Hormone Therapy with/without Afinitor (everolimus) SWOG-S1207
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Is anyone else here luminal b? We are like the red headed step-child of er+ cancer, lol. My ki67 was 78%! I askes the doctor if this migh make Everolimus more effective because of the mTOR inhibition and he said probably yes, but no definite.
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Hi live_deliciously,
I've had my eye on this trial for a while now, mostly because I'm interested in mTOR inhibitors.
I'm not sure how many are currently enrolled but here's the basic enrollment data.
https://clinicaltrials.gov/ct2/show/NCT01674140
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in High-Risk, HR+ and HER2- patients.
Estimated Enrollment: 1900
Study Start Date: April 2013
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Approximately 1163 study locations throughout the US.0 -
My not so small practice only has one participant besides me! I also read that 27% don't make it due to SE.
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everything seems to have dried up on me! The corners of my mouth cracks often. Also Especially painful intercourse. My nails are getting really thin and breaking easy which I've always had hard nails. I blame the estrogen reduction on all these issues and since I was 99% er/PR+ is necessary. Was never told anything about avoiding exchanging body fluids. I didn't see anything in my literature about that? Too late now...... Ha.
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john Smith. Just saw your post. Thank you. I have read many other post from you as well on the immunotherapy thread. I appreciate all the researcb and updates you do. Just Like an angel sent to help us
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I think my husband would take the chance anyway, lol.
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I have to take my Arimidex in the morning and my everolimus at night before bed (I had a horrible reaction and ended in the ER when I closely spaced them). They both require a "light meal" though I've read you can take everolimus on an empty stomach too. I'm already battling a low weight and having an early morning and late night med that requires a pretty much empty stomach is making it hard to keep my weight in the normal range. Does anyone know, can I take everolimus on an empty stomach, wait 30 minutes or an hour, and then eat a full meal? I'm sitting here STARVING and feel like I can't eat more than an apple and too tired to wait another hour to eat.
ETA that my clinical nurse is on vacation, so there's no one to ask.
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I was in the middle of the trial when I had my hysterectomy and switched from tamoxifen to letrozole, and that was when EVERYTHING got dry. I blame lack of estrogen!
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i had my follow up yesterday. Don't know what my numbers are yet but they said they look great. And that nail issue I'm having with them curling and thinning out is from Affinitor. It's a side effect. On the dryness issue she is going to issue a prescription for a vaginal cream with testerone in it. Its going to be compounded by the pharmacy. I leave for vac for a couple of weeks and will get it when I return. I'll let you know if it's worth using And if that doesn't work there are other creams. Maybe testoserone cream will bring my sex drive back. Ha!
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My blood sugar is up but eveything else is holding steady. The fatigue is becoming debilitating. I don't have the energy to be a mom of 3, (twins are 3, son almost 2), an attorney, and have a husband who works 6 days a week with no family in town. Feel like I'm heading for a crash... I fell back asleep after the kids left and woke up frantic, running out the door to court, had to call in to my mediation. For the poster who finished, did your energy rebound out all after you finished the e?
ETA: my white count is down from 4.4 to 2.3 and my ANC from 1.7 to 1.0. Not too thrilled about that.
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cajunqueen1, my fatigue did improve during the course of the trial, but I think it may have more to do with getting further and further out from chemo and radiation. You just finished that part of your treatment a few months ago, right? Between that and your crazy-busy life, it's no wonder you're exhausted! ((hug))
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Hi Bec and thanks! Yes, I pushed hard to move fast through treatment because my cancer was so aggressive. My body has been beat up six ways from Sunday, but I feel mentally great! Young mind, old body, lol.
I had a hard time with Taxol... extreme pain, very allergic, moved to the dose dense schedule just to get Neulasta because I was SO severely neutropenic that I was house-bound and I refused to keep delaying treatment. Last chemo was 1/14. Finished radiation at the end of March. Hysterectomy about 2 weeks later. Started Arimidex and clinical trial about two weeks after that. Quick break in the study drugs after ambulance took me to the ER, restarted the trial a few days later. My WBC counts rebounded right around the time of my hysterectomy into normal levels and then took a big hit after starting the clinical trial. I've already taken 4 rounds of antibiotics since starting e3. Still going forward. I'm not a quitter! Just hoping for some improvement. Other than the mouth sores and low counts and increased blood sugar, it's hard to say what SEs are coming from the e and what are coming from instant menopause/Arimidex, surgeries, etc.
Keep on keeping on, ladies! Good news coming to us from Paul today:
Romans 8:18 "For I consider that the sufferings of this present time are not worth comparing with the glory that is to be revealed in us."
ETA, just looked down at my hands during court and my right hand is significantly peeling as if sunburned.
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I started the trial 3 weeks ago and feel fine except for overwhelming fatigue...so I guess I really don't feel fine then, eh? But no mouth sores. I actually wish I'd get some, just so I'd have a better idea of whether I'm on the drug or the placebo. Will have my first labs done in another 3 weeks.
No one told me not to share body fluids! What is that about??
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hi papaska - I didn't get any mouth sores for the first few weeks. Then I got one on my tongue, but I wasn't sure. I thought perhaps I had burned my tongue or just bit it, but it did look like the chemo mouth sores I had so I was suspicious. It wasn't until I got one on the inside of my lip last week that kept coming back that I was certain that's what it was. And the hand peeling just started today. So I would say... stay tuned! I think this drug often gives itself away.
I take Adderall (for chemo fatigue), and drink sometimes 6 cups of coffee per day just to make it. I know that can't be good for my heart after the Adriamycin, but what can you do?!? I am TIRED and there will be no convalescing in the Swiss Alps for me. ;-) I would like 6 months in the mountains, just relaxing, with a nanny to bring my children to visit me all day and somebody to cook food that actually had flavor (I have to work HARD to keep my weight at the very bottom end of the normal range because food tastes like nothing at all and I miss sugar like crazy).
Oddly, I'm having a CMP tomorrow before my first Prolia injection. I can't figure out why. I just had my blood work done last week. Eh, I've had so much blood drawn (still have my port), I figure, why not?
I've started taking my study drugs 3-4 hours after eating and then waiting another hour to eat. I have so many restrictions on when and how to take all my meds, it's hard to find a time I CAN eat. I know they say you can take it with a light meal, but when I have to eat, it has to be a lot, so that wasn't working. And I can't take it in the morning, because I have to take my Arimidex then with tiny food and the meds must be VERY spaced out.
It's a full time job keeping up with all of this!
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Hey All- I've been having some difficulties on Affinator and Femara. Mostly what is happening is that I am getting mouth sores and low neutrophils and white blood counts.
However, today I am experiencing numbness in my toes and feet. Is this something anyone else has had experience with. I am trying to figure out if it is an issue I bother calling the doctor for on a Friday night.
Thanks for any advice!
Renee
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Hi Renee. I'm sorry to hear you're having trouble with Afinitor. The numbness - yes! It was far worse than when I was on Taxol. I would have days where I would wake up to two totally numb hands... as if I had slept on my arms and constricted the blood flow all night.
Does the numbness resolve at all during the day? Mine would disappear after an hour or so. If you find your hands or feet are numb all day or night, I would call. But if it's temporary... I just rode it out and my study coordinator noted it in my chart. A month later, I haven't noticed any numbness recently.
My WBC is still low. My ANC was low but rallied this week. Because I'm coming off of so much treatment so quickly, it's hard to know what SEs are from the chemo, the rads, the menopause, etc. But I'm pretty sure I'll stay immune compromised for a year.
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oh thank you cajunqueen! The numbness comes and goes so I'll just deal. It isn't too bad but I hadn't mentioned to the MO when I got mouth sores and they were not pleased with my lack of reporting. I'll make sure to mention it at my next appointment though. If the Affinator is working I would hate to have to stop taking it because of white blood count issues so hopefully that won't last if it is in fact working.
Thanks again!!!
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Oh, prayers it puts and keeps you to a NED state for a long, long time. FWIW, I had horrible mouth sores during chemo and an ANC of 0.1. Never was hospitalized, never had a mouth infection. I was frightened by what the chemo was doing to my body, but I like to think that means it was doing it's job and that it's the same for you. Big hugs!
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Re numbness in hands.....mine are numb when I wake up too! I just assumed it was because of my regular sleep position -- which it still could be -- but what an interesting thing we have in common! I can't recall when I first started noticing this happening. The roof of mouth is still hypersensitive to hot foods/liquids and sheds pretty regularly, I used to get really severe canker sores all my life, but then they totally subsided while I was on chemo. While I was on the trial, I got little mouth sores that were nothing compared to what I had gotten before cancer, then they stopped and I generally have been free of mouth sores all together since the trial ended. WBC remains low -- 3.9 last month.
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Wow, your counts are still low a year later? Is that typical? I guess I assumed it would resolve within a few months of stopping the meds.
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cajunqueen15, I'm doing labs at the end of next week and have an MO appointment 6/27.....stay tuned!
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here's hoping you are back up where you started before all of this nonsense began! Xo
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Did anyone have hand and foot syndrome on Afinitor? My heels are cracked and red. My hands are peeling. I emailed the study coordinator who asked me if I wanted a break and I declined, but I'm wondering if it's going to get worse. I've only been on the study for about 9 weeks.
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I didn't have those problems....dry skin in general, but that could be because of menopause. My labs last week were great though.....cholesterol is still higher than it used to be but my ratio is good, WBC still low but acceptable all things considered.
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i have huge cracks on my heels but honestly just thought it was lack of estrogen and the summer months in flip flops. I thought the hand foot thing was blisters or peeling skin. I just have deep cracks and have been using the pedi egg thing to grate them down. I'll have to ask next time I visit. I forgot to share that my chloseterol is back down to where it was before Affinitor. I'm still on crestor but I've been taking half a dose since April because it caused unbearable leg aches . even the half dose has worked on my cholesterol and relieved the leg cramps to tolerable. I know they prescribe it in different mg so I'm taking the equivalent of 5 mg daily. Cajun. Please know that you can take a 12 week break I believe that's what they told me and still be in the study. I asked them to see if I could have the recon surgery while on it by the PS said no anyway. Keep us posted.
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thanks, ladies! I'm so encouraged to hear about these good labs! Progress, progress. No way am I stopping now. I'm riding this crazy train to the end.
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were here for you cajunqueen. That was my attitude too. Unless it's a very serious side effect like liver or lung issues I'm in it til the end of the trial. It goes by very fast. Cant believe it will be a year ive been out of active treatment (chemo and rads) and Thanks to Bec for setting the standard. She soared thru the trial and encourages the rest of us that we can do this. Thanks Bec!
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Awwwwwwww, thank you! Sometimes I wonder when I read everyone's posts whether I actually got Afinitor. It sure seemed like it at the time, so maybe it's just treatment amnesia setting in! The further out I get from active treatment, the less often I think about it. Then, when it does come up, I think, "WOW! I did WHAT??????" Honestly....I still can't believe I ever stood at my bathroom sink and gave myself shots in my own stomach! That famous quote is true...you don't know just how strong you are until strong is the only thing left to be.
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bec, you had to give yourself shots? I take 2, 5 mg tablets.
My eyelashes are falling out. 6 month PFC, the rest of my hair is growing in thick. Not sure what to make of this.
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I had to give myself the Neulasta shots after chemo. Insurance wouldn't pay for office visits for them, so I had to do it myself. Re eyelashes, mine fell out during chemo, then they all grew back 4 months PFC and all fell out again 2 months later. I complained to my MO right away.....WTH?!? Apparently it takes almost 2 years for each lash's shedding cycle to get off-sync from the others. Until then, they start off all shedding then growing back in simultaneously. It seems like after about a year I always had enough lashes to curl. But it happens!
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