Bisogno G, De Salvo GL, Minard-Colin V, Davila Fajardo R, Coppadoro B, Jenney M, Ferrari A, Hladun Alvaro R, Dall’Igna P, Glosli H, Merks JHM. EJC. 2023 May doi: https://doi.org/10.1016/j.ejcped.2023.100014
Clinical trials for pediatric rhabdomyosarcoma (RMS) include specific rules to ensure patient safety and reduce variability. However, it’s not clear how children who don't meet these rules fare. This study looked at the eligibility criteria used in the European paediatric Soft Tissue Sarcoma Study Group RMS2005 trial and compared the outcomes of patients who didn’t qualify for the trial.
Between October 2005 and December 2016, the RMS2005 trial had strict rules: patients had to be 25 or younger, have confirmed RMS without metastases, have not received prior treatment, and had to start treatment within 8 weeks of diagnosis. The study examined the clinical details and survival rates of both eligible and non-eligible patients.
Out of the patients registered, 79 did not meet the eligibility criteria. These non-eligible patients were generally older and had RMS in less challenging locations, with their tumors fully removed at diagnosis. Their 5-year progression-free survival (PFS) and overall survival (OS) rates were slightly lower compared to eligible patients, but not significantly so. Notably, those who had delays in starting treatment or had been pre-treated fared better than those with existing conditions.
The findings suggest that data on non-eligible patients should be systematically gathered. This approach might help adjust trial criteria to improve patient inclusion without compromising the results, potentially enhancing the applicability of the findings to a broader population.
Between October 2005 and December 2016, the RMS2005 trial had strict rules: patients had to be 25 or younger, have confirmed RMS without metastases, have not received prior treatment, and had to start treatment within 8 weeks of diagnosis. The study examined the clinical details and survival rates of both eligible and non-eligible patients.
Out of the patients registered, 79 did not meet the eligibility criteria. These non-eligible patients were generally older and had RMS in less challenging locations, with their tumors fully removed at diagnosis. Their 5-year progression-free survival (PFS) and overall survival (OS) rates were slightly lower compared to eligible patients, but not significantly so. Notably, those who had delays in starting treatment or had been pre-treated fared better than those with existing conditions.
The findings suggest that data on non-eligible patients should be systematically gathered. This approach might help adjust trial criteria to improve patient inclusion without compromising the results, potentially enhancing the applicability of the findings to a broader population.
