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Lapatinib for HER2 overexpressing breast cancer

By Jeremy Jones, Andrea Takeda, Joanna Picot, Camilla von Keyserlingk and A. Clegg


This paper presents a summary of the evidence<br/>review group (ERG) report into the clinical<br/>effectiveness and cost-effectiveness of lapatinib for<br/>the treatment of advanced or metastatic HER2-<br/>overexpressing breast cancer based upon a review<br/>of the manufacturer’s submission to the National<br/>Institute for Health and Clinical Excellence (NICE)<br/>as part of the single technology appraisal (STA)<br/>process. The scope included women with advanced,<br/>metastatic or recurrent HER2-overexpressing<br/>breast cancer who have had previous therapy that<br/>includes trastuzumab. Outcomes were time to<br/>progression, progression-free survival, response<br/>rates, overall survival, health-related quality<br/>of life and adverse effects. The submission’s<br/>evidence came from one randomised controlled<br/>trial (RCT) of reasonable methodological<br/>quality, although it was not powered to detect a<br/>statistically significant difference in mean overall<br/>survival. Median time to progression was longer<br/>in the lapatinib plus capecitabine arm than in<br/>the capecitabine monotherapy arm {27.1 [95%<br/>confidence interval (CI) 17.4 to 49.4] versus 18.6<br/>[95% CI 9.1 to 36.9] weeks; hazard ratio 0.57 [95%<br/>CI 0.43 to 0.77; p = 0.00013]}. Median overall<br/>survival was very similar between the groups [67.7<br/>(95% CI 58.9 to 91.6) versus 66.6 (95% CI 49.1<br/>to 75.0) weeks; hazard ratio 0.78 (95% CI 0.55<br/>to 1.12; p = 0.177)]. Median progression-free<br/>survival was statistically significantly longer in<br/>the lapatinib plus capecitabine group than in the<br/>capecitabine monotherapy group [27.1 (95% CI<br/>24.1 to 36.9) versus 17.6 (95% CI 13.3 to 20.1)<br/>weeks; hazard ratio 0.55 (95% CI 0.41 to 0.74);<br/>p = 0.000033]. The manufacturer’s economic<br/>model to estimate progression-free and overall<br/>HTA 07/10/01<br/>Date of ERG submission:<br/>June 2007<br/>TAR Centre(s):<br/>Southampton Health Technology Assessments Centre<br/>List of authors:<br/>J Jones, A Takeda, J Picot, C von Keyserlingk and A Clegg<br/>Contact details:<br/>Andrea Takeda, Southampton Health Technology<br/>Assessments Centre, Wessex Institute for Health<br/>Research and Development, University of Southampton,<br/>Mailpoint 728, Boldrewood, Southampton SO16 7PX,<br/>UK<br/>E-mail:<br/>The research reported in this article of the journal<br/>supplement was commissioned and funded by the<br/>HTA programme on behalf of NICE as project number<br/>07/10/01. The assessment report began editorial review<br/>in May 2008 and was accepted for publication in May<br/>2009. See the HTA programme web site for further<br/>project information ( This summary<br/>of the ERG report was compiled after the Appraisal<br/>Committee’s review.<br/>The views and opinions expressed therein are those of<br/>the authors and do not necessarily reflect those of the<br/>Department of Health.<br/>Discussion of ERG reports is invited. Visit the HTA<br/>website correspondence forum (<br/>correspond).<br/>Lapatinib for the treatment of HER2-overexpressing breast cancer<br/>2<br/>survival for patients with HER2-positive advanced/<br/>metastatic breast cancer who had relapsed<br/>following treatment with an anthracycline, a taxane<br/>and trastuzumab was appropriate for the disease<br/>area. The base-case incremental cost-effectiveness<br/>ratios (ICERs) for lapatinib plus capecitabine<br/>compared with capecitabine monotherapy or<br/>vinorelbine monotherapy were higher than would<br/>conventionally be considered cost-effective.<br/>When compared with trastuzumab-containing<br/>regimes, lapatinib plus capecitabine dominated.<br/>In sensitivity analyses the ICER for lapatinib<br/>plus capecitabine compared with capecitabine<br/>monotherapy or vinorelbine monotherapy was<br/>robust to variation in assumptions. In all sensitivity<br/>analyses the ICERs remained higher than would<br/>conventionally be considered cost-effective.<br/>ICERs for trastuzumab-containing regimes were<br/>particularly sensitive to assumptions over the<br/>frequency of treatment, which had a large effect on<br/>the cost-effectiveness of lapatinib plus capecitabine.<br/>In conclusion, there was a general lack of evidence<br/>on the effectiveness of comparators included in<br/>the model and on key parameters such as dose<br/>adjustments and the model outputs need to be<br/>interpreted in the light of this uncertainty. At the<br/>time of writing, NICE were still considering the<br/>available evidence for this appraisal

Topics: RC0254
Year: 2009
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Provided by: e-Prints Soton
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