ATEMPT Clinical Trial - Roll Call
Comments
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hi all--I got accepted! First chemo is set for Tuesday. Don't know which arm I'll get. Am excited and a little bit freaked.
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Congrats Ozoner... Keep posting! We're in this together... I'll get an infusion next Tuesday also... Maggie
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Ozoner, I misunderstood your previous post and thought you were already in. So now that you really are in the trial, best of luck as you get started. there is a surreal element to this, for sure, but you get used to the routine of treatment.
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Ozoner, welcome to the "family". I just finished my 3rd cycle of TDM1 and remember the happy/apprehensive/mainly relieved to be proactively doing "something" feelings.
TTfan, congrats on finishing rads! And MaggieCat, I suppose you are homeward bound by now! So happy for you both and I hope the H side of this goes well. What will you ladies do with all this newfound time?
I'm writing from my room here at MDAnderson. After having a few days of fatigue, nausea and D after my 2nd round of TDM1, my 3rd round seemed to go well as I had no fatigue or tummy issues for the first day after. But I found myself in the ER at 2am the next day with horrible D, nausea and vomiting. As a result, after about 8 hrs of this I was badly dehydrated. Note to self- you cannot rehydrate yourself with water when having 30+ episodes of D at home 😩
I'm still in the hospital receiving IV fluids along with magnesium and oral potassium as both were low. Down to 11 episodes of D today, receiving immodium and lomotil.
Ozoner, don't be worried as my MO tells me I'm the only patient in the trial here who has had these issues. Not so happy with her right now as I asked early on for a lomotil script and she declined. I don't think this would be quite so out of hand now had I been able to use something stronger at home.
The other point I've learned through this is that I am extremely thankful for my port! While blood cultures and PTTs had to be drawn from a vein, everything else has been a breeze and the middle of the night lab draws don't even wake me up
Hope the rest of you fellow ATEMPTERs are happy and healthy!
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How are things Mom???
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Feeling much better, MaggieCat, after finally leaving MD Anderson late yesterday :-) Low magnesium & potassium slowed me down a bit on discharge day so I needed back to back 4 hour potassium drips. Now I am armed with meds I need at home (simple things like Lomotil) to hopefully keep things from reaching this point again. I still don't understand why my MO was so reticent to prescribe anything in the first place. She kept saying I was the only one having any of the digestive SEs as if I actually wasn't. My nurses (I fondly named them the "haz mat crew") who cleaned up after me for the last few days know better.
Starting the process to change to another MO as this entire episode really was preventable if I had the tools to do so.
One note, after 14 hrs of treatment in the ER at MDACC, I was moved to their observation unit (Clincal Decision Unit is the official name) which was created 6 months ago. It is run as an outpatient observation unit and I was never officially "admitted" to the hospital. The job in the CDU is for providers to make that return home vs. admit to hospital decision. I give both the ER and CDU rave reviews in terms of my experience there under some trying cirumstances (MDACC was at 100% and on divert status during part of my time there so staff was stretched to their limit but still provided excellent care).
Hope everyone else is doing great and enjoying a beautiful spring weekend!
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Thanks for the update... good to hear you are home! Guess we needed to do an intro between your MO and several of the ATEMPT gals we've come to know here! Geez... digestive SEs.... yep more than one weighing in with that challenge! The support team arrangement at MDACC sounds like a winner!
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Mom2Three, wow, can't believe what you've been through! You sound like a very strong and positive-thinking person. I admire you.
I also kept hearing at Dana Farber that I was the only woman having this or that SE from TDM1--which was true at the time. My onc nurse told me she was sure that sooner or later other SEs would become apparent as the number of participants in the trial grew, and I think we're evidence of that. But I think it IS true that most women have very mild SEs. Those of us who had more serious SEs (my platelet count drop, your D) still seem to be the outliers, and we're very useful for their research into this drug! I do love my MO even though she was excessively (as it turns out) optimistic before I went on the trial that I would have no SEs at all on TDM1.
Now, stay out of trouble, you hear? ;-)
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Isabel - glad to have another outlier for company :-) I still count my blessings every time I am at MDACC as so many people deal with issues much worse. As you say, the manufacturer does need to know about folks like us who are in the miniority.
Will try to stay out of trouble, but no guarantees with me feeling better and full of energy now :-)
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I tried to post a few hours ago, but it didn't show up. First IV therapy today, the HDM1 arm of the ATEMPT trial! Feeling ok so far. Any suggestions?
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Relax!!! I'm home after my 7th...One (more) done!!!!
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So exciting that you're nearing the end of treatment! You have to travel a long way to take your radiation, don't you? That would make things so much harder.
I'll try to relax--and you can get ready to celebrate!
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FYI
A database of cancer-causing gene mutations is being gathered from tens of thousands of women in a pact between a U.S. testing company and French researchers to better predict deadly breast and ovarian malignancies.
"We've begun to reach out to a number of entities and are fielding strong interest, but we cannot name the parties at this point," he said. "We will not turn away any laboratory so long as they're willing to share their data."
The tests may become more popular as consumer awareness of genetic risk increases and sequencing costs decrease. Color Genomics, a Silicon Valley startup, on Tuesday announced a $249 saliva test for 19 genetic variants known to be correlated with a higher risk of breast cancer or ovarian cancer, including mutations in the BRCA1 gene. Color is backed by investors including Khosla Ventures and Laurene Powell Jobs, widow of Apple Inc. co-founder Steve Jobs.
http://www.bloomberg.com/news/articles/2015-04-21/hunt-for-deadly-breast-cancer-genes-pools-thousands-of-patients0 -
Ozoner, great to hear that you're on the TDM1 arm of the trial. My only suggestion is to keep doing whatever it is you like to do--if you feel all right, you ARE all right! I had mild nausea for 2-3 days after the infusion, but it seems many women do not. I hope that's the case for you.
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Thats great advice. After all, it is about a positive attitude. After the infusion, myhyper vigilant mind tracked every twinge or feeling, but now is the time to get on with it. I would so miss walking and light Zumba. Thanks for putting me on the right path.
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Ozoner... How are you? Just wondering... I'm in my usual 3rd day slump! Gets better from here for me. Maggie
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Hi Maggie! I'm tired part of every day, get nauseated, and then constipated, but I think I've got that sorted out. So third day is a slump for you? Good to know.
The more I see around me, the more kindness comes flooding in. Kind patients at the chemo infusion area, plus the knowledge that the regimen we're getting is so much easier. The oncologist practically danced a jig when he informed me I was chosen for TDM-1, and in addition to his Stage IV BC patients, he has two more women in the trial, plus people w other cancers, like rectal, who were being treated wilt the same drug.
Because the oncology radiologist wasn't quite on board w my treatment, the surgeon and onco doctor have elevated my situation to "the tumor board," where other doctors will weigh in. Looks like I will receive rads later in treatment, in addition to the boost I was given after surgery.
Thanks for checking on me. I'm trying to balance rest and activities, plus I don't want to constantly talk to my husband about problems, but you and the other women here are just what I need.
s
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This is my first post so this is somewhat of a test as I begin navigating this site. Recently diagnosed, lumpectomy last week and have been told I am a candidate for the TDM1 trail. Will meet with onc this week for a more detailed discussion. Trying to decide if this is right for me and it seems that many others have gone through this difficult process. Please share any advice or message me. Thank you.
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Kerry... Advise "yes"... Hope TTfan will comment. She's in the medical field and chose to join. I started discussing this clinical trial in October...got "officially" accepted late 2014 with first infusion 12/16/14. My ATEMPT research nurse has been my lifeline for the past 6 months... No downsides from my perspective... a very small group of ladies that qualify. My two cents... and WELCOME!!!!! Maggie
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Kerry--I'm with Maggie on this. My advice is go for it. I am the "veteran" in this forum--I had 7 months of TDM1 which finished a year ago, and then I completed the treatment year with Herceptin only. (TDM1 produced a drop in platelet count for me--this side effect was very unusual among women on the trial and seems to have remained so, so it's not something you should worry about, but it was the reason my onc took me off the drug.) I and others had some side effects, but they are VERY manageable. The main thing I'd say about TDM1 is that it does not interfere with daily life--except for maybe a couple of days of feeling queasy or tired, you can just keep on keeping on. It's really quite fantastic, and this is one reason why doctors are excited about it for stage 1. I see that you're in Boston--I was treated at Dana-Farber and cannot say enough good things about everyone there, from the oncologists right down to the parking garage attendants. I drove 3 hrs each way for treatment every 3 weeks--I was able to drive home after my treatment. Hope this helps! Sorry to welcome you to the club no one wants to belong to, but stage 1 is a good place to be, and the ATEMPT trial is a great thing.
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Maggie- thank you. This is encouraging to hear. Did you receive TDM1 for 3 months (Dec-Mar) and then begin radiation? So are your infusions complete? Do you have to continue with Herceptin following radiation? I will learn more details on the differences in the treatment plans within the trial when I meet with my MO again on Thursday. What side effects did you experience? My only hesitation with doing the trial and receiving TDM1 is because I did not have a mastectomy, I want to be sure to be as agressive as I can with the chemo. I am not convinced that TDM1 has proven to be as effective or better than the standard treatment of Herceptin/Taxol. On the other hand, I'd like to avoid side effects of Taxol. I probably overthink everything. As a nurse, it is difficult to be the patient. Thank you for your encouraging support0 -
Isabel- thank you for responding. So you had 7 months of TDM1 and then switched to Herceptin because of your platelets? Would TDM1 have continued for 1 year if you did not have that response? Any other side effects? How are you feeling now, are you about a year out of treatment? I see that you had a mastectomy. My hesitation in the trial is that I had a lumpectomy only. At the decision making time, I don't think I had enough information about Her2+ and quite frankly I did not want to delay treatment in waiting to schedule mastectomy and recovery before starting systemic treatment. Having a lumpectomy meant I could start treatment sooner and that gave me peace of mind somewhat. In retrospect, I probably would have chosen a mastectomy if I knew then all that I have learned over the past month. I am very worried about recurrence and want to treat this as aggressively as I can now. I am pleased to know you had a good experience at DFCI. I am at MGH where I also work. Was considering a 2nd opinion at DFCI, but after meeting with my "dream team" here at MGH, I decided to stay here. I have great confidence they will take great care of me and I just need to get through my own anxieties and stop over thinking everything. Thank you for your warm welcome!
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Kerry - Understand where you are coming from. I want to find one of TTfan's older posts for you to read. She is(was) triple positive, very small tumor with lump removal and ended up in the Taxol group in the trial. I'm er/pr negative, Her2 3+, had lump removed and am comfortable in my thoughts that T-DM1 is equivalent OR better than paclitaxel plus herceptin. I will receive T-DM1 for a year. Had 5 1/2 weeks radiation with one T-DM1 infusion during that time. Will look for that older posting... Maggie
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Maggie- I just finished reading ALL of the posts in this thread. I feel like I know each one of you! Thank you so much for starting this! I hope to hear from TTfan. I am confused becasue it seems that some receive infusions weekly while others are every 21 days? Shouldn't everyone on the trial be standard? Maybe I am misreading the details. I read about your overlap with rads and infusion, but it was only that one time, rads is complete for you now right? I am +++ so will need Tamoxifen at the completion of rads. I will post again on Thursday after I meet with my MO to finalize treatment plan/decision about trial. Again, my deepest gratitude to you for starting this thread and all who have contributed in providing such helpful information.
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Kerry, I want to answer you point by point (stuff you asked me and Maggie), although by now if you've read the whole thread you probably have all the answers to your questions!
You asked:
So you had 7 months of TDM1 and then switched to Herceptin because of your platelets? YES
Would TDM1 have continued for 1 year if you did not have that response? YES
Any other side effects? Queasiness/mild nausea for a few days after treatment, very mild fatigue for a day. First few weeks: runny nose. One episode of mouth sores a few months in. Dry mouth a few months in--then it came and went. Platelet drop (I think my lowest was 50K), resulting in nosebleeds and some bruising. Bumpy, ridged thumbnails--bizarrely, this has continued to this day. I think that's everything. I was considered quite unusual at DFCI--my research nurse held conference calls about me with the docs on the trial. It became a running joke that because of my unexpected SEs I would be an interesting ATEMPT footnote. But the important thing is that my life went on undisturbed while getting treatment. The queasiness was a drag but it was not full-on nausea and I never vomited.
How are you feeling now, are you about a year out of treatment? Fantastic!
I see that you had a mastectomy. My hesitation in the trial is that I had a lumpectomy only. At the decision making time, I don't think I had enough information about Her2+ and quite frankly I did not want to delay treatment in waiting to schedule mastectomy and recovery before starting systemic treatment. Having a lumpectomy meant I could start treatment sooner and that gave me peace of mind somewhat. In retrospect, I probably would have chosen a mastectomy if I knew then all that I have learned over the past month. I am very worried about recurrence and want to treat this as aggressively as I can now. I had to have a mast. because I had high-grade DCIS in three quadrants plus Paget's disease of the nipple. The HER2+ tumors (a few, largest 1 cm, others a few mm) were not found till tissue analysis after surgery. (So yes, I had three carcinomas in one breast--as my friend said at the time, I won the booby prize.) I would certainly have had a lumpectomy like you if I could have--I urge you not to second-guess your decision. From what I have read, research shows that lumpectomy (with clean margins) outcomes are certainly no worse than mastectomy outcomes.
I am pleased to know you had a good experience at DFCI. I am at MGH where I also work. Was considering a 2nd opinion at DFCI, but after meeting with my "dream team" here at MGH, I decided to stay here. I have great confidence they will take great care of me and I just need to get through my own anxieties and stop over thinking everything. Wonderful! Confidence in your team is SO IMPORTANT! Your anxieties are normal--how could you NOT have them? I was a quivering wreck much of the summer after diagnosis and surgery.
I am not convinced that TDM1 has proven to be as effective or better than the standard treatment of Herceptin/Taxol. That is the nature of a clinical trial--it's not known, hence the need for the trial. There is an element of risk. My MO was very persuasive that TDM1 would be as effective (or more). But she absolutely would have been on board if I'd made the decision to get the "tried and true" Taxol/Herceptin. I had a third opinion from an onc at Sloan-Kettering (a major figure in the BC world). He told me that the fact that the ATEMPT trial is 3 to 1--out of every 4 women, 3 will get TDM1, 1 Taxol--indicates that the researchers are very confident in the trial drug. The trial wasn't being offered at Sloan-Kettering, but he approved of either treatment--Taxol/Herceptin or TDM1. Btw, I began my odyssey with a local onc. who wanted to give me ACT(H)--the "big guns" of chemo. It was only just in 2014 that the research team at DFCI made the case for NOT overtreating stage 1 her2+--we are all benefiting hugely from the most recent advances in understanding.
On the other hand, I'd like to avoid side effects of Taxol. That is the dilemma--Taxol is the tried and true treatment, with SEs and hair loss; TDM1 is experimental, with fewer SEs and no hair loss. You will not be wrong either way (trial or no trial)--and if you enroll in the trial and are assigned to the Taxol arm, you can be confident you are getting proven effective treatment.
I probably overthink everything. This is a hugely important decision--it calls for a lot of thought! I had a gut feeling that I wanted the trial, but the gut feeling was not immediate. The confidence came after a couple of weeks of reflection.
Btw, how old are you?
Also, you mentioned Tamoxifen--i am on it because I am weakly ER/PR+.
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Kerry, one more thing: At one point after I'd started the trial it occurred to me to ask my MO if the chemo element of TDM1 is qualitatively the same as Taxol. She explained that in fact TDM1 makes use of Emtansine, a very powerful chemo drug first used in the 1980s but that was discontinued because patients could not tolerate it (when given as a direct infusion, as opposed to TDM1's delivery method as molecules attached to Herceptin that target only the "bad" cells).
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Hi everyone - sorry to have been MIA but it's actually a good thing! I've been feeling so much better I'm off catching up on the zillion things I ignored while on Taxol and spending far less time on the boards as a result.
Mom - so sorry to hear about your nasty bout of diarrhea, it must have been miserable! Glad you are now better equipped to nip it in the bud if it has the nerve to come back. I find many of the MOs I have talked to downplay SE and just kind of do the psychiatry mhmmm response, almost as if they don't quite believe me. The oncology NP I often see at UCSF (my study site) has been by far the most helpful in that regard. I feel like my UCSF MO kind of lost interest in me once I was assigned to the Taxol arm - I am almost always seen by the NP or the fellow now. I have my own Kaiser MO who is far more available, warm and helpful so its no big deal.
Maggie - congrats on being done with RT! Did you get away without too much skin irritation? I'm two weeks out and the redness is fading, still a little itchy but so far no peeling. I was only mildly uncomfortable and only for a few days. I got to know several other women with similar RT appt slots - we had a fun and helpful little mini-support group going chatting in the waiting room. I never minded the occasional delays as we chatted away. I also found myself very grateful my own situation is so manageable, others were dealing with more advanced disease, both breast and other nasties like tongue cancer.
Isabel - thanks for staying around and being so generous with your hard earned wisdom! And I'm delighted that you are now feeling fantastic! I love hearing that from women on "the other side" of this.
Ozoner - belated congrats on getting in the study and TDM-1 arm - it sounds like you are doing very well - I'm happy for you!
And last but certainly not least, Kerry - I'm so sorry you are faced with this decision and remember well how scary and difficult it was. I agree with Maggie though, Stage 1, if you have to have BC at all, is indeed a great place to be with fabulous cure rates with the right treatment. Triple pos is also a great place to be these days, though I scared myself silly reading about HER+ right after diagnosis, especially when I didn't yet know my tumor size. And even then, I was scared again because I had reassured myself that though HER2 could be nasty, Herceptin would be my savior. My surgeon happily told me right as she told me the tumor was only 4mm that I would thus not need Herceptin. So instead of being delighted it was so small, I was panicked it meant they wouldn't give me the Herceptin. You know the rest of that story since you read through this thread!
I would definitely make the same decision again about this study, even though I briefly considered backing out once I was randomized to Taxol. I could have gotten that same treatment 15 minutes from home so the study really doesn't give me personally any benefit, and requires numerous trips into SF that can be mildly burdensome. But this needs to be figured out, and I decided that if a few extra blood draws and trips to the city could contribute to eventually making the right treatment clearer, it was worth it to me. And I wouldn't have gotten to know all the wonderful folks on this thread!
I agree with the others that while it is very likely that TDM-1 is equal to or better than T/H, we don't yet know that for sure. I am also not completely convinced yet that the SE will turn out to be less with TDM-1. Most folks in this thread on TDM-1 have had something more severe than I experienced on Taxol. Hopefully TDM-1 will prove to be more effective with fewer SE - but without the study we won't know. It will be fascinating to read the paper one day! Hair loss is the one clear difference and I have to say, after the initial shock of the bald lady staring back at me in the mirror, it wasn't the big deal I was afraid it would be. If anything I got more support since the illness showed on the outside (I hated wigs and never wore one).
I also sympathize with you about being in health care and being a patient. We know much too much about what can go wrong! Some of the upsides are that settings that are new and scary to most are very familiar to us and we usually know what questions to ask and what to watch for. It helps.
I won't bore you with all my Taxol experiences since you may never face it, but there is a thread on Taxol/Herceptin alone in the triple positive group. There is tons of helpful info there. I am delighted to share anything you are interested in, but for now, I'll just say Herceptin alone is incredibly easy for me and two and a half months out from starting chemo, I have all the hard stuff behind me - lumpectomy/SNB done, RT done, Taxol done. I have enough hair back to feel totally comfortable in public without scarves etc., feel fabulous and am exercising again and moving on. I just started Arimidex for the ER+ part yesterday, but am hopeful that will not give me any trouble.
I'm happy to catch up with all of you and continue to wish everyone the best! I am always interested to hear how everyone is and how the stories are unfolding! Now I'm off to Kaiser for Herceptin only #4!
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Wow! THANK YOU ALL so very much. I read your responses and am so amazed to meet women who have my exact thoughts, concerns and fears. It is so reassuringly clear to me that everything that has raced through my mind (and lingered to spend unwelcomed time!) has already been thought about by all of you who are a few strides ahead of me on this journey. I have taken care of Oncology patients in my career and thought that I had an understanding of what they were going through- but one lesson I have learned in the past month is that the only ones that truly understand it are the ones who have gone through it. I am blessed to have wonderful support from my husband and family- but this support from you is something so different. Thank you!
To answer/comment on questions above:
Isabel- I am 47, premenopausal. Also of interest here is that I had a mammogram in January of this year. Got the all clear, see you next January. In February I palpated a lump. It felt unusual, but I thought it might be a cyst and it would disappear after my cycle. For a month I was aware of it but kept telling myself that I just had a mammogram, it couldn't be anything. Fibrocystic breast tissue is something I've always had so lumpy things would come and go. This one however was different and after a month it seemed to be saying "I am still here... better check me out!" I went to my PCP who told me it was probably nothing but sent me for an ultrasound and there I could see the black irregular shape and knew at that moment it was definitely not a cyst. My message that I want to tell every woman is even if you feel something a month after your mammogram, do not ignore it! My tumor was close to my chest wall and just out of the range of the mammogram (high and to the center where cleavage would be if I wore a good bra!) It was shocking to me that something so aggressive could be missed on a mammogram. I know that I am so lucky that I found this early. I thank you Isabel for addressing each of my concerns. I am so relieved to know my thoughts are not crazy and more importantly that things will get better.
TTfan- so happy to hear from you. Your story is an interesting one and I enjoyed reading all of your posts. It adds a lot of interest to the other side of the trial. I admire you for remaining in the trial when you could have exited. I am glad that you pointed out that there are definitely side effects (some quite significant) to the TDM1. I've read of 2 (I would assume there are more) that had to stop. It raises a question for me that if the side effects are significant for one year, would one be better off doing Taxol for only 4 cycles and getting it over with? I do want to learn more about the Taxol and will check out the triple positive group you referenced. I am not at all concerned about losing my hair- it's temporary, it's summer, I am not ashamed. I would however like to avoid neuropathy as that can be unpredictable in severity and longevity. Feel free to let me know anything else I need to know about it. Another concern I have is the potential for allergic reaction. I am allergic to juniper plants, and I learned that Taxol is a derivative of this family of plants. My allergist is quite up to date and said if I have a reaction they can do a desensitization if necessary without interruption in treatment. But it does give me another reason to consider the trial and hope for TDM1 arm. I am relieved to hear you are feeling well now after all you've been through. I can't tell you how reassuring all of this is to me.
Questions:
For the trial- TDM1 is given every 3 weeks for one year? vs. Hercetpin/Taxol every 3 weeks for 4 cycles, then radiation (if needed) then Herceptin only to complete the year? If this is correct does it mean that Taxol is only given for 4 doses and then you are done with it and only have to do Herceptin for the remaining treatment?
If premenopausal- any expereinces or knowlege of these chemo drugs and will they put me into menopause? Is it temporary? I've read different things but not in much detail yet.
Thank you all!
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Kerry... Taxol is weekly for 12 weeks (4 cycles of 3 weeks each) along with weekly herceptin, .... at the 12+ week point you would receive any needed rad treatment AND also transition to herceptin only treatment every 3 weeks for the remainder of a year. For comparison, T-DM1 is given every 3 weeks from start to finish and the rad treatment is also at 12+ weeks... Hormone suppression is a different set of drugs. Good info on this site, think if you queried over on the triple positive thread you'd get more than your fill of info! Maggie
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Weekly? Yikes! Can you explain with 4 cycles of 3 weeks each means? Do they change the dosing every cycle? I know this will all be explained to me tomorrow but I am an information junkie and want as much as I can find before my appointment so I can have my questions prepared. Thank you again! All of this information is so helpful.I do remember them talking about Radiation after 12 weeks and then Tamoxifen after that.
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