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
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 cli...
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Published in | Breast cancer (Tokyo, Japan) Vol. 22; no. 2; pp. 192 - 200 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
Language | English |
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Tokyo
Springer Japan
01.03.2015
Springer |
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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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AbstractList | 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. Eligible women received lapatinib 1250 mg once daily and capecitabine 1000 mg/m.sup.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). 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 %). 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. 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. 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.sup.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. 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. 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). 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 %). 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. |
Audience | Academic |
Author | Masuda, Norikazu Iwata, Hiroji Fujii, Hirofumi Gagnon, Robert C. Mukai, Hirofumi Nishimura, Yuichiro Nakamura, Seigo Katsura, Koichi Ellis, Catherine E. |
Author_xml | – sequence: 1 givenname: Hiroji surname: Iwata fullname: Iwata, Hiroji email: hiwata@aichi-cc.jp organization: Aichi Cancer Center Hospital, Breast Oncology – sequence: 2 givenname: Hirofumi surname: Fujii fullname: Fujii, Hirofumi organization: Jichi Medical University Hospital – sequence: 3 givenname: Norikazu surname: Masuda fullname: Masuda, Norikazu organization: National Hospital Organization Osaka National Hospital – sequence: 4 givenname: Hirofumi surname: Mukai fullname: Mukai, Hirofumi organization: National Cancer Center Hospital East – sequence: 5 givenname: Yuichiro surname: Nishimura fullname: Nishimura, Yuichiro organization: GlaxoSmithKline K.K – sequence: 6 givenname: Koichi surname: Katsura fullname: Katsura, Koichi organization: GlaxoSmithKline K.K – sequence: 7 givenname: Catherine E. surname: Ellis fullname: Ellis, Catherine E. organization: GlaxoSmithKline – sequence: 8 givenname: Robert C. surname: Gagnon fullname: Gagnon, Robert C. organization: GlaxoSmithKline – sequence: 9 givenname: Seigo surname: Nakamura fullname: Nakamura, Seigo organization: St. Luke’s International Hospital, Showa University Hospital |
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CitedBy_id | crossref_primary_10_1007_s11523_021_00838_x crossref_primary_10_1016_j_pharep_2017_09_003 crossref_primary_10_4143_crt_2018_598 crossref_primary_10_1136_bmjopen_2016_013053 crossref_primary_10_1590_s1679_45082018rw4007 |
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Keywords | Biomarker Breast cancer Lapatinib HER2 Capecitabine |
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The results from a phase III trial conducted outside of Japan demonstrated a significant improvement in time to progression (TTP) when lapatinib was... The results from a phase III trial conducted outside of Japan demonstrated a significant improvement in time to progression (TTP) when lapatinib was combined... Background The results from a phase III trial conducted outside of Japan demonstrated a significant improvement in time to progression (TTP) when lapatinib was... |
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SubjectTerms | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics Antineoplastic Combined Chemotherapy Protocols - therapeutic use Asian Continental Ancestry Group Biomarkers, Tumor - analysis Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - mortality Cancer Cancer Research Capecitabine - administration & dosage Capecitabine - pharmacokinetics Care and treatment Clinical trials Comparative analysis Diarrhea - chemically induced Female Humans Kaplan-Meier Estimate Medicine Medicine & Public Health Metastasis Middle Aged Oncology Oncology, Experimental Original Original Article Quinazolines - administration & dosage Quinazolines - pharmacokinetics Receptor, ErbB-2 - metabolism Stomatitis - chemically induced Surgery Surgical Oncology Treatment Outcome |
Title | 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 |
URI | https://link.springer.com/article/10.1007/s12282-013-0475-1 https://www.ncbi.nlm.nih.gov/pubmed/23689990 https://pubmed.ncbi.nlm.nih.gov/PMC4331616 |
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