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Follow-up results of NOAH, a randomized phase III trial evaluating neoadjuvant chemotherapy with trastuzumab (CT+H) followed by adjuvant H versus CT alone, in patients with HER2-positive locally advanced breast cancer.
J Clin Oncol 31, 2013 (suppl; abstr 503)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: The monoclonal antibody trastuzumab (H) has been shown to improve event-free survival (EFS) and pathologic complete response (pCR) in patients with HER2-positive locally advanced or inflammatory breast cancer receiving neoadjuvant chemotherapy with or without one year of trastuzumab in the primary analysis of the NOAH study (Gianni L, Lancet 2010). Updated EFS and overall survival (OS) results are now presented. Methods: In this international, multicenter, open-label, randomized phase III trial patients with locally advanced or inflammatory breast cancer were randomized 1:1 to receive CT+H followed by adjuvant H versus CT alone. A parallel cohort of 99 comparable patients with HER2-negative disease was included and treated with the same chemotherapy regimen. The neoadjuvant chemotherapy regimen included doxorubicin, paclitaxel, cyclophosphamide, methotrexate and 5-fluorouracil. The primary objective was to compare EFS defined as time from randomization to disease recurrence or progression [local, regional, distant or contralateral] or death due to any cause). Results: After a median follow up of 5.4 years, the EFS benefit with trastuzumab was confirmed. Cardiac tolerability was good despite concurrent administration of trastuzumab with doxorubicin. Two patients (2%) developed reversible symptomatic congestive heart failure and are presently alive. Conclusions: Present analysis confirms the significant EFS benefit observed in the primary analysis of the NOAH study, and shows a strong trend towards improved OS with the addition of trastuzumab to chemotherapy. pCR rate may be considered as a possible primary endpoint and early indicator of benefit in future neoadjuvant studies of HER2-targeted agents. Clinical trial information: 86043495.
|5-yr EFS (%)||57.5||43.3||0.64, 0.016||60.5|
|5-yr EFS in pCR (%)||86.5||54.8||0.29, 0.008||85.9|
|5-yr OS (%)||73.5||62.9||0.66, 0.055||76.4|
|5-yr BCSS (%)||77.4||63.9||0.59, 0.023||78.6|
Abbreviations: EFS, event free survival; OS, overall survival; BCSS, breast cancer specific survival; HR, hazard ratio.
Abstracts by L. Gianni:
- Meeting: 2011 ASCO Annual Meeting | Abstract No: 4042
Effect of neutropenia with adjuvant epirubicin-CMF on survival in patients with node-negative or 1 to 3 node-positive rapidly proliferating breast cancer.