Posted 5/1/2012 6:43 AM (GMT -5)
Did anybody listen ?
In the TAX327 trial 1006 patients with metastatic hormone-resistant PCa were treated with docetaxel (Taxotere, Aventis) or mitoxantrone (Novantrone , Immunex and Wyeth-Ayerst) chemotherapy. After about 1.5 year of treatment 557 of them were dead (August 2003). Publication of the results took more than a year (October 2004, in N Eng J Med 351(15),pp. 1502-1512), and this publication currently has 2182 citations (Google). First author: Dr. Ian F. Tannock from the University of Toronto, Canada. Let me quote some lines from this document.
• The study was designed by Dr. Tannock in collaboration with Aventis personnel,...
• The data were collected and maintained by Aventis,...
• Aventis personnel undertook the statistical analysis.
• The article was drafted by Dr. Tannock and modified after being reviewed by the cochairs and other coauthors.
• Aventis reviewed the manuscript, but its final content was entirely determined by the investigators.
• (the trial was) Supported by Aventis.
And 8 of the 12 authors reported that they had received payments (grant support, consulting fees, etc.) from Aventis. I think that Aventis did not take much risk in assuring that the conclusions were in their favour. N.B. Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo acquired Aventis (a bid of €54.5 billion). The company dropped the -Aventis suffix of its name on 6 May 2011. Revenue of Sanofi in 2010: €30.38 billion, operating income €5.961 billion (info from Wikipedia).
November 2004 the Dr. F. Joly and Dr. Ian F. Tannock, both from the University of Toronto, Canada, wrote an Editorial in the Annals of Oncology 15(11), pp. 1582-1584: 'Chemotherapy for patients with hormone-refractory prostate cancer'. In this Editorial dr. Tannock and his colleague reflect on the TAX327- as well as on the SWOG9916 trial (where 770 patients received docetaxel plus estramustine or mitoxantrone). Their conclusions: The results of these two important trials will probably change the standard of care in patients who present with symptomatic HRPC. However,
• the modest gain in median survival (2-3 months) obtained with docetaxel needs to balanced against the side-effects and cost of the treatment.
• Residual questions from these trials are: (i) could some of benefits in the docetaxel arms be due to the higher doses of steroids (i.e. dexamethasone) used in the preparative regimes; and,
• (ii) ... could equivalent results be obtained by initiating the cheaper and less toxic mitoxantrone, and crossing over to docetaxel in patients who do not respond after two or three courses ?
• The results of the randomised trials described above should be presented to patients, so that they understand the significant but small survival benefit from docetaxel and prednisone, and the toxicities encountered with this regimen. This will allow an informed choice between starting with a less toxic regimen(mitoxandrone and prednisone for most, ..., versus immediate treatment with docetaxel and prednisone.
So, my dear Dr. Tannock, did they listen to your second-thoughts, honest, 'unsupported' opinion ? No, I have never seen them mentioned anywhere. The pharmaceutical industry sponsors conferences and seminars to bring oncologists up to date with their latest products and that is what we then get.