Clinical Trial: Cycle 2, Day 15 (GDC-0032 + Fulvestrant)

December 12th, 2013 § 22 comments

IMG_7911Monday morning was an icy, rainy mess. I left the house before dawn, hitching a ride into NYC with Clarke as he drove to work. He dropped me right at the hospital because the weather was so nasty. I only had a short wait until the offices opened at 7:30 and started my first meeting around 8:00.

Before each meeting with the Principal Investigator on the trial (an oncologist) I usually meet with a research nurse. On Monday I had the added pleasure of meeting with the Fellow assigned to this trial. She is a fabulous doctor: thorough, curious, caring. We spent more than 45 minutes going over a checklist of symptoms we must review at each appointment. I need to answer if I am having any of those symptoms, describe them in detail, and rate if they are better or worse than at the last visit. Then we discuss what to do to help alleviate the symptoms. Certain medications are allowed and others are not because they could conflict with the investigational drug.

At this visit my main issues were muscle pain in my back, fatigue, occasional bone pain in my collarbone, continued loss of appetite (though my weight has stabilized), occasional shortness of breath, dry skin and cracked heels, and some minor GI issues. My blood pressure and heart rate are elevated. My pleural effusion has stayed at the reduced level, fluid continues just in the lower left lung lobe.

In general, I feel quite good on the combination of GDC-0032 and Fulvestrant. I’m quite happy with my current quality of life on the combo especially compared to other options like IV chemo. I hope that it will continue. I have historically tolerated targeted therapies very well. I have not had any issues so far with mouth sores, rashes, or serious GI issues which are some of the more common side effects with the investigational drug.

I was able to ask all of my questions, most having to do with the coming two weeks. Next week is a big milestone: I will have my first CT scan and that will be the basis for determining if I can continue in this clinical trial. At least two radiologists will examine the CT. One radiologist from the hospital will read the images, while a second, separate radiologist assigned to the trial will make his/her own determination as to how much disease there is compared to the baseline CT 7 weeks ago. If the cancer metastases are considered stable or decreased, I will continue in the trial. If the cancer has progressed (grown) by 20% or more, I will need to stop taking the drugs and be removed from this trial. There are defined days that are the days I must have this scan done so that all of us taking part in the trial are assessed at comparable points in treatment.

Next I met with the Principal Investigator on the trial. This is the oncologist who is the point person for the trial and supervises all of the patients in the trial at Memorial Sloan-Kettering. We reviewed how I am doing in general, what the plan is for the coming 2 weeks, and discussed bloodwork. I told her that am anxious to hear how the other people enrolled in the study nationally are doing. Because we all started within a few weeks of each other, there aren’t many reports yet.

Because I have completed my loading doses of Fulvestrant (an extra dose of the drug is required in the first month of treatment), I did not have to get those injections this week. That was a treat. I will now receive the two injections monthly.

My medication diary documenting the time I stop eating each night and the time I take my medication in the morning was checked as were my  pill quantities. I scheduled my next visit (adjusted a few days earlier because of holiday schedules there, I have a +/- 3 day window for the appointments now) and headed up to the third floor to have my blood drawn.

My port incisions are healing beautifully. I’ve toyed with posting a photo of what it looks like but haven’t decided about that yet. The nurse and I donned the requisite masks for port access and the blood draw was easy. I was then allowed to take my GDC pills and start the clock on the 60 minutes until I could eat and drink (I must always wait one hour after taking them). I left the hospital about 3 hours after I arrived.

We’ve been watching my tumor markers and aren’t quite sure what to make of them. They’ve been rising a lot in the past month but I am also getting varied results from my two testing sites. Of course, the key piece of data to look at is the scan. But it’s been a challenging few weeks emotionally as I see where the markers are, watch them rise, and wait for the scan to tell me what’s truly going on inside by body. In a few days I’ll have answers. And then I’ll either be continuing on the trial for another two months or moving on to plan B (which my team and I have already identified).

I continually try to bring my focus back to the distinction between worrying and planning. Worrying is anticipatory. The way I look at it is that worrying is spending time thinking about things that may or may not be/come true. Planning is taking strategic action to set things in place and control things that I can control in the midst of so much uncertainty.

Having a backup plan or a next step if the scan brings bad news next week is planning. It means if this trial isn’t working I know what I will do next and make sure those steps are in place so I’m not suddenly reeling and trying to cobble together a plan. But worrying about the results next week won’t do me any good. The cancer is doing what it is doing. These drugs are either working or they are not. And my sadness or frustration about that won’t change the reality of the cellular processes.

And so I have been quieter this week, choosing carefully how to spend my time. I’m searching for joy each and every day and finding beauty in the small moments: our dog Lucy playing in the first snowfall of the season, Christmas shopping with Paige last weekend, puzzling through math homework with Tristan, Colin and I getting haircuts together and going Lego shopping.

We hug a lot.
We say “I love you” a lot.
We always have done this.
But now I hold on for an extra second each time and I squeeze just a little tighter.

………………………………….

For those readers new to my posts about this clinical trial, you can see my reports about Cycle 1, Day 1 here and Cycle 1, Day 16 here and my port placement and Cycle 2, Day 1 here.

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§ 22 Responses to Clinical Trial: Cycle 2, Day 15 (GDC-0032 + Fulvestrant)"

  • Erin says:

    I’m not sure I understand why the CT scan is the determining factor in whether you can continue in the trial. I mean, I get that of the cancer is growing, the investigational meds likely aren’t working, but how do they decide how long to give them before making the continue-or-not call? And what happens if the cancer has grown by, say, 10%?

    I have a feeling that my lack of complete understanding is likely due to my dearth of medical experience in this area, and please don’t feel like you have to explain further; I know you will share what happens and explain it.

    I wish I could give you every ounce of strength I possess. Sending you much love and constant appreciation, though.

    • Lisa Adams says:

      Erin, it’s a good question. You want to find the sweet spot between catching things before they spiral further out of control and giving the drugs time to act. Stability (about the same amount of cancer as measured by tumor/lymph node size etc.) is considered success. Growth of 10% as you say, would be considered sufficient to continue on the trial. Now is the decision-making time. They check at the 7 week mark. They consider this to be enough time to see if it’s at least holding things in line. If everything seems stable or better (!) then you allow 8 weeks to pass before checking again. There are different scanning time frames as the trial goes on (at some point it goes to scanning every 12 weeks). If things are grown by 20% in this time they must draw the conclusion that it’s not hitting the target and curtailing the growth. Granted, this could be too soon and you might be missing your chance for it to “kick in” but based on the phase 1 study they must have reason to believe that if it’s not going to be effective it will have shown its true colors at this mark.

      As far as why the CT is used, it’s detailed. There can be false positives in PET scans and CT allows for more precise measurement of tumor/node size so you can more accurately gauge a 20% increase in size. There are no reliable blood tests to give us this information. There must be uniform criteria to assess whether or not it’s working that different facilities must follow to participate in the trial and CT gives the most standardized information to do that.

      I hope this helps to answer your question. I’m happy to answer any follow-up that you have. I should also say that I’ve explained this to the best of my knowledge and ability as a non-physician. I am sure there are other reasons that I am not aware of.

      • Erin says:

        This makes sense–thank you for explaining! Is 20% always the number? I mean, if this scan is good, is the measure for the next one still 20%?

        • Lisa Bonchek Adams says:

          20% is the guideline set for this study. So it will always be 20% for this. I do not know about other studies but I would suspect that there is a minimum margin of error needed to detect the changes and so you wouldn’t see “5%” for example. That isn’t enough of a change. I’ll keep an eye out for other numbers.

  • Sandy Greenstreet says:

    Wishing you continued strength and a wonderful holiday with your family. I admire your honesty and strength, and I hope you feel the love and hugs from those of us who follow your blog.

  • sue says:

    I will be thinking of you next week. I’m glad that you’re having plenty of family time and that you’ll be seeing another Christmas.
    I’m also very glad to hear that you have a plan B lined up, just in case.
    Thank you so much for letting us take this journey with you.

    A big transatlantic hug from me, as always.

    xxx

  • Teresa says:

    Lisa, I so appreciate you sharing things with us. I have learned something valuable from you in each of your posts.

    Today your message about worrying vs. planning resonated inside of me as if a gigantic, ancient gong went off inside my body. I tend to be a worrier, a reactor, more than I care to admit. But today I purpose to take your lead and let the planful approach take hold in me. I took a big step in that direction today with a (successful) inquiry re Wes and school (intermittent home ed. help). Now instead of hitting the panic button next time he is sick, I have a plan in place. For a change. Your blog has helped me learn to be a better parent to my son. Thank you for that.

    The last sentences of your blog today caused my eyes to well up, and they’re welled up now as I write this. I will keep you especially close in my thoughts next week. I want you to have good news, and more than anything I want you to have many more long, tight, hugs with your family and, what is that Yiddish term you use for when you all cuddle in the bed? those, I want you to have many more of those.

    Wishing you love, peace, and good news, dear friend. Love you.

    Ter

  • Beautiful as always. I think this should be required reading for the docs/presenters in San Antonio… We aren’t dots on a scatter plot. And the mets patients really MUST be at the top of the research priorities.

    With love,
    AnneMarie

  • It is good to see a post and update from you and I think of you and your family often, especially as the holidays near.

    Sending every possible thought and vibration up and out to the universe that next week’s scan shows good news.

    Peace of mind, body and spirit to you.

  • Merva says:

    Lisa,

    As always, your words are beautifully chosen even while you are experiencing daily struggles. Today, I vow to plan more and worry less! My family challenges during this past year are so minor compared to what you and many others are going through. Thanks for sharing.

  • Tom says:

    Thank you for giving such a detailed description and understanding of the process of being treated for cancer. You are making a major contribution to the demystification of the shrouded and scary world of oncology. I’ve had family members go through cancer treatment but learned through them but a tiny fraction of what I’ve learned about the ordeal from your blog and tweets. The main reason I follow you is as preparation for the day when I or someone I am close to becomes a cancer patient. Then, because of you, I will be in so much better shape to manage the situation, both practically and emotionally.

    Of course, I am also moved by your personal travail, but since I don’t know you, it’s the education that makes following you a positive experience.
    If it weren’t for gaining copious amounts of information that may well have a practical application in the future, I sometimes wonder if following an illness blog wouldn’t just be medical voyeurism.

    I do have a couple of questions which, I understand, you may or may not have time to answer. It’s about CT v. MRI. Why is CT used instead of MRI in the trial? Can more be seen with CT? Wasn’t the test that revealed your mets an MRI?

    Also, from the patient’s viewpoint, which test is easier to take? If you had a choice of either test because each provided the same information, which one would you choose?

    I fervently hope that the upcoming scan shows that the trial drug is working.

    • Lisa Bonchek Adams says:

      Hi… CT is used because it’s better at looking at bony structures and can still capture soft tissue and blood vessels too. Bone is obviously an important issue with metastatic breast cancer. It’s good for cancer, lungs, and with contrast (how they are done for this) you can differentiate soft tissue well. MRIs are used mainly for soft tissue and in smaller locations, scans take much longer, and aren’t as specifically fine-tuned to be able to measure changes as well as the CT is. MRIs are generally also used for brain studies (soft tissue).

      No, it was not an MRI that led to my diagnosis. My mets were originally found because I had rib pain which prompted my oncologist to run my CA-153 level which showed an elevation. We did a chest x-ray to rule out lung mets that same day and a PET scan the next day to find out exactly where the mets were (bone and nodes only at that time).

      A CT is generally easier because it is SO much faster. But depending on the method of contrast it can be “ickier”… you usually need to drink a large quantity of tracer before the scan (last time I was able to have one that was like Crystal Light… big improvement over barium) and then you often need to have an IV injection of contrast during the scan. There is radiation with a CT though, which is a drawback compared to an MRI. But you just can’t get the same info from both so it’s not a true choice. So my answer to your questions is that even with the tracer drink and IV injection I’d still take the CT because it’s so fast. For claustrophobic patients that is huge bonus too.

      Thanks for reading and I hope that answers your questions.

  • Your lucidity in the face of this enormous psychological and emotional pressure is just one more thing to admire about you.

    Wishing you only good things, today and always. xoxo

  • Ann says:

    Holding you in my heart.

  • Hillarie says:

    I really appreciate your comments on worrying vs. planning. You’ve articulated some ideas I’ve had bouncing in my head as of late. I was boiling mine down into I can’t predict the future, I can only plan for options. Trying to predict is a form of worry, I would say.

  • Rebecca says:

    The “Serenity Prayer” comes to my mind when I read your post. Yes, it is good to have a Plan B. Yes it is hard not to worry about what MIGHT BE and just focus on WHAT IS. So many of us in the world struggle with those things. “It is what it is” try not to think about “What if?” or “Yes, but…”. I am great at thinking things like”Things are okay today, yes BUT tomorrow what if….”

    I bet Lego shopping was fun! Where did you go for that?

    I hope you and your family have a wonderful Christmas and school vacation time. It looks like it’s going to be a white one this year. Have fun with it!

  • Heidi Bright says:

    Hi Lisa,
    My heart goes out to you as you endure this trial. I love how you distinguished between worrying and planning, and that you seek the joy in each day. One of the best predictors of survival is joy, so keep that joy flowing.
    How interesting you have a Tristan. So do I, my 1st-born.
    You might not be allowed to do this, but if you can, you might consider increasing your omega-3 fatty acids (fish oil) to help with dry skin. When my skin became excessively dry during chemo, I started using beeswax on them. It worked beautifully, giving a lot of relief.
    May you find relief and joy every day.

  • […] Lisa Adams continues her fascinating series about what it’s actually like to take part in a cancer trial. […]

  • NS says:

    I have found you, and your site, by accidently googling something about my own issues. I do not belong to any social media. The exception now, is you. Today I send you a hug, and to your precious children. This is a journey I would never wish on anyone.
    Angels are everywhere, you are now one in my life.

  • NS says:

    I left your husband out of my hug post earlier… Give him a big hug too!
    I am reading and reading all your posts. Since just finding this I cannot stop reading. :) There are things you have wrote and others that I could have been the one writing. You are a special person, helping us all along your way in this journey.
    I am sad at times going through this at times, tears and smiles. My biggest ache in my heart is for your children. Do not worry about anything if you cannot change it at this very second is how I live now. Enjoy them, your husband every second this holiday. Praying you feel well enough too to do all you want too.

  • […] to go through the “washout” period leading into the trial, the science behind the compound,how she felt during and after treatment, and what it was like for her physically and emotionally when the drug […]

  • […] to go through the “washout” period leading into the trial, the science behind the compound, how she felt during and after treatment, and what it was like for her physically and emotionally when the drug […]

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