Stage 1, grade 1 and pre-menopausal

PoohBear-61

Hi Min937 ....

My Oncologist told me that the women in the ZEBRA TRIAL who got there periods back after 2 years of O/S had the same recurrence rates as those that did not ....so this helped me make my decision....

Here is a snippet of the zebra trial ....I put in bold the comment about the " return of menses " at the BOTTOM note that the women in this trial had positive nodes .....

ZEBRA trial

To date, the ZEBRA (Zoladex Early Breast Cancer Research Association) trial is the largest adjuvant trial investigating the effect of goserelin in pre/perimenopausal women with early breast cancer (n = 1640) ( Jonat et al. 2002). In this study, patients were ≤50 years of age, with node-positive, stage II breast cancer who had received no previous systemic treatment. After patients had completed their local therapy (surgery and/or radiotherapy), patients were randomized to receive either goserelin (3.6 mg s.c. every 28 days for 2 years) or CMF (6 cycles) consisting of cyclophosphamide (500 mg/m² i.v. on days 1 and 8 or 100 mg/m² orally on days 1–14), methotrexate (40 mg/m² i.v. on days 1 and 8) and 5-fluorouracil (600 mg/m² i.v. on days 1 and 8). Hormone receptor status was not required for entry into the study, but it was left to each center’s discretion to enter ER-positive patients. Primary endpoints were DFS and OS. A planned subset analysis of ER status and age was conducted. Return of menstrual function was also assessed. In the first analysis with a median follow-up of 6 years, patient characteristics were well balanced between the groups. In the overall population, DFS was significantly better for CMF compared with goserelin (hazard ratio (HR) = 1.18, 95% confidence interval (CI) = 1.02–1.37, P = 0.029) unlike OS (HR = 1.21, 95% CI = 0.99–1.49, P = 0.067). When looking only at those patients with ER-positive disease, the results were different. In ER-positive patients only, DFS was demonstrated to be similar with CMF and with goserelin (HR = 1.01, 95% CI = 0.84–1.20, P = 0.94) while in ER-negative patients goserelin was inferior to CMF (HR = 1.76, 95% CI = 1.27–2.44, P = 0.0006). Overall survival was similar for CMF and for goserelin in the ER-positive group (HR = 0.99, 95% CI = 0.76–1.28, P = 0.92); however, ER-negative patients did significantly better with CMF (HR = 1.77, 95% CI = 1.19–2.63, P = 0.0043) ( Jonat et al. 2002).

Updated analyses of the efficacy data were conducted after a median follow-up of 7.3 years and the findings were very similar ( Kaufmann et al. 2003). In the overall population, DFS was significantly better for the CMF arm compared with the goserelin arm (P = 0.007). In the ER-positive patients, DFS was no better with goserelin compared with CMF (P = 0.597) while for ER-negative patients, DFS demonstrated that goserelin was inferior to CMF (P = 0.0001). At the time of the updated analysis, 28% of patients had died. Overall survival for the entire population illustrated no difference with goserelin treatment compared with CMF (P = 0.137). ER-positive patients showed non-inferiority of goserelin vs CMF (P = 0.622) while ER-negative patients continued to demonstrate significantly better OS with CMF compared with goserelin (P = 0.009) thus confirming the lack of efficacy of hormonal treatment for such tumors.

Amenorrhea occurred more rapidly in the goserelin group compared with the CMF arm ( Jonat et al. 2002). At 24 weeks, 95% of patients in the goserelin group had amenorrhea compared with only 59% in the CMF group. Three years after treatment, menses had returned in the majority of women randomized to goserelin (compared with the only 23% who remained amenorrheic). Seventy-seven percent of patients treated with CMF maintained amenorrhea, suggesting a permanent ovarian ablation. Return of menses did not impact recurrence rate or OS in this patient population. This information was based on a subset analysis not originally planned at the beginning of the trial and the authors concluded that this should only be thought of as ‘exploratory’ data ( Jonat et al. 2002).

Hi Rozem......If i am not mistaken ....the women in the SOFT trial were on the ZOLADEX shots for 5 years.

voraciousreader

pooh...ZEBRA was a snapshot of a shorter duration.

Anonymous

Vora..... if you are the 2.5 that would have been Stage 4 it does make a difference.  Most people who do chemo have a 1-4% chance of it helping and they do chemo which is much tougher than endocrine therapy.

voraciousreader

Aug....I am pointing out how to interpret the info. I am NOT making a judgment. Each patient needs to decide what is right for them. If you read the ATLAS study carefully, it is very nuianced....just like SOFT. For some sisters there is an appeal that can be made that it would be in their best interest to be aggressive and for others it is more about choice. That said, the more info the better in choosing a treatment plan.

Anonymous

Vora..... thanks always love the discussion.

labelle

With an oncotype score of 11, highly ER+/PR+ cancer, but low grade, and with one positive node, no chemo was offered to me but based on everything I've found, I've scheduled an oopherectomy for Jan 8th / may or may not do AI therapy (as far as I'm concerned the oopherectomy IS hormone therapy). Many past studies showed premenopausal women w ER+ cancers who had chemo that put them into "chemopause" faired better than those not put into "chemopause" by their treatments, suggesting the effectiveness of chemo for some is due as much to stopping menstruation as to the chemo drugs themselves. At 51 and peri-menopausal, and having rejected Tamoxifen for myself, this seems to me to be my best option. My oncologist loves Tamoxifen too, but respects my reasons for refusing it, says she will support any decisions I make re: AI treatment or not, but with AI therapy there are some options-if one type doesn't agree with you, you can switch to another and I think options are good.

PoohBear-61

Annice ......a little while ,in December, you mentioned that you had a little health issue ...I truly hope you are okay and doing well..... ? Ive been checking this thread fairly often to see if you had posted any news ..... ?

I don't mean to be nosy ...just hope you are okay ?

sending hugzzzz

Annicemd

Pooh Bear thank you so much for your thoughts, I should have posted my progress before. I got all my biopsies and results back and I got the all clear so I don't need a hysterectomy 😄👍

I had 10 relatives staying with me over Christmas, big family get together, so I was busy with them and I have been a little distracted... But all good

I wish everyone on the thread a happy and healthy 2015

Annice 😘

PoohBear-61

 I love good news ...glad your fine

Fourminor

AnniceMD,

I'm about to go on OS and AI following failed attempt at chemo (allergic rxn to first dose). Oncotype 20 so not clearly in the "no chemo" group from SOFT trial. But chemo benefit was not expected to be much, so I was ambivalent about it and sort of glad its off the table. I'm 47 and still very premeno. My new MO is behind me on this but she wasn't entirely sure when to start the AI. It seems to her from the SOFT paper that they were started simultaneous with the Zolodex. I had thought we would start with Zolodex and then check estrogen levels and add AI in when they had dropped off. However I am unsure where I got that idea. Does it matter?

4

Annicemd

fourminor,

I do not have a definitive answer but it would be logical to suppress your estrogen before starting

AI as this treatment would be superfluous whist your estrigen levels are detectable

Best wishes Annice

voraciousreader

Perhaps begin Zoladex injections with Tamoxifen and after a month or two, switch to an AI....

rozem

It took 2 injections to stop my periods so im waiting an extra 2 before i switch from a tamox to an AI.

Fourminor

Thanks AnniceMD

eloqui

To my understanding, you should make sure that your ovaries are adequately suppressed on Zoladex/Lupron to ensure that you are menopausal before beginning any type of aromatase inhibitor. Otherwise the AI could trigger a hormonal surge instead. That's why I get my estrogen levels checked periodically on Lupron + AI.

Fourminor

Well I did just the Zoladex, and two weeks later the only thing I've noticed has been an occasional mild headache, and a few times I've been colder than everyone else. My period arrived yesterday right on time.

So I guess it takes a while for levels to drop.

Lucy1010

I'm new to this site. I just started treatment last month - I've had two zoladex shots and a month and a half of aromasin. Onco score of 13 and 99% er/pr positive so no radiation or chemo -just hormonal treatment. I am 41 with two girls -6 and 8 - so I figured I would do the most I could to prevent a recurrence.

Mabs

Hi Girls! I had a blood test and my estradiol is stratospheric! Over 1000! Does any of you had the same problem? I didn't have chemo, and I'm on Tamoxifen since november (4 months now). I'm going to meet my oncologist today... I'll let you know what she says...

Mabs

Just to keep you updated, my oncologist said that as I had a cyst in my ovary a few months ago, it may have disturbed the estradiol levels... Now, that the cyst disapeared by itself, the estradiol level might go back to normal... I'll repeat the blood test next month... But if the estradiol levels doesn't go down I'll have to have my ovaries shut down... I'm praying It will go down!!!

ndgrrl

Mabs I hope it goes down for you. 

I have never been tested but with my huge ovarian cysts which I will have removed this coming Tues I am sure the numbers would have been high.  Makes me wonder why they do not just take out the ovaries for woman who are not wanting more children.

 

Mabs

Dear all, unfortunatelly my estradiol levels hasn't go down... in fact it went up... the second mesure was more than 2000 when the maximmum reference number is aprox. 500... I think I'll have to have my ovaries shut down... I would like to hear from those who were pre-menopausal and had the ovaries shut down what were the SE... I'm so afraid... I'm only 36 and want more children (I have one baby girl), although I'm not sure if I'll have the courage to get pregnant again since the BC I had was 90% hormone responsive...

Can you help me sharing your experience?

Thanks

Fourminor

I am up for my third injection of zolodex tomorrow. Hot flashes started right after my last post and my January period is it-none since. Hot flashes have decreased with daily magnesium -- from 12-15/day to 4-5 a day within 48 hours of starting it. Tomorrow we recheck estrogen and I'm guessing I'm going on AI. I'm worried sbout sex. Sad to have just one child but I am lucky to have him and I want to be around for him.

ReneeinOH

Hi Ladies,

I don't know who is still around (I have been off of the boards for a long time now); I wanted to share that today my oncologist OKed that I stop ovarian suppression (2+ years int\ the treatment). I asked about the SOFT Trial results, and, given my stats, if I really need this treatment. So glad I asked.

I hope you all are doing well. Let me know.

Best, Renee

min937

Hi Renee,

I have also been off the boards for a while, and I also stopped Zoladex back in January after two years of injections. I expected something miraculous to happen as far as feeling better, lol, but all I've noticed is that my joints don't seem to be quite as sore. I'm 43, and my Dr predicted that my cycles would return, but it's been eight months and nothing yet. Good luck to you, and keep us posted!

(p.s. We may have discussed this a long time ago, but do you see a Dr at The James?)

Mindy

Cuetang

Hey ladies, how timely of this conversation! I just received my last injection of Lupron/OS. I was going to ask for experiences of those that had OS coming off of it. When did your periods return?

Hi Renee!!

ReneeinOH

Hi Mindy and Cuetang,

So glad to hear from you again. I would have had my monthly shot this past Monday, and I am feeling bloated and crampy, so I am expecting my period any time. Perhaps it's just in my head, but I did miss my shot once, and ended up having breakthrough bleeding. I was advised it will be really heavy. I ended up staying home today; I could't get out of bed. Slept a lot.

Yes, I think we both have Dr. Ramaswamy for our onc. Farrar was my BS.

Let's stay in touch, at least while we are going through this. Amazing, yet again we find each other to go through this together.

Best, Renee

Annicemd

Hi all, I have also been away from these boards a while. I stopped zoladex after 2 years, was still post- menopausal a year after stopping, the zoladex certainly shut down my ovaries, but 18months after stopping zoladex my periods gradually returned and over the last few months I have returned to being premenopausal! Renee I had monthly period symptoms without having an actual bleed for a few months before my periods actually returned.

o my ovaries eventually woke up. Our response after stopping ovarian suppression will vary with age of starting the treatment, length of treatment and how close we are to our natural menopause age. So it will be different for each of us. I continue on tamoxifen which seems to continue to be the pre-meno early staggers best friend 😄

ReneeinOH

Hi Annice, glad to hear from you and how you are doing. What do you think about the SOFT trial results?

Mabs

Annice, why did you stop zoladex?

I had to start zoladex because my estrogen levels went very very high with tamoxifen only, now I'm on tamox + zoladex... I'm 36 so I gess very premenopausal...

Annicemd

I stopped for similar reason to others. 2 years of ovarian suppression is well tolerated in younger women and risks of this length of treatment are relatively modest. Longer term ovarian suppression in younger women increases ris of osteoporosis and vascular disease so must be weighed up against benefit. Given the SOFT study has not shown any dramatic effects to date there are no hard and fast answers to whether the more belt and braces approach gives a favourable risk benefit ratio. So I hedged my bets after recommendations from my BS and onc to stop treatment. I effectively had 3 years of low estrogen until my ovaries woke up and I think that will have been a good supportive treatment to the tamoxifen. However I have now let my body return to premenopausal. I continue tamoxifen. And hopefully that will also protect my bones and blood vessels given that I am only 46. I wish there was a clear answer for all of us but there isn't!