On Friday morning after I sent our three children off to school I traveled to Memorial Sloan-Kettering Cancer Center (MSK) to have a port implanted. My first appointment of the day was at 10:15 to have an electrocardiogram (EKG/ECG). MSK requires an EKG on one of their machines within 48 hours of the port procedure. It takes longer to find the bathroom than it does to have this test done. Electronic leads are attached with sticky sensors to specific points all over your body and hooked up to a machine. After about one minute of recording you are done, and the sticky round patches and the attached wires are removed. Easy as can be. The test measures the electrical activity of your heart to make sure it is normal. I won’t go into details on this test because it’s such a piece of cake and so common.
After that test was complete (by 10:08) I went to a different floor in the same building to the Interventional Radiology department. There, a friendly team checked me in and sent me to the waiting room, a large attractive area brimming with patients and family members. After a little while a woman called my name and I was taken back to be prepped for surgery about 30 minutes before my scheduled 11:15 arrival time. I will say that for every test and procedure I’ve had so far at MSK’s main hospital they have been on early or on time. This has been a pleasant surprise at such a large medical center.
Once we reached a small prep room a very cheerful nurse gave me a garment bag to store my clothes in and I changed into a standard issue hospital gown with a thin navy blue bathrobe to wear over the top. She weighed me, measured my height, and reviewed my medical history. This was the first surgery I had at MSK so I had to review my surgeries and allergies along with current medications, etc. They wanted to do another pregnancy test but I refused on the grounds that I had an oophorectomy and the test was unnecessary. Because the surgery had not been done there they didn’t have the exemption in my file. They confirmed that I had not used any blood thinners (including medications or pain remedies that can act as blood thinners) in the days prior to surgery.
I then met the surgeon for the first time and he and I discussed the precise placement site of the port and also the ramifications of my sensitivity to adhesives. Usually it’s not too much of an issue but for this procedure the surgeons usually close the incisions with Dermabond (skin glue) and my skin cannot tolerate that. Sutures would be used instead.
The surgeon pinched the skin between my collarbone and the top of my breast implant and said that there was enough tissue there to use the preferred port, called a MediPort or PowerPort. Each person has a different amount of fatty tissue in this area, and a mastectomy may affect this as well. Age, body type and other factors can affect which model of port can be used and where it will be positioned. Obviously, children and people using a port for only a short period of time may have different limitations and needs. There were a few times during the day when someone said to me, “You’ll just have this for a while and won’t even know it’s been there after it’s gone.” They assumed that I would only need it temporarily. “It’s here for good,” I said more than once.
There are many different kinds of ports. They have changed a lot over the years. The one I have is quite small and is triangular in shape. This shape is an indicator that the port can be used for injections of contrast dye (these are called “power-injectable”) in addition to being used for blood draws and any future IV chemo. The power-injectable feature means that when I go for CT scans, bone scans, or PET scans, the technician can inject any dye that might be needed for that test into the port rather than having to use an IV line into my hand or arm. This is one reason I decided to get the port. Being in clinical trials now means frequent blood draws and scans.
The nurse started an IV in the holding area and I was wheeled through a maze of hallways until we stopped outside the operating room. I got off the gurney, walked into the OR, and hopped onto the table. After a lot of prep including hooking me up to monitors and draping and cleaning the area, they finally pushed Fentanyl and Versed into my IV. I didn’t actually go to sleep but probably could have. They numbed the two incision areas with local anesthetic and after about 15 minutes including a few periods of tugging and pushing it was over. I’m going to just link to the actual description that MSK gives about the procedure itself. I’m not sure I can explain it any better than they do.
I stayed in the OR for about ten minutes and then was wheeled to a very small private recovery room where I stayed for about an hour. The one surprise is that in the Interventional Radiology department’s recovery area at MSK they do not give you anything to eat or drink after procedures. So I needed to wait until I left to have anything (tip: if you are going to have a port placed, tuck a snack and drink in your bag. After fasting until the procedure you will want something convenient to eat and drink afterwards and radiology departments might not provide them the way that surgical recovery areas often do).
My husband was able to join me in this recovery area after I was settled. A nurse reviewed my discharge instructions. I needed to wait slightly longer to get the incisions wet than usual because I did not have the Dermabond. Usually it’s a 1-2 day wait. I was quite sore immediately after and was glad I had put a cushion and pillow in the car. If your port is put on the right side, as mine is, the passenger side seat belt will not be pleasant so I recommend bringing a padded seatbelt cover or other method of cushioning the strap. I was quite sore for about 24 hours, but quickly that shifted from being generally aware of the pain to being very localized and only when using that arm. That quickly became localized discomfort if touching it. Today (three days later) it’s still sore to the touch but otherwise not bothersome. I did not use any pain medication.
The port is much smaller than I would have thought. It’s placed so low that it won’t be visible in a tank top. The surgeon was very careful to try to pinpoint a location that would be cosmetically most appealing which I appreciated since this will not be temporary. Eventually I will need IV chemo and this will be used for that as well. For now there are two red incisions but I know those will fade. They are far more visible than the port, a bump under the skin the size of a quarter.
I will not be able to use the port for blood draws that I do near my home and many people are not aware that not all phlebotomists can access the port. Only certain people (most often at hospitals and oncology offices) can access the port because you need special training and also special equipment. In addition, if you do not use the port for a period of about 30 days you must go to have it flushed (with saline and Heparin) to prevent clotting. It only takes a minute to do that.
I’m happy to answer any questions that readers have about the port or anything I missed in the description.
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Today I was back at MSK for my regular clinic day for Cycle 2, Day 1 of my clinical trial of Genentech GDC-0032 + Faslodex. I met with a nurse first who checked my weight, blood pressure, oxygen saturation, did a physical exam, reviewed my side effects (I won’t go into those in this post). Next I met with the Principal Investigator on the trial who is the one in charge of my care during this time. I gave her the four remaining pills of my 30 day supply (two each of 1 mg and 5 mg capsules of GDC-0032) and signed and turned in my medication log which lists what time I stop eating each night and what time I take my pills each morning. We discussed scheduling for the month which includes my CT scan three weeks from now where we will get our first look at what, if any, effect the drug combination is having on the cancer.
Next I went to the chemo suite to get my Faslodex injections and have my blood drawn as required by the protocol. I had a different nurse this time from the last two times. I told her that I had a new port and asked her to explain the process for the draw now. She warned me it might be sore as she palpated it to find the right spot to insert the needle and also said the actual needle stick might be a bit more painful today depending on the exact location of my incision.
We each needed to put masks on to cover our nose and mouth during the blood draw to minimize the chance of infection. She gently felt for the circular center of the port where the reservoir is and inserted a special needle to access it. It was a bit tender but certainly not at all more painful than my usual stick on the back of my hand. It really was just a second and it was great to know there was no chance of “failure”… blood would flow! And it did. Six tubes were done quickly and then she flushed the port with saline and Heparin to prevent clotting. The needle was removed, a gauze and paper tape bandage applied (no adhesives for me) and then we removed our masks. Easy and no anxiety. These steps must be taken every time.
Next it was time for the two nasty Faslodex injections. As I’ve written before these are two jumbo intramuscular injections, one in each butt cheek. The nurse kept apologizing and saying how she hates to give them because they’re just so big and painful. They are always very sympathetic when administering these. Today’s were painful, I think the worst of the 3 rounds I’ve had. I think it’s just chance about where they hit and also that I’ve had to do them every two weeks this month during the loading phase. Now I will only need them every month so there is longer recovery in between from the soreness and muscle pain. I find that a heating pad is the most comforting way to ease the pain, I’m definitely getting used to it and also knowing what to expect.
Once done I stopped into the pharmacy (right next to the chemo suite) to pick up my next month’s supply of GDC-0032. I needed to wait to take today’s dose until after my bloodwork. I took my pills with a glass of water while still standing in the pharmacy and noted the time in my new medication log. I would now need to wait one hour before eating or drinking (as I always do when I take my dose each morning).
I went down one floor to scheduling, made my next appointments, and was on my way about 2.5 hours after I first walked back to the exam room. I met a friend for breakfast and had that blissful first cup of coffee at precisely the time allowed. I took the train home, and fell asleep on the way.
I’ll be back at MSK in two weeks for an appointment with the doctor and bloodwork. The week after that will be my scan and then I’ll be back again a few days before Christmas to begin Cycle 3 if all is stable.
If my cancer has grown (“progressed”) by 20% or more, however, the drug combination is deemed not working. I will stop the trial (and be dropped from it) and I will need to move on to something else. I’m already at work researching what that next choice should be.
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We are entering a fragile time of year. The holidays are difficult for many people. Some miss loved ones who have died. Some mourn their own lives, no longer what they were. Grief takes many forms. The pressure to create memorable and uplifting occasions can sometimes be oppressive.
Be kind to those who are struggling during this time; physical and mental illnesses can be especially difficult to manage. Understand that happiness and sadness can coexist. Reach out to others if you can.
Find a bit of beauty in the world. Share it. If you can’t find it, create it. Some days this may be hard to do. Persevere.
There is so much to say about the start of the phase 2 clinical trial earlier this week. I think it’s important to be as complete as I can on the main parts. I really want readers to get a sense of what it’s like to go through this and also what to expect if they decide to enter a trial themselves.
That said, it is obvious to me (and hopefully to you) that my experience is very unique. I have no earthly clue what other trials are like. I just want to make all of the disclaimers that I think you all know already: this is my experience only. If that helps in some way, great. But it can’t possibly tell you what another clinical trial might be like.
I still think it’s valuable. And I know I would have wanted to read posts like these a few weeks ago when I was signing up for the trial. So that’s my guide: if I think it would have helped me, I’m going to share it.
Twitter friends have been telling me that they are interested in five main topics: 1) what is the science behind this drug? 2) what does the treatment consist of/logistics 3) how did I choose this trial out of the ones available 4) side effects physically 5) effects emotionally. The last two will obviously be the ones we follow over time. I won’t be able to address all of those topics here but I’m getting a good jump on them.
This post is long. I’ve opted to just publish it and not divide it up. If you want to read it in chunks you can decide how to divide it up. If you want to skim the science parts, you’ll still have my report of my day at the end. I look forward to hearing your questions and comments. If you have questions I will try to answer them.
First, a bit about the drugs and the science behind them. My trial has me taking 6 mg of an investigational drug called GDC-0032 made by Genentech every morning. I receive two injections of a drug called Faslodex every month, with an extra dose halfway through the first month.
It is important to understand that these particular drugs for metastatic breast cancer are not traditional (cytotoxic) chemotherapy drugs. What I mean by that is that most people think about chemo as being drugs you receive, most often via IV, that makes you feel rotten and your hair fall out. That’s the type most people are familiar with and that class of drugs includes what I had when I had treatment for stage II breast cancer in 2007 (Adriamycin, Cytoxan (least creatively-named drug of all), and Taxol).
Those drugs are cytotoxic (cyto= cells, toxic= poisonous). So, the drugs kill the cancer cells but they kill other cells too. That’s why your hair falls out, you feel sick, your blood counts drop and a host of other issues.
With my kind of cancer (estrogen receptor positive, progesterone receptor positive, HER2 negative) there are other types of drugs to use to try to slow the cancer’s growth down. This is not the case for all types of breast cancer. With some you can only use traditional chemotherapy. In addition, and most importantly for this trial, my cancer shows a mutation in the Pi3k pathway. I know this is getting very science-y. But I’ll try to explain the rationale for this drug.
Many people with my kind of breast cancer (and other types of cancers, we’re learning) show a mutation in this pathway. You might have heard of genomic sequencing. It is testing the tissue of your cancer to see if your particular cancer has any mutations in its coding that facilitate the cancer’s growth (I’m oversimplifying here). This pathway, which is called the Pi3K/AKT/mTOR pathway, can become overactive and drive the cancer’s growth.
I have one mutation in the Pi3k section of the pathway. There are many forms of mutations in the Pi3k pathway. There can be other mutations in other areas as well. Mine is called a Pi3k-alpha mutation.
So what the investigational drug is targeted to do (hence the term “targeted therapy”) is to block this Pi3k/AKT/mTOR pathway that has been over-activated, potentially by this mutation.
This all sounds great. But it’s not so easy. It isn’t as easy as “find the mutation, create the drug, block the pathway, cancer goes away.” We don’t have indications it will ever be like that. The signaling pathways of cancer are highly complex, variable at any given point, and also change over time.
In addition, not everyone with the same mutation responds to the same drug. And combinations of drug seem to work better. Think about doing clinical trials of endless permutations of drug combinations with different mutations, different cancers, in different bodies… well, this is why science seems to move at lightning speed but our advances in treatment just don’t mirror that in all cancers. We have no way at the moment to predict what the best course of treatment is for any individual person. For now, you throw the pasta at the wall and see if it sticks. Unfortunately, our lives are the test cases.
To return to the science, I’ve already tried an mTOR inhibitor in my last treatment phase. That was called Afinitor (combined with another drug called Aromasin). But that targeted a different end of the pathway, and not the mutation. The problem with all of these right now is that the cancer figures out a way around the blockages. It develops feedback loops. If you’ll allow me to anthropomorphize cancer for a minute, it says, “Hey, okay, so you want to block the road? I’ll just detour and still get the end point. I’ll get fuel to the cancer somehow. If you block me, I’ll just keep finding a new way to deliver the goods.” And that’s why metastatic breast cancer is incurable. It keeps finding a way to find fuel and becomes resistant to each thing you throw at it. I became resistant to that Aromasin/Afinitor combination after about six months.
In terms of side effects, unlike traditional IV chemo, with this investigational drug you don’t “feel rotten” right after treatment. It can take weeks and potentially months for side effects (especially some of the serious ones) to take hold. So that’s one way this differs from what people might think. My phone has been buzzing non-stop since Monday: “How do you feel? How do you feel?” I will have some effects from the injections (which are hormonal agents, this one is an estrogen receptor agonist) quickly. I already have some of those. Other side effects from the pills (the GDC-0032) will come later.
So… here we go.
Monday was Cycle 1, Day 1.
If you are interested, my trial protocol is here (I am in the phase II group). This tells you exactly what this study is. If you want to read a bit about the early results of this drug in phase 1 trials you can see that here.
On day 1 I received my GDC-0032 pills for the month (and took the first dose), received two injections of Fulvestrant (Faslodex), and had about 8 vials of blood drawn.
The logistics of getting to the city were a bit of a challenge this week given fatigue and the lingering pleural effusion. The train, subway, and walk were tough but I always try to push myself. Knowing I’d be stuck inside for a few hours definitely had me enjoying the cool crisp fall air on the walk to the hospital.
Because of train times I arrived one hour early for my appointment. I wasn’t sure if I was doing this blood draw before seeing the doctor or after so I settled in. After only a few minutes I was surprised to be called back to an exam room. There I had a long meeting with research nurse whom I’ve spoken with by phone but not met in person. It was an extremely thorough meeting. She answered questions, reviewed the protocol, went through my current medications again, noted all physical symptoms I’m having now. We also discussed my most recent bloodwork (my lipids changed drastically during the 3 week washout period. My prior chemo had raised my cholesterol significantly. My LDL dropped a whopping 100 points in a two week period once I stopped the old chemo, for example). Blood pressure, pulse, oxygen saturation, height, weight. Other research assistants on the protocol come in and talk to me, discuss things, physical exam, as eventually does the Principal Investigator (the doctor in charge of the trial).
It took about two hours to complete these meetings, exams, tests, questions, medication review, etc. Everyone was very thorough and I was offered every opportunity to ask questions about not only the trial but also about any symptoms I was having and how they could be helped.
They also stressed how important it is to call with any and all side effects. As the more serious side effects become more possible/likely, it’s important to report any issues right away so they can be managed before they get too serious. Communication is key in clinical trials. I’ll talk about the side effects more in the future.
For some questions about side effects we needed to refer to the protocol of the trial (Can I get radiation to a bone if my bone pain continues: Yes, but not within the first two weeks of the trial start. Can I get the fluid around my lung tapped if it becomes too troublesome: Yes, at any time).
We also discussed a port for my blood draws/access for radioactive dye injections for CT and bone scans that I will need to have done every 8-12 weeks on the trial. I am still undecided about the port. We agreed to see how it goes in the next few weeks with the blood draws. I can only use my right hand which doesn’t allow for easy access or many misses. They tell me there is a “three miss rule.” If they can’t get the blood they need within three tries, they stop. I have a terrible feeling this rule will come in handy.
At the end of the meetings they handed me many sheets of paper.
First, I received a medication diary where I need to document the time I stop eating every night and the time I take my GDC-0032 pills (the “investigational drug”) the next morning. The pills must be taken on an empty stomach one hour before food, with a full glass of water at approximately the same time every day.
Second was a list of drugs and supplements I cannot take while I am on this protocol.
Finally, there was a schedule for the next 8 weeks of what will happen at each appointment, what tests and drugs I will receive, what I need to do to prepare, and what I need to bring to each appointment. The pills are given in quantities of 30 but I will probably be at appointments every 28 days. The surplus pills must be traded in and counted before I can receive the next month’s supply. Though it is only one drug it is dispensed in two capsules, one dark red, one pine green. One is a 5 mg, one is a 1 mg for a total of 6 mg.
I was then sent to do scheduling for my next appointments. I will need to return in two weeks (plus or minus 2 days) to do vital signs, exam, fasting blood draw (but this time it must be done twice: before taking my pills and then again 4 hours after), and my two injections.
I then went to the hospital pharmacy to collect my pills. They are labeled with my name, the drug name, instructions, and so on, just like a regular prescription. The protocol number is labeled on the bottles too. The bottles also say “Cost $0.00” on them.
This drug is provided free of charge to me but my insurance company is billed for the injections of Faslodex, lab work, and all scans. Trials differ in what is covered. In this case, only the investigational drug is provided free of charge. The rest of the expenses including the visits with the doctors are not provided for free. I am fortunate. My insurance will help pay for those things. Your care is not necessarily fully covered when you are in a trial, contrary to popular belief.
The pharmacy cashier placed the two bottles (one bottle of the 5 mg, one bottle of the 1 mg) in a brown paper lunch bag and handed it to me. In that moment I feel like I have something very valuable and secret in my possession, perhaps even magical. I don’t know if these pills will do anything for me. They could do me more harm than good. They could do nothing. But they might buy me time. Those are, for now, mysteries.
The brown paper bag with the drug bottles inside seems very wrong, far too flimsy for the weight of the hope that lies within.
I then left the pharmacy and headed upstairs to the chemo floor where I had my fasting bloodwork done (by now it was past 11 AM and I was glad I started early. I really don’t mind not eating, it’s the lack of coffee that gets me. Also, the longer I wait the harder the blood draw is likely to be).
In this room I will also receive my two injections. As I enter the room, I’m wondering about those and anxious. The number of needles I have in a month is astounding sometimes. I was the girl so afraid of shots as a kid I once ran into the parking lot to try to run away to avoid getting a vaccination at a pediatrician’s visit.
One chemo room is dedicated to this trial. I have gone to the same room each time so far. The trial tech doesn’t even try to draw my blood. He calls in the reinforcements. Eight or so vials of blood are taken by a nurse who goes after my hand vein with a vengeance. Unfortunately I receive a call the next day that two of the vials are unusable (hemolyzed). This happens sometimes when large blood draws require a lot of work (suction) to get. I was able to go locally the next day to have the two vials redrawn.
After the blood draw it was time for the “standard of care” drug. This is part two of my clinical trial protocol. The “standard of care drug” means I am given not just the experimental drug, but also a drug that is a reasonable option for treatment for this stage of my disease.
On its own (“single agent”) Faslodex works for some people but seems to have a better track record when combined with another agent. My trial is one that combines Faslodex injections (standard of care) with the GDC-0032 (the investigational drug). There is no placebo. This is a phase II trial. I will get both. We will see if taking the GDC-0032 provides a better result than the historical success rate of those who have received the Faslodex injections alone. There will be 60 people nationally doing this combo, about 10 of them at Sloan-Kettering. I am the fourth person, I believe, to get started on it (the trial just opened a few weeks ago at Sloan).
Faslodex is given by injection, intramuscularly, in your rear. No fancy fun way to say it. You drop your trousers and they have syringes that are over 4″ long (can’t find any literature that states exact measure. I’m going to ask to measure it after my shots next round. I confess I saw them when we were done and they made me a bit nauseated and I didn’t want to be precise!). The needles are thick because the liquid that has to be inserted is very viscous and doesn’t go into the muscle easily. I was fortunate and the nurse did a great job. I tried to remember the tip to keep your muscles relaxed during an intramuscular injection, but it’s hard when you know the size of the needle that’s taking aim for your ass.
The first injection really wasn’t worse than a regular shot. The second one hurt more than the first but still less than I had expected. I opened my bottles of pills, took out one of each, drank my water as directed. I noted the time in the diary.
At this point I was free to go. The injection sites were not immediately painful and I was sent on my way.
Everything was incredibly efficient and while I was exhausted, I was relieved. I kept thinking to myself: “Once again after three weeks of not being actively treating my cancer because of the mandatory ‘washout’ period, I am doing all I can. Action feels good.”
I celebrated getting through day 1 by having lunch with my friend Julie Klam which was such a luxury after the poking and prodding of the morning. I took the train home and felt a sense of accomplishment.
So, in case it wasn’t clear, my next appointment will be two weeks after my start date (“Cycle 1, day 15 +/- 3 days” in protocol speak.).
I think the word that most defines metastatic breast cancer to me is “uncertainty.” You have to figure out a way to live with it. My coping mechanisms are research and action. I can only hope these will serve me well.
I thank you for your support and encouragement this week.
On Friday morning after I sent our three children off to school I traveled to Memorial Sloan-Kettering Cancer Center (MSK) to have a port implanted. My first appointment of the day was at 10:15 to have an electrocardiogram (EKG/ECG). MSK requires an EKG on one of their machines within 48 hours of the port procedure. It takes longer to find the bathroom than it does to have this test done. Electronic leads are attached with sticky sensors to specific points all over your body and hooked up to a machine. After about one minute of recording you are done, and the sticky round patches and the attached wires are removed. Easy as can be. The test measures the electrical activity of your heart to make sure it is normal. I won’t go into details on this test because it’s such a piece of cake and so common.
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