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EVIDENCE-BASED-HEALTH  June 2006

EVIDENCE-BASED-HEALTH June 2006

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Subject:

Re: evidence based oncology

From:

"Djulbegovic, Benjamin" <[log in to unmask]>

Reply-To:

Djulbegovic, Benjamin

Date:

Sat, 17 Jun 2006 13:09:24 -0400

Content-Type:

text/plain

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Felice, this is a key (if not THE key) issue in modern practice of medicine (oncology including): WHAT should we study? In other words, who should be controlling the RESEARCH AGENDA? As you have alluded, there is increasing dissonance between what is studied and what is actually needed (by patients and practitoners like you and me). Sponsors typically favor generation of one type of evidence, while the users of evidence need different types of answers. Increasingly, calls are being made to define research priorities. Unfortunately, I don't see this happening any time soon. In the mean time, I am afraid you will be proved correct: we will have another permutation on the theme (of trastuzumab, in this case) with no real answers.

I wonder what other folks on the list think about defining research priorities? Perhaps this list can help catalyze such a list and then share with the rest of scientific community? So, I am proposing that others respond to your challenge: in your field of interest, what is the research problem (priority) that you'd like to be addressed?

thanks for your stimulating thoughts

best

ben



________________________________



From: Felice Musicco [mailto:[log in to unmask]]

Sent: Sat 6/17/2006 5:58 AM

To: Djulbegovic, Benjamin; [log in to unmask]

Subject: R: evidence based oncology





hi Ben, thanks for your answer.

My question was from the patient point of view. 

>>The guidelines then list 3 chemotherapy regimens equally acceptable for the use together with trastuzmab

You, as me, are working in a research oncological institute. Do you know if are there in progress (non sponsorized or sponsorized) phase III study to decide which is the most effective and less harmful regimen? Isn't this a relevant question from the patient perspective? Are we waiting the next phase II sponsorized study that will bring to 4 the list of chemotherapy regimens equally acceptable for the use together with trastuzmab? This is the point I'd like to challenge.

best 

Felice







	-----Messaggio originale-----

	Da: Evidence based health (EBH) [mailto:[log in to unmask]] Per conto di Djulbegovic, Benjamin

	Inviato: martedì 13 giugno 2006 19.01

	A: [log in to unmask]

	Oggetto: Re: evidence based oncology

	

	



	Hi, Felice



	The question you asked is "bane" of EBM: what to do when the field is rapidly evolving and commercial pressures are such that early adoption of insufficiently proven therapy has been so fast that the majority of physicians have already changed their practice?  If your question is asked from the perspective of the need to make a policy decision related to reimbursement and the use of this expensive drug, then commissioning a (rapid) systematic review to assess what we really know and what we don't know in terms of benefits/harms for the most important patients' outcomes is the way to go. If the question is asked from the point of view of a practitioner who needs to make this decision today or tomorrow, then you don't have other recourse but to consult "experts" in the field. For example, the NCCN guidelines (http://nccn.org/professionals/physician_gls/PDF/breast.pdf), consensus guidelines of the leading 20 cancer institutions in the US, will tell you to use  trastuzumab +/- chemotherapy. The guidelines then list 3 chemotherapy regimens equally acceptable for the use together with trastuzmab. (One of advantages of the consensus guidelines is that can be updated faster than EBM guidelines. This indeed is the case with the NCCN guidelines that are updated annually). If the health system cannot afford this treatment, then it should perform cost-effectiveness analysis (based on the systematic review of totality of relevant evidence) to assess if spending the resources on this non-curative treatment is worthwhile...



	 



	Unfortunately, there is no easy and quick answers here...until there is more funding for EBM (including funding to regularly update systematic reviews as the new evidence is generated) people will have to make their judgments and decisions on the imperfect information (not that evidence is ever perfect...)



	 



	Hope this helps



	 



	best



	 



	ben



	 



	Benjamin Djulbegovic, MD,PhD 

	Professor of Oncology and Medicine 

	H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida Department of Interdisciplinary Oncology, MRC, Floor 2,Rm# 2067H



	12902 Magnolia Drive 

	Tampa, FL 33612 



	e-mail:[log in to unmask] 

	http://www.hsc.usf.edu/~bdjulbeg/ <http://www.hsc.usf.edu/~bdjulbeg/>  

	phone:(813)972-4673 

	fax:(813)745-6525 



	 



	

________________________________





	From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Felice Musicco

	Sent: Tuesday, June 13, 2006 11:49

	To: [log in to unmask]

	Subject: evidence based oncology



	 



	hello,



	this is a question for everyone is interested in EBoncology and particularly for Ben Djulbegovic. 



	I should like receive an "evidence based" opinion about the use of trastuzumab+vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer. I found only phase II trials. I didn't find comparison trial between trastuzumab alone after chemio and trastuzumab + vinorelbine.



	In your guidelines do you consider trastuzumab after chemio or others protocol in first-line therapy for HER2-overexpressing metastatic breast cancer?



	I know combining trastuzumab+vinorelbine is largely used by oncologist.



	Do you use trastuzumab in combination with paclitaxel only for women with tumours with excessive human epidermal growth factor receptor 2 (HER2) at levels of 3+ who have not had chemotherapy for metastatic breast cancer and for whom anthracycline treatment is inappropriate?



	What do you think about the problem that the formally health system authorized indications of chemotherapy drugs are often not updated? Can we say that this is evidently correct?



	thanks in advance



	Felice



	 



	1: J Clin Oncol. 2003 Aug 1;21(15):2889-95. Related Articles, Links  



	Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm.



	Burstein HJ, others



	1: J Clin Oncol. 2001 May 15;19(10):2722-30. Related Articles, Links  



	Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer.



	Burstein HJ



	1: Oncologist. 2002;7(5):410-7. Related Articles, Links  



	Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2(+) metastatic breast cancer.



	Jahanzeb M, others



	 



	_________________________________



	Dott. Felice Musicco



	Hospital Pharmacist in an oncology research hospital in Rome, Italy



	Resp. Attività di Farmacovigilanza IFO e Flusso Informativo F



	tel. +39 06 52662047



	fax +39 06 52665123



	email [log in to unmask] <mailto:[log in to unmask]> 



	http://www.ifo.it/IFO.3B02363D.RUN <http://www.ifo.it/IFO.3B02363D.RUN> 



	<mailto:[log in to unmask]>  



	 



	

________________________________





	





	

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