A few days/weeks ago I seemed to have read a post by someone from NEW Zealand, I think, who said their government only offered 6weeks of herceptin as it had been shown to be no less effective than 1 year. I kept my mouth shut
(or fingers folded) although they only quoted a tiny Finnish study which used a very unusual combination of chemos with herceptin and I knew of no other LARGE studies which found any duration of herceptin treatment less than a year to be non-inferior (ie equavalent or better)
THE ARTICLE QUOTES:
ONE OF THE PREVIOUS TRIALS WHICH FAILED TO SHOW NONINFERIORITY WAS THE PHARE TRIAL.
. Conversely, in early breast cancer, two small studies suggested that when trastuzumab is administered concomitantly with chemotherapy for 9 weeks to 6 months, the reduction in the risk of relapse is similar to longer treatment [7-9].
7. Joensuu H, Kellokumpu-Lehtinen PL, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006; 354: 809-20.
8. Moja L, Tagliabue L, Balduzzi S et al. Trastuzumab containing regimens for early breast cancer. Cochrane Database Syst Rev 2012; 4: CD006243.
9. Buzdar AU, Ibrahim NK, Francis D et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy:results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J Clin Oncol 2005;23:3676-85.
IT LISTS SEVERAL ONGOING STUDIES LOOKING AT JUST THIS QUESTION
HERE IS THEIRS/ THE LATEST:
Ann Oncol. 2015 May 1. pii: mdv213. [Epub ahead of print]
Six versus twelve months of adjuvant trastuzumab in combination with dose-dense chemotherapy for women with HER2-positive breast cancer: A multicenter randomized study by the Hellenic Oncology Research Group (HORG).
Mavroudis D, Saloustros E, Malamos N, Kakolyris S, Boukovinas I, Papakotoulas P, Kentepozidis N, Ziras N, Georgoulias V; Breast Cancer Investigators of the Hellenic Oncology Research Group (HORG), Athens, Greece.
Abstract
BACKGROUND:
Adjuvant trastuzumab in combination with chemotherapy improves survival of women with HER2-positive early breast cancer. In this study we compared 12 versus 6 months of adjuvant trastuzumab.
PATIENTS AND METHODS:
Axillary node-positive or high-risk node-negative women with HER2-positive early breast cancer were randomized to receive 12 or 6 months of adjuvant trastuzumab concurrently with dose-dense, G-CSF-supported docetaxel (75mg/m2 every 14 days for 4 cycles). All patients received upfront dose dense, G-CSF-supported FEC (5-fluorouracil 700mg/m2, epirubicin 75mg/m2, cyclophosphamide 700mg/m2 every 14 days for 4 cycles). Randomization was performed before commence of chemotherapy. The primary endpoint was the 3-year disease-free survival (DFS).
RESULTS:
481 patients were randomized to receive 12 months (n=241) or 6 months (n=240) of adjuvant trastuzumab. Chemotherapy was completed in 99% and 98% of patients, while trastuzumab therapy in 100% and 96% of patients in the 12- and 6-month group, respectively. After 47 and 51 months of median follow-up, there were 17 (7.1%) and 28 (11.7%) disease relapses in the 12- and 6-month groups (p=0.08). The 3-year DFS was 95.7% versus 93.3% in favor of the 12-month treatment group (HR=1.57; 95%CI=0.86 to 2.10; p=0.137). There was no difference in terms of overall survival and cardiac toxicity between the two groups.
CONCLUSIONS:
Our study failed to show non-inferiority for the 6-month arm. The results further support the current standard of care that is administration of adjuvant trastuzumab for 12 months.
© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email:
journals.permissions@oup.com.
KEYWORDS:
6 months; adjuvant; breast cancer; randomized; trastuzumab
PMID: 25935793 [PubMed - as supplied by publisher]