Trial Suggests Imatinib Discontinuation Safe, Some Responses Persist

More positive news on World CML day – we need to keep working towards a cure. K

Trial Suggests Imatinib Discontinuation Safe, Some Responses Persist

Evidence continues to mount that discontinuing imatinib treatment for chronic myeloid leukemia (CML) in the chronic phase is safe. A new phase II Dutch and Belgian study showed only about two-thirds of patients relapsed after discontinuing treatment with imatinib and cytarabine, and all patients remained sensitive to imatinib after relapse.
Tyrosine kinase inhibitors including imatinib have revolutionized CML treatment in recent years, but the need to continue treatment indefinitely is limiting. Several recent studies have begun to suggest that alternate treatment schedules or discontinuation of therapy are feasible among patients with good molecular responses. In a study of the Dutch-Belgian Cooperative Trial for Haemato-Oncology, researchers led by Noortje Thielen, of the VU Medical Center in Amsterdam, 33 patients with a molecular response lasting at least 2 years on imatinib and cytarabine combination therapy were randomized to either continue (18 patients) or cease (15 patients) imatinib treatment. Results were published online ahead of print in July in the European Journal of Cancer.

After a median follow-up period of 36 months, three patients randomized to continue treatment (17%) and 10 patients in the discontinuation arm (67%) had a molecular relapse; all three of the former patients had stopped imatinib treatment after randomization.

The molecular relapse rate at 12 months was 0% in the continued therapy group and 53% in the discontinuation group; at 24 months, those rates were 6% and 67%. In an as-treated analysis (accounting for the patients who ceased treatment in spite of randomization to continue imatinib), the two-year rate was 61% for discontinued therapy and 0% for continued imatinib.
The five patients in the discontinuation group who did not relapse showed a stable molecular response. The 13 patients who relapsed all regained molecular response after a median of 6 months from the restart of imatinib or nilotinib treatment.

“To our knowledge, this is the first randomized trial regarding the discontinuation of imatinib in first chronic phase CML patients who have achieved a durable and stable molecular response,” the authors wrote. “Our results are encouraging.” They noted that the addition of cytarabine to the initial regimen may have contributed to the persistence of response after therapy discontinuation, but that remains unclear.

Further studies on this issue will need to define predictive factors for successful discontinuation of imatinib, as well as of other TKIs including nilotinib and dasatinib, the researchers wrote. “Although imatinib treatment was previously expected to be life-long, our data suggest that, under close PCR monitoring, discontinuation of imatinib is safe in CML patients with a long-lasting molecular response,” they concluded.

http://www.cancernetwork.com/chronic-myeloid-leukemia/content/article/10165/2157668

Leukaemia and Lymphoma Research Impact Day 2013

It was all about the ‘c’ word wasn’t it? No not cancer, the other one. Yes, CURE.

We had to wonder what Leukaemia and Lymphoma Research (LLR) were up to when it was announced they weren’t going to have an annual conference this year and instead have an Impact Day. What would the impact be? Were we simply victims of yet another marketing experiment to re-brand what we already knew? No. This was a day filled with hope, emotion, researchers, scientists, (the) Calendar Girls, volunteers, patients and the amazing staff at LLR. Credit has to be given to, Chief Executive, Cathy Gilman who has energised the charity, brought everyone together and invested in a challenging vision.

There was a distinct split between the morning and afternoon sessions and the morning documented how far blood cancer treatment had come. The day opened with the inspirational Daisy Turner, a transplant patient now in remission, who set the scene. I was privileged to have been asked to speak along with another patient Federica Nardella, a lymphoma patient. We provided the personal stories, first hand, for Dr Emma Morris and Professor David Grimwade, research scientists for LLR, who are the most engaging, lovely people you could wish to meet. We spoke about the magnificent treatment advancements, in particular the targeted therapies which are saving lives, like mine, and revolutionising the blood cancer battle. It was a humbling moment for me to be able to talk to an audience of fund-raisers and supporters whose efforts saved my life and given me a son. Only through the hard work of professionals like my consultant Charlie Craddock, Dr Emma, Professor David and Research Director of LLR, Chris Bunce, I got my life back. I’m just one voice, there are thousands. It’s that important.

It was fiercely obvious the afternoon was about business, not the dull stuff bathed in facts and figures, but where the charity is going next. Even though treatment has been revolutionised: more and more patients are being treated successfully, dare I say cured, the charity told us they are steadfast in not stopping until everyone is saved. I was particularly captivated by one of their mission statements which proclaimed, “We stop people dying from blood cancer“. Brave, bold and scary all at the same time. All of the work and methodology over the next 5 years is heading towards finding cures, making the lives of patients better and being daring. Yoda in the The Empire Strikes Back said, “Do or do not, there is no try” – whilst proving my geek credentials I also believe this is the direction LLR are taking. There is no middle ground here, they will either cure blood cancers or they won’t. If they don’t the progress made whilst trying is worth the effort and contemplation alone.

So at last we have a charity who are trying to do what is said in their literature: beating blood cancers. The room was invigorated, people filed out with renewed drive and determination. I felt like we were all part of something very special and what made this extra special was that there wasn’t a politician or bureaucrat in sight telling us we couldn’t do it. I don’t think they’d dare. There was grit and conviction and most importantly belief. Bravery too and the courage to make a real Impact on a perfect Day.

Me with the AMAZING Calendar Girls.

Me with with Dr Emma Morris.

Me with Federica Nardella.

Me on stage with Dr Emma Morris

Cancer Drug Fund Running Dry

The Cancer Drug Fund (CDF) is big news today, it’s all over the news and as I type this I am waiting for my local BBC radio station to call for an interview. The problem is that
this story has been brewing for a long time now and as we approach the moment funding will run out in 2014 the panic has started to set in.

The £650 million fund has paid for treatment for over 28,000 patients nationally since 2010. This is money the Government has set aside to pay for cancer drugs that haven’t been
approved by NICE (National Institute for Health and Care Excellence) and aren’t available within the NHS in England. For some it brings quality of life, others it gives precious time and for many it is truly life-saving.

The drug that I take for my leukaemia is called dasatinib. I receive it through the NHS, free at the point of delivery, as I should. But recently, since a change in NICE  guidelines, dasatinib is only available to patients who apply for it through the CDF. There are alternative treatments available but by restricting access we are restricting progress and potentially putting lives at risk. For patients who rely on the CDF for their medication this news will bring cause for concern and unnecessary worry on top of a cancer diagnosis.  They don’t know how their drugs will be funded post-2014 and no-one is reassuring them.

When I managed to catch up with Shadow Secretary of State for Health Andy Burnham MP and Secretary of State for Health Jeremy Hunt MP before Christmas neither man was willing to commit to extending the funding for the CDF and nearly 4 months later we still don’t have an answer or an alternative. I have written to both men and am still waiting for a response.

I am getting support. My local MP Mark Garnier, as always, is being very helpful as is the All Party Political Group (APPG) on Cancer. I hope that today is the start of the real pressure. Laura Weir, head of policy and campaigns at the MS Society and chair of the Patients Involved in NICE group, concerns me with her view that other conditions needed to be considered too. I wonder if Laura is aware that dasatinib is currently considered a breakthrough treatment for MS (see link here) and without the CDF no one would receive it, no funding, no drugs, no progress, no cures. For once I believe that we really are all in this together.

There is no point in us all fighting over funding, this is healthcare and if it benefits the patient we must all get behind it. 1 in 3 of us will be affected by cancer at some point in our lives, I was 32 when I was diagnosed. Those numbers are too high for us to sit back and do nothing.

I implore the Department for Health to either extend the CDF or provide us with plans for a real alternative now.

www.news.sky.com/story/1073672/cancer-drugs-fund-patients-to-lose-out
www.bbc.co.uk/news/health-22013399

Cancer Drug Fund usage from October 2010 – October 2012

Foreseeing a Cure for CML – interview with Dr. Baccarani

Many patients with CML are now living well while taking powerful medicines that keep the disease in check. Researcher Dr. Michele Baccarani, from Italy, thinks that even a few years of taking medicine could enable some patients to cease therapy and remain in overall good health. For other patients, concern still remains in those who develop resistance to today’s approved medicines, cannot tolerate the effects of the medicine or develop the T315i mutation. In this interview from the Controversies in Hematology 2012 in Barcelona, Dr. Baccarani explains his hope for these patients with the use of Ponatinib.

Source: Patient Power

New Data Confirm Safety of Stopping Imatinib in CML

I’m making a supposition here. IF the 40% of patients who come off imatinib stay in remission this is great news. But what could be even more interesting is if that figure could rise given the deeper response dasatinib and nilotinib bring. As I have said many times before this is the start of our cure and that NICE doesn’t recognise this and doesn’t see this treatment as “cost effective” is criminal.

Kris

New Data Confirm Safety of Stopping Imatinib in Leukemia
IMNG Medical Media. 2012 Jun 26, S Freeman

AMSTERDAM (EGMN) – Stopping imatinib in patients who have achieved stable remission of chronic myeloid leukemia for at least 2 years appears to be a safe therapeutic strategy, according to updated results of the Australasian Leukemia and Lymphoma CML-8 trial.

“Approximately 40% of patients who had been in a stable complete molecular response and stopped their treatment are in a complete molecular response with a median follow-up of 3 years,” said consultant hematologist Dr. David Ross in an interview at the annual congress of the European Hematology Association.
As of April 2012, 18 of 40 patients remained in stable complete molecular remission (CMR) while off treatment. Although 22 patients had a molecular recurrence at some point after imatinib (Gleevec) withdrawal, they all responded to the reintroduction of imatinib, with most patients rapidly regaining CMR.
These data build on those already released from the STIM (Stop Imatinib) trial (Lancet Oncol. 2010;11:1029-35) and the STOP 2G-TKI study, which have also shown that imatinib, dasatinib (Sprycel), and nilotinib (Tasigna) withdrawal is a feasible therapeutic strategy for some patients with chronic myeloid leukemia (CML).

The CML-8 trial involved 40 adult patients who had been treated with imatinib for at least 3 years and were in CMR for at least 2 years. CMR was defined as no detectable BCR-ABL mRNA as determined by real-time quantitative polymerase chain reaction (RT-PCR) analysis. The latter was checked every month during the first year after imatinib withdrawal, every 2 months in the second year, and then every 3 months for up to 5 years of total follow-up. The last patient entered the trial in 2011, so further data from the trial are likely in the future.
“We’ve not seen any relapses later than 2 years,” said Dr. Ross, of SA Pathology and Flinders Medical Centre in Adelaide, Australia.

read full article here:
www.oncologystat.com