Z Gastroenterol 2017; 55(08): e57-e299
DOI: 10.1055/s-0037-1605001
Kurzvorträge
Leber und Galle
HCC: Multimodale Therapie: Donnerstag, 14 September 2017, 12:35 – 13:55, St. Petersburg/Forschungsforum 1
Georg Thieme Verlag KG Stuttgart · New York

Outcomes with sorafenib (SOR) followed by regorafenib (REG) or placebo (PBO) for hepatocellular carcinoma (HCC): Results of the international, randomized phase 3 RESORCE trial

P Galle
1   Universitätsmedizin Mainz, I. Medizinische Klinik, Mainz, Deutschland
,
RS Finn
2   David Geffen School of Medicine at UCLA, Los Angeles, Vereinigte Staaten von Amerika
,
P Merle
3   Groupement Hospitalier, Lyon, Frankreich
,
A Granito
4   University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italien
,
YH Huang
5   Taipei Veterans General Hospital, Taipei, Taiwan, Republik China
,
G Bodoky
6   St Laszlo Teaching Hospital, Budapest, Ungarn
,
M Pracht
7   Service d'Oncologie Médicale, Rennes, Frankreich
,
O Yokosuka
8   Chiba University, Chiba, Japan
,
O Rosmorduc
9   Hopital de la Pitié-Salpétriére, Paris, Frankreich
,
R Gerolami
10   CHU Timone, Marseille, Frankreich
,
C Caparello
11   Azienda Ospedaliero-Universitaria Pisana, Pisa, Italien
,
R Cabrera
12   University of Florida Health Cancer Center, Gainesville, Vereinigte Staaten von Amerika
,
C Chang
13   Mount Sinai Medical Center, New York, Vereinigte Staaten von Amerika
,
W Sun
14   Universitiy of Pittsburgh Cancer Institute, Pittsburgh, Vereinigte Staaten von Amerika
,
MA LeBerre
15   Bayer Healthcare SAS, Loos, Frankreich
,
A Baumhauer
16   Bayer Vital GmbH, Leverkusen, Deutschland
,
G Meinhardt
17   Bayer Healthcare Pharmaceuticals, Whippany, Vereinigte Staaten von Amerika
,
J Bruix
18   University of Barcelona Hospital Clinic, Liver Unit, Barcelona, Spanien
› Institutsangaben
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Publikationsverlauf

Publikationsdatum:
02. August 2017 (online)

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    Background:

    SOR is standard first-line systemic treatment for HCC unsuitable for locoregional therapy. RESORCE showed that REG improves overall survival (OS) in patients who progressed during SOR treatment (HR 0.63, 95% CI 0.50, 0.79; P, 0.001). This exploratory analysis describes outcomes for the sequence of SOR followed by REG.

    Methods:

    573 patients were randomized 2: 1 to receive REG 160 mg/day (d), 3 wks on/1 wk off or PBO. Data on prior SOR treatment and radiologic progression were prospectively collected. Efficacy and safety were evaluated by the last SOR dose. Time from the start of SOR to death was assessed.

    Results:

    Baseline characteristics were balanced. Times from the start of SOR to progression on SOR and times from progression on SOR to start of study drug were similar.

    Tab. 1:

    Outcomes of the RESORCE study

    REG (n = 379)

    PBO (n = 194)

    Duration of SOR treatment (months)- Median (IQR; Mean (SD)

    7.8 (4.2 – 14.5); 11.6 (11.3)

    7.8 (4.4 – 14.7); 11.5 (10.7)

    Months from start of SOR to progression on SOR, median (95% CI)

    7.1 (6.0, 8.0)

    7.1 (5.8, 8.7)

    Months from start of SOR to start of study drug, mean (SD)

    12.7 (11.3)

    12.5 (10.7)

    Months from progression on SOR to start of study drug, mean (SD)

    1.8 (1.4)

    1.8 (1.7)

    Months from last dose of SOR to start of study drug, mean (SD)

    1.0 (0.5)

    1.0 (0.5)

    Last SOR dose 800 mg/d

    60%

    60%

    Median OS by last SOR dose, months (95% CI)- 800 mg/d; < 800 mg/d

    10.6 (8.1, 12.6); 10.6 (7.4, 14.0)

    7.0 (5.3, 9.0); 8.5 (5.6, 10.0)

    When analyzed based on last SOR dose 800 mg/d vs. 800 mg/d, rates of all grade treatment-emergent adverse events (TEAEs) on study were similar (REG: 100% vs. 100%; PBO: 92% vs. 93%). TEAE grades 3/4/5 by last SOR dose 800 mg/d vs. 800 mg/d were 52/11/15% vs. 61/10/12%, respectively, with REG and 30/8/24% vs. 32/7/14% with PBO. HRs (95% CI) REG/PBO for OS by last SOR dose were similar: 0.67 (0.51, 0.87) for 800 mg/d and 0.68 (0.48, 0.97) for 800 mg/d. Median OS (95% CI) from the start of SOR was 26.0 months (22.6, 28.1) for REG and 19.2 months (16.3, 22.8) for PBO.

    Clinical trial information:

    NCT01774344.

    Conclusions:

    This exploratory subgroup analysis by prior SOR dose demonstrates a consistent survival benefit for REG. In addition, the safety profile of REG was not remarkably different when analyzed by the last SOR dose.


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