Publié sur : The European Journal of Cancer, Volume 35, suppl. 4. Page 267 - 1999
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Multicentric randomized trials for high grade osteogenic osteosarcoma (OS). Cost-effectiveness?
G. Delépine, S. Alkallaf, B. Markowska, H. Cornille, Nicole Delepine

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Multicentric randomized trials for high grade osteogenic osteosarcoma (OS). Cost-effectiveness?

Purpose:
These last 20 y. chemotherapy (CT) of patients (p.) with OS has been dramatically improved. Nevertheless dilemmas and controversies have continuously developed.

Methods:
This study of the last 20 y. tries to evaluate the benefice of randomized trials in term of DFS for p. and cost effectiveness for the community.

Results:
The literature demonstrates the following facts:
1) the multicentric trials to verify the effectiveness of CT in OS delayed the systematic
use of CT for 3 or 4 y.
2) Preliminary results of COSS 77-62 which falsely concluded that amputed p. had more chances of DFS than others, delayed the conservative surgery for 5 y.. The definitive conclusions of these trials invalidated their preliminary reports.
3) the superiority of Rosen's protocols leas been continuously challenged for 15 y., by randomized studies. But these trials didn't respect the most important backgrounds of Rosen's protocol (delay between 2 courses of MTX, individualization of MTX dose
upon evaluation of clinical efficacy, too large hydration of p. receiving MTX,
too long preoperative phase, too low numbers of MTX courses, etc.). Furthermore,
independent evaluation of T7 and TIO demonstrates, 15 y. later, that these protocols remain the most effective in OS DFS at 10 y. and the fundamental value of HDMTX became evident by macro-analysis of all published trials on this subject (Cancer, 08/1996).

Conclusion:
In OS, multicentric trials led always to worse results than pilot studies performed in big centers. They served only to convince reticent medical community of the necessity of CT in OS. In the same time, many p. let their limb or/and their life because of these bad trials.

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