A new plan

My wife Teresa and I went to see our oncologist Friday, April 27. Based on that meeting, it looks like we have a plan for what to do about my three (or conceivably four) rogue tumors, and it’s a straightforward one: Sloan Kettering will probably treat them with radioactive pellets of a substance called Yttrium.

            This is good on a bunch of counts. First, it means we don’t need to start traveling somewhere for a clinical trial. Instead, I can continue to be treated by Sloan Kettering, which knows my case and which is also easily available if something goes wrong. The clinical trials we were beginning to think about were in Boston, Bethesda (near Washington, D.C.) and Houston – not so convenient!

            Second, it means we’re not moving into the world of clinical trials of experimental treatments. Those treatments are interesting and may be promising, but they are all more or less unknown quantities. Using Yttrium pellets is considerably more familiar territory.

            Third, our oncologist believes this treatment will make a real difference. We were concerned that there might be no point in attacking these rogue tumors by themselves, and that instead we might need to completely switch my treatment plan. We were worried that even if a selective attack on just these tumors destroyed them, more would spring up as soon as these were dealt with. But the oncologist said that she doesn’t treat things just because they’re there; she wants the treatment to make long-term sense. Why does going after these tumors make sense? The very encouraging answer is that she thinks the biology of my particular cancer is in my favor; my cancer – with the exception of the tumors we’re going to attack -- seems slow-moving and uninterested in leaving my liver. She feels that I’m an outlier among cholangiocarcinoma patients – in a good way. (Of course I say all this with fingers crossed!)

            This won’t be a done deal until we go see the “interventional radiologist” who would actually do the Yttrium treatment, who not incidentally already works closely with our oncologist. Conceivably he could recommend some other way to proceed, but that doesn’t seem likely. Assuming we go ahead with this approach, there’d be a session with the interventional radiologist for him to map the targets in my liver, and then another session for the actual procedure. Chemotherapy may also get added to the mix.

The procedure itself, as I understand it, is called “selective internal radiation therapy” (SIRT), and, aside from the fact that I hope it works, it’s really pretty amazing to learn about. In this treatment, they run a catheter from my groin via the femoral artery up to the liver, and then they send tiny glass beads infused with Yttrium-90 – millions of them! -- through this catheter. The beads embed themselves in the tumors’ blood vessels (this is clever of them – it’s a result of there being more blood flow in the tumors than in the healthy liver around them). Then they emit radiation, almost all of it within about 11 days and traveling only a quite short distance, so the rest of me shouldn’t be much affected. Meanwhile I go home, I believe the same day as the procedure. Side effects are likely to be mild. Direct effects on the tumors, I hope, will not be mild but intense.

And that’s the plan!

The end of the intrahepatic pump?

I was amazed to learn today from a friend at the Cholangiocarcinoma Foundation that the sole manufacturer of the intrahepatic pump, also known as the “Codman pump” – which I have in my abdomen, and through which I’ve received chemotherapy since it was surgically implanted in August 2016 – plans to stop production. But this is in fact the case, as the New York Times reports.

Dr. Nancy Kemeny, a Memorial Sloan Kettering doctor who was “a pioneer in using the pump,” is quoted as saying: “I don’t know what we’re going to do …. We have enough for another month or so.” The Times reports that “[a]t least 10 operations to implant the pump at Sloan Kettering have been postponed” already, and apparently similar things are taking place at other medical centers.

The manufacturer in question is Cerenovus, which is owned by Johnson & Johnson. It “told doctors in a letter dated April 4 that it had decided to stop production effective April 1 ‘because of significant and multiple raw material supply constraints within the manufacturing process.’” That explanation is interesting for what it does not say: it doesn’t assert that in fact the supply constraints made production of the pumps impossible, nor does it say that these constraints even made production unprofitable. They evidently sell for $7000 - $11000 each, which you would think would cover quite a few supply constraints.

Perhaps Cerenovus could have said more, but the letter certainly permits the impression that the company just can’t be bothered with the burdens of producing this minor item on its product line. Apparently there are only about 300 of these pumps sold each year in the US (although medical interest in them is said to be growing just as they’re ceasing to be available), and somewhat more than 1000 people have received them in total.

1000 people isn’t that many – unless you happen to be one of them. I am. Though the pump is used for people with a number of different cancers, I react to this company’s decision as someone with a rare cancer, a cancer for which the pump is a valuable treatment that is now to be discontinued for reasons, at least according to what the company has said so far, not of necessity but of something less. (Fortunately for me, the pumps don’t have to be returned; the people who won’t have access to treatment are the ones who would receive them in the future. Maybe not so fortunately for me, Teresa tells me that the kits used to load and unload the pump every two weeks are also made by this same company. Will they decide to stop making these too?)

It’s also notable that Cerenovus only sent notice to doctors on April 4, telling them that its decision had already taken effect on April 1. There’s also no suggestion in the article that there was any prior discussion with doctors before the decision was made. This is not a company trying to proceed in a consultative manner.

Can anything be done? The Food and Drug Administration says that it doesn’t have the power “to compel manufacturers to sell a specific product,” and that’s not surprising in a society that respects private property as much as ours does. There may be substitute products from other companies, though whether they are as good as the Codman pump I do not know. 

But even though Cerenovus and Johnson & Johnson may be immune from legal requirements, they certainly aren’t immune from popular pressure. So I hope you will visit their websites, their facebook pages, and your representatives in Congress and express in every way you can how disturbed you are by this position. And if you feel like telling Johnson & Johnson that you’ll be boycotting their other products, such as Band-aids, Benadryl, Tylenol and Motrin, until they change their mind about producing the Codman pump, well, that would be really good too.

New scan, mixed results

The immediate aftermath of the high excitement I wrote about last time was fairly hum-drum. I’m trying to watch my diet – it’s amazing how many foods may be more prone than others to block one’s intestines – and so far things seem reasonably under control. Foods aside, the main effect of my hospitalization may have been that I lost my regular Friday appointment slot at MSK. Once I got out of the hospital, it took multiple phone calls to get another time – Wednesday, April 11. That meant that my treatment was delayed by the 5 days between when my appointment would normally have been (Friday, April 6) and this new Wednesday time. Meanwhile, it was only on Monday, April 9 that they got me scheduled for a CT scan the following day, April 10, so that the oncologist would be able to evaluate the results of my recent treatment when we met. (They didn’t schedule me for an MRI, which I’ve always had in the past; apparently my oncologist believes in switching between MRI’s and CT scans, though – frustratingly – this change was made without any prior discussion.)

So we came to NYC on April 11. Besides going to MSK, we planned to stop afterwards at New York Law School to see my friends there (and return a couple of overdue books). As it turned out, our timing was very good: we got to see a bunch of my clinical program colleagues (just to be clear: I’m using “clinical” as in teaching lawyering skills, not as in medical treatment) and had a lot of fun talking with them. But I didn’t say much then about the day’s test results; it just didn’t seem the time.

In any case, earlier in the day our oncologist had given us the results of the April 10 CT scan. The results weren’t terrible, but they weren’t perfect either: while my large tumor, off on the left side of my liver, is admirably stable, three smaller tumors over on the right side have grown between 0.5 and 0.9 millimeters. (I asked whether these results could be an artifact of using a CT scan instead of an MRI, but the oncologist assured me that this wasn’t the case.)

Growth is not what I wanted, though it’s still very good that the growth isn’t in newly emerging tumors and that it’s all still confined to my liver. It’s also good that my liver function tests are all in the normal range, so once again my loyal liver cells seem to be able to do their thing despite the presence of the tumors. And despite this tumor growth, when my oncologist checked my abdomen she couldn’t actually feel my liver – which suggests that the tumors aren’t affecting the liver’s overall dimensions.

Over a year ago, when I had just started on the clinical trial using the pump to deliver chemo right to the liver, I had something similar happen: everything was stable or smaller, except that one tumor had appeared and grown. Apparently that one rogue tumor is one of the three that are growing now. A year ago, the fact that there was any tumor behaving this way was enough to knock me out of the clinical trial. Now that I’m not in a formal trial, but just receiving treatment – through the pump again – the Sloan Kettering reaction hasn’t been as dramatic.

Our oncologist thinks that the stability elsewhere in my liver indicates that the chemo I’ve been receiving through the pump over the past several months is still having a positive effect – just not everywhere. So the question is what to do. What she did on April 11 was to give me another dose of my current chemotherapy, which will continue to flow to the liver via my pump for the next two weeks. Then, at my appointment next week – also still not quite scheduled – we’ll consider multiple other options. These include:

(1)  Trying to destroy these three growing tumors. There are a bunch of ways to attack individual tumors, but the ones the oncologist mentioned use radiation, either by putting radioactive beads of a substance called Yttrium on or near the tumors or by hitting them with radiation beams. One particularly interesting option is proton radiation, which evidently can be aimed with more precision than other forms of radiation; we’re not sure, however, whether MSK offers this. I like the radiation idea, since it really seems like there’s something different about these three tumors as compared to the rest. I believe that the biopsy done on one of them after it first appeared showed a different genetic mutation than my other biopsies have found, and certainly their behavior has been different from that of my other tumors. Also they’re in a spot, the oncologist says, where they can be attacked without risk to other parts of the liver.

(2)  Continuing the current pump treatment and perhaps adding a systemic chemo drug that wouldn’t go in via the pump but instead intravenously, to affect my whole body directly; that might in the process also jolt these three growing tumors in my liver.
 

(3)  Immunotherapy: evidently our oncologist can get the drug Jimmy Carter took for his melanoma (keytruda) quite easily as a “compassionate use.” This drug was great for Jimmy, but of course my cancer isn’t the same as his. (The fact that it’s so easy to get this drug as a “compassionate use” – that is, a use for which the drug hasn’t yet been approved by the FDA – is one indication that the “right to try” legislation that Congress is currently considering may really be unnecessary, but that’s another discussion.)
 

(4)  Immunotherapy plus: Sloan Kettering is doing early-stage clinical trials using combinations of immunotherapy and chemotherapy. There’s some ground for believing that two complementary attacks are better than one. (Just by way of explanation: immunotherapy aims to get your own immune system working more effectively against the cancer; chemotherapy simply tries to kill cancer cells directly.)
 

(5)  Targeted medicine, aiming at vulnerabilities created by particular genetic aspects of my tumors; these also would be early-stage clinical trials at Sloan Kettering. Unfortunately, so far my tumors haven’t shown any terribly attractive targets for attack this way – but a few weeks ago Sloan Kettering did a new blood biopsy which may turn out to suggest some promising ways to proceed.
 

(6)  Clinical trials not at Sloan Kettering; Sloan Kettering is really good but there are several other places that are really good too, and each place tends to have its own projects under way.

The good news is that there are all these options. That really is good news, though I’d certainly have preferred a longer period of stability on the current chemo regime. Now we have a lot of studying and thinking to do. Teresa’s putting her formidable internet research skills to work to update the list of possible clinical trials she compiled months ago, and I’m going to be studying up too – while continuing to write my book!

Back to treatment

Last Friday, March 9, Teresa and I made our way back to MSK. I wasn’t terribly optimistic. The last time I’d been taken off treatment because of my liver’s reaction to the chemotherapy – in the fall of 2017 – it had taken two months before MSK was satisfied that my liver was restored to health. This time it had just been two weeks. I also hadn’t been feeling that well (more on this below), so I didn’t have any strong intuition that everything was now working as it should inside me.

But our experience on March 9 was completely different from what it had been on our previous visit, on February 23. That time the whole process of getting my blood tested and the reports submitted to my oncologist had gone awry, with the result that when we left the oncologist’s office we didn’t know, and neither did she, what my blood numbers actually were. This time the testing took place promptly, and when we arrived in the oncologist’s office her staff already had my results (though they weren’t yet completely posted on the MSK portal so that we could see them too).

The results were good. In fact they were really good. All my liver numbers were back in normal range. Meanwhile my platelets, which had dropped quite sharply (platelets aren’t a liver issue, but platelet production can also be affected by chemotherapy; in fact, this is a quite common side-effect), were now also back solidly in normal range. This particular change no doubt owes a great deal to the many platelet-encouraging foods that Teresa had fed me since our February 23 visit. (Papayas, avocados, lentils – platelet foods are good!)

Even with these good results, the oncologist might have felt more time off was needed. I’d had pretty good blood work at one point during the previous chemo holiday, and MSK had felt that what I needed then was additional downtime. But this time there was no delay. The actual chemo dose was reduced – just a little, the oncologist said – and later that morning it was injected into my pump. So I’m actually on chemotherapy, via the pump, as I write this.

That’s the good news, and the main news. The only fly in this ointment is that I’ve had a return of the painful stomach cramping that I’ve written about on this blog in the past. The worst night was Tuesday, March 6. As it happened, that night we were at Teresa’s mom’s house because of an impending snowstorm. We knew that Teresa would need to be there to deal with the snow – her mom wound up with about two and a half feet in her backyard – and though the snow wasn’t really due in force till Wednesday, it seemed best to be there in advance. And Teresa was concerned that if she left me at home while going to take care of her mom, I might suddenly need her help too. I didn’t think that was very likely, since I hadn’t had any sudden episodes in quite a while, but I conceded the point. Up we went to her mom’s house (it’s about 15 miles north of ours), and almost as soon as we got there my stomach went on the blink. About 5 hours later, when I was completely emptied out, it settled down, and the next day I felt just about normal, and while the snow came down in really remarkable quantities I was able to do some writing. 

The best thing about this digestive trouble is that it doesn’t actually appear to be a symptom of my illness. Instead, the word the oncologist used – and Teresa had also picked up on – is “kinks.” Not kinks of the sensual kind, but rather of the plumbing variety. There’s a lot going on in my abdomen these days: the chemotherapy pump itself, the catheter leading from the pump on my lower left side over and up to my liver, the surgical staples and maybe some scar tissue left over from the surgery that installed the pump, and of course the liver itself, functioning pretty well but still hosting a bunch of tumors. The net result: sometimes things get blocked. The cure, besides patience, may actually have something to do with relaxation and visualization of unblocking – though in the middle of one of these episodes, peaceful visualization is not easy to achieve.

Anyway, no real harm done. Still, the issue hasn’t quite gone away. I haven’t had anything like a full-blown stomach episode this week but I’ve had more discomfort than I would have liked. I’m taking as many medications for digestive issues as I can, hoping to get things to become once again uneventful, and reminding myself that I should be visualizing an unkinked digestive system.