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Study Design

Phase II Randomized Trial on Dose-Escalated Sorafenib vs Best Supportive Care (BSC) in Patients With Advanced Hepatocellular Carcinoma (HCC) With Disease Progression on Prior Sorafenib Treatment.

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Study Design

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  1. Phase II Randomized Trial on Dose-Escalated Sorafenib vs Best Supportive Care (BSC) in Patients With Advanced Hepatocellular Carcinoma (HCC) With Disease Progression on Prior Sorafenib Treatment Pressiani T1, Rimassa L1, Boni C2, Labianca R3, Fagiuoli S3, Ardizzoni A4, Foa P5, Cortesi E6, Porta C7, Artioli F8, Latini L9, Carnaghi C1, Lutman FR1, Torzilli T1, Tommasini MA1, Cerianl R1,Covini G1, Giordano L1, Locopo N1, Santoro A1. 1Humanitas Cancer Center, Istituto Clinico Humanitas, Rozzano (MI), Italy; 2Arcispedale Santa Maria Nuova, Reggio Emilia, Italy; 3Ospedali Riuniti, Bergamo, Italy; 4Azienda Ospedaliero - Universitaria, Parma, Italy; 5Ospedale San Paolo - Polo Universitario, Milano, Italy;6Azienda Policlinico Umberto I, Roma, Italy; 7I.R.C.C.S. Policlinico San Matteo, Pavia, Italy; 8Ospedale B. Ramazzini, Carpi (MO), Italy; 9Ospedale Generale Provinciale, Macerata, Italy.

  2. Study Design Primary endpoint: PFS Advanced HCC Child-Pugh Class A/B Suitable for systemic treatment (300 patients) Sorafenib600 mg BID 49 patients Randomization 1:1 (101 patients) Sorafenib400 mg BID PD BSC52 patients From April 2007 to July 2008, 300 patients were prospectively treated with sorafenib 400 mg BID. At documented radiological PD, 101 patients (34%) were randomized: 49 patients (48.5%) to increased-dose sorafenib (600 mg BID) + BSC and 52 patients (51.5%) to BSC, respectively PD=radiological progression, PFS=progression-free survival. Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  3. Baseline Patient Characteristics Associations are tested using the Chi-square test. *The sum does not add up to the total due to missing values. †Associations are tested using the Fisher exact test. Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  4. Progression-Free Survival HR sorafanib vs BSC, 0.67; CI 95%: (0.43-1.06), Pvalue: .089 Risk reduction of 33% CI=confidence interval, HR=hazard ratio. Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  5. Time to Progression HR sorafanib vs BSC, 0.59; CI 95%: (0.33-1.05), Pvalue: .070 Risk reduction of 41% TTP=time to progression. Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  6. Overall Survival (OS) HR sorafanib vs BSC, 0.71; CI 95% : (0.47-1.08); Pvalue: .107 Risk reduction of 29% Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  7. Adverse Events Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  8. Drug Exposure Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  9. All Patients (300): PFS and OS According to Child-Pugh Class Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

  10. Conclusions These results demonstrate that increased-dose sorafenib in HCC patients progressing on standard-dose sorafenib is feasible, with an acceptable safety profile. Trend toward improved PFS and OS, although not statistically significant, may justify the use of increased or standard dose of sorafenib beyond progression as an active control arm in Phase II – III trials evaluating new drugs as second-line therapy in HCC Adapted from Pressiani T et al. Presented at: ASCO Annual Meeting; June 3-7, 2011; Chicago, IL.

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