Statistical analysis
death
DISEASE PROGRESSION, EVENT, METASTASIS
The efficacy population included all participants who met the eligibility criteria and who received at least one complete or two incomplete treatment cycles. All enrolled patients who initiated the study treatment were included in the safety analysis.PFS was defined as the time from the date of metastasis diagnosis to the first recorded evidence of disease progression by RECIST, clinical evaluation or death. OS was calculated as the time from the date of metastasis diagnosis to the date of death. The median follow-up was calculated using the reverse Kaplan–Meier method, and survival endpoints are described using the Kaplan–Meier method. Data for patients who were alive and event free were censored at the date of last follow-up. Survival probabilities were estimated using the Kaplan–Meier method, and survival curves were compared using the log-rank test. The 95% CIs for fractional survival at any particular time were added to survival curves. Univariate Cox proportional hazard models were performed to estimate the HR and 95% CI to test the association of the different variables with OS and PFS.Quantitative variables are described as median and range. Qualitative variables are described using number, percentage and the 95% CI (binomial law). Estimated parameters are reported with two-sided 95% CIs. Calculations were performed using high-performance computing resources from DNUM CCUB (Centre de Calcul de l’Université de Bourgogne).