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Article: Treatment With Trastuzumab For 1 Year After Adjuvant Chemotherapy In Patients With Her2-positive Early Breast Cancer: A 4-year Follow-up Of A Randomised Controlled Trial

TitleTreatment With Trastuzumab For 1 Year After Adjuvant Chemotherapy In Patients With Her2-positive Early Breast Cancer: A 4-year Follow-up Of A Randomised Controlled Trial
Authors
Issue Date2011
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/j.lancetoncol
Citation
The Lancet Oncology, 2011, v. 12 n. 3, p. 236-244 How to Cite?
AbstractBACKGROUND: Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial. METHODS: The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48·4 months (IQR 42·0-56·5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11. FINDINGS: The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78·6%) compared with the observation group (4-year disease-free survival 72·2%; hazard ratio [HR] 0·76; 95% CI 0·66-0·87; p<0·0001). Intention-to-treat analysis of overall survival showed no significant difference in the risk of death (4-year overall survival 89·3%vs 87·7%, respectively; HR 0·85; 95% CI 0·70-1·04; p=0·11). Overall, 885 patients (52%) of the 1698 patients in the observation group crossed over to receive trastuzumab, and began treatment at median 22·8 months (range 4·5-52·7) from randomisation. In a non-randomised comparison, patients in the selective-crossover cohort had fewer disease-free survival events than patients remaining in the observation group (adjusted HR 0·68; 95% CI 0·51-0·90; p=0·0077). Higher incidences of grade 3-4 and fatal adverse events were noted on 1-year trastuzumab than in the observation group. The most common grade 3 or 4 adverse events, each in less than 1% of patients, were congestive cardiac failure, hypertension, arthralgia, back pain, central-line infection, hot flush, headache, and diarrhoea. INTERPRETATION: Treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up. The substantial selective crossover of patients in the observation group to trastuzumab was associated with improved outcomes for this cohort.
Persistent Identifierhttp://hdl.handle.net/10722/251813
ISSN
2017 Impact Factor: 36.421
2015 SCImago Journal Rankings: 13.940
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorGianni, L-
dc.contributor.authorDafni, U-
dc.contributor.authorGelber, RD-
dc.contributor.authorAzambuja, E-
dc.contributor.authorMuehlbauer, S-
dc.contributor.authorGoldhirsch, A-
dc.contributor.authorUntch, M-
dc.contributor.authorSmith, I-
dc.contributor.authorBaselga, J-
dc.contributor.authorJackisch, C-
dc.contributor.authorCameron, D-
dc.contributor.authorMano, M-
dc.contributor.authorPedrini, JL-
dc.contributor.authorVeronesi, A-
dc.contributor.authorMendiola, C-
dc.contributor.authorPluzanska, A-
dc.contributor.authorSemiglazov, V-
dc.contributor.authorVrdoljak, E-
dc.contributor.authorEckart, MJ-
dc.contributor.authorShen, Z-
dc.contributor.authorSkiadopoulos, G-
dc.contributor.authorProcter, M-
dc.contributor.authorPritchard, KI-
dc.contributor.authorPiccart-Gebhart, MJ-
dc.contributor.authorBell, R-
dc.contributor.authorKwong, A-
dc.date.accessioned2018-03-19T07:01:40Z-
dc.date.available2018-03-19T07:01:40Z-
dc.date.issued2011-
dc.identifier.citationThe Lancet Oncology, 2011, v. 12 n. 3, p. 236-244-
dc.identifier.issn1470-2045-
dc.identifier.urihttp://hdl.handle.net/10722/251813-
dc.description.abstractBACKGROUND: Treatment with adjuvant trastuzumab for 1 year improves disease-free survival and overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We aimed to assess disease-free survival and overall survival after a median follow-up of 4 years for patients enrolled on the Herceptin Adjuvant (HERA) trial. METHODS: The HERA trial is an international, multicentre, randomised, open-label, phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after standard neoadjuvant, adjuvant chemotherapy, or both in patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. After a positive first interim analysis at a median follow-up of 1 year for the comparison of treatment with trastuzumab for 1 year with observation, event-free patients in the observation group were allowed to cross over to receive trastuzumab. We report trial outcomes for the 1-year trastuzumab and observation groups at a median follow-up of 48·4 months (IQR 42·0-56·5) and assess the effect of the extensive crossover to trastuzumab. Our analysis was by intention-to-treat. The HERA trial is registered with the European Clinical Trials Database, number 2005-002385-11. FINDINGS: The HERA trial population comprised 1698 patients randomly assigned to the observation group and 1703 to the 1-year trastuzumab group. Intention-to-treat analysis of disease-free survival showed a significant benefit in favour of patients in the 1-year trastuzumab group (4-year disease-free survival 78·6%) compared with the observation group (4-year disease-free survival 72·2%; hazard ratio [HR] 0·76; 95% CI 0·66-0·87; p<0·0001). Intention-to-treat analysis of overall survival showed no significant difference in the risk of death (4-year overall survival 89·3%vs 87·7%, respectively; HR 0·85; 95% CI 0·70-1·04; p=0·11). Overall, 885 patients (52%) of the 1698 patients in the observation group crossed over to receive trastuzumab, and began treatment at median 22·8 months (range 4·5-52·7) from randomisation. In a non-randomised comparison, patients in the selective-crossover cohort had fewer disease-free survival events than patients remaining in the observation group (adjusted HR 0·68; 95% CI 0·51-0·90; p=0·0077). Higher incidences of grade 3-4 and fatal adverse events were noted on 1-year trastuzumab than in the observation group. The most common grade 3 or 4 adverse events, each in less than 1% of patients, were congestive cardiac failure, hypertension, arthralgia, back pain, central-line infection, hot flush, headache, and diarrhoea. INTERPRETATION: Treatment with adjuvant trastuzumab for 1 year after chemotherapy is associated with significant clinical benefit at 4-year median follow-up. The substantial selective crossover of patients in the observation group to trastuzumab was associated with improved outcomes for this cohort.-
dc.languageeng-
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/j.lancetoncol-
dc.relation.ispartofThe Lancet Oncology-
dc.titleTreatment With Trastuzumab For 1 Year After Adjuvant Chemotherapy In Patients With Her2-positive Early Breast Cancer: A 4-year Follow-up Of A Randomised Controlled Trial-
dc.typeArticle-
dc.identifier.emailKwong, A: avakwong@hku.hk-
dc.identifier.authorityKwong, A=rp01734-
dc.identifier.doi10.1016/S1470-2045(11)70033-X-
dc.identifier.pmid21354370-
dc.identifier.hkuros284568-
dc.identifier.volume12-
dc.identifier.issue3-
dc.identifier.spage236-
dc.identifier.epage244-
dc.identifier.isiWOS:000288483500022-
dc.publisher.placeUnited Kingdom-

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