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Clinical Trial
. 2015 Mar;22(2):192-200.
doi: 10.1007/s12282-013-0475-1. Epub 2013 May 21.

Efficacy, safety, pharmacokinetics and biomarker findings in patients with HER2-positive advanced or metastatic breast cancer treated with lapatinib in combination with capecitabine: results from 51 Japanese patients treated in a clinical study

Hiroji Iwata  1 , Hirofumi Fujii, Norikazu Masuda, Hirofumi Mukai, Yuichiro Nishimura, Koichi Katsura, Catherine E Ellis, Robert C Gagnon, Seigo Nakamura
Affiliations
Clinical Trial

Efficacy, safety, pharmacokinetics and biomarker findings in patients with HER2-positive advanced or metastatic breast cancer treated with lapatinib in combination with capecitabine: results from 51 Japanese patients treated in a clinical study

Hiroji Iwata et al. Breast Cancer. 2015 Mar.

Abstract

Background: The results from a phase III trial conducted outside of Japan demonstrated a significant improvement in time to progression (TTP) when lapatinib was combined with capecitabine compared with capecitabine alone in patients with HER2-positive advanced or metastatic breast cancer. In this clinical study of lapatinib in combination with capecitabine, efficacy, safety, pharmacokinetics (PK) and biomarkers were investigated in Japanese patients with HER2-positive advanced or metastatic breast cancer treated with prior trastuzumab.

Methods: Eligible women received lapatinib 1250 mg once daily and capecitabine 1000 mg/m(2) twice daily on days 1 through 14 of a 21-day cycle. The primary endpoint was the clinical benefit rate (CBR: complete response, partial response or stable disease for at least 24 weeks).

Results: Lapatinib in combination with capecitabine was well tolerated in the 51 patients enrolled in this study. CBR was 59 % (95 % CI 44.2, 72.4), and the median TTP in the Kaplan-Meier estimate was 36 weeks (95 % CI 27.1, 48.0). The majority of drug-related adverse events were mild to moderate (grade 1 or 2); the most common adverse events reported were palmar-plantar erythrodysesthesia syndrome (76 %), diarrhea (67 %) and stomatitis (41 %).

Conclusions: Lapatinib in combination with capecitabine in Japanese HER2-positive breast cancer patients was well tolerated. Overall, our findings on the efficacy, safety and PK were similar to those reported from the overseas studies.

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Figures

Fig. 1
Fig. 1
Kaplan-Meier estimates for the time to progression as assessed at the Independent Review Facility
Fig. 2
Fig. 2
Baseline serum concentration of HER2 ECD according to response to lapatinib plus capecitabine. a Kaplan-Meier plots stratified by HER2 ECD status; b box plot of HER2 ECD level according to the clinical benefit
See this image and copyright information in PMC

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References

    1. Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009;14:320–368. doi: 10.1634/theoncologist.2008-0230. - DOI - PubMed
    1. Herbst RS, Maddox AM, Rothenberg ML, Small EJ, Rubin EH, Baselga J, et al. Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial. J Clin Oncol. 2002;20(18):3815–3825. doi: 10.1200/JCO.2002.03.038. - DOI - PubMed
    1. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006;355(26):2733–2743. doi: 10.1056/NEJMoa064320. - DOI - PubMed
    1. Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu CG, et al. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat. 2008;112(3):533–543. doi: 10.1007/s10549-007-9885-0. - DOI - PubMed
    1. Cameron D, Casey M, Oliva C, Newstat B, Imwalle B, Geyer CE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist. 2010;15(9):924–934. doi: 10.1634/theoncologist.2009-0181. - DOI - PMC - PubMed

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