. non-responders - 8.89, p = 0.001) and swallowing of solid food (- 16.67 vs. non-responders - 5.06, p = 0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05-1.20, p = 0.0009). In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC. ClinicalTrials.gov, NCT00122460 . Registered 22 Juli 2005.
Sections du résumé
BACKGROUND
BACKGROUND
Head and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC.
METHODS
METHODS
In this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score.
RESULTS
RESULTS
Fourhundred seventy patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (- 2.13 vs. non-responders + 1.15, p = 0.048), and even more for the best post-baseline assessment (- 7.82 vs. non-responders - 1.97, p = 0.0005). The VAS for pain (- 16.37 vs. non-responders - 8.89, p = 0.001) and swallowing of solid food (- 16.67 vs. non-responders - 5.06, p = 0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05-1.20, p = 0.0009).
CONCLUSION
CONCLUSIONS
In unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT00122460 . Registered 22 Juli 2005.
Identifiants
pubmed: 32993574
doi: 10.1186/s12885-020-07440-w
pii: 10.1186/s12885-020-07440-w
pmc: PMC7526421
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Platinum
49DFR088MY
Cetuximab
PQX0D8J21J
Cisplatin
Q20Q21Q62J
Banques de données
ClinicalTrials.gov
['NCT00122460']
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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