CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01)
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CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01). / Pestalozzi, Bernhard C; Holmes, Eileen; de Azambuja, Evandro; Metzger-Filho, Otto; Hogge, Laurence; Scullion, Matt; Láng, István; Wardley, Andrew; Lichinitser, Mikhail; Sanchez, Roberto I Lopez; Müller, Volkmar; Dodwell, David; Gelber, Richard D; Piccart-Gebhart, Martine J; Cameron, David.
in: LANCET ONCOL, Jahrgang 14, Nr. 3, 01.03.2013, S. 244-8.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01)
AU - Pestalozzi, Bernhard C
AU - Holmes, Eileen
AU - de Azambuja, Evandro
AU - Metzger-Filho, Otto
AU - Hogge, Laurence
AU - Scullion, Matt
AU - Láng, István
AU - Wardley, Andrew
AU - Lichinitser, Mikhail
AU - Sanchez, Roberto I Lopez
AU - Müller, Volkmar
AU - Dodwell, David
AU - Gelber, Richard D
AU - Piccart-Gebhart, Martine J
AU - Cameron, David
N1 - Copyright © 2013 Elsevier Ltd. All rights reserved.
PY - 2013/3/1
Y1 - 2013/3/1
N2 - BACKGROUND: Several randomised trials have confirmed the benefit of adjuvant trastuzumab for patients with HER2-positive early breast cancer. However, concern has been expressed that adjuvant trastuzumab might be associated with an increased frequency of CNS relapses. We assessed the frequency and course of CNS relapses, either as first event or at any time, using data from the HERA trial.METHODS: We estimated the cumulative incidence of first disease-free survival (DFS) events in the CNS versus other sites by competing risks analysis in patients with HER2-positive early breast cancer who had been randomly assigned to receive 1 year of trastuzumab or to observation in the HERA trial after a median follow-up of 4 years (IQR 3·5-4·8). To obtain further information about CNS relapse at any time before death, we circulated a data collection form to investigators to obtain standardised information about CNS events that occurred in all patients who had died before July, 2009. We estimated the cumulative incidence of CNS relapse at any time with a competing risks analysis.RESULTS: Of 3401 patients who had been assigned to receive 1 year of trastuzumab or to observation, 69 (2%) had a CNS relapse as first DFS event and 747 (22%) had a first DFS event not in the CNS. The frequency of CNS relapses as first DFS event did not differ between the group given 1 year of trastuzumab (37 [2%] of 1703 patients) and the observation group (32 [2%] of 1698; p=0·55 [Gray's test]). 481 data collection forms were distributed, of which 413 (86%) were returned. The proportion of patients who had died and experienced a CNS relapse was numerically higher in the observation group (129 [57%] of 227) than in the group given trastuzumab for 1 year (88 [47%] of 186; p=0·06 [Gray's test]). Most CNS relapses were symptomatic (189 [87%] of 217).CONCLUSION: Adjuvant trastuzumab does not increase the risk of CNS relapse in patients with HER2-positive early breast cancer.FUNDING: None.
AB - BACKGROUND: Several randomised trials have confirmed the benefit of adjuvant trastuzumab for patients with HER2-positive early breast cancer. However, concern has been expressed that adjuvant trastuzumab might be associated with an increased frequency of CNS relapses. We assessed the frequency and course of CNS relapses, either as first event or at any time, using data from the HERA trial.METHODS: We estimated the cumulative incidence of first disease-free survival (DFS) events in the CNS versus other sites by competing risks analysis in patients with HER2-positive early breast cancer who had been randomly assigned to receive 1 year of trastuzumab or to observation in the HERA trial after a median follow-up of 4 years (IQR 3·5-4·8). To obtain further information about CNS relapse at any time before death, we circulated a data collection form to investigators to obtain standardised information about CNS events that occurred in all patients who had died before July, 2009. We estimated the cumulative incidence of CNS relapse at any time with a competing risks analysis.RESULTS: Of 3401 patients who had been assigned to receive 1 year of trastuzumab or to observation, 69 (2%) had a CNS relapse as first DFS event and 747 (22%) had a first DFS event not in the CNS. The frequency of CNS relapses as first DFS event did not differ between the group given 1 year of trastuzumab (37 [2%] of 1703 patients) and the observation group (32 [2%] of 1698; p=0·55 [Gray's test]). 481 data collection forms were distributed, of which 413 (86%) were returned. The proportion of patients who had died and experienced a CNS relapse was numerically higher in the observation group (129 [57%] of 227) than in the group given trastuzumab for 1 year (88 [47%] of 186; p=0·06 [Gray's test]). Most CNS relapses were symptomatic (189 [87%] of 217).CONCLUSION: Adjuvant trastuzumab does not increase the risk of CNS relapse in patients with HER2-positive early breast cancer.FUNDING: None.
KW - Adult
KW - Aged
KW - Antibodies, Monoclonal, Humanized
KW - Antineoplastic Agents
KW - Breast Neoplasms
KW - Central Nervous System Neoplasms
KW - Chemotherapy, Adjuvant
KW - Clinical Trials as Topic
KW - Disease-Free Survival
KW - Female
KW - Humans
KW - Middle Aged
KW - Neoplasm Staging
KW - Receptor, erbB-2
KW - Recurrence
KW - Retrospective Studies
U2 - 10.1016/S1470-2045(13)70017-2
DO - 10.1016/S1470-2045(13)70017-2
M3 - SCORING: Journal article
C2 - 23414588
VL - 14
SP - 244
EP - 248
JO - LANCET ONCOL
JF - LANCET ONCOL
SN - 1470-2045
IS - 3
ER -
