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Pautier, Patricia; Tanguy, Marie-Laure; Archambaud, Baptiste
The lancet oncology, October 2022, 2022-10-00, 20221001, Volume: 23, Issue: 10Journal Article
For the clarification of the immaturity of overall survival, the analysis was done when the number of events required to provide 80% power to the primary analysis (progression-free survival) was reached. To respond to Sütcüoğlu and colleagues’ concerns about the effect of surgery and maintenance treatment on results, we did a Cox regression analysis that included the following variables: surgery as a time-dependent covariate, treatment group, and stratification factors. Because the toxicity was as expected, we reproduced the same schedule in the phase 3 study.1 In response to Sasi and colleagues, we agree with their remarks, but sarcomas are heterogenous diseases with different responses to therapies, different evolutions even when metastatic, and some patients, even with metastatic disease, could have a curative intent to their treatment for these particular diseases (eg, young patient with oligometastatic disease); hence, a small decrease in their quality of life, lasting about 5 months with doxorubicin combination treatment, could be acceptable.
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