Clinical Trial – Wozzers Journey with Cancer

52 – More Art than Science

10 November 2024

Oh dear – just looking back, it was March when I last wrote a post on here. One or two people have dropped me a note, I guess to check I’m still alive (which I am) – because of my silence.

And yes, I really do need to update everyone with what’s been happening since last time. Although in some respects, not much happening – but in other ways, quite a bit…

In terms of CT scans, I had these in April, July and September of this year. Nothing remarkable in terms of change in the April and July ones.

Looking back to last year as well, I had eight CT scans in total at either The Royal Marsden in London or locally here in Gloucestershire. None of these scans showed any measurable growth of the tumours and all of my medics agree on one thing…

They’re not quite sure why I’m still alive, but of course we all take it as an amazing result just the same!

As Professor Harrington told me in April 2024, ‘Warren, I consider you’re now more art than science’. He said this because it’s difficult to explain exactly what has interrupted the growth of said tumours.

Seems the best explanation is that while all the SACT treatments I’ve had (more on SACT soon) have not performed in terms of SHRINKING tumours, the tumours haven’t grown either – just remained stable in terms of growth.

So that’s been good news and it’s allowed me to live a fairly stable summer period. Albeit, I still have breathing issues and have to use external oxygen to keep me on the go.

Oh yes – SACT. Seems there’s a new acronym that’s crept in to the world of oncology. It stands for Systemic Anti-Cancer Treatment.

Systemic in this case means using Chemotherapy or Immunotherapy treatments, which of course enter the general bloodstream and distribute through the whole body.

This is opposed to the new and exciting developments in anti-cancer vaccines, which can be targeted to a specific tumour. Most new clinical trials currently starting – and for the foreseeable, will be based around vaccines, with and without immunotherapy I suppose.

Unfortunately, in my case, because of the issue I had with immunotherapy drugs last year, it precludes me from any further trials of this type.

So with no treatment planned, the summer of 2024 has been quite good to me. I’ve had a couple of trips abroad – overland by train, because flying takes too much to arrange because of my oxygen requirement.

I won’t go into all of the details, but each airline has its own policy regarding passengers requiring additional oxygen – and they differ widely.

But in every case – a Fit-to-Fly certificate will be required. This is the case for pretty much anyone requiring medical assistance to fly – even say a broken leg has to have a certificate signed off by a doctor.

For us external-oxygen reliant people, obtaining a Fit-to-Fly certificate begins at a hospital
with specialist equipment that can perform a Hypoxic Challenge Test. This is a procedure in a chamber or similar that can simulate the reduced oxygen levels that are found in an airline cabin, which are around 17% lower than at normal ‘land’ levels.

It’s not generally a ‘pass or fail’ test, more that it will indicate the type of equipment and oxygen requirement of the patient / passenger to be able to fly safely.

The test itself is chargeable at around £300 and the result would most likely have additional costs associated with the airlines. In-cabin oxygen is, believe it or not – not widely available for medical needs. And I haven’t even started on the cost of the equipment I’d need to take!

link to origional image

This all actually worked out better for me because I decided to travel overland by train, using Interrail passes. I did two trips, one with mates over a week in April and as it was so good, we did another as a family of the 3 of us in July. Completely by train we travelled in a couple of weeks to Bruges, Cologne, Berlin, Krakow, Prague and then finishing in Paris, before the Eurostar back to the UK. Such a wonderful and memorable trip.

The three of us at The Old Market, Krakow, Poland

I should say my consultants did add that as they’re not quite sure of my prognosis in terms of longevity – that I should get out and enjoy myself whenever I can. Of course, I never need telling twice to enjoy myself.

So to add to the train adventure – me, Samros, Nisa, my kids (Rachel, Verity and Alex are kids?) husbands and grandchildren, all descended on Center Parcs Sherwood Forest in September for a long weekend of playing, relaxation and the most precious family time together.

Wozzers tribe at Center Parcs, Sherwood Forest

So, all in all a lovely summer – but all the while I’m wondering if it’s my last.

There’s no getting away from my condition and it really is quite miraculous that I’ve had four and a half years of a condition that has, on average, a survival time of perhaps two years,

Sure – the near 40 radiotherapy sessions, 18 weeks of chemotherapy, 6 cycles of immunotherapy, a clinical study, holistic care, support by family and friends including of course my amazing wife and in maybe some small way, my positive attitude has allowed me carry on regardless of cancer.

But – and I have to say this – my body is beginning to tell me differently. And so are the medics.

I’m more closely involved with my Palliative Care team and while I’ve written before about the wider meaning of ‘Palliative Care’ – this is now including some shall we say ‘end of life planning’.

Nope, it’s not going to happen very soon (I hope), but a number of factors are coming into play that are all pointing towards a more difficult period ahead of me.

It’s those bloody tumours (no surprise there).

I’m lucky (I guess) they’re still in the one location of my right lung, but they’re now becoming more active. My most recent CT scan in September 2024 is showing tumour growth. That didn’t surprise me at all, because my breathing and back pain are telling me that.

Because the tumour growth is pressing on my windpipe and causing restriction, (for a simple explanation) and this is seriously affecting my breathing and the capacity to breathe properly. I have around half the breathing capacity of a normal adult of my age.

This is why I have to rely on external oxygen therapy whenever I’m active.

Logic says that the more the breathing is restricted by the tumours – eventually one day I just won’t be able to breathe. And from what I’ve heard over the years, here and there – running out of breath is not a happy event 😉

And if that’s not enough, the tumours are also getting to my rib-cage.

Two ribs – posterior 4 and 5 are being attacked (eaten) by the cancer. I suppose eating ribs is a happy event for many of us – preferably smothered in BBQ sauce – but this type is definitely not happy for me.

The ribs are to all intents and purposes broken or fractured.

The radiologists report from the CT scan describes ‘New destruction of the medial right 4^th and 5^th ribs’.

Link to original image

So I understand this to be not in the general sense of broken ribs like by an accident or impact, but more by attrition over the past few months.

This is significant, because it appears to have happened only since the July 2024 CT which didn’t show any damage and the September CT that has reported this.

Again, I’m not surprised. My body has been telling me by pain that something is amiss. And my back pain has worsened significantly these past few months.

As written before, I’ve been on Morphine for quite some time now and it’s interesting to see the correlation between dose and pain.

To put it in perspective, earlier this year I was taking 20mg of Morphine per day. This has been monitored by my Palliative Care team each month – and I’m now on 120mg (and sometimes plus) per day.

I dread to think how I’d feel without Morphine – I’m just happy to be addicted!

And on that happy thought, I’ll sign off for now – but will promise to write another post soon – if only to let everyone that I’m still around 😊

Take care wherever you are in the world x

51 – Four years on and living to tell the tale

27 March 2024

Wow! This time it’s been three months since my last blog post – and the main reason is…
No excuse really!

It’s just coming on to 4 years since my initial cancer diagnosis, back in those crazy days of April 2020, when the Covid pandemic was just unfolding.

As a close family, we’ve been through a fair share of ups and downs. I’ve surpassed most prognoses, which in fairness are at best an assessment on the success(es) of treatment(s) and what generally happens to patients of similar state of health.

It was nearly 2 years ago that things weren’t looking so good and this was the first time Samros and me were introduced to another of the NHS protocols that we don’t know about – until we need to know about them. There we were sitting with my GP in her surgery in mid-2022, discussing end-of-life (EOL) care. There were options open to us about the how, what and where things should happen.

I won’t go into the fine details, but one thing that did happen as part of the protocol is to issue me with a box of EOL drugs, to keep at home and that remains sealed until the medics need to use them. The NHS euphemistically calls it a ‘Just in Case’ box.

So you might be able to imagine our joy when I returned the box to the pharmacy last week, because the EOL drugs have expired their use by date.

It’s a great feeling to outlive the end-of-life drugs and if I say so myself – I love the irony of this. And of course, the smiles I received from the pharmacy staff too.

Medically, our National Health Service continues to excel itself in terms of my care. Since I last wrote – I had a CT scan in January which is still showing no real development of my right-lung tumours – although there is some growth and I’m still being monitored by both the ever-wonderful Dr Grant and also by The Royal Marsden. It don’t get much better really.

The tumour growth I mentioned is, we believe, small but significant enough to affect a nerve somewhere that’s troubled me on and off for the 2-3 years. But it’s now more constant and normal painkillers of various flavours aren’t doing the trick any more.

So, I’m back on morphine and this will most likely continue for the foreseeable future.

I have a slow-release morphine capsule – which is taken orally morning at night time.

It’s a fairly low dose, which dulls, rather than completely eradicates the pain. The slow-release action spreads the effect over around 10 hours. This is in contrast to ‘normal’ morphine which gives a more immediate relief, but over a shorter period.

I prefer this low dose, so it doesn’t affect my driving and generally I hope not to become too addicted or dependent in the future. But probably will at some point.

Along with this – I did have lung function tests and a follow-up with a respiratory consultant, to discuss my breathlessness in general and my (clinical trial) damaged left lung in particular.

While the inflammation has subsided in the main – I’m still on supplemental oxygen, although I do try short, level walks without it. Again, this is because I hope not to be dependent – and also for me, I’ve become quite self-aware of the plastic tubes (cannula) that go in my nose.

It could be argued I’m not a pretty sight at the best of times – unfortunately a nose cannula does absolutely nothing to improve that 😉

Anyway – for the time being I’m still on external oxygen when required and I’ll have some more tests and further evaluation / consultation around mid-year. That’s when I should get to know whether this will be a permanent accessory, or not.

And if all of that isn’t enough, we’re finally getting somewhere with the falling-down/ dizzy spells stuff. I had a meeting with a consultant physician at Gloucester Royal Hospital, Syncope dept.

I think Syncope is a much better term for fainting/falling down. Doesn’t sound so ‘old people / silly old git’.

The tests began with blood pressure readings taken laying down and standing up. My laying down reading was 135/59 mmHg, but after 5 minutes of standing up, the reading was just 55/25 mmHg. Not good at all – but nothing new to me as I’d been monitoring my BP with a home test kits pretty much daily.

This has been officially diagnosed as Orthostatic Hypotension, which simply means low blood pressure, when standing – especially from a prone position.

The interesting thing is what causes the significant drop. It’s known as autonomic failure or autonomic dysfunction.

So, as I understand it – our autonomic function(s) are those things that the brain controls and happens without us having to think about it – examples being what makes our heart beat, eye blinking and so on.

Now – when we stand up from a sitting or laying position – our autonomic system is supposed to counteract the natural tendency of blood falling to our legs by gravity. It does this by restricting the blood vessels in our legs and increasing our heartbeat – so that oxygen-containing blood is sent back up to our brain.

When this doesn’t happen – as in my condition, then the brain can sense the lack of oxygen and quickly shuts down functions that aren’t required at that moment. Legs aren’t really required, so the muscles don’t function and this usually results in the fainting / momentary loss of consciousness episodes that occur.

Many people might experience a slight feeling of dizziness when standing quickly, but their body counteracts things quicker than mine is capable of, so they don’t fall down.

These also a discussion that my lower oxygen levels due to damage now to both lungs, is possibly exacerbating the blood oxygen / brain function issue. Well, that’s my excuse for many things that I forget now!

So, apart from the right-lung tumours and radiotherapy scarring, my left-lung damage do to severe pneumonitis and my autonomic disfunction thingy – I’m doing okay!!

And this is what people are saying to me – ‘you look well Woz’. Even my GP and Oncologists say this.

So it can’t be all that bad.It even makes for some moderately interesting subjects to write about 😊

Until next time…

Woz

50 – Dodging Bullets

23 December 2023

Blimey – December already!

I didn’t realise it’s been two months since my last blog post, and while I’ve felt not much has changed – and it hasn’t really, I have at least made some gradual progress.

The treatment regime for pneumonitis has got me out of the worst of the problems and the lung inflammation has subsided. But I’m pretty certain there’s still some lasting damage to what was my good lung – and I’ve got more lung function tests lined up during February 2024 to try and quantify the situation.

The smart money at this stage seems to indicate I’ll be on supplemental oxygen long term. And while I’m getting more used to being hooked up to a machine and I can get out and about, it isn’t much fun at all really.

Still, on the bright side the last CT scan that I had in mid-November shows that the tumours in my right lung are still ‘stable’ – that means no growth (or disease progression as the medics say) since April, a good 6 months or so. I’ll take that as a win any day!

And yes, that’s given me another Xmas to celebrate – which is four Xmas’s since being pronounced Stage IV incurable, back in September 2020

I feel I can now share some history of prognosis discussions over the past few years:

In September 2020, the expected survival for my cancer of between 9-14 months. Skipped past that.

In Jan 2022 it was 50/50 I’d see the year out. Skipped past that one too!

In May 2023 it was just a matter of months. That took some getting around in my mind, but I reckon I’ve dodged this bullet also.

Because here we are at Xmas 2023 - I’m still doing okay and working on milestones for 2024 😊

Anyway – the clinical trial is stopped and won’t resume. I won’t be able to have any immunotherapy treatment in the future because of the serious risk of inflammation of one or more organs. So, as there’s currently no disease progression, I’m on observation only (no drug treatment), with CT scans until things change. Then it’ll be the 4^th (and final) palliative chemotherapy – but hopefully not for a while yet.

49 – Fighting Back

16 October 2023

Well, as a period in my life – I have to say the past month has been the most stressful I’ve ever experienced.

I mean, not much really shocks me medically any more. Three and a half years of cancer – interspersed with periods of Radiotherapy, Chemotherapy, Immunotherapy – experimental trial drugs, all kinds of scans and three PICC lines and a PEG feeding tube, there isn’t much that I can’t (or haven't) taken in my stride!

But this Pneumonitis and its potential of facing down death, really had me and Samros on the ropes.

Anyway – one month later – and very close crucial medical care, along with a specific drugs plan have made me feel that things are generally going in the right direction. Not out of the woods completely and there’s still a lot of treatment to be administered.

Inogen One G3 Portable Oxygen Concentrator

To help me get out and about, I’ve been issued with a portable oxygen concentrator.

This natty little unit, runs on a rechargeable battery and works by filtering the atmosphere to create oxygen-rich air by pulling surrounding air into the oxygen machine, compressing it, purifying it and removing nitrogen and other impurities.

The purified, oxygen-rich air is then delivered to the patient, at variable pluses of air, depending on the patient’s prescription, or effort and levels of breathlessness.

I can get between around two and four hours battery life, depending on effort expanded. I don’t usually need it operating when I’m at rest – just when on the move. It has a mains charger and a car charger to keep everything topped up.

48 – Reaction to Immunotherapy

A couple of weeks ago – 12^th September, to be precise, Samros and I were back in London for another round of treatment. Samros was with me, because a few days earlier – I had another unexplained collapse. Legs just went from under me – and I went down like a sack of spuds.

I decided, for the first time ever – I couldn’t trust myself to be unaccompanied for 3 days around London, in case of any other mishap. And I’m ever so glad we both went.

The day started off at hospital as any other. I had a scheduled CT scan first, followed by the blood sampling and finally the review meeting / consultation with the research / trial doctors.

And that’s when everything changed.

“Warren. We’ve just examined the CT scan you had an hour ago and I have to inform you, that your left (non cancerous) lung appears to be highly inflamed. We need to do more tests but the strong suspicion is you have Immune-Related Pheunomitis.”

Samros and I continued listening. “This can be life-threatening and potentially life-ending condition”

“We have to pause the trial immediately and begin oral high dose steroid and antibiotic treatments, to try and control this”.

Well of course the medics had our complete attention, although we were also in a daze, trying to believe the unbelievable.

Assessed as Grade 3 – adverse event Common Terminology Criteria for Adverse Events (CTCAE)

Pneumonitis is an ‘itis’ or inflammation. The pneumo bit is of course, related to the lungs. Other similar itis’ include hepatitis, colitis, meningitis or even dermatitis.

All can be triggered by Immunotherapy treatment actually over-stimulating our body’s own immune system, in such a way that the body begins to ‘attack’ itself. It’s a known, but fairly rare side effect of treat.

I felt like saying ‘so, it might be a bit serious huh?’ But no one was smiling.

And it’s about as serious as it gets. The next 4-6 weeks will range between ‘crucial and critical'. It all depends on whether the drugs treatment can overcome the inflation’ in which I’ll prevail, or – and let’s not beat around the bush – this condition could very well take me down.

Which is pretty ironic that a man that’s survived over three years of Stage 4 cancer without too many dramas, could succumb in such a highly regulated and closely observed clinical trial, to something probably immediately worse than my cancer.

Medically, when something like this happens, it’s called an Adverse Event and are graded 1-5. I’m currently graded 3. So, I’m being treated as an outpatient, but with close observations at home and taking oral drugs. Any regress, however slight - and I'll be hospitalised.

I’m also now hooked up to oxygen at home for most of the day. I have cylinders to take with me for any outside journeys, including for my now one or two trips to London for assessment each week.

My lovey Samros has had to reduce her working hours to weekends only, so she can be my carer during the week. At weekends, Nisa takes over that role, brilliantly! This agreement (taken with the medics) is about the only thing keeping me from being taken as an inpatient into the Royal Marsden in London.

Hospitalisation needs to be a last resort for me. If I get worse, it will become a Grade 4 Adverse Event, which is being treated by IV and strong immunosuppressive drugs, which all have their own complications.

That’s about the highest grade .

Well, there is a Grade 5, but patients never know. Because that is death.

So currently, it’s fair to say we’re getting by day by day. I don’t feel so bad, but mainly that’s the high does of steroids masking my ills.

Wozzer with the must (not) have accessory. Shown here with a plug-in oxygen condenser

Breathlessness is a serious problem though and if I try and do almost anything without my medical oxygen connected, I’m feeling poorly within seconds.

This is because I've very little lung capacity to make oxygen, which is then trnsferred, via my blood cells to muscles, throughout my body. So the reason for the falling has been explained, that my brain senses a lack of oxygen and immediately prioritises oxygen to the heart.

In order to do this, the brain will cut oxygen supply to limbs etc that don't need it at that precice moment. Therefore my collapses were caused by low oxygen to the brain, whice cut supply to my leg muscles - and down went Wozzer!

47 – On Trials at Chelsea

9^th September 2023

Yes, beating the transfer deadline by just a few hours, Wozzer can reveal that he’s on a free transfer from Cheltenham Town to Chelsea. As a lifelong Manchester United fan, this took some serious thinking about 😉

Well, actually it’s really that I’ve transferred from Cheltenham Oncology Centre, to the Royal Marsden Hospital, which is just along the Fulham Road from Chelsea FC, but that sounded better!

Even though I’m one of the few people Chelsea haven’t signed recently, I can reveal there were some preliminary discussions with my agents about playing on the Outside Right, but they insisted I was better positioned Right Outside.

Anyways, back to reality. Here we are some 7 weeks into the clinical trial and so far, so good. The whole experience at The Royal Marsden has been outstanding – everyone is very organised; treatment appointment times are met and information flow from medics to patient is always up to date.

After the issue with the canula and leaking of contrast dye for the CT scan (described in my previous post) and the amount of blood sampling required going forward, I’ve been fitted with another PICC line.

While it has its inconveniences (weekly flushing and dressing changes) and keeping it dry with a special sleeve when showering, it’s so much better than stabbing my poor old veins, that have had over 3 years of needles and cause quite a few problems.

In terms of treatments – currently I have two drugs. They are both known as Immunotherapy drugs and intended to train my body to better recognise and attack the cancerous tumours, without too many harsh side effects, as in generally the case with say, chemotherapy.

Sampling blood is so easy and painless, with a PICC line

That’s not to say I get off scot-free. One of the drugs is a powerful vaccine given by injection into either upper arms (one jab in each) or thighs (again one in each). I have to say it hurts like hell for a few minutes, then subsides over 1-2 weeks- but with inflammation and pain around the injection sites.

This is definitely grown-up stuff, much more painful as any normal flu or covid jab! The other drug is intravenous, so that goes through my PICC line and thankfully painless.

The reason for using two drugs is - to my understanding – that neither is particularly strong enough to deal with the tumours individually – and the trial is to determine if the combination of two give a better result than the individual parts. Kind of 1+1=3

Currently, it’s too early to say if the trial drugs are working – this will mostly be determined by CT scans. One is due on 12^th September, which MAY give an initial indication – but my guess is the following one around mid-November will have more meaningful results.

I find it best not to speculate on possible results and scenarios– just take it as comes!

Ongoing monitoring of my general wellbeing is done each visit by way of blood-sampling (a lot of blood) and also vital signs checking and interview with the trial doctors.

All of these tubes are filled. That must be almost an armful 😉

This (and any scans etc) usually take place on the first day of hospital visit and then drug treatments are on the next day. This is now settling into a pattern of every 3 weeks. I stay overnight in a local hotel near the hospital. The drugs companies cover my reasonable hotel costs and other expenses.

So, for now – even though it’s near Chelsea, I’m pretty happy with how things are going.
More in a few weeks – or when I have updated news.

Until then, stay safe and well 🙂

46 – Preparing for a Clinical Trial

24th July 2023

Bit by bit, I’m getting there.

I previously mentioned the mishap at Gloucester Railway station on 22^nd June, when I collapsed on my way to probably my most important meeting of this year – a pre-trial consultation to see if I qualify for the screening process and subsequent entry to a clinical trial, to test some potential new cancer treatments.

And so, a week later on 29^th June, I did make it to the meeting with Professor Harrington and a couple of his research team. My eldest daughter Rachel came with me, ostensibly to take notes – but in reality, to catch me if I decided to keel over again.

Thankfully I stayed on my feet – unaided

Impressive Entrance photo credit - Amanda Slater

The consultation started exactly on time at The Royal Marsden Hospital, in London. No hanging about, which can happen and just adds to stress levels.

Prof Harrington is clearly a leader in his field, but had a very easy-going manner about how he interviewed me. And we went through a lot, from my cancer history to prior lifestyle, current medications and a physical checkup, Then the meeting continued with a detailed explanation of the proposed clinical trial and allowed me to work through my list of questions, which were either answered there and then, or certainly in the 20+ page of trial description, treatment scheduling that I was given.

Everything looked good to me, but I wasn’t permitted to say ‘yes’ there and then. I had to consider the trial paperwork and then return to hospital a few days later (4^th July), to initial and sign consent in person.

Very professional and correct.

Once the consent was signed, we started again on a full physical examination, blood samples taken, ECG and finally a ‘baseline’ CT scan with contrast was undertaken. Baseline means a reference scan - so that all future scans and imaging of my tumours can be compared back to this original.

CT with contrast is actually two scans. The first pass in the scanner is without the dye, then a small pump injects the dye into a vein and a second pass in the scanner is done. The dye helps to improve the images and highlight cancerous areas within the body.

Scanner with contrast dye pump (top left) Sample Image - not me 😉

Unfortunately, when injecting the contrast dye into my veins, the dye leaked out into the tissues under my skin, this is called ‘extravasation’. It’s not serious, but pretty uncomfortable for a few hours – and then a couple days for the swelling to subside.

So, this meant another visit on 7^th July to re-scan me. Thankfully this went well, and all of my screening interviews / test results / scans etc have been sent to the drug company that is behind this particular trial for the final decision on my suitability to enter the trial.

I received positive confirmation a week or so ago and this coming week, I begin treatments in what is honestly something with an unknown outcome, but very much worth doing in any case.

I have a full schedule, with various treatments and tests on days 1, 8, 29, 50 and 71. Following this there are subsequent treatment intervals of around 3 weeks, with comparative CT scans every nine weeks.

All in all then, while it's been a pretty hectic month for me with a few trips to London, I'm very glad to be on this trial and starting soon.

But also I'm pragmatic enough to know and understand that a clinical trial is just that - a trial.

And it's primarily in place to test the drug(s). The patients on a trial I suppose, always hope this might just be the 'miracle drug'. Realistically though. it'll simply provide data and other information for future development of cancer treatments.

But for me, right now - after having two longish lines of treatment without success and being faced with a third (and probably final) course of chemotherapy, this trial allows me an additional line, while being extremely well looked after.

And that can’t be bad at all 🙂