First-year quality of life assessment of an intra-arterial (RADPLAT) versus intravenous chemoradiation phase III trial.
BACKGROUND
We report the results of a multicenter randomized phase III study, assessing quality of life (QOL) in intra-arterial (IA) versus standard intravenous (IV) chemoradiation in advanced head and neck cancer.


METHODS
Two hundred seven patients with inoperable stage IV disease-152 men and 55 women; mean age, 55 years-were included in this study. The patients were treated with standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions. The QOL assessments carried out were EORTC-C30, H&N35, and trial-specific questionnaires.


RESULTS
Overall QOL deteriorated in all patients during treatment, is gradually improving over 1 year. IA patients showed significantly less nausea and vomiting at week 7 (p <.001). IV patients were significantly more fatigued (p <.006). At 1 year, no significant difference in tube feeding was found. Voice quality slightly exceeded the pretreatment values at 1 year. Forty-two of 62 employed patients returned to work.


CONCLUSIONS
During treatment, significantly fewer problems with nausea and vomiting occurred in IA than in IV patients. Both groups showed improved voicing and oral intake during follow-up, often exceeding pretreatment values at 1 year.
Ackerstaff
Annemieke H
AH
Department of Head and Neck Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. a.ackerstaff@unki.nl
Balm
Alfons J M
AJ
Rasch
Coen R N
CR
de Boer
Jan Paul
JP
Wiggenraad
Ruud
R
Rietveld
Derk H F
DH
Gregor
R Theo
RT
Kröger
Robert
R
Hilgers
Frans J M
FJ
D000428:Alcohol Drinking / Q000453:epidemiology; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005221:Fatigue / Q000453:epidemiology; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D015438:Health Behavior; D006305:Health Status Indicators; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D007261:Infusions, Intra-Arterial; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D015999:Multivariate Analysis; D009325:Nausea / Q000453:epidemiology; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D011788:Quality of Life; D012907:Smoking / Q000453:epidemiology; D011795:Surveys and Questionnaires; D014839:Vomiting / Q000453:epidemiology; D014987:Xerostomia / Q000453:epidemiology
D000970:Antineoplastic Agents; D002945:Cisplatin