Randomized clinical trials in soft tissue sarcoma.

What has been learned thus far from the very best prospective randomized controlled clinical trials for soft tissue sarcoma that will guide physicians in the quest for evidence-based treatment decision making? Based on the evidence provided in the following articles, we have learned that limb-sparing surgery with adjuvant radiation is equivalent (and therefore preferable) to a radical amputation in controlling local disease. We also learned that adding radiation therapy (both external beam and brachytherapy) to a complete surgical resection of extremity soft tissue sarcoma significantly improves local control over surgery alone. This is true for high-grade lesions and may be true (external beam) for larger low-grade lesions also. Local control, however, does not govern overall survival as most patients who die from this disease do so from systemic (not local) manifestations. Finally, further studies are required to identify the role of adjuvant chemotherapy in the treatment of soft tissue sarcoma as no single study has demonstrated a consistent long-term survival benefit with the use of any chemotherapeutic regimen. Based on a recent large meta-analysis, however, if there is any benefit to adjuvant doxorubicin based chemotherapy, it must be a very small one.