12 months of herceptin wins again--look out you government bean counter!!

[Lani]

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]

[Mtngrl]

I have a friend who was recently diagnosed with early stage HER2+, ER+ breast cancer. No node involvement. They're not giving her chemo and/or Herceptin at all. Her onc thinks mastectomy and Tamoxifen is all she needs.

I suggested she get a second opinion.

[PeaceMomma]

I hope your friend gets a second opinion. From what limited amount I've been able to read in the past month-and-a-half since my diagnoses, that seems foolish. Plus, between my initial MRI, where my mass (they said it wasn't a solid tumor) measured 6.5cm at the largest dimension and an ultrasound in Houston 2.5 weeks later (for a second opinion), the mass had grown to 8.75cm at it's longest. This was a change that I could see and feel, as it morphed my breast during those two weeks. This is aggressive (and somewhat frightening) and doing anything less than what has proven to work, well, actually, I'm just at a loss for words.

[Mtngrl]

I hear you, PeaceMomma. I think she brought it up because she was doubtful. She told me she'd see to it as soon as finals are over (we're both graduate students).

HER2 seems to metastasize awfully fast. I and a friend with a similar diagnosis were metastatic at diagnosis. Hers was one month after a "clean" mammogram. She found an enlarged lymph node in her armpit.

[sarah]

Amy, your friend must get some Herceptin, no question about that. in 1999, I was told the same thing - guess what it came back and now i have metastatic bc. It's old fashioned thinking. get her to a doctor who'll give her herceptin.
love sarah

[jaykay]

I suggest she get a new onc since standard of care regardless of stage or node status is chemo and Herceptin.

I was stage 1a, node negative, ER+, HER2+ in 2000. Hello 2012. Considered a new primary, but....

[Mtngrl]

I'm going to email her this thread. . . .

[Cathya]

Amy;

I was told I wouldn't be getting chemo at first as well. 3 cm tumour removed by lumpectomy and that was enough. My oncologist (the third doctor to examine me and only one to find it) found the 1 cm tumour in my supraclavicular node the same day and everything changed. Very aggressive, fast growing tumours. She definitely should get a second opinion.

Cathy