What does this mean?

Recently, when I asked my doctor about my allergic reaction to Genasense, I remarked that the drug company might want to do some additional tests to try to identify some characteristic in me that provoked this reaction. Surely, now that it’s happened once, this type of reaction will occur again. Is there more they can know about how to predict its likelihood? Is it as simple as the fact that there are no longer any active tumors in my body, no more Bcl-2 protein to attack?

She thought for a second, then related an experience with one of her earliest study subjects that refutes my last question. The patient has remained cancer-free the entire eight years since the study. The drug committee’s protocol at the time called for eight cycles; the patient’s cancer was gone after four. It was a new study then. My doctor and her patient were both nervous about stopping treatment, so they continued on for sixteen cycles with no adverse reaction to the drug.

So there you have it: one patient with a life-threatening allergic reaction, one non-cancerous patient tolerating the same drug for over two years. Is there any information in that? Is that even a meaningful sample? My experience may be so rare as to be of questionable value, just a red herring.

This may be the end of it. “Everyone’s allergic to something,” my doctor says. I only hope that my altered program continues to produce good results. But I’m trying real hard to keep anxiety out of the equation.

Freak-out

A friend sent me an article announcing Genta’s completed appeal to the FDA in clinical trials with CCL (Chronic Lymphocytic Leukemia). It was a typical cut-and-dried news release until I came to the section on “Safety” where it mentioned casually that nine patients experienced "adverse events that resulted in death" in the course of treatment with Genasense.

You can call me naïve if you want. I realize I'm in a potentially life-threatening situation, but I guess I didn't actually think I was in danger of dying until I saw the word "death" in print. That scared me.

My untrained mind connected my severe allergic reaction with the adverse events in the article. I was under the impression that only a handful of patients had this kind of reaction and nine deaths then seemed like a huge percentage of the allergic population.

But it seems I may have mixed apples and oranges and jumped to an unwarranted conclusion.

I emailed my doctor with my questions and concerns and a few hours later received her thoughtful response:

“You cannot apply this to patients with solid tumors. Patients with CLL undergo tumor lysis which can cause kidney failure, heart abnormalities from the rapid release of potassium and they already have a severely impaired immune system with the CLL, so many get very odd infections. You are not this population. …. None of these deaths were from “allergic reactions” they were from “adverse events”. None of the reported info pertains to you.”

She cited her own article on a study in which no melanoma patients in the group of 771 died of drug related complications, and went on to give me an out: if I am not comfortable with the proposed plan of treatment, I can choose to forgo Monday’s in-hospital Genasense infusion and continue with Abraxane and Temodar alone.

What I appreciate most about this woman is that she takes me and my concerns very seriously. She always answers my questions patiently and in language I can understand. She is a treasure!

I will be in the hospital Monday morning for treatment.

Plan B and a half

I got to the cancer center this morning with computer, clothes, and personal items in tow, ready to start pumping Genasense into my mediport IV and then head for the hospital. As I waited in the exam room for the pre-treatment meeting with my doctor I could hear bits of conversation in the hall. They were talking about me. Things were not going to proceed as planned….

There were a number of reasons to pull the plug again today. Top on the list were the hospital arrangements. It seems there was no guarantee of a room, availability going first to ER patients who are stacked up in hallways as I witnessed firsthand two weeks ago. In addition, the oncology nurse stationed at the hospital is on vacation this week. Although the floor nurses are good, they are each responsible for six patients, whereas the oncology nurse is familiar with and devoted to the special needs of my situation.

There were additional issues, questions posed by the cancer center nursing staff. They didn’t like the idea of starting treatment in one place and moving me to another venue. What if I had a reaction in transit? Who in the hospital has experience with a pump and mediport and can start my IV? Where would they prepare the drug and pump, in hospital or in the cancer center pharmacy? And how will they get the drug to me?

So we’re making progress. We still have a plan, but we also have another delay. I have another week to feel good and energetic and they have another week to work out the details. It’s a bit disappointing to be prepared to move ahead and then have to wait, but it’s not anywhere near as bad as not knowing.

I will get a phone call Sunday telling me when to show up at the hospital Monday morning. Two of my regular nurses will be there to help get things started, a nurse supervisor from the infusion floor and the nurse program coordinator in charge of research. And we should know by Tuesday how well the pre-treatment works for me.

Plan B

After a week of keeping my mind disengaged during awake-time with PacMan and Sudoku online, my current mind-numbing techniques of choice, and nights of poor sleep, I sat down to talk with my doctor this morning and started to cry.

“I don’t usually cry about this, but I’m so scared,” I confessed somewhat apologetically. “What was saving my life is now threatening to kill me.”

“It’s okay. I have a plan.”

I knew she would, of course, but the wait had seemed interminable.

She spoke with the Genta research representatives late last week. They were, in fact, in New York to attend two of her presentations to cancer professionals on this research study. When she told them about my experience they weren’t overly surprised; they knew what to do. My doctor has administered over half the Genasense drug taken by melanoma patients in this country and had never encountered this reaction with “solid tumor”, but they had seen it in a handful of Chronic Lymphocytic Leukemia (CLL) patients in other trials. Their method of dealing with the situation is to “pre-treat” the patient with a high dose of a strong steroid that counteracts and prevents the allergic reaction. When they pre-treat, the patients go on to receive a full week of IV infusion without life-threatening side effects.

I looked at her skeptically. “What if I go home and pass out on my kitchen floor when the steroid wears off?”

“That’s why I want to keep you under observation for a couple of days,” she said. “We’ll start the treatment and then you can go to the hospital for an overnight stay, maybe two nights. If something happens, it will be in the first twenty-four hours. I want you here in the cancer center most of the day, where we know your treatment history, and I want you there after that, so they can monitor your blood pressure and condition.”

Which ruled out staying at my daughter’s apartment.

“This begs the question in my untrained mind. Do I possibly have leukemia?”

“No chance of it,” she said. “The major symptom of that is a very high white blood cell count. We monitor your blood all the time and your counts are normal.”

“It’s a little scary, but I’ll do it if you believe it’s worth a try.”

“The worst case scenario is that it happens again, we have to scrap the Genasense, and we continue with Abraxane and Temodar alone. In your case, there were no live tumors on your last scans, so I’d be pretty comfortable with that option. And if you have to abandon the Genasense, they’ll still keep you in the study,” which means they’d continue to follow my progress, and pay for drugs not covered by insurance.

So she sent me home to pack a bag, and we scheduled Day 1 for tomorrow.

How can this be?

When I was mid-attack yesterday, throwing up, flushed with heat, throat tightening, and nearly passing out, I asked my doctor, “How come this is happening? Why now?”

She said that allergies can develop over time because the body builds up antibodies that eventually reach a critical mass. Also, there may be reactions along the way that don’t register as such. For example, early in my first treatment cycle I had an episode where I nearly passed out in Grand Central. They’re rethinking now that it might have been an unregistered reaction.

I didn’t end up in the hospital ER yesterday. Forewarned is forearmed. Everyone was prepared to notice symptoms. The results of the previous week’s CT scan ruled out an embolism; if it happened again, it would be a pattern implicating allergy. My doctor wrote orders in advance for steroid and Benadryl; the IV bags would be there if needed.

I am so out of sorts today. It’s been very difficult to keep my mind clear and focused. I’ve been trying to attack my mountain of paperwork, but I keep getting distracted.

I called the oil company this morning to report that my heat didn’t go on. I went downstairs and pushed the furnace’s red button to reignite the pilot light, but nothing happened. They scheduled an appointment for later in the day, commenting that it might take a while since there were a lot of service calls for heat problems.

When the heat guy finally showed up, he walked to the thermostat first, turned up the temperature, and without missing a beat, the heat went on! All day I thought the furnace wasn't going on because the pilot light wouldn't start, but it was because the thermostat was set too low. Oy vey!

Mystery unraveling

It happened again….

I went into the City to start the third treatment cycle after my aborted attempt last week. Everyone seemed a little nervous.

I talked first with the nurse program coordinator and with my oncologist, as I always do on infusion days. They were particularly interested in how I’ve felt this past week. My doctor was now leaning toward the theory that my freakish episode last Monday was the result of a bolus of Genasense getting pushed too fast into my system. She wanted to exercise caution and have me stay in the center for observation for about an hour after starting my IV pump. That was okay with me since I had my computer with me, as I always do in such situations.

I went to the treatment floor to start my infusion. Everything went smoothly. I ate my lunch (not pastrami) while waiting for the drugs to come up from the pharmacy. The infusion nurse drew blood from my arm rather than through the mediport. She started the IV and I sat in my cubicle for an hour or so while it pumped quietly. Several people poked their heads in to see how I was doing. Everything appeared fine.

I heard the nurse on the phone at her station telling someone that I looked good. She came in to tell me I could go home. I leaned forward to pack up my computer and…. “I don’t think so,” I said. All of a sudden I felt the heat rush, the nausea, the dizziness, the closed throat. “I think you should take my blood pressure.” And sure enough, it had suddenly fallen to 84/53.

Oh no, here we go again. In minutes I was throwing up and feeling faint.

“Once is a fluke. Twice is an allergy,” My doctor said as they pumped me with steroid, Benadryl, oxygen, and she made the decision to abort treatment again for another week.

I am so bummed!

“What are we going to do?! Can’t we just keep the pump going and I’ll live with the symptoms?” I asked.

She looked at me as if explaining to a child. “I’m not going to kill you with this treatment. We’ll come up with something.”

And she will. She has more experience with this drug than anyone else, and she hasn’t seen this kind of reaction before. But maybe the drug company has some information to share. She will come up with an altered plan by next week. Maybe we’ll continue Abraxane and Temodar, the killing drugs, without the Genasense. Maybe Genasense has done its work and the other two can continue to finish the job without it.

This is not going to be an easy week. I’ll try not to speculate and worry too much. The medical details are, after all, way beyond my expertise. But it sure was comforting to have a plan and simply be able to follow it. This business of being unsure about where I’m going is scary. The best part is that I know I’m in good hands and I trust my doctor to come up with something. Until I know more, I’m going to fight the urge to let it get me down.