Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma

10.1371/journal.pone.0090909PLoS ONE93-POLN

Treatment-related toxicities,^* stratified by time.

<p>* Treatment-related toxicities included all those assessed as either definitely, probably, possibly related to treatment and unlikely to be related to treatment (excluding only those events assessed as definitely unrelated to treatment); If a toxicity occurred multiple times to the same patient, it was counted once for that patient at the highest grade that was assessed.Post-RE: Post-radioembolization/Pre-sorafenib period of 14 days; N = number of patients alive at each time interval; National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.</p><p>Abbreviations: ALP: alkaline phosphatase; ALT: alanine transaminase; AST: aspartate aminotransferase GI: gastrintestinal.</p>†<p>This was a grade 5 event.</p

Sorafenib dose modifications.

<p>Sorafenib dose modifications.</p

Summary of efficacy measures.

<p>CI: confidence interval nr: not reached.</p

Figure 2

<p>Liver function tests, stratified by time, for (A) total bilirubin, (B) albumin, (C) AST, (D) ALT and (E) alkaline phosphatase at baseline and after radioembolization followed by sorafenib. Post-RE: Post-radioembolization/Pre-sorafenib period of 14 days.</p

Figure 3

<p>(A) Time to progression and (B) overall survival.</p

CONSORT diagram of Phase II trial of radioembolization followed by sequential sorafenib in patients with HCC.

<p>CONSORT diagram of Phase II trial of radioembolization followed by sequential sorafenib in patients with HCC.</p

Smoothed EQ-5D quality of life index over time stratified by BCLC stage.

<p>Smoothed EQ-5D quality of life index over time stratified by BCLC stage.</p

Treatment-related toxicities,^* stratified by time.

<p>* Treatment-related toxicities included all those assessed as either definitely, probably, possibly related to treatment and unlikely to be related to treatment (excluding only those events assessed as definitely unrelated to treatment); If a toxicity occurred multiple times to the same patient, it was counted once for that patient at the highest grade that was assessed.Post-RE: Post-radioembolization/Pre-sorafenib period of 14 days; N = number of patients alive at each time interval; National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.</p><p>Abbreviations: ALP: alkaline phosphatase; ALT: alanine transaminase; AST: aspartate aminotransferase GI: gastrintestinal.</p>†<p>This was a grade 5 event.</p