Efficacy
DISEASE
With a median follow‐up duration of 12.6 months (range, 0.1–29.2), the median PFS by the independent central review, the primary endpoint of this study, was 5.6 months (95% CI, 4.4–6.8) with S + XP and 5.3 months (95% CI, 4.2–5.7) with XP alone (HR 0.92, 95% CI 0.67–1.27; Figure Progression‐free survival according to the blinded central radiologic review (A) and overall survival (B). With a median follow‐up duration of 12.6 months (range, 0.1–29.2), median progression‐free survival was 5.6 months (95% CI, 4.4–6.8) with S + XP and 5.3 months (95% CI, 4.2–5.7) with XP alone (HR 0.92, 95% CI 0.67–1.27; Subgroup analysis of progression‐free survival in the intent‐to‐treat population.Among the patients assigned to the XP arm, 51 patients (52%) received sorafenib alone after progression on XP. Median PFS with second‐line sorafenib was 1.3 months (95% CI, 1.2–1.7). No patient achieved a partial response while 19 patients (37%) had stable disease as their best response.Median OS was 11.7 months (95% CI, 9.0–13.5) with S + XP and 10.8 months (95% CI, 8.9–12.7) with XP (HR 0.93, 95% CI 0.65–1.31; Figure 