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Lapatinib for HER2 overexpressing breast cancer

Lapatinib for HER2 overexpressing breast cancer
Lapatinib for HER2 overexpressing breast cancer
This paper presents a summary of the evidence
review group (ERG) report into the clinical
effectiveness and cost-effectiveness of lapatinib for
the treatment of advanced or metastatic HER2-
overexpressing breast cancer based upon a review
of the manufacturer’s submission to the National
Institute for Health and Clinical Excellence (NICE)
as part of the single technology appraisal (STA)
process. The scope included women with advanced,
metastatic or recurrent HER2-overexpressing
breast cancer who have had previous therapy that
includes trastuzumab. Outcomes were time to
progression, progression-free survival, response
rates, overall survival, health-related quality
of life and adverse effects. The submission’s
evidence came from one randomised controlled
trial (RCT) of reasonable methodological
quality, although it was not powered to detect a
statistically significant difference in mean overall
survival. Median time to progression was longer
in the lapatinib plus capecitabine arm than in
the capecitabine monotherapy arm {27.1 [95%
confidence interval (CI) 17.4 to 49.4] versus 18.6
[95% CI 9.1 to 36.9] weeks; hazard ratio 0.57 [95%
CI 0.43 to 0.77; p = 0.00013]}. Median overall
survival was very similar between the groups [67.7
(95% CI 58.9 to 91.6) versus 66.6 (95% CI 49.1
to 75.0) weeks; hazard ratio 0.78 (95% CI 0.55
to 1.12; p = 0.177)]. Median progression-free
survival was statistically significantly longer in
the lapatinib plus capecitabine group than in the
capecitabine monotherapy group [27.1 (95% CI
24.1 to 36.9) versus 17.6 (95% CI 13.3 to 20.1)
weeks; hazard ratio 0.55 (95% CI 0.41 to 0.74);
p = 0.000033]. The manufacturer’s economic
model to estimate progression-free and overall
HTA 07/10/01
Date of ERG submission:
June 2007
TAR Centre(s):
Southampton Health Technology Assessments Centre
List of authors:
J Jones, A Takeda, J Picot, C von Keyserlingk and A Clegg
Contact details:
Andrea Takeda, Southampton Health Technology
Assessments Centre, Wessex Institute for Health
Research and Development, University of Southampton,
Mailpoint 728, Boldrewood, Southampton SO16 7PX,
UK
E-mail: A.L.Takeda@soton.ac.uk
The research reported in this article of the journal
supplement was commissioned and funded by the
HTA programme on behalf of NICE as project number
07/10/01. The assessment report began editorial review
in May 2008 and was accepted for publication in May
2009. See the HTA programme web site for further
project information (www.hta.ac.uk). This summary
of the ERG report was compiled after the Appraisal
Committee’s review.
The views and opinions expressed therein are those of
the authors and do not necessarily reflect those of the
Department of Health.
Discussion of ERG reports is invited. Visit the HTA
website correspondence forum (www.hta.ac.uk/
correspond).
Lapatinib for the treatment of HER2-overexpressing breast cancer
2
survival for patients with HER2-positive advanced/
metastatic breast cancer who had relapsed
following treatment with an anthracycline, a taxane
and trastuzumab was appropriate for the disease
area. The base-case incremental cost-effectiveness
ratios (ICERs) for lapatinib plus capecitabine
compared with capecitabine monotherapy or
vinorelbine monotherapy were higher than would
conventionally be considered cost-effective.
When compared with trastuzumab-containing
regimes, lapatinib plus capecitabine dominated.
In sensitivity analyses the ICER for lapatinib
plus capecitabine compared with capecitabine
monotherapy or vinorelbine monotherapy was
robust to variation in assumptions. In all sensitivity
analyses the ICERs remained higher than would
conventionally be considered cost-effective.
ICERs for trastuzumab-containing regimes were
particularly sensitive to assumptions over the
frequency of treatment, which had a large effect on
the cost-effectiveness of lapatinib plus capecitabine.
In conclusion, there was a general lack of evidence
on the effectiveness of comparators included in
the model and on key parameters such as dose
adjustments and the model outputs need to be
interpreted in the light of this uncertainty. At the
time of writing, NICE were still considering the
available evidence for this appraisal.
breast cancer, systematic review, cost effectiveness, economic evaluation
1366-5278
Jones, Jeremy
270b303b-6bad-4be7-8ea0-63d0e8015c91
Takeda, Andrea
55a013c5-ae02-46c2-b778-93060d250e2d
Picot, Joanna
324d6f20-a105-49fd-9fb0-88791be84ada
von Keyserlingk, Camilla
7df7984e-9adb-4fee-bb54-f760300d49f4
Clegg, A.
838091f5-39df-4dbe-a369-675b26f2301b
Jones, Jeremy
270b303b-6bad-4be7-8ea0-63d0e8015c91
Takeda, Andrea
55a013c5-ae02-46c2-b778-93060d250e2d
Picot, Joanna
324d6f20-a105-49fd-9fb0-88791be84ada
von Keyserlingk, Camilla
7df7984e-9adb-4fee-bb54-f760300d49f4
Clegg, A.
838091f5-39df-4dbe-a369-675b26f2301b

Jones, Jeremy, Takeda, Andrea, Picot, Joanna, von Keyserlingk, Camilla and Clegg, A. (2009) Lapatinib for HER2 overexpressing breast cancer. Health Technology Assessment, 13, supplement 3. (PMID:19846022)

Record type: Article

Abstract

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

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Published date: 2009
Keywords: breast cancer, systematic review, cost effectiveness, economic evaluation

Identifiers

Local EPrints ID: 153077
URI: http://eprints.soton.ac.uk/id/eprint/153077
ISSN: 1366-5278
PURE UUID: 66e22eab-cd41-42c9-9184-b3b8384244b1
ORCID for Joanna Picot: ORCID iD orcid.org/0000-0001-5987-996X

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Date deposited: 18 May 2010 12:18
Last modified: 14 Mar 2024 02:49

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Contributors

Author: Jeremy Jones
Author: Andrea Takeda
Author: Joanna Picot ORCID iD
Author: Camilla von Keyserlingk
Author: A. Clegg

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