Trial: Discontinuation of dasatinib

The results of this trial represent an incredible leap forward for CML patients who, like me, are on dasatinib (sprycel). For the patients in this trial, nearly 50% who stopped dasatinib maintained a deep molecular response. The other 50% started taking tablets again and all regained a deep molecular response.

This represents a huge benefit for the patient who could, effectively, remain drug-free but it also represent an economic benefit. What was once considered an expensive drug could soon be considered a drug-for-life for only half of the patients who take it. This could be enough to present a new case to NHS England over funding.

Thanks, Kris

Taken from The Lancet haematology

Summary
Background
First-line imatinib treatment can be successfully discontinued in patients with chronic myeloid leukaemia after deep molecular response has been sustained for at least 2 years. We investigated the safety and efficacy of discontinuing second-line or subsequent dasatinib after at least 1 year of deep molecular response.

Methods
The Dasatinib Discontinuation trial was a prospective multicentre trial done in Japan. Eligible patients taking dasatinib and with confirmed stable deep molecular response were enrolled between April 1, 2011, and March 31, 2012. All patients received dasatinib consolidation therapy for at least 1 year. In those with sustained deep molecular response, dasatinib was discontinued. Patients were followed up every month in year 1 (clinical cutoff), every 3 months in year 2, and every 6 months in year 3 for deep molecular response and immunological profiles. The primary endpoint was the proportion of patients with treatment-free remission at 6 months after discontinuation. Molecular relapse was defined as loss of deep molecular response at any assessment. This study is registered, number UMIN000005130.

Findings
88 patients were enrolled in the consolidation phase, 24 were excluded from the discontinuation phase due to fluctuations in BCR-ABL1 transcript levels. One patient was excluded because of positive expression of major and minor BCR-ABL1 transcripts in chronic myeloid leukaemia cells and the detection of minor BCR-ABL1 transcripts during consolidation. Thus, 63 patients discontinued dasatinib treatment. The 25 patients who were excluded from discontinuation continued to receive dasatinib and none showed disease progression. Median follow-up was 20·0 months (IQR 16·5–24·0). Of the 63 patients who discontinued and were not excluded, 30 patients maintained deep molecular response while 33 patients had molecular relapses, all within the first 7 months after discontinuation. The estimated overall treatment-free remission was 49% (95% CI 36–61) at 6 months. No severe treatment-related toxic effects were seen. Treatment was restarted in the 33 patients with relapse; rapid molecular responses were seen in all 33 patients, of whom 29 (88%) regained deep molecular response within 3 months, as did the remaining four by 6 months.

Interpretation
Dasatinib discontinuation after sustained deep molecular response for more than 1 year is feasible.

Funding
Epidemiological and Clinical Research Information Network (ECRIN).

TKI survey on behalf of CML Advocates Network

A request from the CML Advocates Network who I fully endorse and would ask you complete the survey. Many thanks, Kris

—-

Imatinib, dasatinib and nilotinib are a tyrosine kinase inhibitors (TKIs) that have been established as effective therapies in chronic myeloid leukemia. While imatinib (marketed as Gleevec/Glivec), and in some markets nilotinib (marketed as Tasigna) as well as Dasatinib (marketed as Sprycel), have been available for some years, non-original copy versions of these drugs have also been provided to CML patients in a number of countries. With the patent ending on Glivec/Gleevec from 2013 in some markets, the use of generic TKIs in CML is becoming more and more widespread.

With the CML Horizons 2013 patient conference putting a spotlight on the situation of generics and copies in CML therapy, this survey intends to understand the availability of original TKIs and other non-original TKIs for the treatment in CML in countries all across the globe. It also aims to understand how CML patient groups are addressing the issue of quality assurance when generics and copies become available.

This survey is run by the CML Advocates Network without any commercial interest and without support from any pharmaceutical company. The results of this survey will be presented to the community at the CML Horizons 2013 meeting in May.

It should take 10-15 minutes of your time to complete the 10 questions. We would like to cover as many countries as possible – your contribution is greatly appreciated and will help us a lot!

Please respond to the survey here: http://www.cmladvocates.net/tkisurvey
(and please also respond if NO generics/copies are available in your country, which is equally important to know)

Can you please respond latest by 12 April 2013?

Many thanks and best wishes,

Jan (on behalf of the CML Advocates Network)

Freedom of Information campaign update

Just to let you know that the Freedom of Information request to all Strategic Health Authorities (SHAs) is now live. The questions we have asked are listed below, I’ll keep you up-to-date with progress.

Best,

Kris

1) How many people within your catchment area have been diagnosed with Chronic Myeloid Leukaemia (CML) in:
a) 2008
b) 2009
c) 2010
d) 2011
e) 2012

2) Is Dasatinib (Sprycel) currently on your approved list of treatments that can be funded under the Cancer Drugs Fund (CDF)?
– If not, is there any particular reason for this and could it be easily added?

3) How many applications for funding for Dasatinib did you receive under the interim Cancer Drugs Fund, between 1st October 2010 and 31st March 2011?
– Of these applications, how many were successful?

4) How many applications for funding for Dasatinib did you receive in the first year of the full Cancer Drugs Fund from 1st April 2011 to 31st March 2012?
– Of these applications, how many were successful?

5) How many applications for Dasatinib have you received in the second year of the full Cancer Drugs Fund since 1st April 2012?
– Of these applications, how many were successful?

4 written Parliamentary Questions tabled: Chronic Myeloid Leukaemia treatment

I’m happy to announce today that we have 4 written Parliamentary Questions (PQs) tabled about Chronic Myeloid Leukaemia treatment.

They can be found here, you need to scroll down to 112, 113, 114 and 115: http://www.publications.parliament.uk/pa/cm201213/cmordbk2/120713o01.htm

My local MP Mark Garnier has been kind enough to submit these and I am very grateful to him for this.

I will update you when these questions have been answered by the Secretary of State for Health. I have posted them below for information.

All my best wishes,

Kris

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, how many people were diagnosed with chronic myeloid leukaemia in (a) 2007, (b) 2008, (c) 2009, (d) 2010, (e) 2011 and (f) 2012 to date.

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, what steps his Department plans to take to ensure that chronic myeloid leukaemia patients have a wide range of treatment options (a) when newly diagnosed and (b) at the second line of treatment.

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, how many patients have received the drug Dasatinib on the Cancer Drugs Fund since the fund was created in 2010.

Mark Garnier (Wyre Forest): To ask the Secretary of State for Health, what long-term plans his Department has to ensure that those diagnosed with chronic myeloid leukaemia have access to a wide range of treatment options after the end of the Cancer Drugs Fund in 2014.

6 year follow up data on dasatinib

Another study showing positive results for patients on dasatinib after 6 years who were resistant or intolerant to Glivec (imatinib). Yet more evidence showing that we need dasatinib to offer patients a complete range of treatment.

The original press release can be found here.

PARIS, June 15, 2012 /PRNewswire/

Results Presented at 17^th Congress of the European Hematology Association

Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Europe Ltd., today announced six-year follow-up results from a Phase 3 randomised, open-label, dose-optimisation study of SPRYCEL^® (dasatinib) in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) adult patients resistant or intolerant to Glivec^® (imatinib).

Long-term survival data

The six-year data shows progression-free survival of 49.3% and an overall survival of 71% for patients randomised to dasatinib 100 mg once daily (n=167), with 6% of patients (n=10) progressing to accelerated or blast phase on study at six years of follow-up.^[1]

Safety and tolerability data from patients randomized to the 100 mg arm during the six-year follow up are consistent with the previously reported safety profile of dasatinib 100 mg once daily. In this 100 mg QD arm, the most common grade 3/4 adverse events (AEs) were (cumulative 6 year occurrence): neutropenia (36%), thrombocytopaenia (24%), and anaemia (13%).^[1] The cumulative incidence rates of the most common non-haematological AEs of Grade 3/4 at six years of follow-up were: diarrhoea (4.3%), fatigue (4.3%), infections (6.1%) and pleural effusion (5.3%).^[2]

This is the longest reported follow-up of 2^nd generation Tyrosine Kinase Inhibitors for patients resistant or intolerant to imatinib.

Safety and Tolerability at Six Years

Safety and tolerability data from the six-year study are consistent with the previously reported safety profile of dasatinib 100 mg once daily. For full information on SPRYCEL (dasatinib) please refer to SmPC at http://www.ema.europa.eu/.

These data were presented today at the 17^th Congress of the European Hematology Association in Amsterdam. (Poster 0199).

About Study CA180-034

Study CA180-034 was designed to assess the efficacy and safety of dasatinib following intolerance or resistance to imatinib. The trial enrolled 670 CP-CML patients with resistance (n=497) or intolerance (n=173) to imatinibwho were randomised to one of four treatment arms: 100 mg once daily (n=167), 50 mg twice daily (n=168), 140 mg once daily (n=167) and 70 mg twice daily (n=168). In this pre-treated population, the median time from onset of CML to randomisation in patients on the 100 mg once daily arm was 55 months and 46% of these patients had more than three years of prior imatinib treatment. Data on the primary endpoint of the study, major cytogenetic response with a minimum follow up of 6 months in imatinib-resistant patients, have been previously reported. Thirty-one percent of patients randomised to receive dasatinib 100 mg once daily remained on treatment at 6 years.^[1]

About SPRYCEL^®

Discovered and developed by Bristol-Myers Squibb, dasatinib was initially approved by the FDA and the European Commission in 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including imatinib and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) intolerant or resistant to prior therapy. In the U.S., dasatinib received accelerated FDA approval for this indication. Since then, dasatinib has been approved for this indication in more than 60 countries worldwide.

In 2010, dasatinib 100 mg once daily was approved by the FDA and European Commission for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase. In the U.S., dasatinib received accelerated FDA approval for this indication. The effectiveness of dasatinib is based on cytogenetic response and major molecular response rates. The first-line trial (known as DASISION) is ongoing and further data will be required to determine long-term outcome. Now, more than 50 countries have approved dasatinib for this indication.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukaemia in which the body produces an uncontrolled number of abnormal white blood cells.^[3] CML accounts for 15% of all leukaemias.^[4] The incidence is estimated at 1-2 cases per 100,000.^[5]

CML occurs when pieces of two different chromosomes (9 and 22) break off and attach to each other. The new chromosome is called the Philadelphia-positive chromosome, which contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. There is no known cause for the genetic change that causes CML.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 23 countries and regions around the world.

Visit Otsuka Pharmaceutical Co., Ltd. at http://www.otsuka.co.jp/en.

References: 1. Rea, D., et al. Six-year follow-up of patients with imatinib-resistant or imatinib-intolerant chronic-phase chronic myeloid leukemia (CP-CML) receiving dasatinib. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands. 2. Shah, N., et al. Six-year follow-up of patients with imatinib-resistant or -intolerant chronic-phase chronic myeloid leukemia (CML-CP) receiving dasatinib. Oral Presentation at: 2012 American Society of Clinical Oncology Annual Meeting. 3.Macmillan Cancer Support. Leukaemia Overview.   Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Leukaemia/Leukaemiaoverview.aspx. Last accessed April 2012. 4. National Comprehensive Cancer Network (NCCN). Chronic Myelogenous Leukemia – Clinical Practice Guidelines in Oncology – v.1.2007. 5. Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167.

UK job codes: 729UK12NP019 / OPUK/0612/SPC/2016, date of preparation June 2012

SOURCE  Bristol-Myers Squibb & Otsuka Pharmaceutical Europe Ltd.

Trial evidence shows that dasatinib works faster and deeper

I’m delighted to be able to share these results on the blog. The DASISION trial shows that dasatinib is more effective than imatinib. These findings prove that dasatinib works at twice the speed and with better results than imatinib and it makes the recent NICE decision and consultation completely irresponsible.
Many patients do extremely well on imatinib but this data shows how important it is to ensure our consultants have total access to dasatinib. In the meantime this serves as excellent evidence in persuading each SHA (Strategic Health Authority) to fund dasatinib locally and ensure we don’t allow this drug to become embroiled in a postcode lottery.

I urge you to, again, write to NICE and write to Sir Andrew Dillon updating them with this research and, again, ask them how they can justify their recent decisions, denying access to a drug that we now KNOW works better than the one they have recommended.

The original press release can be found here.

Results Presented at 17th Congress of the European Hematology Association;  June 14-17, 2012; Amsterdam, The Netherlands

Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Europe Ltd., today announced results from the 3-year follow-up of the DASISION trial, which show that first-line treatment with SPRYCEL(R) 100 mg results in faster and deeper response rates compared with Glivec(R) (imatinib) 400 mg [as defined by time to achieve Complete Cytogenic Response (CCYR) or Major Molecular Response (MMR)].

Additionally, an exploratory landmark analysis of the study suggests that patients with a deeper molecular response at three months (defined as having a less than or equal to 10% BCR-ABL) show a trend towards improved outcomes [such as Progression Free Survival (PFS), Overall Survival (OS) and a lower risk of disease transformation to Accelerated Phase or Blast Phase (AP/BP)] than the patients who did not achieve this level of response at three months. In this analysis, a deeper molecular response at three months was achieved in 84% of dasatinib treated patients and 64% of imatinib treated patients.[1]

“These findings are meaningful for newly diagnosed patients with Chronic Myeloid Leukaemia (CML),” said Dr Andreas Hochhaus, Professor of Internal Medicine and Head of the Department of Hematology and Medical Oncology at the Jena University Hospital, Germany. “We are now seeing that, in general, in CML an early and deep level of response to treatment appears to be associated with a lower rate of disease progression, and may be a promising indicator of better long-term outcomes for patients. However, longer follow up is needed.”

Faster and Deeper Response by 3 Months

Research suggests that achieving a deep response earlier may predict better long-term outcomes for patients.[2,3] In this 3 year follow up of the DASISION study, the median time to response (Complete Cytogenic Response, or CCYR) for dasatinib was 3.2 months vs 6.0 months for imatinib. The median time to major molecular response (MMR) was 15 vs 36 months, respectively.[4]By 3 years, MMR was achieved in 68% of dasatinib treated and in 55% of imatinib treated patients (p<0.0001)[1]

Additional exploratory analyses of the three year follow-up of DASISION show:

    - At 3 months, 84% of evaluable patients receiving dasatinib achieved less than or equal to 10% BCR-ABL levels vs 64% of imatinib treated patients (p=0.0001)[1]
    - A higher probability of 3-year PFS and OS was seen in patients achieving less than or equal to 10% BCR-ABL compared to patients who had >10% BCR-ABL levels at 3
      months[1]
    - A lower level of transformation to AP/BP was seen in patients achieving less than or equal to 10% BCR-ABL (dasatinib 3%: 6 of 198 patients; imatinib 2.6%: 4 of 
      154 patients) compared with patients who had >10% BCR-ABL levels at 3 months (dasatinib 13%: 5 of 37 patients; imatinib 13%: 11 of 85 patients) during this three year
      follow-up.[1]

Continued Tolerability at 3 Years

The overall three-year data also showed that the safety profile for dasatinib continues to be generally well-tolerated. Specifically, the data show:

    - Minimal changes in the tolerability profile at three years and with a similar pattern of adverse events as previously observed[1]
    - Rates of grade 3/4 non-hematologic AEs at 3 years in both arms remained low (0-3%)[1]
    - By the third year of treatment, 11% of patients discontinued dasatinib and 6% discontinued imatinib due to intolerance[5]

Efficacy and safety Results in the European Subpopulation

Results of an exploratory analysis of the European subpopulation (defined as patients treated in the European Union) of DASISION were also presented at the 17th Congress of the European Hematology Association. This analysis demonstrated that the efficacy and safety profile of dasatinib in the European population (170 out of 519 included in DASISION) appeared comparable to that seen in the total study population. The exploratory data for the EU subgroup show:

    - Rates of MMR (65% for dasatinib and 56% for imatinib by 3 years)[5]
    - Level of transformation; no patients treated with dasatinib vs 3 patients on imatinib had transformation of CP-CML to AP/BP at or by 3 years [5]
    - Tolerability generally consistent with previously reported at 3 years for entire population[5]

For full information on SPRYCEL (dasatinib) please refer to SmPC at http://www.ema.europa.eu.

About the DASISION Trial

The DASISION trial is a pivotal Phase 3, randomised open-label study looking at the efficacy and safety of dasatinib versus imatinibin newly diagnosed, treatment-naïve CP-CML patients. Patients were randomised to receive treatment with dasatinib 100 mg once-daily (n=259) or imatinib 400 mg once-daily (n=260).[6] Dasatinib was superior to imatinib for the primary endpoint of the study, confirmed complete cytogenetic response (cCCyR) by 12 months (77% vs 66%; p=0.007).[6] Given the established relationship between achieving CCyR by 12 months and improved survival rates, longer follow-up may demonstrate that dasatinib improves long-term outcomes.[6] Three-year data is now available. Patients will be followed for a planned 5 years.

About SPRYCEL(R)

Discovered and developed by Bristol-Myers Squibb, dasatinib was initially approved by the FDA and the European Commission in 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including imatinib and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) intolerant or resistant to prior therapy. In the U.S., dasatinib received accelerated FDA approval for this indication. Since then, dasatinib has been approved for this indication in more than 60 countries worldwide.

In 2010, dasatinib 100 mg once daily was approved by the FDA and European Commission for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase. In the U.S., dasatinib received accelerated FDA approval for this indication. The effectiveness of dasatinib is based on cytogenetic response and major molecular response rates. Now, more than 50 countries have approved dasatinib for this indication.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukaemia in which the body produces an uncontrolled number of abnormal white blood cells.[7] CML accounts for 15% of all leukaemias.[8] The incidence is estimated at 1-2 cases per 100,000.[9]

CML occurs when pieces of two different chromosomes (9 and 22) break off and attach to each other. The new chromosome is called the Philadelphia chromosome, which contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. There is no known cause for the genetic change that causes CML.

Response to treatment can be measured either by Complete Cytogenetic Response (CCYR) or Major Molecular Response (MMR). CCYR is the absence of Philadelphia+ chromosomes in a Cytogenetic Testing made from a bone marrow aspiration. MMR is a 3-log reduction of BCR-ABL compared to a standardized baseline sample usually measured in peripheral blood.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over seriousdiseases.

About Otsuka Pharmaceutical Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group has business operations in 23 countries and regions around the world.

Visit Otsuka Pharmaceutical Co., Ltd. at http://www.otsuka.co.jp/en.

References:

1. Hochhaus A, et al. Molecular response kinetics and BCR-ABL reductions in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) receiving dasatinib vs imatinib: DASISION 3-year follow-up. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands.

2 Hanfstein B, et al. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML). Leukemia accepted article preview 26 March 2012; doi: 10.1038/leu.2012.85.

3. Marin D, et al. Assessment of BCR-ABL1 transcript levels at 3 months is the only requirement for predicting outcome for patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. J Clin Oncol. 2012;30:232-8.

4. Jabbour E, et al. An exploratory analysis from 3-year DASISION follow-up examining the impact on patient outcomes of early complete cytogenetic response at 3 months and major molecular response at 12 months. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands

5. Mayer J, et al. Efficacy and safety of dasatinib vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): European subpopulation analysis of the phase 3 DASISION trial. To be presented at: 17th Congress of the European Hematology Association (EHA); June 14-17, 2012; Amsterdam, The Netherlands.

6. Kantarjian H et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010; 362:2260-2270.

7. Macmillan Cancer Support. Leukaemia Overview.

Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Leukaemia/Leukaemiaoverview.aspx . Last accessed April 2012.

8. National Comprehensive Cancer Network (NCCN). Chronic Myelogenous Leukemia – Clinical Practice Guidelines in Oncology – v.1.2007.

9. Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167.

My Story: Kris Griffin

When were you diagnosed with CML?

It was February 2008 and I was 32. I had recently started a new job in the education sector doing marketing and PR (Head of marketing & PR) for a not-for-profit academy sponsor.

How did the diagnosis come about?

The new job involved a longer commute and I was experiencing some pains in my back. I was also having night sweats and had lost a little weight which, quite frankly, felt totally insignificant. I had no idea that my body was sending out a distress signal. I went to the GP who prescribed paracetamol and wasn’t overly concerned. Still in pain I returned 4 weeks later and was tested for arthritis. The blood results returned a white blood count of 190+ and a diagnosis of CML.

What has happened since? (An outline chronology of events is fine)

After diagnosis I had a 3 day wait before seeing my consultant at Worcester hospital. My GP didn’t know anything about CML so was unable to advise what my future held; if I was going to live or die. I felt numb and then, ridiculously, proceeded to scare myself senseless on the Internet for 3 days looking at out-of-date, incorrect information. I walked in to the hospital expecting an immediate bone-marrow-transplant and a slim chance of survival and walked out with hope. My consultant spent a long time with my partner and I explaining what had happened and how we were going to treat it. He was marvellous.

I immediately made a conscious decision to be very open about my situation. Telling family was tough, telling friends, oddly, was worse. I was open with everyone about my diagnosis and encouraged people to ask questions – it seemed to help. My work was very supportive as was my partner but it felt like we were really all along for the ride. I was totally in the hands of the healthcare professionals.

To this end it appeared all I could do was cooperate, live more healthily, do what I was told and stay positive. So I got on with my life. Kelly and I got married just 7 months after diagnoses, we had been together for 12 years and the whole situation made me grow up a little. We discovered Italy after being priced out of our American holidays because the travel insurance was so expensive. We worked hard and we played hard.

In the first 3 years my body didn’t ever really take to the first line of treatment which was Glivec (Imatinib). Almost immediately I was put up to 600mg per day from the standard 400mg. Some of the side effects weren’t nice: constantly upset stomach, bone pains and tiredness. However if this drug was going to keep me alive I was going to keep at it. My consultant was brilliant, always patient, always willing to try something different or new.

Perhaps the worst part were the fairly regular bone marrow biopsies. I tend to call them a necessary evil. Marrow and bone is extracted using a long needle inserted at the top of the buttock. The flesh could be numbed using anaesthetic, the bone couldn’t. I found it extremely painful but adrenalin, good care and a 3 day recovery got me back on my feet. In the first 3 years I probably had around 12 of these. The results of these gave my consultants a birds-eye view how well I was doing on the drugs.

I didn’t spend a single night in hospital and never really considered myself sick, I was too busy getting on with things. We managed to reduce the % of Philadelphia Chromosome right down to 4% at one point but it was hard to stabilise and sometimes crept up. My consultants were determined that considering my young age, dashing good looks and general good health I really should be having a better reaction.

Under the guidance of the magnificent Professor (Charlie) Craddock at the Queen Elizabeth Hospital in Birmingham I was taken off Glivec and put on Sprycel (Dasatinib). The was a newer drug with excellent results but Glivec was my safely net and I felt very nervous. There was a chance these new drugs may not work and I’d potentially I’d be looking at a transplant.

It was just before this happened that Kelly and I decided to have a baby. My consultant had sent me off to the sperm bank 3 years previously as they were unsure what affect the Glivec would have on my sperm. We went through ICSI treatment at the Women’s Hospital at the Queen Elizabeth in Birmingham and Kelly found out she was pregnant around the same time I was switching tablets.

It was quite an uncertain time and although very recently all feels a bit of a blur to me. After 3 months of being on the Dasatinib I had a bone marrow biopsy and just a few days after returning from a short holiday to Italy I received a phone call from my Worcester consultant Mark. He was very pleased with my progress and the results showed I had achieved major molecular remission, just one step away from the best result possible which is complete molecular remission. Needless to say I am hoping I’ll hit this target after the next biopsy.

To all intents and purposes I have very little to worry about. The likelihood is that Leukaemia will not kill me. The unknown has never been so welcome to top it all off baby Luca Arthur Francesco Griffin arrived in October 2011

How have you managed to cope with CML?

Quite frankly you aren’t left with a huge choice. I was determined it wouldn’t scar me psychologically or let it define me. That’s why I told people so early. I believe the only thing you can do is look for the positives and let your survival instincts kick in. Believe it or not there are many positives.

The support and advice I received at Worcester, Kidderminster and Birmingham hospitals was amazing and still is. I was exposed to a world of care filled with many wonderful people. I stopped searching the Internet for stories about Leukaemia and got my work/life balance just right. I tried being the best person I could possibly be. The CML became secondary, I let the medical professionals worry about my treatment. I’m a fit strong 36-year-old guy with a lovely wife and 2 cats. I’m learning Italian and enjoy writing film scripts. I’ve discovered that I’m strong enough to deal with CML so it isn’t important anymore. In my mind this reduces the effectiveness of the condition.

There are many people worse off than me. People diagnosed with cancer and other horrific diseases every day. On a grand scale I am lucky. I’m still here and I tell myself that every day.

I honestly believe I am a better person because of my experience, it has made me more mature, more considered, patient and understanding towards the needs of others.

What has been the impact of CML on your life?

Before diagnosis I knew very little about Leukaemia. To me it seemed to be the worst form of cancer. I was aware that Ian Botham walked to raise money for it and Geoff Thomas had it but was OK now. It made me understand mortality, at 32, very sobering.

I’m not the impact on my life is that important, as I said before I’m along for the ride. I think it was tough for my family and friends, I know that they felt pretty helpless about what I was going through but they did all they can to support me.

I tried to avoid the highs and the lows. I didn’t sob or get depressed upon diagnosis and I didn’t celebrate remission. I took, and take, everything in my stride. I’ve tried not to let myself get caught up in emotion.

The impact on my life: I got married, I’m having a son, I discovered a new country that I love (and a football team in AS Roma) and I’ve learnt valuable life lessons. It hasn’t all been a bed of roses, of course, but I believe in hope and positivity and that’s what I’ll take from this experience.

What do you hope for the future of CML research and awareness, and what needs to change?

Doing charity work is important for those of us that can. Society should be defined by how we look after those in need. I’m in a position where I am happy to appear on TV, radio or in print and tell people to support me in my charity efforts because I have Leukaemia. It’s the least they can do. I am happy to push any emotional button I can to ensure the fundraising and awareness continues.

The anti-cancer drugs that I take are revolutionising treatment for CML. In 2001 Glivec made the cover of Time magazine as the “magic bullet” to cure cancer. I believe that this revolution will continue on to treat other forms of cancers. Haven’t we been talking about a “cure for cancer” for decades, well here it is!

What needs to change is the bureaucratic process of healthcare, government departments that are incapable of making decisions and clueless national institutes that profess to have the best interest of health at heart but in reality are simply Government puppets designed to make unpopular decisions.

Assuming we are this close to the cure shouldn’t we be saying to people like Professor Craddock in Birmingham and his medical colleagues; what do you need? How much do you need? There should not be a price on life, these decisions should not come down to budgets and spreadsheets. These are the people who will improve our lives, be remembered for truly great things. They look after our health and we must do all we can to support them. Seeing them struggle for budget and campaign for the implementation of procedure that will save lives is plain and simply wrong and this needs to change.

We owe Doctors, Nurses and Scientists everything for dedicating their lives to health-care and for looking after us, if that isn’t inspiring I don’t know what is.

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Quote from comedian Bill Hicks: “The world is like a ride in an amusement park, and when you choose to go on it you think it’s real because that’s how powerful our minds are. The ride goes up and down, around and around, it has thrills and chills, and it’s very brightly coloured, and it’s very loud, and it’s fun for a while. Many people have been on the ride a long time, and they begin to wonder, “Hey, is this real, or is this just a ride?” And other people have remembered, and they come back to us and say, “Hey, don’t worry; don’t be afraid, ever, because this is just a ride.” And we can change it any time we want. It’s only a choice. No effort, no work, no job, no savings of money. Just a simple choice, right now, between fear and love.”

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