A randomized, open-label, phase II study of lapatinib/capecitabine, lapatinib/vinorelbine, or lapatinib/gemcitabine in patients with ErbB2-amplified metastatic breast cancer progressing after taxane treatment: Results of an interim analysis (GLICO-0801/EGF111792)

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dc.contributor Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.author GOMEZ, Henry Leonidas
NECIOSUP, Silvia P.
TOSELLO, Celia
XAVIER, Patricia
NASCIMENTO, Yeni Neron do
FANELLI, Marcelo
ISMAEL, Gustavo
BINES, Jose
SAMPAIO, Carlos
LERZO, Guillermo Luis
CAPO, Adolfo Miguel
MANO, Max S. FMUSP-HC
FEIN, Luis
WERUTSKY, Gustavo
BARRIOS, Carlos H.
dc.date.issued 2012
dc.identifier.citation JOURNAL OF CLINICAL ONCOLOGY, v.30, n.15, suppl.S, 2012
dc.identifier.issn 0732-183X
dc.identifier.uri http://observatorio.fm.usp.br/handle/OPI/2833
dc.description.abstract Background: Lapatinib-capecitabine is approved for the treatment of ErbB2-amplified metastatic breast cancer (MBC) after failure to anthracyclines, taxanes and trastuzumab. GLICO-0801 evaluates different lapatinib-based chemotherapy combinations as 1st/2nd line treatment for ErbB2 amplified MBC progressing after taxane treatment. We present the results of a planned safety interim analysis. Methods: This is an open-label, randomized, international, phase II trial exploring lapatinib (L) 1250mg qd in combination with capecitabine 2000mg/m2 d 1-14 (Arm A) or vinorelbine 25mg/m2 d 1 and 8 (Arm B) or gemcitabine 1000mg/m2 d 1 and 8 (Arm C). Primary objective is to determine the clinical benefit rate (defined as CR+PR+SD for ≥24 weeks). This trial is registered at www.clinicaltrials.gov number: NCT01050322 Results: The first83 randomized patients (pts) (Arm A=29, B=28 and C=26) were included in this analysis. Of them, 65 (78%) have discontinued therapy with mean number of cycles of 4.7, 6.2 and 7.5 in arms A, B and C respectively. Eighteen (21%) pts are still on treatment. Median age was 52y (29-84); 80 pts (96%) had PS 0-1; 51 (61%) were postmenopausal. Fifty-six pts (67%) had visceral metastasis, 52 (63%) were treated as 2nd line therapy and 36 (43%) had received prior trastuzumab. Most reported adverse events (AE) (87%) were grade 1-2. The most common AE (any grade) in arm A: diarrhea 72%, hand-foot syndrome 45%, vomiting 39%, anemia 36%; in arm B: diarrhea 75%, neutropenia 68%, nausea 43%, vomiting 39%; in arm C: diarrhea 72%, neutropenia 60%, anemia 44%, increase in ALT 44%. The most frequent serious AE reported in arm A: diarrhea in 3 pts (10%) and thrombocytopenia in 2 pts (7%); in arm B: febrile neutropenia in 2 pts (7%) and in arm C: sepsis in 1 pt (4%). There was one toxic death related to chemotherapy in arm C. Conclusions: There were no unexpected toxicities so far in this trial with most AEs being mild to moderate and manageable. This interim analysis supports the continuation of the study.
dc.language.iso eng
dc.publisher AMER SOC CLINICAL ONCOLOGY
dc.relation.ispartof Journal of Clinical Oncology
dc.rights restrictedAccess
dc.title A randomized, open-label, phase II study of lapatinib/capecitabine, lapatinib/vinorelbine, or lapatinib/gemcitabine in patients with ErbB2-amplified metastatic breast cancer progressing after taxane treatment: Results of an interim analysis (GLICO-0801/EGF111792)
dc.type conferenceObject
dc.rights.holder Copyright AMER SOC CLINICAL ONCOLOGY
dc.description.conferencedate JUN 01-06, 2012
dc.description.conferencelocal Chicago - IL, EUA
dc.description.conferencename 48th Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO)
dc.description.group LIM/24
dc.type.category meeting abstract
dc.type.version publishedVersion
hcfmusp.author MANO, Max S.:FM:MDR
hcfmusp.origem.id WOS:000318009800170
hcfmusp.publisher.city ALEXANDRIA
hcfmusp.publisher.country USA
dc.description.index MEDLINE
hcfmusp.citation.wos 0


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