Cetuximab plus radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck

Abstract

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of cetuximab plus radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) considered inappropriate for chemoradiotherapy but appropriate for radiotherapy, based upon the evidence submission from Merck Pharmaceuticals to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer's submission was generally of good quality and was an accurate representation of the original reference data. One good-quality randomised controlled trial comparing radiotherapy plus cetuximab with radiotherapy alone in patients with stage III or IV non-metastatic LA SCCHN was included, demonstrating that the duration of locoregional control was significantly longer with radiotherapy plus cetuximab than with radiotherapy alone; also, overall and progression-free survival were significantly longer and the overall response rate was significantly better with the combination therapy. Cetuximab did not exacerbate the common toxic effects associated with radiotherapy of the head and neck. No supporting evidence for these findings are available. The patient population in the trial included a high proportion of patients who would be expected to be suitable for chemoradiotherapy and therefore does not DOI: 10.3310/hta13suppl1/08 Cetuximab plus radiotherapy for the treatment of LA SCC of the head and neck50 match the population described in the submission's decision problem. Also, the radiotherapy regimens used in the trial are not typical of current UK practice. The ERG considered the manufacturer's economic evaluation to comprise the only relevant evidence to consider for the purposes of this STA. The economic model was considered appropriate for the decision problem. The results suggested that cetuximab plus radiotherapy was cost-effective compared with radiotherapy alone under a broad range of different assumptions on the basis of a cost-effectiveness threshold of £20,000. In the base case the incremental cost-effectiveness ratio of cetuximab plus radiotherapy compared with radiotherapy alone in the treatment of patients with LA SCCHN was £6390 per additional QALY. Simple sensitivity analyses to examine the robustness of the results were undertaken, suggesting that areas of uncertainty that emerged in the modelling are unlikely to have a material effect on the conclusions. The guidance issued by NICE in May 2007 as a result of the STA states that cetuximab in combination with radiotherapy is not recommended for patients with LA SCCHN.

Elevated Beclin 1 expression is correlated with HIF-1α in predicting poor prognosis of nasopharyngeal carcinoma

“…11 EGFR monoclonal antibody, cetuximab (C225), had demonstrated a gratifying survival benefit in combination with chemotherapy or radiotherapy for NPC and other types of HNSCC. [12][13][14] Thus, to identify more novel molecular markers that not only can predict the prognosis individually but also provide promising therapy targets will be of great benefit for advanced NPC patients.…”

Spotlight on Cetuximab in Squamous Cell Carcinoma of the Head and Neck†

“…[9] However, there was no significant association between the appearance of a rash and OS in the EXTREME study in patients with recurrent and or metastatic SCCHN. [29] Pharmacoeconomic analyses suggest that, in mainland Europe and or the UK, cetuximab plus radiotherapy is cost effective compared with radiotherapy alone for the treatment of patients with locally advanced SCCHN who are not amenable to chemoradiotherapy, [38][39][40][41][42] whereas cetuximab plus platinumbased chemotherapy is not cost effective compared with platinum-based chemotherapy alone for the first-line treatment of patients with recurrent and or metastatic SCCHN. [41,42] These analyses were based on modeling of data from the pivotal phase III clinical trials and were carried out from the perspective of a public health provider.…”

Survival Time Outcomes in Randomized, Controlled Trials and Meta-Analyses: The Parallel Universes of Efficacy and Cost-Effectiveness

“…In Table 1 ([ [7][8][9][10][11][12][13][14][15][16][17][18][19] 14 of the 16 CEAs were based on parametric models (first 3 columns). On the other hand, none of the efficacy analyses specified parametric models (first two lines).…”