An international phase 3 trial in head and neck cancer: quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group.
BACKGROUND
The European Organization for Research and Treatment of Cancer (EORTC) 24954 phase 3 randomized clinical trial compared 2 schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx: sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy. The current study reports detailed effects of both treatment arms on health-related quality of life (HRQOL) and symptoms.


METHODS
A total of 450 patients aged 35 years to 76 years (World Health Organization performance status (WHO PS) ≤ 2) with untreated, resectable advanced squamous cell carcinoma of the larynx (tumor classification of T3-T4) or hypopharynx (tumor classification of T2-T3-T4) with regional lymph nodes in the neck classified as N0 to N2 with no metastases were randomized in this prospective phase 3 trial into either the sequential arm (control) or the alternating arm (experimental). QOL assessment was performed at randomization; at baseline; at 42 days; and at 6, 12, 24, 36, and 48 months.


RESULTS
There were no observed differences with regard to the primary endpoint of Fatigue and secondary endpoint of Dyspnea. Significant differences were found in the secondary endpoints of Swallowing and Speech problems at 42 days after randomization in favor of patients in the sequential arm. Explanatory and sensitivity analysis revealed that the primary analysis favored the sequential arm, but the majority of differences in HRQOL did not exist at the end of treatment, and returned to baseline levels.


CONCLUSIONS
In the current study, a trend toward worse scores was noted in the patients treated on the alternating chemoradiotherapy arm but very few differences reached the level of statistical significance. The HRQOL scores of the majority of patients returned to baseline after therapy.
Quality of Life Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
Andrew
A
Bottomley
Gloria
G
Tridello
Corneel
C
Coens
Frederic
F
Rolland
Margot E T
ME
Tesselaar
C Rene
CR
Leemans
Pierre
P
Hupperets
Lisa
L
Licitra
Jan B
JB
Vermorken
Danielle
D
Van Den Weyngaert
Gilles
G
Truc
Isabelle
I
Barillot
Jean-Louis
JL
Lefebvre
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000523:psychology* / Q000628:therapy*; D059248:Chemoradiotherapy; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000523:psychology* / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life; D000077195:Squamous Cell Carcinoma of Head and Neck
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30); alternating chemoradiotherapy; chemotherapy; health-related quality of life; hypopharynx cancer; larynx cancer; radiotherapy