STORM: A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (HCC)

Bruix, Jordi; Takayama, Tadatoshi; Mazzaferro, Vincenzo; Chau, Gar‐Yang; Yang, Jiamei; Kudo, Masatoshi; Cai, Jianqiang; Poon, Ronnie Tung‐Ping; Han, Kwang‐Hyub; Tak, Won Young; Lee, Han Chu; Song, Tianqiang; Roayaie, Sasan; Bolondi, Luigi; Lee, Kwan Sik; Makuuchi, Masatoshi; Souza, Fabrício Henrique Pereira De; Berre, Marie-Aude Le; Meinhardt, Gerold; Llovet, Josep M.; Investigators, Storm

doi:10.1200/jco.2014.32.15_suppl.4006

Cited by 48 publications

(32 citation statements)

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“…This trial did not meet its primary end point. 92 Extrapolating the reasons for failure in the adjuvant setting based on findings of effectivenenss in patients with advancedstage HCC is not straight forward. The reasons for this lack of extrapo lation between disease stages could be an intrinsic inabil ity of sorafenib to prevent de novo hepatocarcinogenesis or even early progression of undetected tumour clones, both of which might have contributed to its failure in this treatment setting.…”

Section: The Adjuvant Settingmentioning

confidence: 99%

Advances in targeted therapies for hepatocellular carcinoma in the genomic era

et al. 2015

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Mortality owing to liver cancer has increased in the past 20 years, and the latest estimates indicate that the global health burden of this disease will continue to grow. Most patients with hepatocellular carcinoma (HCC) are still diagnosed at intermediate or advanced disease stages, where curative approaches are often not feasible. Among the treatment options available, the molecular targeted agent sorafenib is able to significantly increase overall survival in these patients. Thereafter, up to seven large, randomized phase III clinical trials investigating other molecular therapies in the first-line and second-line settings have failed to improve on the results observed with this agent. Potential reasons for this include intertumour heterogeneity, issues with trial design and a lack of predictive biomarkers of response. During the past 5 years, substantial advances in our knowledge of the human genome have provided a comprehensive picture of commonly mutated genes in patients with HCC. This knowledge has not yet influenced clinical decision-making or current clinical practice guidelines. In this Review the authors summarize the molecular concepts of progression, discuss the potential reasons for clinical trial failure and propose new concepts of drug development, which might lead to clinical implementation of emerging targeted agents.

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Section: The Adjuvant Settingmentioning

confidence: 99%

Advances in targeted therapies for hepatocellular carcinoma in the genomic era

et al. 2015

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“…An early clinical chemoprevention trial is currently evaluating whether erlotinib is able to revert this high-risk HCC signature into a low risk (NCT02273362). To date, no drug including Sorafenib, has been able to decrease HCC incidence in high-risk patients, or prevent tumor recurrence after curative treatments 22 .…”

Section: Genetic Predisposition Environmental Factors and Mechanism mentioning

confidence: 99%

Genetic Landscape and Biomarkers of Hepatocellular Carcinoma

et al. 2015

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“…At the recent ASCO meeting, the final results of the STORM, a randomized, Phase III, placebo-controlled trial were presented [43]. This study included patients with no detectable disease after surgical resection or local ablation with curative intent and with an intermediate or high recurrence risk, and no differences in recurrence-free survival, time to recurrence and OS between sorafenib and placebo were disclosed.…”

Section: Hepatocellular Carcinomamentioning

confidence: 99%

Sorafenib: 10 years after the first pivotal trial

Gadaleta-Caldarola¹,

Infusino²,

Divella

et al. 2015

Future Oncol.

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Sorafenib is an oral multikinase inhibitor with anticancer activity against a wide spectrum of cancers. It is currently approved for the treatment of patients with hepatocellular carcinoma, advanced renal cell carcinoma or progressive, locally advanced or metastatic differentiated thyroid carcinoma. In this review, we present a number of studies that investigated the efficacy and safety of sorafenib in these settings. We also discuss the perspectives on the use of this molecule, including the role of sorafenib as comparator for the development of new drugs, the combination of sorafenib with additional therapies (such as transarterial chemoembolization for hepatocellular carcinoma) and the use of this treatment in several other advanced refractory solid tumors.

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STORM: A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (HCC)

Cited by 48 publications

References 0 publications

Advances in targeted therapies for hepatocellular carcinoma in the genomic era

Advances in targeted therapies for hepatocellular carcinoma in the genomic era

Genetic Landscape and Biomarkers of Hepatocellular Carcinoma

Sorafenib: 10 years after the first pivotal trial

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