A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study)

Henry L. Gómez; Silvia Neciosup; Célia Tosello; Max Mano; José Bines; Gustavo Ismael; Patrícia X. Santi; Hélio Pinczowski; Yeni Nerón; Marcello Fanelli; Luis Fein; Carlos Sampaio; Guillermo Lerzo; Adolfo Capó; Juan J. Zarba; César Blajman; Mirta S. Varela; Jeovany Martínez-Mesa; Gustavo Werutsky; Carlos H. Barrios

doi:10.1016/j.clbc.2015.10.005

A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study)

Henry L. Gómez
, Silvia Neciosup
, Célia Tosello
, Max Mano
, José Bines
, Gustavo Ismael
, Patrícia X. Santi
, Hélio Pinczowski
, Yeni Nerón
, Marcello Fanelli
, Luis Fein
, Carlos Sampaio
, Guillermo Lerzo
, Adolfo Capó
, Juan J. Zarba
, César Blajman
, Mirta S. Varela
, Jeovany Martínez-Mesa
, Gustavo Werutsky
, Carlos H. Barrios

Instituto Nacional de Enfermedades Neoplásicas Eduardo Cáceres Graziani
Instituto Brasileiro de Controle Do Câncer
University of São Paulo
INCA
Fundação Doutor Amaral Carvalho
Instituto de Ensino e Pesquisa São Lucas
Centro de Pesquisas Oncológicas de Santa Catarina (CEPON)
Hospital A.C. Camargo
Centro Oncológico de Rosário
Clínica AMO
Investigaciones Clínicas Ciudad de Buenos Aires
Fundación Centro Oncológico de Integración Regional
Centro San Roque
ISIS Clínica Especializada
CER Instituto Médico
Latin American Cooperative Oncology Group (LACOG)
Museu de Ciência e Tecnología - PUCRS

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

Background Novel targeted agents and combinations have become available in multiple lines of treatment for human epidermal growth factor receptor 2-positive (HER2⁺) metastatic breast cancer (MBC). In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted. Patients and Methods In the present phase II, multicenter study, patients with HER2⁺ MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m² on days 1 to 14 (LC), vinorelbine (V), 25 mg/m² on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m² on days 1 and 8 (LG), every 21 days. The primary endpoint was the overall response rate. Results A total of 142 patients were included from 2009 to 2012. No differences were found in the patient baseline characteristics. The median age was 51 years, 69% were postmenopausal, 32% had liver metastasis, 57% were hormone receptor negative, and 48% had been previously treated with trastuzumab. The overall response rate was 49% (95% confidence interval [CI], 34.8%-63.4%), 56% (95% CI, 40%-70.4%), and 41% (95% CI, 27%-56.8%) in the LC, LV, and LG groups, respectively. The median progression-free survival was 9 months in the LC arm and 7 months in the other 2 arms (P =.28). The most common grade 3 and 4 adverse events were hand-foot syndrome (18%), diarrhea (6%), and increased alanine aminotransferase/aspartate aminotransferase (4%) in the LC arm; neutropenia (36%), diarrhea (9%), and febrile neutropenia (6%) in the LV arm; and neutropenia (47%), alanine aminotransferase/aspartate aminotransferase (13%), and rash (4%) in the LG arm. Conclusion LV and LG seem to be active combinations in patients with HER2⁺ MBC after taxane failure. The overall toxicity was manageable in all regimens.

Original language	English
Pages (from-to)	38-44
Number of pages	7
Journal	Clinical Breast Cancer
Volume	16
Issue number	1
DOIs	https://doi.org/10.1016/j.clbc.2015.10.005
State	Published - 1 Feb 2016
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Chemotherapy
Human epidermal growth factor receptor 2-positive
Lapatinib
Metastatic breast cancer
Treatment outcome

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Gómez, H. L., Neciosup, S., Tosello, C., Mano, M., Bines, J., Ismael, G., Santi, P. X., Pinczowski, H., Nerón, Y., Fanelli, M., Fein, L., Sampaio, C., Lerzo, G., Capó, A., Zarba, J. J., Blajman, C., Varela, M. S., Martínez-Mesa, J., Werutsky, G., & Barrios, C. H. (2016). A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study). Clinical Breast Cancer, 16(1), 38-44. https://doi.org/10.1016/j.clbc.2015.10.005

@article{2abbf287143f48a0ab3f892dabca3d59,

title = "A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study)",

abstract = "Background Novel targeted agents and combinations have become available in multiple lines of treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted. Patients and Methods In the present phase II, multicenter study, patients with HER2+ MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m2 on days 1 to 14 (LC), vinorelbine (V), 25 mg/m2 on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m2 on days 1 and 8 (LG), every 21 days. The primary endpoint was the overall response rate. Results A total of 142 patients were included from 2009 to 2012. No differences were found in the patient baseline characteristics. The median age was 51 years, 69\% were postmenopausal, 32\% had liver metastasis, 57\% were hormone receptor negative, and 48\% had been previously treated with trastuzumab. The overall response rate was 49\% (95\% confidence interval [CI], 34.8\%-63.4\%), 56\% (95\% CI, 40\%-70.4\%), and 41\% (95\% CI, 27\%-56.8\%) in the LC, LV, and LG groups, respectively. The median progression-free survival was 9 months in the LC arm and 7 months in the other 2 arms (P =.28). The most common grade 3 and 4 adverse events were hand-foot syndrome (18\%), diarrhea (6\%), and increased alanine aminotransferase/aspartate aminotransferase (4\%) in the LC arm; neutropenia (36\%), diarrhea (9\%), and febrile neutropenia (6\%) in the LV arm; and neutropenia (47\%), alanine aminotransferase/aspartate aminotransferase (13\%), and rash (4\%) in the LG arm. Conclusion LV and LG seem to be active combinations in patients with HER2+ MBC after taxane failure. The overall toxicity was manageable in all regimens.",

keywords = "Chemotherapy, Human epidermal growth factor receptor 2-positive, Lapatinib, Metastatic breast cancer, Treatment outcome",

author = "G{\'o}mez, \{Henry L.\} and Silvia Neciosup and C{\'e}lia Tosello and Max Mano and Jos{\'e} Bines and Gustavo Ismael and Santi, \{Patr{\'i}cia X.\} and H{\'e}lio Pinczowski and Yeni Ner{\'o}n and Marcello Fanelli and Luis Fein and Carlos Sampaio and Guillermo Lerzo and Adolfo Cap{\'o} and Zarba, \{Juan J.\} and C{\'e}sar Blajman and Varela, \{Mirta S.\} and Jeovany Mart{\'i}nez-Mesa and Gustavo Werutsky and Barrios, \{Carlos H.\}",

note = "Publisher Copyright: {\textcopyright} 2016 The Authors.",

year = "2016",

month = feb,

day = "1",

doi = "10.1016/j.clbc.2015.10.005",

language = "Ingl{\'e}s",

volume = "16",

pages = "38--44",

journal = "Clinical Breast Cancer",

issn = "1526-8209",

number = "1",

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Gómez, HL, Neciosup, S, Tosello, C, Mano, M, Bines, J, Ismael, G, Santi, PX, Pinczowski, H, Nerón, Y, Fanelli, M, Fein, L, Sampaio, C, Lerzo, G, Capó, A, Zarba, JJ, Blajman, C, Varela, MS, Martínez-Mesa, J, Werutsky, G & Barrios, CH 2016, 'A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study)', Clinical Breast Cancer, vol. 16, no. 1, pp. 38-44. https://doi.org/10.1016/j.clbc.2015.10.005

A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study). / Gómez, Henry L.; Neciosup, Silvia; Tosello, Célia et al.
In: Clinical Breast Cancer, Vol. 16, No. 1, 01.02.2016, p. 38-44.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study)

AU - Gómez, Henry L.

AU - Neciosup, Silvia

AU - Tosello, Célia

AU - Mano, Max

AU - Bines, José

AU - Ismael, Gustavo

AU - Santi, Patrícia X.

AU - Pinczowski, Hélio

AU - Nerón, Yeni

AU - Fanelli, Marcello

AU - Fein, Luis

AU - Sampaio, Carlos

AU - Lerzo, Guillermo

AU - Capó, Adolfo

AU - Zarba, Juan J.

AU - Blajman, César

AU - Varela, Mirta S.

AU - Martínez-Mesa, Jeovany

AU - Werutsky, Gustavo

AU - Barrios, Carlos H.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Background Novel targeted agents and combinations have become available in multiple lines of treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted. Patients and Methods In the present phase II, multicenter study, patients with HER2+ MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m2 on days 1 to 14 (LC), vinorelbine (V), 25 mg/m2 on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m2 on days 1 and 8 (LG), every 21 days. The primary endpoint was the overall response rate. Results A total of 142 patients were included from 2009 to 2012. No differences were found in the patient baseline characteristics. The median age was 51 years, 69% were postmenopausal, 32% had liver metastasis, 57% were hormone receptor negative, and 48% had been previously treated with trastuzumab. The overall response rate was 49% (95% confidence interval [CI], 34.8%-63.4%), 56% (95% CI, 40%-70.4%), and 41% (95% CI, 27%-56.8%) in the LC, LV, and LG groups, respectively. The median progression-free survival was 9 months in the LC arm and 7 months in the other 2 arms (P =.28). The most common grade 3 and 4 adverse events were hand-foot syndrome (18%), diarrhea (6%), and increased alanine aminotransferase/aspartate aminotransferase (4%) in the LC arm; neutropenia (36%), diarrhea (9%), and febrile neutropenia (6%) in the LV arm; and neutropenia (47%), alanine aminotransferase/aspartate aminotransferase (13%), and rash (4%) in the LG arm. Conclusion LV and LG seem to be active combinations in patients with HER2+ MBC after taxane failure. The overall toxicity was manageable in all regimens.

AB - Background Novel targeted agents and combinations have become available in multiple lines of treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted. Patients and Methods In the present phase II, multicenter study, patients with HER2+ MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m2 on days 1 to 14 (LC), vinorelbine (V), 25 mg/m2 on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m2 on days 1 and 8 (LG), every 21 days. The primary endpoint was the overall response rate. Results A total of 142 patients were included from 2009 to 2012. No differences were found in the patient baseline characteristics. The median age was 51 years, 69% were postmenopausal, 32% had liver metastasis, 57% were hormone receptor negative, and 48% had been previously treated with trastuzumab. The overall response rate was 49% (95% confidence interval [CI], 34.8%-63.4%), 56% (95% CI, 40%-70.4%), and 41% (95% CI, 27%-56.8%) in the LC, LV, and LG groups, respectively. The median progression-free survival was 9 months in the LC arm and 7 months in the other 2 arms (P =.28). The most common grade 3 and 4 adverse events were hand-foot syndrome (18%), diarrhea (6%), and increased alanine aminotransferase/aspartate aminotransferase (4%) in the LC arm; neutropenia (36%), diarrhea (9%), and febrile neutropenia (6%) in the LV arm; and neutropenia (47%), alanine aminotransferase/aspartate aminotransferase (13%), and rash (4%) in the LG arm. Conclusion LV and LG seem to be active combinations in patients with HER2+ MBC after taxane failure. The overall toxicity was manageable in all regimens.

KW - Chemotherapy

KW - Human epidermal growth factor receptor 2-positive

KW - Lapatinib

KW - Metastatic breast cancer

KW - Treatment outcome

UR - https://www.scopus.com/pages/publications/84952870820

U2 - 10.1016/j.clbc.2015.10.005

DO - 10.1016/j.clbc.2015.10.005

M3 - Artículo

C2 - 26642810

AN - SCOPUS:84952870820

SN - 1526-8209

VL - 16

SP - 38

EP - 44

JO - Clinical Breast Cancer

JF - Clinical Breast Cancer

IS - 1

ER -

Gómez HL, Neciosup S, Tosello C, Mano M, Bines J, Ismael G et al. A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study). Clinical Breast Cancer. 2016 Feb 1;16(1):38-44. doi: 10.1016/j.clbc.2015.10.005

A Phase II Randomized Study of Lapatinib Combined with Capecitabine, Vinorelbine, or Gemcitabine in Patients with HER2-Positive Metastatic Breast Cancer with Progression after a Taxane (Latin American Cooperative Oncology Group 0801 Study)

Abstract

UN SDGs

Keywords

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