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Autologous Bone Marrow Transplantation - Blog Science Connections

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International Randomized Trial in Non-Hodgkin's<br />

Lymphoma in Relapse<br />

F. Chauvin, A. Leizorovicz, Y. Alamercery, C. Lasset, Z. Abdelbost,<br />

and T. Philip<br />

For a decade, high-dose chemotherapy with autologous bone marrow transplantation<br />

(ABMT) has been used as salvage therapy in non-Hodgkin's<br />

lymphoma at relapse to increase the response and survival rates using the<br />

dose-effect relationship. In the same way, conventional regimens have been<br />

administered and a good response rate observed with acceptable toxicity.<br />

The results of high-dose therapy with ABMT (30% of patients surviving free of<br />

disease at 2 years) seem better than those obtained with conventional therapy<br />

(5-10% surviving free of disease at 2 years). However, it is obvious that the<br />

ABMT group is carefully selected and exclusive and not comparable with<br />

groups that include all patients who relapse, the typical organization of<br />

groups in conventional therapy studies. Although these two therapeutic<br />

strategies are equally used, their efficacies and toxicities have never been<br />

compared properly in a randomized clinical trial. Now this comparison is<br />

slated to be the objective of a phase III international randomized trial. In such<br />

a trial, several steps must be carefully considered by methodologists and<br />

statisticians; selection of patients, method of randomization, and method of<br />

evaluations can cause biases and invalidate results.<br />

335

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