You are here

EURO-SKI study

Hi everyone,

I don't post very often on here but continue to visit the site every now and again to try to keep up to date.

I just wondered if anyone has been asked about taking part in the EURO-SKI trial which is due to start at the end of year. Apparently it is similar to the STIM trial as it is a complete stopping study but will have a larger sample group. I have been asked by Jane Apperley at Hammersmith if I would like to take part. I don't qualify for DESTINY as at some point in my early treatment days I was taking 600mg of Imatinib although I have been on 400mg for at least 8 years. My PCR has been at the level of 0.003 for around 5 years or so. I was diagnosed in 2002, aged 34 when I was pregnant with my second son. Everything has gone well ever since and the side effects have been minimal.

Jane has also said that if I was reluctant to completely stop medication then I could follow the same protocol of DESTINY (without being part of the study) in that I would go on the half dose initially with the view to stopping after 12 months if things were going well.

I just wanted to see if anyone else is considering EURO-SKI and to see how those who might have started the DESTINY study are doing. I feel that I want to do something that will benefit future patients as I have benefitted hugely from all the advances in the treatment of CML and that if it wasn't for the brave people who took part in the initial trials for TKI's then I wouldn't be here today.

Thanks very much

Daniella

Hi Daniella,
good to hear that you're doing well enough to consider stopping.

I think the EURO-SKI study has been recruiting since some time in 20l2 in several EU countries- Netherlands, France, Czech Republic, Finland, Portugal, Sweden, Germany, Norway, Denmark, Greece-
and yes, it is very similar to the STIM studies and the lead investigators are again based in France and this time in Germany. (see more details on our clinical trials page. I assume HH will open the trial soon as the first UK centre to do so?

As your side effects have been minimal, maybe it would be worth considering Prof. Apperley's offer of you following the same protocol as DESTINY?- it may be a more cautious approach but in my view it does help you assess how likely you are to hold your MR without any treatment, rather than jumping straight in with stopping suddenly and then risking the disappointment of molecular relapse.

It will be interesting to see if EURO-SKI consolidates the previous STIM trials results.

Sandy

The following might be more relevant to others on this forum, the ENEST Path study which may benefit those who have not yet reached a low enough PCR with imatinib to qualify for one of the other stopping trials. See post in red at top of this page.

Hi Daniella,

Like you, I`m not a regular contributor to the forum but after reading your post I thought it might help if I gave you an insight into my CML journey.

I was diagnosed in June 2009. I decided then to take part in a 5yr Spirit2 trial - imatinib v dasatinib. Until Dec 2013 I was on a daily dose of 100mg dasatinib. It was then my consultant advised me to take 50mg due to the side effects of pleural effusion. My PCR has been at the level of 0.003 for around 3yrs, even during the 6 months of dose reduction.By June I had completed the trial and was eager to participate in the DESTINY study but I wasn`t eligible because my medication had been reduced.However, my consultant, at HH, gave me the opportunity of completely stopping my medication and be closely monitored, every 4-6 weeks. Since June I`ve been "drug free" and feeling so much better. My PCR is a stable 0.003!

I would say to anyone who is reluctant to completely stop medication, "go for it"!- whether it be in a trial or through your consultant.

My gratitude goes to all the clinicians who have made this possible.

Sue.

My wife has been looking forward to joining the DESTINY trial ever since it was first announced. She is treated in Birmingham and when that centre recently joined the trial, she was delighted that she could start the enrolment process. With the appointment for the bone marrow aspiration made and the reduced dose Imatinib ordered, she was devasted to learn yesterday that she could not be accepted for the trial because, like Danielle, she had also spent a few months on a 600mg dose about 8 years ago.

It is very encouraging to learn that Professor Apperley has offered to allow Daniella to follow the DESTINY protocol without being part of the trial or to enter the EURO-SKI trial instead. Is anyone aware of any other UK centres making this offer? My wife really does want to try a drug free life again. Even if her counts started to rise, she would at least have given it a try.

Also it seems to us to be a win-win for the NHS because we doubt the extra monitoring would cost as much as the saving made by halving the drug dose. Any information to help persuade her consultant would be greatly appreciated.

Simon

Hi Simon... this does seem so unfair. The trial inclusion criteria is always very strict- but in this (and Daniela's) case it seems a little churlish. Over time it might be that this particular criteria may relax a little- one would hope so anyway. Especially as they seem to be having a lot of success with the dose reduction part- which as you rightly point out is a win win for the NHS. Is your wife being treated at B/ham QE? If so then they should be able to talk with Prof. Apperley and take a lead from her. It is likely to save a lot of money so they should be willing to listen I would have thought.
I will PM you about this as a possibility.
Sandy

Hi everyone,

I posted back in November that I was looking into enrolling on the EUROSKI study after Prof Apperley at Hammersmith had suggested it at my check up. We also talked about the possibility of following the DESTINY protocol as an alternative as I wasn't eligible for the study itself.

Anyway, after returning to Hammersmith in January after taking some time to think about the options, it turns out that the EUROSKI study didn't even open in the UK as they filled their quota with patients from other European countries. Fortunately, I had already decided that I would prefer to follow the DESTINY protocol anyway. So from mid January I started the 200mg dose and I am due to return to Hammersmith on Monday to have my first PCR test. One benefit from not being part of the study is that Jane is happy for me to just have the PCR done every 2 months. Fingers crossed, it will still be around the 0.003 mark.

Judging from most of the comments from those on the DESTINY study things seem to be going well for those involved, and long may it continue!!

Daniella

Hi Daniella,

Thanks for updating on your progress. I am sure you are very happy to be able to do the DESTINY protocol inspite of not being eligible for the study. Even though your data will not be included at the end of the study, your response will be logged by HH so will add to the overall knowledge base about who can reduce dose without loss of MR and/or stop.

As you say, reading the posts from those enrolled in DESTINY does give a lot of hope that a larger group than previously thought can safely reduce their dose of TKI for the longer term. This has a lot of implications - all good as far as I can see.

Regarding both EuroSki and DESTINY, both studies have been very quick to fill their required cohorts. I am not sure of how many are now in EuroSki but there are a total of 168 patients enrolled on DESTINY at 20 sites within UK, and we should see some published interim data in early Summer.

Sandy