You know I posted last week about the Mysteriously Tender Breasts? Well, not so mysterious, as it happens…. PMT. (I know. D’oh. In fairness to me, this is my second period since March 2009, and I’m not supposed to be having periods anyway, because I am simultaneously having a medical sodding menopause. I know. You couldn’t make it up.)

Anyway, I was searching PMT on the blog, and I found this post from September 2009, which reminded me that It Could Be Worse. (I’d completely forgotten about being cold all the time. And the sinus thing.)

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Herceptin isn’t cheap, as you probably know – in fact, as I’ve mentioned before, it comes in at around £3000 per dose. It’s made up for specific patients (calibrated to body weight) and has a short, short shelf life.

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-Why is Herceptin such a wonder drug?

Herceptin has proved to be a major advance as it helps to cure a certain type of aggressive breast cancer described as HER2 positive. This cancer is made of cells which contain HER2, a molecule involved in the rapid multiplication of cancer cells.

- In layman’s terms, what is the Persephone trial and how did it come about?

The PERSEPHONE trial is about finding the right dose of Herceptin for the patient. At the moment, Herceptin is given for a whole year based on evidence from an international trial comparing 12 months to nothing. A more recent trial has suggested that Herceptin might be just as effective if given for 6 months rather than 12.

- Why is the Persephone trial important?

PERSEPHONE is an important academic trial because it addresses the question of how long you need to take Herceptin for.

- Is it really a big issue if Herceptin is over-prescribed?

Yes, because Herceptin can cause damage to the heart. Some chemotherapy treatments can also do this. Patients who receive both treatments are therefore at a greater risk of experiencing some damage to their heart. Also, it means that patients may be experiencing the side-effects of treatment for longer than necessary instead of returning to normal life quicker without the inconvenience of prolonged treatment.

- When will the trial report?

The trial should report 2 years after it has recruited its 4000th patient. Obviously this depends on the speed of recruitment but we are currently on target to have reliable results reported in 2016.

- If it turns out that 12 months of Herceptin is better than 6 months of Herceptin, what will happen to everyone who only had 6 months of treatment?

This is very unlikely based on the results of previous trials. Duration trials throughout Europe have safety committees and trial steering committees who regularly monitor safety and efficacy.

There is only a very small risk that 12 months of Herceptin is better than 6 months. However, if it was the case, patients who received only 6 months will be follow-up more closely than the others.

If it is reported that 6 months is safer than 12 months then the patients randomised to the 12 month arm will be closely monitored in terms of cardiac toxicity.

- Where is the Persephone trial taking place?

PERSEPHONE is offered in 117 hospitals throughout the UK. Another 20 hospitals will be open soon.

- What’s involved with taking part in the trial, apart from the 6 or 12 months of Herceptin?

We’d also like you to complete a quality of life questionnaire at various stages of treatment. This will help to give us a clearer picture of the impact of Herceptin treatment on everyday life. Also, the research team will ask you if they can send a sample of your blood and some of your tissue taken at surgery to the Cambridge Research Institute where analysis will be conducted to get a better understanding of HER2 positive breast cancer and how Herceptin works.

- Can anyone join, or ask to join?

To join, you have to be HER2 positive and have received less than 6 months of Herceptin treatment.

- Are other, similar trials being conducted?

Similar trials are conducted all over Europe and in New Zealand. In total more than 13,000 patients are going to participate in Herceptin duration trials comparing 12 months with a lesser duration.

- Where can those affected by breast cancer find out about this and other trials?

If you are interested, please ask your oncologist or contact the clinical trials team at your hospital.

Also, a list of trials that operate in the UK is accessible here. and here.

The Persephone trial website provides more information and it’s here.

What I forget, of course, is that the patient perspective is a pretty straightforward one. I have a disease: you will tell me what you think will cure me: I will go along with it, unless the cure becomes unbearable, or turns out not be working, in which case we try something else. Thinking about survival makes everything black and white.

But for those at the other end of cancer treatment, it’s more complex. I found out a lot more about this in a rather sublime setting on Monday – eating macaroons (the vanilla was best) in La Duree in Harrods department store in London. I was meeting with Emma and Anne-Laure, who are involved in the Persephone drug trial, which is looking at the efficacy of 6 months versus twelve months of Herceptin treatment.

I was approached by Emma shortly after I wrote about stopping Herceptin. She asked me if I would contribute to a leaflet; I asked if she would answer some questions. We’ve been in touch ever since, and we met to talk about how I can support the Persphone trial.

During the course of our meeting, I got an insight into just what clinicians and scientists trying to further cancer treatment are up against. We talked about recruitment, about ethics, about data protection. We discussed making literature both patient-friendly and scientifically accurate. I found a bit about the hoops that researchers have to leap through to get a trial (a)designed (b)approved (c)underway (d)completed. Let me tell you, many of those hoops are on fire. Which is right and good, of course. Without this kind of rigour, results are meaningless, and it’s good to see respect for patients so high on the agenda.

Not that Emma and Anne-Laure were complaining. They were just explaining. And as they did, I thought about how it’s a miracle, really, that any trial anywhere happens. The Persephone trial is looking for 4000 women in the UK with a HER2+ve breast cancer diagnosis who are also being treated with chemotherapy. Sadly, the statistics show that shouldn’t be difficult. But those 4000 women need to be told about the trial, have the trial explained to them, and be in a hospital that is part of the trial, where research nurses are able to reassure and answer questions. They need to read information and sign consent forms. They need to be sure about the purpose of the research and happy to take the (very small) risks involved. They must understand the concepts of anonymisation and randomisation. They must trust the NHS and the oncologist who is recommending the trial to them.

I always appreciated the treatments and drugs available to me – even the really nasty ones that had me begging for mercy, and peace, and sleep – because I’d a million times rather have the chance of treatment than hear the words, “I’m sorry, but there’s nothing else I can do”. But after Monday, I appreciate them all the more: I gained an insight into how we get these treatments, and the people, like Emma and Anne-Laure, who work so hard to make trials happen.

The upshot of our meeting was that I am going to advise on, and contribute to, consent forms, leaflets, newsletters, etc, which I’m really happy to do. (Don’t worry, I won’t be advising on any science.) Also, I may now be addicted to vanilla macaroons.

(I feel I ought to say that Emma and Anne-Laure do not mostly swan about taking tea with bloggers in exclusive cafes. They were in London for a meeting just round the corner.)

I’ll be publishing my interview with the Persephone team next week. In the meantime, there is more information here.

There wasn’t really any hurry to let the hospital know, so I didn’t really hurry. Partly because we were away in the immediate aftermath of the decision; partly, I think – although I didn’t make a conscious decision about this – so that I could let the decision sit a while and see if it really was the right one. I wasn’t worrying about it, or thinking about it, so I assumed that it was. (I once nearly bought a handbag, decided against it, and woke up thinking about the handbag every day for a fortnight afterwards. Which made me think that maybe I should have bought the handbag.)

So, last week I thought I really ought to let the hospital know, so I called a few of times, and got the answering machine, and an engaged tone, and the answering machine again. I left a message but my call wasn’t returned.

I called again this morning, and the phone was answered (Hurrah! the first), and the person I needed to speak to was there (Hurrah! the second) and I told her that I had decided against having any more herceptin (Hurrah! the third). She was perfectly lovely about it, and told me what will happen next. Essentially, it seems that I will be discharged to the tender mercies of the surgery follow-up team, who will scrutinise, prod, photograph and scan my breasts pretty constantly, forever. (I hope they have warm hands.)

Then there was a heartfelt, “Take care of yourself”, and then I put the phone down.

And then… nothing. No balloons. No whistles. No confetti falling from the ceiling. No people running out of my kitchen waving champagne bottles and letting off party poppers and shouting ‘Surprise!’. For such a momentous moment – The Official End Of Stephanie’s Cancer Treatment (Except Tamoxifen And That’s Only Pills) – it was very quiet. But that’s just fine by me.

It’s half an hour since I made the call now, and apart from telling you about it, all I’ve done is sit here and enjoy the peace I’ve just acquired. I like the feeling that there’s nothing nasty in the immediate vicinity. The path ahead is unremarkable. The sky is a serene blue. For me, for now -and, I hope, forever – it’s over.

The gist of what we learned was this:

The original herceptin trial had 3 arms: no herceptin, a year of herceptin, and 2 years of herceptin. The survival rates from the 1-year arm of the trial were so dramatic compared to no herceptin that a year became the standard of care. The two-year arm is unlikely to continue/report becaue of the strength of the one year results.

Then there was the Finnish study I told you about, which found a 9 week course of herceptin to be as effective in preventing the return of a cancer as a year. This and other evidence prompted the oncology community to consider that herceptin may be being over-prescribed, and led to the Persephone trial, which is currently looking at survival rates of 6 months versus a year of herceptin, and is likely to report in 2014.

All of this was useful.

A diversion: in our jobs, Alan and I often work with organisations when we’re there to support change, help make decisions, or work with teams that are having difficulty. The first stage is always to ask questions, and what we often find is that during a meeting we get a lot of helpful information. But the real insights often come as the briefcases are being snapped shut, the notebooks closed, the hand is on the door. When we hear, “I don’t know if anyone else has mentioned this, but…”, or “What you might find is…” or “There’s one more thing…” we know that we’re about to learn something that’s really key to the change that we are trying to make.

So. We thanked the oncologist. We said how helpful the meeting had been. I put my notebook into my bag and gave Alan his pen back.

And then the oncologist said, “Of course, if you came to me now, I would be recommending you for the Persephone trial, and then there would be a good chance that you would only be having 6 months of herceptin anyway.”

That was what we needed. In a slightly different universe, the medical profession would be sanctioning 6 months of herceptin. That, together with the side effects, and the fact that we have all pretty much had enough of the whole hospital/treatment/cancer thing, means that we have made the decision to stop herceptin.

It’s not a “Yessss!!” air-puncher of a decision. But it is a decision that we can live with: should the cancer return I think we will be able to look back and still feel that we did the right thing. And the decision is not simply to stop herceptin. The decision is to be well. The decision is to get on with living in a world that doesn’t have cancer at the heart of it. The decision feels right.

(And the dragon likes the decision. She’s somersaulting in the sky. If you live in the north east and have a look out of the window you might just catch a glimpse.)

Cue secret weapon: it was time to get the Six Thinking Hats® out. (As you my know, this thinking tool – involving notional hats and enabling parallel thinking, fast, good decisions, and no arguments, was invented by Dr. Edward de Bono and forms the core of my work.) This is a tool I use all the time with teams, businesses and organisations to help them to make complex decisions, and it works brilliantly, time after time after time. And if ever there was a complex decision, we are looking at it. So, over the remains of brunch in Reds Bar and Grill in Wimbledon, Alan and I did some structured thinking. Here’s what we came up with. As so often happens with the Hats, we got further in 20 minutes than we did in the last three weeks.

Red Hat: what is our gut instinct about continuing with herceptin?

- Uncertain, x 2.

White Hat: what information do we have?

- The cancer has been removed in its entirety, as far as anyone can tell

- I’ve had 2 (chemotherapy, radiotherapy) and a half (9 rounds of herceptin) ‘insurance policies’ against it returning

- Throughout the whole pea thing, every medical professional assured me it was next to impossible for the pea to be a cancer, after all of the treatment I’ve had

- I have continual but varying side effects, which include: joint aches, muscle cramps, heart flutterings, chest pain, constantly sore and bleeding nose, and nausea. (Oh, and I sleep badly, but looking at that list, it’s hardly surprising, is it?!)

- Side effects have been getting progressively worse, as I have not fully recovered from one dose before I have the next

- Roche, the manufacturers of herceptin, recommend that it should be prescribed for a year

- A Finnish study has shown 9 weeks of herceptin to be as effective as a year

- The on-call oncologist who had my infected PICC removed said there is evidence to suggest that too much herceptin is given

- Herceptin has been shown to deliver great results, especially when give concurrently with chemotherapy

- One study suggests that I am in the group of people least likely to benefit from herceptin – and that’s women with HER2 positive, hormone positive, node negative cancers, not blondes or mothers or people who knit

- I will be taking Tamoxifen for another 4 years, which takes care of the hormone-positive risk element

Yellow Hat: what are the benefits of continuing with herceptin?

- We would be doing the right thing in terms of current medical thinking

- If I did accidentally sprout aother cancer in the future, we could be confident that we did everything we could have to prevent it

- The herceptin might be stopping a new cancer from growing

- I’d have something to blog about every three weeks (Alan gave me a Look when I said that. But hey, benefits is benefits.)

Black Hat: what are the risks of continuing with herceptin?

- There could be a continuing decline in my physical health and in my mental wellbeing if the process continues to drain my resources as it’s doing now

- I’d need a new means of delivery, such as a PICC or Hickman line, which means discomfort, limitations and infection risk

- The treatment may be compleely unnecessary, if there is no cancer for it to prevent

- The treatment is time consuming and hospital visits are frustrating

- We would face another 6 months of worry and stress around side effects

- It would be 6 months before we, as a family, could put this behind us

- Treatment is a drain on everyone, not just me, so we’d have another 6 months of that

Green Hat: how could we overcome those Black Hat difficulties?

-We could design a structured programme of interventions and therapies for me – hypnotherapy, yoga, counselling etc – which would happen throughout treatment rather than waiting for crisis points

- We could ask about a PowerPort or have the PICC sited somewhere where there would be less risk of infection

- We could ask about having the treatment accelerated and book other hospital appointments in on herceptin days

- We could start looking forward to what we will be doing in 6 months and onward to help us to focus on then rather than now

- We could ask the oncologist what s/he can tell us about current research and current oncological (?) thinking about herceptin

- We could involve more people in my welfare and ask for more help from friends and family in terms of helping me to cope with side effects and keeping my spirits up

Red Hat: having looked at this, how do we now feel about continuing herceptin?

Alan: still don’t know, but feel better equipped to deal with it either way

Me: happy to go on if necessary

Blue Hat: what are the next steps?

- List questions for oncologist and go to appointment tomorrow open-minded and aware that we don’t have enough information to make the decision

- If we do decide to go ahead with herceptin, put our Green Hat ideas into action immediately

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So, there you have it. I feel much better now: much more comfortable that, whatever the decision is, we will handle it and it will be OK. We have knowledge, we have questions, we have plans.

We’ll be OK.

(If you want to find out more about Six Thinking Hats®, the book is here, and there’s more about the workshop here.)

Well meant? Undoubtedly. Thoughtless? Spectacularly so. Or maybe it was a comment intended to make me think about someone other than myself. Hurtful? Deeply. I sat on the train trying to keep it together. I was doing that ‘not actually crying but tears rolling everywhere’ thing. Because I’m learning about asking for support, I texted Alan and forwarded the email to him. (I didn’t dare call becuase that would have really opened the floodgates.)

An hour on a crowded tube, and a little steer from a friend, gave me time to put myself in the position of the writer. She probably has small children and cannot imagine making choices that may suggest she may not be there to see then walk, talk, grow. She probably hasn’t had cancer and so she may have bought into the whole ‘cancer = probable death = anything is better than that’ line. Chances are she doesn’t walk like an old woman, wake three or four times every night with violent cramp, bleed constantly from the nose, and isn’t going through a medical menopause. She may never have had to deal with a couple of robot arms and weapons-grade antibiotics to get rid of infection. She may not have spent 16 months of non-stop medical treatment which depletes energy, resources, and the ability to deal with thoughtless comments. She may think that doctors always know what they are doing and to go against medical advice is reckless and irresponsible.

I arrived home to hugs, love, and apple doughnuts. I told Alan, Ned and Joy that the comment had made me feel that I was a bad mother by even thinking about not taking herceptin to the bitter end. I cried. Ned said simply that “we can all see that herceptin is doing more harm than good”. Joy had already texted me her view, that “you are not going to die from this – herceptin or no herceptin. You are just thinking about what’s good for your body, and it’s much more important that you look after yourself and know what is good for YOU than any drug.”

Alan and I exchanged a look that said, “wise children’. I feel better and I feel as though I understand where the comment may have come from. Everything that I’ve posted in the last week or so on the subject of herceptin still holds. Just. I must admit that I am quite a bit more wobbly on this than I was before I read that email. The spectres of selfishness and bad mothering are hanging over me and cackling and it’s not a pleasant sound.

So this is what we’ve decided.
We’ve decided that we are talking this problem around and around and around and it’s not helping.
So we’ve made, if you like, a ‘holding decision’ that we think there’s been enough herceptin, and the physical and emotional damage outweighs the probably incremental benefit/insurance that comes with it.
This is a holding decision because we want to see whether it feels like the right decision. We have another week before we see the oncologist so we have agreed to talk about it again next weekend and check if we think it still feels right.
And of course we will listen to what the oncologist has to say. I’m assuming that we’ll get a “fair enough, it’s your decision” at best – which is what we got when we declined the final round of chemotherapy last year, and confirmed our feeling that we were doing the right thing.
Of course we might get a “hands thrown up in horror” reaction, in which case we will listen, and ask questions, and consider, and think again.
So. That’s where we are. It’s a decision of threads and patches, really, but it feels like the best we can do.

I know that Roche recommend giving herceptin for a year and they have the stats to show why. I know enough about the pharmaceutical industry to be a little bit sceptical about drug-company-sponsored trials. I know that a study in Finland has shown herceptin to be effective when given for nine weeks. I know that trials are going on looking at the efficacy of herceptin when given for 6 months versus a year, and one year versus two years. I know that some small-scale studies have shown that 6 months works as well as a year.

I know that herceptin hasn’t been around for long enough for anyone to know what the long term effects of the collateral damage to the heart might be.

I know that herceptin has been shown to be mightily effective in preventing the return of breast cancer. I know that the trials that have shown this effectiveness has been where herceptin has been given at the same time as regular chemotherapy, rather than after it. I know that herceptin has been shown to be slightly less mightily effective when given subsequently rather than concurrently.

I know that “it is likely that patients with “small,” especially hormone receptor-positive, node-negative cancers, may derive little absolute incremental benefit from the addition of trastuzumab to chemotherapy ± hormone therapy.” I didn’t figure that out myself. Edward H. Romond, MD did, and he wrote about it in a punchily titled article “Adjuvant Treatment of HER2-Positive Breast Cancer: Refining Clinical Use of Trastuzumab in the Adjuvant Setting”. (Trastuzumab is the doctor word for herceptin.) As someone who had a hormone-receptor-positive, node-negative cancer I found this comment especially interesting, although I note that the definition of ’small’ varies and that Dr. Romond’s conclusion is that pending further information, a year of herceptin should remain the standard of care.

I know that many doctors take a belt and braces, better safe than sorry, herceptin’s not as bad as chemotherapy, it can’t do any harm approach with herceptin.

I know that I don’t want another PICC line, or a Hickman line, or any bits of bionic medical kit, if I can possibly help it.

I know that I get a little bit achier with every treatment that goes by. I know that the aching as not as bad as it was during the nadir of chemotherapy. I know that it’s starting to get in the way and I know that I’m starting to get a little bit snappy because I am in pain all the time.

I know that my heart often flutters and my chest sometimes hurts.

I know that I really, really don’t want another dance with cancer.

I know that I am concerned that because I am run down and in pain I could make the easy decision and not the right decision about whether or not to continue with herceptin.

I know I’ve got another 10 days before I see the oncologist to discuss this. I don’t know whether more time will help.

I still don’t know what to do. I don’t think any of us do, really. I feel as though flipping a coin will be as good a way of deciding as any other.

Heads or tails, anyone?

I still wasn’t entirely surprised when I didn’t get a call on Monday. Or Tuesday. Wednesday went taxi-plane-taxi-boardroom-taxi-plane-taxi, leaving home at 5.30am and getting back at 9.30pm, so I didn’t have the time or the energy to be surprised or not. Yesterday, I realised that I hadn’t heard from anyone and that I was, in theory, supposed to be having herceptin today. So I called to confirm that I wasn’t coming in, because herceptin costs around £3000 per dose, and I didn’t want some poor pharmacist having the skin taken off her fingers in a sterile room full of poisons unnecessarily.

It soon became clear that if the conversation had taken place, the result of the conversation hadn’t been communicated to me or to the Trevor Howell Unit, where I was expected. So I had one of those just-slightly-missing-the-point conversations which are so frequent in dealings with hospitals.

ME:… <tells story of arm> So, as I hadn’t heard anything, I thought I’d better check that you weren’t expecting me tomorrow.

NURSE: We were expecting you… so you’re on antibiotics?

ME: Yes, two sorts.

NURSE: Well, you can still have your herceptin when you’re on antibiotics.

ME: Well, yes, but I am feeling a bit grotty with them, and anyway, I really want to talk about whether I should be continuing with herceptin or not, with the oncology team, before I have any more.

NURSE: (Tearing up my nomination for the March ‘Patient Of the Month’ award) Let me speak to the doctor and call you back.

(Which she does. This is unusual. The calling back, I mean. Although I have found in the past that refusing to take one’s medicine gets concerns listened to faster.)

NURSE: I’ve spoken to the doctor and she’s happy for you to have the herceptin with the antibiotics, or if you like, you could wait until you’ve finished the antibiotics and do it then, maybe next week, I could book you in for Monday or Tuesday?

ME: The thing is, I don’t want to have any more herceptin until I’ve thought and talked about whether I need to have any more and made that decision.

NURSE: We have got a few days leeway but then we have to give you a loaded dose if it’s been too long.

ME: Yes. I really need to speak to the oncologist before I have any more treatment.

NURSE: Well you’ll need to come to clinic, but probably not on Monday, if you’re not feeling well?

So there you are. Well enough for herceptin on Monday, but not well enough to come in and discuss treatment. Anyway, we agreed that I will go in on Monday 23rd March to talk about what happens next. I’d rather go in on a Sunday and talk about it with the locum, which is a sad reflection on the hospital. But for now, my arm  continues to heal, and I don’t have herceptin today, which I’m pleased about, because I’m still riddled with cramps, aches and nosebleeds from last time. (Well, the nosebleeds aren’t riddling me. They’re just in my nose.)

And herceptin research is on my to-do list. I’ll let you know what I come up with.