Abstract
Results of clinical studies are often contradictory in real time, and in other instances therapies may be adopted due to information from clinical studies where the data may be premature or resulting from small studies. Much of the data may have inherent selection biases, and their interpretation may be confusing and difficult. The hematological literature is full of such examples, and this review will describe some such instances in the hope of introducing both a cautionary note and encouraging more precise description of study conditions as well as an appreciation of the importance of allowing data from clinical studies to mature. Several examples will be drawn from clinical studies in lymphomas, leukemia, and bone marrow transplantation.
Highlights
Results of clinical studies are often contradictory in real time, and in other instances therapies may be adopted due to information from clinical studies where the data may be premature or resulting from small studies
Preliminary data, presented at international meetings in 1992 and 1993 (Figure 3), were widely interpreted as demonstrating that high-dose therapy with autologous transplantation did not provide a significant improvement. This created quite a stir in the transplant community until the definitive results from the trial were published in the New England Journal of Medicine in 1995, demonstrating that, compared with conventional chemotherapy, treatment with high-dose chemotherapy followed by autologous bone marrow transplantation increases the survival in patients with chemotherapy-sensitive relapsed lymphoma (Figure 4)
The problem here relates to data published in the late 1980s and the 1990s, which indicated that using virtually identical drug regimens the complete remission rate varied from 55% to 60% among the Southwest Oncology Group (SWOG) in the US, 65%–70% among the Eastern Cooperative Oncology Group (ECOG) in the US, 70%–75% in the Cancer and Leukemia Group B (CALGB) in the US, and 75%–85% in Medical Research Council (MRC) in Britain (Table 2)
Summary
Interpreting Outcome Data in Hematological Malignancies: A Paradigm for Clinical Studies. M.D.* Department of Hematology, Shaare Zedek Medical Center, Jerusalem, Israel; Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, Haifa, Israel; and Technion, Israel Institute of Technology, Haifa, Israel
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