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Article: 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial

Title2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial
Authors
Issue Date2013
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
Citation
The Lancet, 2013, v. 382 n. 9897, p. 1021-1028 How to Cite?
AbstractBackground Trastuzumab has established efficacy against breast cancer with overexpression or amplification of the HER2 oncogene. The standard of care is 1 year of adjuvant trastuzumab, but the optimum duration of treatment is unknown. We compared 2 years of treatment with trastuzumab with 1 year of treatment, and updated the comparison of 1 year of trastuzumab versus observation at a median follow-up of 8 years, for patients enrolled in 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 chemotherapy, adjuvant chemotherapy, or both in 5102 patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. The comparison of 2 years versus 1 year of trastuzumab treatment involved a landmark analysis of 3105 patients who were disease-free 12 months after randomisation to one of the trastuzumab groups, and was planned after observing at least 725 disease-free survival events. The updated intention-to-treat comparison of 1 year trastuzumab treatment versus observation alone in 3399 patients at a median follow-up of 8 years (range 0–10) is also reported. This study is registered with ClinicalTrials.gov, number NCT00045032. Findings We recorded 367 events of disease-free survival in 1552 patients in the 1 year group and 367 events in 1553 patients in the 2 year group (hazard ratio [HR] 0·99, 95% CI 0·85–1·14, p=0·86). Grade 3–4 adverse events and decreases in left ventricular ejection fraction during treatment were reported more frequently in the 2 year treatment group than in the 1 year group (342 [20·4%] vs 275 [16·3%] grade 3–4 adverse events, and 120 [7·2%] vs 69 [4·1%] decreases in left ventricular ejection fraction, respectively). HRs for a comparison of 1 year of trastuzumab treatment versus observation were 0·76 (95% CI 0·67–0·86, p<0·0001) for disease-free survival and 0·76 (0·65–0·88, p=0·0005) for overall survival, despite crossover of 884 (52%) patients from the observation group to trastuzumab therapy. Interpretation 2 years of adjuvant trastuzumab is not more effective than is 1 year of treatment for patients with HER2-positive early breast cancer. 1 year of treatment provides a significant disease-free and overall survival benefit compared with observation and remains the standard of care.
Persistent Identifierhttp://hdl.handle.net/10722/251820
ISSN
2017 Impact Factor: 53.254
2015 SCImago Journal Rankings: 14.638
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorGoldhirsch, A-
dc.contributor.authorGelber, RD-
dc.contributor.authorPiccart-Gebhart, MJ-
dc.contributor.authorde Azambuja, E-
dc.contributor.authorProcter, M-
dc.contributor.authorSuter, TM-
dc.contributor.authorJackisch, C-
dc.contributor.authorCameron, D-
dc.contributor.authorWeber, HA-
dc.contributor.authorHeinzmann, D-
dc.contributor.authorLago, LD-
dc.contributor.authorMcFadden, E-
dc.contributor.authorDowsett, M-
dc.contributor.authorUntch, M-
dc.contributor.authorGianni, L-
dc.contributor.authorBell, R-
dc.contributor.authorKöhne, CH-
dc.contributor.authorVindevoghel, A-
dc.contributor.authorAndersson, M-
dc.contributor.authorBrunt, AM-
dc.contributor.authorOtero-Reyes, D-
dc.contributor.authorSong, S-
dc.contributor.authorSmith, I-
dc.contributor.authorLeyland-Jones, B-
dc.contributor.authorBaselga, J-
dc.contributor.authorKwong, A-
dc.date.accessioned2018-03-19T07:01:47Z-
dc.date.available2018-03-19T07:01:47Z-
dc.date.issued2013-
dc.identifier.citationThe Lancet, 2013, v. 382 n. 9897, p. 1021-1028-
dc.identifier.issn0140-6736-
dc.identifier.urihttp://hdl.handle.net/10722/251820-
dc.description.abstractBackground Trastuzumab has established efficacy against breast cancer with overexpression or amplification of the HER2 oncogene. The standard of care is 1 year of adjuvant trastuzumab, but the optimum duration of treatment is unknown. We compared 2 years of treatment with trastuzumab with 1 year of treatment, and updated the comparison of 1 year of trastuzumab versus observation at a median follow-up of 8 years, for patients enrolled in 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 chemotherapy, adjuvant chemotherapy, or both in 5102 patients with HER2-positive early breast cancer. The primary endpoint was disease-free survival. The comparison of 2 years versus 1 year of trastuzumab treatment involved a landmark analysis of 3105 patients who were disease-free 12 months after randomisation to one of the trastuzumab groups, and was planned after observing at least 725 disease-free survival events. The updated intention-to-treat comparison of 1 year trastuzumab treatment versus observation alone in 3399 patients at a median follow-up of 8 years (range 0–10) is also reported. This study is registered with ClinicalTrials.gov, number NCT00045032. Findings We recorded 367 events of disease-free survival in 1552 patients in the 1 year group and 367 events in 1553 patients in the 2 year group (hazard ratio [HR] 0·99, 95% CI 0·85–1·14, p=0·86). Grade 3–4 adverse events and decreases in left ventricular ejection fraction during treatment were reported more frequently in the 2 year treatment group than in the 1 year group (342 [20·4%] vs 275 [16·3%] grade 3–4 adverse events, and 120 [7·2%] vs 69 [4·1%] decreases in left ventricular ejection fraction, respectively). HRs for a comparison of 1 year of trastuzumab treatment versus observation were 0·76 (95% CI 0·67–0·86, p<0·0001) for disease-free survival and 0·76 (0·65–0·88, p=0·0005) for overall survival, despite crossover of 884 (52%) patients from the observation group to trastuzumab therapy. Interpretation 2 years of adjuvant trastuzumab is not more effective than is 1 year of treatment for patients with HER2-positive early breast cancer. 1 year of treatment provides a significant disease-free and overall survival benefit compared with observation and remains the standard of care.-
dc.languageeng-
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet-
dc.relation.ispartofThe Lancet-
dc.title2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial-
dc.typeArticle-
dc.identifier.emailKwong, A: avakwong@hku.hk-
dc.identifier.authorityKwong, A=rp01734-
dc.identifier.doi10.1016/S0140-6736(13)61094-6-
dc.identifier.hkuros284575-
dc.identifier.volume382-
dc.identifier.issue9897-
dc.identifier.spage1021-
dc.identifier.epage1028-
dc.identifier.isiWOS:000324742200022-
dc.publisher.placeUnited Kingdom-
dc.identifier.f1000718043513-

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