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An open-label study of lapatinib in women with HER-2-negative early breast cancer: the lapatinib pre-surgical study (LPS study).
Coombes, R C; Tat, T; Miller, M L; Reise, J A; Mansi, J L; Hadjiminas, D J; Shousha, S; Elsheikh, S E; Lam, E W-F; Horimoto, Y; El-Bahrawy, M; Aboagye, E O; Contractor, K B; Shaw, J A; Walker, R A; Marconell, M H; Palmieri, C; Stebbing, J.
Afiliação
  • Coombes RC; Division of Cancer, Department of Surgery and Cancer, Imperial College London, 1st Floor ICTEM, Hammersmith Hospital Campus, Du Cane Road, London W12 0NN, UK.
Ann Oncol ; 24(4): 924-30, 2013 Apr.
Article em En | MEDLINE | ID: mdl-23233650
BACKGROUND: This phase II, open-label, multicentre study aimed to evaluate changes in cell proliferation and biomarkers, as well as efficacy of lapatinib in treatment-naïve patients with HER-2-negative primary breast cancer. PATIENTS AND METHODS: Patients received 1500 mg lapatinib for 28-42 days before surgery with repeat biopsies and measurements. The primary end point was inhibition of cell proliferation measured by Ki67; the secondary end points included clinical response, adverse events and changes in FOXO3a, FOXM1, p-AKT and HER-3. RESULTS: Overall, there was no significant reduction in Ki67 with treatment (assessment carried out in 28 of 31 subjects enrolled). However, four patients (14%) showed a reduction in Ki67 ≥50%. Four of 25 patients (16%) had a partial response to treatment judged by sequential ultrasound measurements. Response, in terms of either Ki67 or ultrasound, did not relate to changes in any biomarker assessed at baseline, including the estrogen receptor (ER) and epidermal growth factor receptor (EGFR). However, all four clinical responders were HER-3 positive, as were three of four Ki67 responders. CONCLUSIONS: Overall, a pre-surgical course of lapatinib monotherapy had little effect on this group of patients; however, in subsets of patients, especially those with HER-3-positive tumors, we observed either reduction in proliferation (Ki67) or tumor size; EGFR/ER status had no impact.
Assuntos

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Quinazolinas / Neoplasias da Mama / Regulação Neoplásica da Expressão Gênica / Proliferação de Células Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Ann Oncol Assunto da revista: NEOPLASIAS Ano de publicação: 2013 Tipo de documento: Article

Texto completo: 1 Bases de dados: MEDLINE Assunto principal: Quinazolinas / Neoplasias da Mama / Regulação Neoplásica da Expressão Gênica / Proliferação de Células Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Ann Oncol Assunto da revista: NEOPLASIAS Ano de publicação: 2013 Tipo de documento: Article