ATEMPT Clinical Trial - Roll Call
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I also had liver enzyme elevation but not high enough to take me off
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Wishing everyone a happy and healthy new year!
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thanks dancer, happy new year to you and all our crew. May 2019 be filled with joy and good health
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Happy New Year, everyone! I hope you’re all feeling great in 2019. It’s nice to put cancer even further behind us.
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The Katherine trial is first to report excellent results with adjuvant T-DM1 for early BC... nice way to end 2018 and start 2019!
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MaggieCat, thanks for posting this. The link required a subscription/membership but I googled it and was able to read a report elsewhere. The study was of women with early BC but who had "residual disease," either in the breast or lymph nodes, after neoadjuvant chemo plus surgery. I'm confused by this. 1) do you know why women with early BC would be given chemo before surgery? I thought that was for situations where a tumor needs to be shrunk--but early-stage tumors are small. 2) if there's residual cancer after surgery, wouldn't further surgery be called for? Any clarifications you might be able to give would be welcome.
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Here's a summary from the ASCO with more info.... Neoadjuvant treatment followed by surgery is a more broadly available treatment for early stage BC than 4 or 5 years ago. The residual disease was found in the tissue removed during surgery.....so no known cancer remains.
The phase III KATHERINE clinical trial compared the use of ado-trastuzumab emtansine (T-DM1; Kadcyla) vs trastuzumab (Herceptin) as adjuvant therapy in patients with HER2-positive early-stage breast cancer with residual invasive disease after receiving neoadjuvant chemotherapy and trastuzumab. The study showed that T-DM1 reduced the risk of developing an invasive recurrence or death by 50%. Secondary efficacy endpoints of disease-free survival and distant recurrence–free interval also demonstrated clinically meaningful improvements with T-DMI.
Clinical Significance
"We found that T-DM1 reduced the risk of developing an invasive recurrence of the breast cancer or death by 50%, corresponding to an absolute improvement of 3-year invasive disease–free survival rate by 11.3 percentage points (77% with trastuzumab and 88.3% with T-DM1)," said Charles E. Geyer, Jr, MD, Professor of Medicine at Virginia Commonwealth University School of Medicine and lead author of this study, in a statement. "I believe these results will be practice-changing. The results should form the foundation of a new standard of care in patients with residual invasive breast cancer following neoadjuvant therapy. KATHERINE demonstrates that neoadjuvant therapy can be used to identify patients at increased risk for recurrence based on less than optimal response to standard neoadjuvant therapies who can benefit by switching to T-DM1."
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MaggieCat-- Thanks--I think I understand now. The patient has chemo, then surgery, and if there's cancer in the removed tissue at that point, it's called residual. And the trial tested adjuvant TDM1 v. Herceptin. Is that right?
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Hello Ladies, I have been having...overactive bladder or sensitive bladder issues for a while now. It doesn't matter how much I drink either. I will see my MO on Feb 1st, for a check up and I will talk to him about it. Just curious if anyone else is experiencing this, and if so, what are you doing to fix it?
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TinyDancer, I had this off an on, both before cancer and after. Before cancer, it was caused by hormonal changes going into menopause. It felt like I had a bladder infection--urgency and burning, but when I would run to pee, not much came out--but there was no infection. At the time the midwife at my gyn prescribed estrogen cream to apply to the genital area. After using that briefly (maybe 2 weeks) the problem went away--it was a HUGE relief--and didn't return. Then after cancer, while on Tamoxifen, I sometimes had overactive bladder--having to pee a lot, and producing a lot. Post-Tamoxifen, I've been mostly back to normal. I never discussed with my onc whether the Tamox was to blame, I just assumed it. Curious to hear what yours will say. Good luck--I hope you're not too uncomfortable!
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Hi Isabel, It sounds like you were on Tamoxifen for 5 years then stopped. Did your MO discuss staying on it longer? Mine said some people stay on for 10 years now, and “we’d talk about it when the time came.” I’ll have been on for 3 years in March.
PS: No bladder issues!
PPS: Regarding the previous thread, I have two friends who had some chemo first to reduce the tumor (early stage, but larger than most if not all of ours), the surgery, then more chemo - but weren’t on TDM1.
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Hi Serenity-- I was on Tamox for 4 years plus a few months. My onc took me off a little early because I was having slight gyn issues--not actual bleeding but a lot of discharge and some of it brownish. Ultrasound at gyn office showed a probable polyp. Possible (rare) SE of Tamox is uterine cancer so you can't mess around with this. After going off Tamox that gyn problem completely cleared up. I was supposed to have a followup U/S but I confess I have been too lazy. I will get around to it.
Anyway, when I started Tamox my onc and I had the exact same convo that you did with yours--that Tamox can be given for 10 yrs in some cases and we would revisit the issue later. What she concluded in my case, at the 4+ year mark, was that (a) the possible benefits of taking it were too small to outweigh the risk of the gyn issues I was having, and (b) for HER2 ladies the benefits are possibly negligible in any case. I think even without my gyn issues she was leaning toward stopping at 5 years.
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Isabel, thanks and I will discuss this with my dr.
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Hi Isabel, thank you for sharing your experience with Tamoxifen. I do have some issues with somewhat greater than normal discharge, but so far not too worrisome, just annoying. And I’m not sure whether to attribute it to the drug, anyway. I do intend to stop taking it after 5 years, unless I develop a reason to get off sooner.
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I met with my MO on Friday, and we discussed possibly staying on Tamoxifen for 10 years, but we'll discuss this again at my next visit. I am stopping the monthly Lupron injections and will have a blood test to check my estrogen levels next month. I am hoping they are lower and say that I am post-menopausal now. My latest bone density test results say that I have Osteopenia in my hips and lumbar spine which has increased since my last test 2 years ago. We discussed possibly taking Prolia or Reclast injections twice a year to protect my bones and keep them healthy. That's a decision I will make after I read more about the benefits and risks and side effects of both. Bladder issues - hmmm, maybe it is an UTI, but I have an appointment with my gyno on Friday for a check up.
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TinyDancer, did you have the bone density test 2 yrs ago for a particular reason? .
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Isabel, I was just curious to find out what condition my bones were in after I finished all of my treatments. When the results came back with osteopenia, I wanted to have another test to see if it has gotten worse.
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Tiny--Thanks for explaining. Btw, this is a weird coincidence, but I've been dealing with that overactive bladder issue again--with symptoms that feel like a UTI but no infection. I'm going back on topical estrogen cream for a couple of weeks, prescribed by GYN and approved by my oncologist. Absorption is minimal so there is not thought to be any risk. I need relief!
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Dr said no UTI, just an over active bladder so she gave me a sample of Myrbetriq to try. I hope it works. After discussing my bone density test results, she did a "FORE 10 Year Fracture Risk Calculation" and it says Patient's Risks and Average Risk for Any of 4 Fractures in Next 10 Years - is 5%, and it shows that I am a low risk of fracture. So no need for Prolia or Reclast right now.
After reading about Osteopenia treatments I have decided to get my butt outside (as soon as it warms up - right now it's 24) and walk more, run around the block a few times, do weight bearing exercises and eat better (not that I wasn't eating good before). Then in two years I will have another bone density test and compare all of the results.
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TinyDancer, sounds like a good plan!
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I have my annual mammogram tomorrow and I’ve kept it together pretty well. That is until my son refused to go to a taekwondo class and I ended up in the bathroom hyperventilating and crying. The positive point is that he didn’t know that this happened. I hate that I will have this feeling every year for the rest of my life
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MIPat, that fear is something we keep deep inside, locked up and very purposely ignored, until the annual day approaches. Then it takes over. I still haven't figured out if I'm better off squelching it as much as possible or letting it out. Brave face or crying mess--nothing in between! But you are SO NOT ALONE in this! Let us know how things went.
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Thank you IsabelArcher. Test done and nothing abnormal found. Went into the bathroom for a stress reducing cry, texted my husband that our trip to Italy was still a go, and went for a brutal Chinese acupressure massage to get the tension and knots out of my body. Good for another year
I too am not sure if it is better to buck up or let it all come out as an ugly cry.
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Great news MIPat! My personal trainer cancelled my session this morning. He was going with his wife for a follow-up breast imaging session. Hope she receives the same good news you did!
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MiPat--Woohoo! I'll tell you, though, I cannot walk into a mammo appt alone. I'm fortunate my husband can come with me (mammos in summer--he's off during summer months). If he couldn't go, I'd have to enlist a friend. I can't do it alone. But try to forget about this completely for another 364 days.
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Congratulations MIPAT!
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Thanks everyone. IsabelArcher my husband offered to come with me, but I told him that he didn’t need to. He couldn’t be with me for a large part of the waiting time. I sometimes have a harder time holding together when I have someone trying to be sympathetic or empathetic. Goes back to when I was 13 and my father died. Luckily I have enough going on with my kids (good and bad) that I am easily distracted the other 364 days. Hope everyone gets good news this y
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MIPat, I totally understand. Similar emotional issues since my father died when I was 16. Happy spring to you and to all.
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Hi Everyone!
I was here 4+ years ago when I was first diagnosed and considering ATEMPT -
Diagnosed January 2015 (ER-/PR-) HER2+
Stage 1A
I was in the trial from February 2015-February 2016
Does ANYONE know when we'll know the results of this trial??????!!!!!
Thanks and hope you're all doing well!
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Thinking was the first presentation for ATEMPT - end of 2018 at the big breast cancer conference - Not final results but something on lower side effects with T-DM1. I checked abstracts for the conference and found nothing. So I guess we continue to wait! (Have read interesting results on longevity for metastatic treatment with T-DM1 that looks most excellent!)...
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