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Posts tagged ‘European Hematology Association’

The patient advocacy session at the recent 16th Congress of the European Hematology Association in London focused on adherence to cancer treatments, and was filled to capacity, with the many attendees having to watch it from an overflow area.

Dr David Marin, Reader in Onco-Haematology at Imperial College, London presented research published last year in the Journal of Clinical Oncology that dramatically demonstrated how adherence to chronic myeloid leukemia (CML) therapy is the critical factor for achieving molecular responses.

In a study of 87 CML patients taking imatinib (Glivec®/Gleevec®) for a median period of 91 days, Dr Marin showed that no major molecular response (MMR) was observed when adherence was ≤ 80% and no complete molecular responses (CMR) were observed when adherence was ≤ 90%.  The graphical figure that he presented from his paper, dramatically shows how missing only a few doses of drug can have a major impact on outcome:

Source: Marin D, et al.  J Clin Oncol 2010; 28(14):2381-2388

Although the work by Marin and colleagues at the Hammersmith Hospital was undertaken with CML patients taking imatinib, the paper notes that adherence problems

“may apply equally to patients receiving second-generation tyrosine kinase inhibitors.”

Imatinib is the only TKI approved in the UK, thus that’s the only one available for studies there to date.

What made this data so compelling was the study rationale that used an electronic pill container, the medical event monitoring system (MEMS™) from the Aardex Group. This product contains a microchip that records the date and time it is opened.

Dr Marin’s study showed that “lack of adherence is underestimated by conventional methods.”  Self-reporting of adherence and pill counts are inaccurate compared to electronic data capture using MEMS (study subjects were unaware of the micro-chip in the pill bottle).

When psychologists at the Hammersmith Hospital subsequently interviewed patients who missed doses of drug, they found intentional and non-intentional adherence reasons.

A few excepts of  patient quotes from Dr Marin’s presentation:

Intentional non-adherence:

“Oh I can’t be bothered tonight, it’s not going to kill me [to miss a dose]”

“I thought there was no way I was going [on holiday] and being tired.”

Unintentional non-adherence:

“And sometimes you just forget”

“[the pharmacy] had no medication for me, so I went for nearly a week with no medication.”

Other speakers in the excellent patient advocacy session chaired by Jana Pelouchová (European Cancer Patient Coalition, Czech Republic) and Jan Geissler (CML Advocates Network, Germany) included Giora Sharf (Israeli CML patient’s Organization and CML Advocates Network, Israel) and Professor Rudolf Schoberberger (Medical University of Vienna, Austria).

Professor Schoberberger focused on the impact of drug packaging on compliance, particularly in elderly patients, and presented compelling research on how “child-proof” equals “age-proof.”  Sally Church in her video blog from EHA also discusses the patient advocacy session and how pharma/biotech companies could improve drug packaging.

The issue of adherence is a personal choice that every patient taking a chronic therapy makes. However, as Sally notes on Pharma Strategy Blog more patient and physician education is needed so that patients know there may be dramatic consequences from missing only a few doses per month.

Not only may adherence have a major impact on patient outcome, but as one questioner from France pointed out at the end of the EHA patient advocacy session, “for a statistician it is a nightmare.” Poor adherence in clinical trials “means that the true effect of a drug is not well known. Efficacy may be under-estimated if adherence is low.”

More monitoring of adherence in clinical trials through the use of MEMS technology may, therefore, be necessary to ensure that clinical trial data shows the true efficacy and adverse event profile of a drug.

I hope that the European Hematology Association (EHA) will make a webcast of this informative patient advocacy session publicly available online as it raised issues of considerable importance to patients, physicians and biotech/pharma companies alike.

ResearchBlogging.orgMarin, D., Bazeos, A., Mahon, F., Eliasson, L., Milojkovic, D., Bua, M., Apperley, J., Szydlo, R., Desai, R., Kozlowski, K., Paliompeis, C., Latham, V., Foroni, L., Molimard, M., Reid, A., Rezvani, K., de Lavallade, H., Guallar, C., Goldman, J., & Khorashad, J. (2010). Adherence Is the Critical Factor for Achieving Molecular Responses in Patients With Chronic Myeloid Leukemia Who Achieve Complete Cytogenetic Responses on Imatinib Journal of Clinical Oncology, 28 (14), 2381-2388 DOI: 10.1200/JCO.2009.26.3087

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European Hematology Association (EHA) Congress London 2011At the 16th Congress of the European Hematology Association (EHA) that was held in London this past weekend, the educational sessions were extremely well attended.

The reason for this was the quality of the thought leaders who presented on science and emerging treatments.

The quality of the education sessions and the fact they are repeated twice, so you can avoid schedule clashes, is one of the things I particularly like about both the American Society of Hematology (ASH) and European Hematology Association (EHA) annual meetings.

As I have written before while at EAU in Vienna, I’m not a fan of promotional satellite symposia.  As an example on the Thursday before EHA, attendees interested in CML could attend the Novartis symposia in the morning about how nilotinib was better than imatinib, then in the afternoon attend the BMS sponsored symposia to hear how dasatinib was also better than imatinib.  Indeed, two of the speakers were identical in both symposia, but with entirely different messages.

Two other satellite symposia also had speakers talking about second-generation tyrosine kinase inhibitors.  What, of course, was on everyone’s mind was when to use one second-generation TKI over the other?  Also given that imatinib is reimbursed in many countries, while nilotinib and dasatinib are often not yet available in that setting, the issue of how to treat patients second-line with these therapies was also a hot topic.

However, just attending the individual company-sponsored symposia, to me, meant that it was hard to put together a big picture of exactly what to do when.  Perhaps a better way to handle it would have been to have one CML satellite symposia sponsored by all the companies with a dog in the race (Novartis, BMS, Ariad, Pfizer). We might have heard what the experts really thought that way. 🙂

The other issue that arose during the meeting is how data is presented when looking strategically at one treatment or trial to another in the same indication.  Are you truly comparing apples with oranges?

M Baccarani European Hematology Association Congress London 2011As Professor Michele Baccarani pointed out, there is a big difference between data that shows a cytogenetic or molecular response “BY” a certain time as compared to “AT” a certain time.

“BY” can include patients who had a response then went in remission, so could present a higher number than “AT” data that shows only those patients who have a response at that cut-off date.  This is an important distinction, for example, when comparing data from the BMS DASISION trial and Novartis ENESTnd trials to long-term survival data for imatinib versus interferon-alpha from the IRIS trial.

So, it was left to the EHA education symposia to provide some practical guidance.  In an excellent presentation, Hagop Kantarjian M.D. from MD Anderson provocatively presented his CML treatment guidelines, and discussed when you would use one drug over the other along with the importance of routine monitoring to evaluate how well a patient was doing on therapy.

Webcasts from the EHA education sessions will be available online soon and are well worth watching if you were unable to be in London this past weekend.

 

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