Lapatinib in combination with capecitabine in the management of ErbB2-positive (HER2-positive) advanced breast cancer

Figures & data

Figure 1 Kaplan-Meier estimates of time to progression (HR 0.57; 95% CI 0.43 to 0.77) p = 0.00013) (A) and overall survival (B) in ITT population and based on independent review. Reproduced Cameron D, Martin A-M, Newstat B, et al. 2007. Lapatinib (L) plus capecitabine (C) in HER2+ advanced breast cancer (ABC): updated efficacy and biomarker analysis. J Clin Oncol, 2007 ASCO Annual Meeting Proceedings Part I, 25:1035.

Table 1 Most frequent adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 (Tykerb 2007)

Adverse event	Capecitabine + lapatiniba (n = 198)			Capecitabineb (n = 191)
	All grades, %	Grade 3, %	Grade 4, %	All grades, %	Grade 3, %	Grade 4, %
Diarrhea	65	13	1	40	10	0
PPE	53	12	0	51	14	0
Rash	28	2	0	14	1	0
Nausea	44	2	0	43	2	0
Vomiting	26	2	0	21	2	0
Mucosal inflammation	15	0	0	12	2	0

a Lapatinib 1250 mg once daily orally (continuously) and capecitabine 2000 mg/m² in two divided doses (Days 1 through 14) of a 21-day cycle.

b Capecitabine 2500 mg/m² in 2 divided doses (Days 1 through 14) of a 21-day cycle.

Abbreviations: PPE, palmar plantar erythrodysesthesia.

Table 2 On-going randomized phase III trials of lapatinib in patients with breast cancer

Study	Patient population	Randomization
EGF104900	Trastuzumab-refractory MBC	Lapatinib + trastuzumab Lapatinib monotherapy
EGF30001	1st-line treatment of ErbB2-negative or untested MBC	Lapatinib + paclitaxel Paclitaxel + placebo
EGF104535	1st-line treatment of ErbB2-overexpressing MBC	Lapatinib + paclitaxel Paclitaxel + placebo
EGF104383	1st-line treatment of ErbB2-overexpressing MBC	Lapatinib + paclitaxel + trastuzumab Placebo + paclitaxel + trastuzumab
EGF108919	1st-line treatment of ErbB2-overexpressing MBC	Lapatinib + taxane Trastuzumab + taxane
EGF30008	1st-line treatment of HR+ advanced breast cancer (postmenopausal patients only)	Lapatinib + letrozole Letrozole + placebo
CALGB 40302	1st-line treatment of HR+ advanced breast cancer (postmenopausal patients only)	Lapatinib + fulvestrant Placebo + fulvestrant
EGF105484 (TEACH)	Trastuzumab-naïve patients with ErbB2- overexpressing ESBC who have completed adjuvant chemotherapy	Lapatinib Placebo
EGF105485 (ALTTO)	Adjuvant treatment of ErbB2-overexpressing ESBC	Lapatinib Trastuzumab Concurrent trastuzumab/lapatinib Sequential trastuzumab/lapatinib
EGF106903 (Neo-ALTTO)	Neoadjuvant treatment of ErbB2-overexpressing ESBC	Lapatinib Trastuzumab Concurrent trastuzumab/lapatinib
NSABP B-41	Neoadjuvant treatment of ErbB2-overexpressing ESBC	Lapatinib Trastuzumab Concurrent trastuzumab/lapatinib

Abbreviations: ALTTO, Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization; CALGB, Cancer and Leukemia Group B; ESBC, early stage breast cancer; DFS, disease-free survival; HR+, hormone-receptor positive; MBC, metastatic breast cancer; NSABP, National Surgical Adjuvant Breast and Bowel Project; TEACH, Tykerb Evaluation after Chemotherapy.

CameronDMartinA-MNewstatB2007Lapatinib (L) plus capecitabine (C) in HER2+ advanced breast cancer (ABC): updated efficacy and biomarker analysisJ Clin Oncol, 2007 ASCO Annual Meeting Proceedings Part I251035

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Tykerb (lapatinib) tablets2007Product informationResearch Triangle Park, NCGlaxoSmithKline

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