An International Phase 3 Trial in Head and Neck Cancer: Quality of Life and Symptom Results

Andrew Bottomley*, Gloria Tridello, Corneel Coens, Frederic Rolland, Margot E. T. Tesselaar, C. Rene Leemans, Pierre Hupperets, Lisa Licitra, Jan B. Vermorken, Danielle Van Den Weyngaert, Gilles Truc, Isabelle Barillot, Jean-Louis Lefebvre

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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. METHODSA 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. RESULTSThere 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. CONCLUSIONSIn 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. Cancer 2014;120:390-398.
Original languageEnglish
Pages (from-to)390-398
Issue number3
Publication statusPublished - 1 Feb 2014


  • hypopharynx cancer
  • larynx cancer
  • chemotherapy
  • radiotherapy
  • alternating chemoradiotherapy
  • health-related quality of life
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)

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