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, F Rivera, A Kawecki, S Rottey, R Hitt, H Kienzer, D Cupissol, D De Raucourt, M Benasso, P Koralewski, J-P Delord, C Bokemeyer, D Curran, A Gross, J B Vermorken, R Mesía, F Rivera, A Kawecki, S Rottey, R Hitt, H Kienzer, D Cupissol, D De Raucourt, M Benasso, P Koralewski, J-P Delord, C Bokemeyer, D Curran, A Gross, J B Vermorken

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.

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.

References

    1. Schantz SP, Harrison LB, Forastiere A. Tumors of the nasal cavity and paranasal sinuses, nasopharynx, oral cavity, and oropharynx. In: DeVita VT, Hellman SA, Rosenberg SA, editors. Cancer. Principles and Practice of Oncology. 6th edition. Philadelphia, PA: Lippincott Williams & Wilkins; 2001. pp. 797–860.
    1. Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008;359:1116–1127.
    1. Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007;25:2171–2177.
    1. Burtness B, Goldwasser MA, Flood W, et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005;23:8646–8654.
    1. Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006;354:567–578.
    1. Bourhis J, Rivera F, Mesia R, et al. Phase I/II study of cetuximab in combination with cisplatin or carboplatin and fluorouracil in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. J Clin Oncol. 2006;24:2866–2872.
    1. Au H-J, Karapetis CS, O'Callaghan CJ, et al. Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 trial. J Clin Oncol. 2009;27:1822–1828.
    1. Folprecht F, Nowacki M, Lang I, et al. Cetuximab plus FOLFIRI first line in patients (pts) with metastatic colorectal cancer (mCRC): a quality-of-life (QoL) analysis of the CRYSTAL trial. J Clin Oncol. 2009;27:15s. (Abstr 4076)
    1. Sobrero AF, Maurel J, Fehrenbacher L, et al. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26:2311–2319.
    1. Curran D, Giralt J, Harari PM, et al. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007;25:2191–2197.
    1. Fayers PM, Aaronson NK, Bjordal K, et al. EORTC QLQ-C30 Scoring Manual. Brussels, Belgium: EORTC; 1999.
    1. Bjordal K, de Graeff A, Fayers PM, et al. A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group. Eur J Cancer. 2000;36:1796–1807.
    1. Sherman AC, Simonton S, Adams DC, et al. Assessing quality of life in patients with head and neck cancer: cross-validation of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Head and Neck module (QLQ-H&N35) Arch Otolaryngol Head Neck Surg. 2000;126:459–467.
    1. Grignon LM, Jameson MJ, Karnell LH, et al. General health measures and long-term survival in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg. 2007;133:471–476.
    1. Karvonen-Gutierrez CA, Ronis DL, Fowler KE, et al. Quality of life scores predict survival among patients with head and neck cancer. J Clin Oncol. 2008;26:2754–2760.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel