This summary table contains detailed information about research studies. Summary tables offer an informative look at the science behind many breast cancer guidelines and recommendations. However, they should be viewed with some caution. In order to read and interpret research tables successfully, it is important to understand some key concepts. Learn how to read a research table.
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Introduction: The drug lapatinib (Tykerb) is a tyrosine-kinase inhibitor. This class of drugs targets enzymes important for cell functions (called tyrosine-kinase enzymes). Lapatinib is used to treat HER2/neu-positive metastatic breast cancer in women who have already had chemotherapy and trastuzumab (Herceptin).
Lapatinib combined with chemotherapy, hormone therapy or trastuzumab may increase the time to metastatic cancer spread.
Side effects of lapatinib
Side effects of lapatinib include diarrhea, nausea, vomiting, rash and fatigue. In rare cases, it has been linked to lung problems [2].
Study selection criteria: Phase III clinical trials with 100 or more participants with HER2/neu-positive metastatic breast cancer. For phase III clinical trials of chemotherapy, all participants had past treatment with chemotherapy and trastuzumab for metastatic breast cancer. For phase III clinical trials of hormone therapy, past treatment varied.
Study
|
Study Population
(number of participants)
|
Drug(s) Used
|
Overall Response Rate—
Percent who Responded to Treatment
(95% CI)
|
Overall Survival
at One Year
|
Phase III Clinical Trials-Chemotherapy
|
Geyer et al. [3]
|
324
|
Lapatinib with chemotherapy
(capecitabine)
|
22%
(16-29%)
|
14%
|
| |
|
Chemotherapy alone
(capecitabine)
|
14%
(9-21%)
|
14%
|
| Phase III Clinical Trials-Hormone Therapy |
Schwartzberg et al. [4]
|
219
women with no prior treatment
for metastatic breast cancer
|
Lapatinib with letrozole
|
28%*
|
|
| |
|
Letrozole alone
|
15%*
|
|
Johnston et al. [5]
|
219
|
Lapatinib with letrozole
|
33%
|
72%†
|
| |
|
Letrozole alone
|
32%
|
64%†
|
Phase III Clinical Trials-Trastuzumab
|
Blackwell et al. [6-7]
|
291
|
Lapatinib with trastuzumab
|
10%
|
56%
|
| |
|
Lapatinib alone
|
7%
|
41%
|
* Statistically significant difference between the two treatment groups.
† Estimated overall survival at 15 months.
References
1. Amir E, Ocaña A, Seruga B, Freedman O, Clemons M. Lapatinib and HER2 status: results of a meta-analysis of randomized phase III trials in metastatic breast cancer. Cancer Treat Rev. 36(5):410-5, 2010.
2. Capri G, Chang J, Chen SC, et al. An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer. Ann Oncol. 21(3):474-80, 2010.
3. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 355(26):2733-43, 2006.
4. Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 15(2):122-9, 2010.
5. Johnston S, Pippen J Jr, Pivot X, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 27(33):5538-46, 2009.
6. Blackwell KL, Burstein HJ, Storniolo AM, et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol. 28(7):1124-30, 2010.
7. Blackwell KL, Burstein HJ, Storniolo AM, et al. Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J Clin Oncol. 30(21):2585-92, 2012.
Updated 01/22/13
