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Clinical Trial
. 2010 Oct;21(10):1967-1973.
doi: 10.1093/annonc/mdq077. Epub 2010 Mar 24.

Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck

R Mesía  1 , F Rivera  2 , A Kawecki  3 , S Rottey  4 , R Hitt  5 , H Kienzer  6 , D Cupissol  7 , D De Raucourt  8 , M Benasso  9 , P Koralewski  10 , J-P Delord  11 , C Bokemeyer  12 , D Curran  13 , A Gross  14 , J B Vermorken  15
Affiliations
Clinical Trial

Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck

R Mesía et al. Ann Oncol. 2010 Oct.

Abstract

Background: A phase III trial demonstrated that cetuximab is the first agent in 30 years to improve survival when added to platinum-based chemotherapy (platinum-fluorouracil) first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). This analysis of the trial assessed the impact of treatment on quality of life (QoL).

Patients and methods: The European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQ-C30) and QLQ-Head and Neck 35 (QLQ-H&N35) module were used to assess QoL.

Results: Of 442 patients randomly assigned, 291 (QLQ-C30) and 289 (QLQ-H&N35) patients completed at least one evaluable questionnaire. For QLQ-C30, cycle 3 and month 6 mean scores for platinum-fluorouracil plus cetuximab were not significantly worse than those for platinum-fluorouracil. Pattern-mixture analysis demonstrated a significant improvement in the global health status/QoL score in the cetuximab arm (P = 0.0415) but no treatment differences in the social functioning scale. For QLQ-H&N35, the mean score for the cetuximab arm was not significantly worse than that for the chemotherapy arm for all symptom scales at all post-baseline visits. At cycle 3, some symptom scores significantly favored the cetuximab arm (pain, swallowing, speech problems, and social eating).

Conclusion: Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.

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Figures

Figure 1.
Figure 1.
(A) EORTC QLQ-C30 global health status/quality of life and (B) social functioning scores over time from baseline to month 6 by treatment arm (least-squares means). EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.
Figure 2.
Figure 2.
EORTC QLQ-H&N35 multi-item symptom scale scores: mean change from baseline to worst post-baseline scores. EORTC QLQ-H&N35, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35.
See this image and copyright information in PMC

References

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