Pam - Interview 21

Age at interview: 70

Brief Outline: Pam has breast cancer which spread to her bones and liver. She joined an open-label expanded access study of lapatinib and capecitabine, before lapatinib was licensed for general use. She left the study after lapatinib stopped working. (Wife of Tony, Interview 36)

Background: Pam is a retired solicitor and magistrate. She is married with 2 adult children and 3 step-children. Ethnic background/nationality' White Jewish.

More about me...

Pam was diagnosed with breast cancer in 2002. She was successfully treated with surgery and tamoxifen, but in 2005 she discovered a bony lump and was told the cancer had spread to her bones. Further tests showed she also had a tumour in her liver. This was treated with chemotherapy, then further breast cancer was discovered, and Pam took taxol and herceptin, followed by herceptin on its own. Things remained stable for about a year, and then it was found that the tumour in her liver had doubled in size. At this point, she was offered tablets combining two drugs, lapatinib and capecitabine. These drugs had already been researched in randomised clinical trials, but lapatinib had not yet been licensed for use in the UK (until licensing was approved in July 2008). Women who were eligible could only be given the drug as part of a supervised study monitoring effectiveness and side effects - an ‘open label expanded access’ study. (‘Open label’ means both the patient and doctor know what drug is being taken).

 

Pam felt the study was a lifeline and she was grateful for the chance to take part. She thinks she probably would have agreed to take part even if it had been a randomised trial and there was a chance she wouldn’t get the trial drug. At the time of the interview her liver tumour had shrunk back to a smaller size than it had been when she was taking taxol and herceptin, so she was very pleased with the results, and continues to try to live life to the full. There were some unpleasant side effects – some of her toenails have fallen out, and she has had considerable swelling and soreness in her hands and feet. At first she experienced bad diarrhoea but that was successfully controlled with additional tablets. She has regular scans and careful monitoring of her symptoms. At one point early on when she was experiencing a lot of side effects, she was taken off the drug for a while to allow her body to recover. That was the only time she thought about withdrawing from the study, but she describes herself as a fighter and was determined to carry on as long as she could. Shortly after the interview, Pam was told the lapatinib was no longer working so she was taken off the study, but she is still glad it helped for seven months.

 

Pam feels she was well-informed about the purpose of the study and the possible side effects, and that the choice to take part was entirely left to her. Her main reason for taking part was because of the possible benefit to herself, but she has offered to speak to anyone else involved in the trial who would like someone to talk to for support. Most people cannot appreciate what it is like, but patients can provide each other with a lot of sympathy and understanding. Pam is motivated by showing other people you can live a good life with cancer, and wants to encourage others to keep going. Her Jewish faith provides continuing inspiration.

 

She advises other people to give positive consideration to taking part in a trial if their doctor offers it. She is concerned that not everyone has the chance to take part in the study and gain access to the drug. She suggests health professionals should explain everything clearly and simply; appreciate how stressed and uncertain their patients are feeling; answer questions as often and as fully as needed; and encourage patients to bring someone with them who can help clarify the information.

Pam has breast cancer which spread to her bones and liver. Taking a trial drug seemed 'a lifeline'...

Then I stayed on herceptin after the taxol regime had finished, and I was scanned, and the scans seemed to be showing things were stable, and this lasted for a year. And then suddenly, yet returning from the Edinburgh Festival once again, I was told that the tumour in liver had doubled in size. That was very dramatic, although on paper it doesn’t look that dramatic because it had gone down to 1.3 cm and it only went up to 2.7 cm, which of course was much less than the original, but it was still awful. And the oncologist said to me, “You wouldn’t have felt anything, you wouldn’t have known any difference, but we recommend that you go onto this trial drug.”

 

That at that point seemed to be the only option at the time*, and she left it entirely to me, and other people like my husband, to discuss whether or not I should go on the trial drug. Well, what would you do if you were handed a lifeline? It would have been very foolish, I think, to have refused that, and I felt very privileged to be able to go through it.

 

The first session - it’s tablets, which means that you don’t get a three-hour infusion, so in a way that’s better, but they have to work out the amount of tablets you should have depending on your weight and all sorts of things, and at the very beginning it’s experimental. Well, the first three weeks were pretty dire. At the end of the third week two of my toenails had come off and that was extremely painful. If it’s not losing your hair, losing your toenails is not a particularly viable option, but that was really very nasty. I had lots of horrid diarrhoea, which was copeable with because I had tablets for that, but it was not much fun, and in fact I was taken off the tablets and everything for two weeks while my body had a chance to recover, because it can be cumulative, and then the side effects can be worse in the end, and so it’s not worth it.

 

Anyway, we settled down to a happy regime, and the tablets have been varied, depending on my weight and how I’ve been reacting. Fortunately, the first scan after the first two sets of treatments showed that the cancer in the liver had reduced back to where it had started, in fact it went down to somewhat smaller - 1.2 cm - so that was very encouraging, so I forgot about the rotten old toenails. And then the next scan, which took place after two more treatments, showed that my condition was stable even though it had gone up by 1 mm they still reckoned that was stable, and happily it’s been stable ever since.

 

*FOOTNOTE' At the time Pam agreed to take part, the drug was only available as part of this study.

Pam could only get lapatinib through an open-label expanded access study. She'd have joined a...

If - this was an experimental treatment and you could only get it if you took part in the trial. If this had been set up as a randomised trial where you might get it or you might not, how would you have felt about taking part in that?

 

Oh, I would have gone for it definitely. Oh yes. If there was some treatment available which would be helpful, then I would definitely take it.

 

And how would you have felt if you’d been randomised to the group that didn’t get it?

 

Would I have known that is was the group that didn’t get it?

 

You might or you might not - depends whether the trial is blinded or not.

 

Mmmm, [sigh] well, I suppose it’s a bit like entering a competition and not winning. I’d have felt, “Well, that’s just the way the cookie crumbles.” It would have been helpful if I’d had the trial. If I couldn’t have the trial, then hopefully there’s a different treatment that could deal with me. But with this particular trial it’s been going on for a long time, and it’s very well established, and it will eventually, hopefully sooner rather than later, for the benefit of other people in my position, be approved by NICE [National Institute for Health and Clinical Excellence]. And hopefully it will be available in hospitals, so people don’t have to go through that terrible, terrible stress of deciding to pay for a treatment and then being landed with the whole of the costs of the NHS, which is diabolically unfair. Because when you have cancer it’s very stressful, you don’t need the added stress of the financial worry. That is really a life sentence. I feel that if the people who are in charge, all the bureaucrats, if they were in our position they wouldn’t behave like that. And I really feel that so strongly. And if there was something, you know, one could do about it, like petition or something - I know there are doctors who are very involved and being very cross about it as well, and doing something about it.

 

I suppose that what they would argue is that they don’t yet know whether it’s safe and whether it works, and that that’s what this trial is trying to find out before they make it available to everyone.

 

Yes, I’m sure that’s right. But it is, it is available. It’s available in America, and the Americans, of course, have a very good track record of cancer treatment, better than here, as I understand it.

 

Mmm, so there is some evidence actually over there?

 

Yes absolutely, absolutely. And also I think with this particular hospital I’m at and with the consultants I’m under, they wouldn’t recommend anything that wasn’t appropriate. Because there’s another thing - people can take the same drug but the side effects can be different, because everybody is different. People can react differently. The way the drug reacts on your cancer can be different, one person to another, so that’s another thing. It’s all very complicated.

Footnote' Licensing for use in the UK was approved in July 2008 shortly after Pam's interview.

Pam was told grapefruit, evening primrose oil and antibiotics can interact with the trial drug ...

Those side effects have been quite severe. Have there ever been any times when you’ve felt like stopping taking the drugs?

 

At the very beginning. When my toenails fell off, my local GP thought that I had an infection in my foot and she gave me some antibiotics. When I was put on this trial I was given a list by the oncology nurse of exactly what I could have and what I couldn’t have. For example, I’m not allowed grapefruit* - don’t ask me why - or grapefruit juice, or evening primrose oil, and various antibiotics, and we had to go carefully through and make sure I didn’t have this. But this particular antibiotic plus I don’t know what else that I was taking at the time gave me the most awful stomach cramps, and yes, then I just really just did want to curl up in a little hole and just disappear off this earth, and that was really awful. That was the worst time. I call my little booklet Ruth, because in the Bible, in the story of Ruth, she says to her mother-in-law, “Whither thou goest, I will go.” And that’s what happens to my booklet. Everywhere I move, I don’t go anywhere without my little booklet, because suppose I were to have some sort of accident when I’m out? Then the hospital, or wherever I go and see the first aid department, must know exactly what they’re allowed to give me and what they’re not, so it’s really important that I carry that with me. So that’s yet another thing to think about.

 

What made you stick with it in the end?

 

The alternative, as my husband keeps saying, is not really to be countenanced, and truthfully while I still think that there’s some “need” for me [gestures inverted commas] - I mean, I’ve got three gorgeous grandchildren and one on the way - and I’m conceited enough to think that there might be some people that might be sorry if I wasn’t around, I’m going to plod on. Also I, I tend to fight and I won’t take no for an answer, and that’s about it really.

 

*FOOTNOTE' Grapefruit can increase the amount of the drug lapatinib which is absorbed by the body. 

Pam would like to see more research into the needs and experiences of family carers. Her husband...

I think the effect of living with someone that has a condition like mine needs a lot of research. It’s the partner that suffers, it’s the partner who’s in 24/7 contact that has to cope with the mood swings, of which there are plenty. There is a very good actual course that one can do. It’s called The Expert Patients Plan, and that helps you to live with long term conditions regardless of what they were. I actually did that, and there were people with emphysema and people with arthritis who were in a great deal of pain, and as it was a group situation we all fed in how we felt, what our problems were, and how we could problem-solve. And our facilitators were absolutely marvellous, and we really gained a great deal of benefit. But really I think if people could work and help the partner and perhaps possibly the wider family as well, the effects on them, and how they can best assist the patient, that would be extremely useful.

 

Has being in the trial had particular implications for your partner?

 

I don’t actually think of it as a trial. I think of it as just another treatment. And he’s been through this third lot of chemotherapy, and each of the chemotherapies has had a different side effect. But he’s been extremely supportive and has taken over lots of domestic roles, like washing up and things like that, which really is fantastic. This time, actually, I haven’t been able to stand quite as much as normal. I’m supposed to sit with my feet up, and so therefore there are things that I had been doing heretofore but find it far more difficult to do now. So he’s, I’m afraid, had to be landed with that, as well as having his own heart condition. So it’s tough, but we, we rub along.

Pam finds her regular scans reassuring. Talking to fellow patients helps keep her spirits up, and...

What happens is that I get, at the beginning I got scanned after every two sets of treatment, and they want to see what’s happening to the cancer cells, basically. So I get scanned from my neck through my abdomen, and then they have a look at the scan result and they see what’s been going on, and now I’m scanned every three treatments.

 

After my first scan they were really, really thrilled that the tumour had gone down by so much. They said it was not all that usual to have it go down. And the fact that it then stayed as stable as it has done, they’re extremely pleased with what I do, and they really are quite, also, chuffed at the way I try and use my lifestyle.

 

When we are in our chemo unit having treatments, we do all talk to each other and in fact it’s the one place where you can really, really, really feel safe. You can say, “I’m absolutely fed up. It’s just not fair, why have I been landed with this? Oh dear, I’ve got to go and do this, that and the other, and I really don’t feel like it”, and you can really unburden yourself both to your fellow sufferers and to the nurses, who are extremely empathetic and sympathetic.

 

Also the chemo nurses make you want to keep going as well. They get extremely upset if you have a backward step. When they found that the tumour liver had got bigger, they were really desperately upset, and they said, you know, “Of all the people, we just really find it quite remarkable that it’s happened to you and we’re so sorry.” And they’re really just wonderfully, wonderfully sympathetic. And we know all about their holidays and their friends and all sorts of things like that, which is very nice, and the treatment is super and so that’s great as well. Because if you can trust your medical practitioners, that’s what you really, really need. When you go up there and you think, “Yes, that’s fine. They’re going to get the cannula in without making me feel like a pin cushion and they’re going to be able to take my blood quite easily”, then at least that’s one bit of you that’s quite secure. And that’s what you need. There’s enough other things going on which make you feel insecure, but at least when you get to the hospital and get your treatment, if you’re there and you’re in this cushioned environment, it’s very, very encouraging.

Remembering to take the trial tablets is quite daunting. Pam has to save the empty packets and...

I ought to say something else about this trial as well. One of the things about this trial is the number of pills you have to take, and the regime of taking them, which can be a bit daunting. Because the trial drug, the lapatinib, you have to take five quite large tablets at least an hour before breakfast, or an hour afterwards, but it’s much more convenient to take them before. So about half past six - I have measured them out carefully the night before because the thought of measuring five at half past six in the morning when I’m fairly bleary is not to be countenanced.

 

So there they are waiting for me, and some time in the region of between six and seven I will take that. The chemotherapy I have to take with food, as well as tablets that stop soreness in my mouth - oh yes, that was another thing. The other side effect was awful, awful sores on my mouth. I thought it was because I went to Spain on holiday at the beginning of my treatment, the trial treatment, but in fact, that may have exacerbated it but certainly I do have stuff for that. So I take those, but I have to take them also during the day, so I have to make sure I remember to take them, and then in the evening I have to remember to take my chemo plus these other two sets of drugs, and then thereafter I also have to take [coughing] my iscador, which is a very interesting homeopathic remedy and which has been around for 60 years, and I have to take that in the morning after one hour from my Tykerb - my lapatinib – which is, Tykerb’s another word for it, and at least twenty minutes before breakfast. So it’s quite complicated. It’s like having a full time job, really, and not everybody can cope with that, but it just has to be, and there we are.

 

I measure out the tablets and things each time I have a meal. After breakfast I will measure out my evening tablets, and also the other thing is that I have to take my empty tablet packets back. As the oncology nurse said at the very beginning, “You might have given all your tablets to the cat, we’re not to know that, but we do like to have the empty packets back again.” So I religiously save those and when I’m on holiday I’m taking chemotherapy I have to make sure that they come back in my suitcase.

Pam asks doctors to understand how difficult it is to take in all the information, to be patient...

Please be very patient with us. We are stressed, we are very, very worried about our conditions, we are very scared, we are going into an unknown area and that can be very, very worrying. Please answer all our questions. Some of them may seem stupid to you, sometimes we may not take on board everything you say to us. Please do put up with us when we do ask you the same thing, we ask you to repeat things in a different way. Please let us bring somebody with us, and make sure that they’re included in any discussions, and just we rely on you for your help, so you’ve got to make sure that we can trust you, so therefore you’ve got to give us confidence in the trial, and explain all, explain it all in words of one syllable. You’ve got to explain the advantages, you’ve got to explain the disadvantages – okay, so at the end of the day you leave us to weigh it up for ourselves, but your guidance is absolutely vital and that’s what we need.