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01.04.2016 | SHORT REPORT | Ausgabe 2/2016

Investigational New Drugs 2/2016

Post-progression survival in patients with advanced hepatocellular carcinoma resistant to sorafenib

Zeitschrift:
Investigational New Drugs > Ausgabe 2/2016
Autoren:
Sadahisa Ogasawara, Tetsuhiro Chiba, Yoshihiko Ooka, Eiichiro Suzuki, Naoya Kanogawa, Tomoko Saito, Tenyu Motoyama, Akinobu Tawada, Fumihiko Kanai, Osamu Yokosuka
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Electronic supplementary material

The online version of this article (doi:10.​1007/​s10637-016-0323-1) contains supplementary material, which is available to authorized users.

Summary

Background Since the approval of sorafenib, no other agent has been proven to show survival benefits in clinical trials involving patients with advanced hepatocellular carcinoma (HCC) resistant to sorafenib. Prognostic factors for survival after tumor progression in sorafenib-treated patients are critical for designing second-line trials. Methods To determine the factors affecting the post-progression survival (PPS) after sorafenib treatment, additional analyses were conducted using fixed data obtained from our previous prospective study. Data on patients with advanced HCC treated with sorafenib were analyzed in view of patient characteristics at the time of tumor progression and the progression pattern (intra−/extrahepatic growth or emergence of new intra−/extrahepatic lesions). Results Of the 89 enrolled patients, 70 were diagnosed with disease progression according to the Response Evaluation Criteria in Solid Tumors version 1.1. Multivariate Cox’s regression analysis revealed that Child–Pugh scores of ≥7, macrovascular invasion (MVI), and alpha-fetoprotein of >400 ng/mL were independent predictors of poor PPS. Although both extrahepatic metastasis (EHM) and MVI were characteristics of advanced HCC, EHM was not determined as a prognostic factor. Additionally, the emergence of new extrahepatic lesions also served as an independent indicator of a poor prognosis. The PPS of the patients was well stratified according to the index based on the sum of these prognostic factors, ranging from 0 to 4. Conclusions Child–Pugh score of ≥7, AFP of >400 ng/mL, MVI, and new extrahepatic lesions at the time of progression may be utilized to assess the prognosis and taken into consideration when designing second-line trials.

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