Are Existing Data Reliable Enough to Support Using Chemo for Soft-Tissue Sarcoma?
In round 1 of the debate mediated by Brian Van Tine, MD, PhD, experts Jonathan Trent, MD, PhD, and Robin Jones, BSc, MB BS, MRCP, MD (Res), deliberated over the integrity of existing study data on the use of adjuvant and neoadjuvant chemotherapy in patients with soft-tissue sarcoma.
Listen to a preview of Dr Trent's argument defending the veracity of the limited study data that he asserts support the use of adjuvant chemotherapy in this setting.
Transcript
Dr Trent: The sarcoma meta-analysis and the combined analysis, these 2 studies are data from randomized trials, so yes, there’s going to be some biases in any trial, but the purpose of randomization is to account for biases.
And so, the 28% with unknown grade, one reason to randomize is that you would expect a normal distribution of the unknown patients such that the low-grade tumors are equally distributed in randomization, as are the tumors of different sizes, as are the different chemo-resistant histologies. And when you accept the randomization to account for the unknown, then you’ll see again there are a sarcoma meta-analysis and a combined analysis that both not only show a recurrence-free survival benefit, but also an OS benefit for chemotherapy, particularly in extremity patients. And in the Italian study, there was an early survival benefit that did not hold up over extreme amounts of time, but remember, OS is a composite end point, and it was not disease-specific survival.
