The Who, What, Where, When and Sometimes, Why.

Lapatinib (Tykerb) for treatment of metastatic breast cancer

This summary table contains detailed information about research studies. Summary tables are a useful way to look at the science behind many breast cancer guidelines and recommendations. However, to get the most out of the tables, it’s important to understand some key concepts. Learn how to read a research table.

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-positive metastatic breast cancer in women who’ve already had chemotherapy and trastuzumab (Herceptin).

Lapatinib combined with chemotherapy, hormone therapy or trastuzumab may increase progression-free survival (give people more time before the cancer spreads).

Learn more about lapatinib, including its side effects.

Study selection criteria: Phase III clinical trials with 100 or more participants with HER2-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

Guan et al. [1]

444

Lapatinib with chemotherapy
(paclitaxel)

 69%
(63-75%)

69%*

  

 Chemotherapy alone
(paclitaxel)

 50%
(43-56%)

63%*

Geyer et al. [2]

324

Lapatinib with chemotherapy
(capecitabine)  

22%
(16-29%) 

14%

 

 

Chemotherapy alone
(capecitabine)

14%
(9-21%)

14%

Phase III clinical trials-Hormone therapy

Burstein et al. [3]

295

Lapatinib with fulvestrant

20%
(13-29%)

77%†

  

Fulvestrant alone

9%
(5-17%)

80%†

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%

* Estimated overall survival at 15 months

† Estimated overall survival at 12 months

‡ Statistically significant difference between the 2 treatment groups

References

  1. Guan Z, Xu B, DeSilvio ML, et al. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 31(16):1947-53, 2013. 
  2. 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.
  3. Burstein HJ, Cirrincione CT, Barry WT, et al. Endocrine therapy with or without inhibition of epidermal growth factor receptor and human epidermal growth factor receptor 2: a randomized, double-blind, placebo-controlled phase III trial of fulvestrant with or without lapatinib for postmenopausal women with hormone receptor-positive advanced breast cancer-CALGB 40302 (Alliance). J Clin Oncol. 32(35):3959-66, 2014.
  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.

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