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Autologous stem cell transplantation for soft tissue sarcoma: insufficient research into therapy
Date:12/8/2009

for example, the European Group for Blood and Marrow Transplantation (EBMT) reported a total of only 69 autologous stem cell transplants as a result of a soft tissue sarcoma diagnosis. Considering the low number of cases and the probability of a low number of clinical trials overall, IQWiG and its external experts did not limit their search to specific study types.

Although studies without a control group, such as case reports, are generally associated with a high uncertainty of results, they were included in this benefit assessment. Under certain conditions, they can help to identify dramatic effects or adverse events.

All studies were susceptible to bias

IQWiG and its external experts included a total of 105 studies in its assessment. Only 5 studies had a comparative design, i.e. each included a group receiving treatment either with or without autologous stem cell transplantation. In none of these 5 studies were the patients randomly assigned to one of the 2 groups, i.e. these were non-randomized studies. The remaining 100 studies described case series or individual cases.

Due to their design and the quality of their conduct, all studies were highly susceptible to bias. There were some contradictory results, and for this reason no robust results could be derived from the comparative studies, either.

Patients must be informed of uncertainty in quality of data

Despite the wide-ranging search for suitable studies, the evidence currently available is not sufficient to derive a possible additional benefit or harm from autologous stem cell transplantation in soft tissue sarcomas.

In IQWiG's opinion, therefore, the use of this type of therapy cannot be justified outside of controlled clinical trials. These trials would be the best way to close the gaps in knowledge and thus increase patient safety. Not all these clinical comparisons would have to be randomized trials. However, it would have t
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Contact: Dr. Anna-Sabine Ernst
info@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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