Sorafenib (SOR) or placebo (PL) in combination with transarterial chemoembolization (TACE) for intermediate-stage hepatocellular carcinoma (SPACE).

Lencioni, Riccardo; Zou, Jingwen; LeBerre, M.-A.; Meinhardt, Gerold; Voliotis, D.; Bruix, Jordi; Llovet, Josep M.

doi:10.1200/jco.2010.28.15_suppl.tps178

Cited by 22 publications

(12 citation statements)

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“…Preliminary efficacy results for combined sorafenib and DEB-TACE were promising, as demonstrated by an excellent disease control rate. Results from the current trial provide safety and preliminary efficacy data in support of ongoing randomized, multicenter trials such as the SPACE (Sorafenib or Placebo in Combination With TACE) 23 and ECOG (Eastern Cooperative Oncology Group) 1208 cTACE/DEB-TACE sorafenib versus placebo trials. 24 Collectively, data from our study and these other emerging trials should help determine whether the combination of sorafenib plus DEB-TACE will become the standard of care for patients with unresectable HCC.…”

Section: Discussionmentioning

confidence: 53%

Phase II Trial of Sorafenib Combined With Concurrent Transarterial Chemoembolization With Drug-Eluting Beads for Hepatocellular Carcinoma

Pawlik

Reyes

Cosgrove

et al. 2011

JCO

274

206

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Purpose To evaluate safety and efficacy of combined transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) and sorafenib in patients with advanced hepatocellular carcinoma (HCC). Patients and Methods A prospective single-center phase II study was undertaken involving patients with unresectable HCC. The protocol involved sorafenib 400 mg twice per day combined with DEB-TACE. Safety and response were assessed. Results DEB-TACE in combination with sorafenib was successfully administered in 35 patients: mean age, 63 years; Child’s A, 89%; Barcelona Clinic Liver Cancer stage C, 64%; Eastern Cooperative Oncology Group performance status of 0 and 1, 46% and 54%, respectively; and mean index tumor size, 7.7 cm (standard deviation, ± 4.2 cm). Patients underwent 128 cycles of therapy (sorafenib plus DEB-TACE, 60 cycles; sorafenib alone, 68 cycles). Median number of cycles per patient was two (range, one to five cycles); median number of days treated with sorafenib was 71 (range, 4 to 620 days). The most common toxicities during cycle one were fatigue (94%), anorexia (67%), alterations in liver enzymes (64%), and dermatologic adverse effects (48%). Although most patients experienced at least one grade 3 to 4 toxicity, most toxicities were minor (grade 1 to 2, 83% v grade 3 to 4, 17%). Toxicity during cycle two was decreased. Over the course of the study, there were 40 sorafenib dose interruptions and 25 sorafenib dose reductions. Sorafenib plus DEB-TACE was associated with a disease control rate of 95% (Response Evaluation Criteria in Solid Tumors Group)/100% (European Association for the Study of the Liver [EASL]), with an objective response of 58% (EASL). Conclusion The combination of sorafenib and DEB-TACE in patients with unresectable HCC is well tolerated and safe, with most toxicities related to sorafenib. Toxicity is manageable with dose adjustment of sorafenib. Preliminary efficacy data are promising.

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Section: Discussionmentioning

confidence: 53%

Phase II Trial of Sorafenib Combined With Concurrent Transarterial Chemoembolization With Drug-Eluting Beads for Hepatocellular Carcinoma

Pawlik

Reyes

Cosgrove

et al. 2011

JCO

274

206

View full text Add to dashboard Cite

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“…If the criteria for TACE are similar in the intermediate stage of the BCLC staging system [5] and in the treatment algorithm of the Japanese guidelines: equal to or more than 4 lesions and/or 2 or 3 lesions >3 cm [11], the current data will be useful to compare the survival outcomes of TACE in the East and West. The survival rates of our study will be also used as reference data when clinical trials of TACE with or without anti-angiogenic drugs are newly designed [12,13].…”

Section: Discussionmentioning

confidence: 99%

Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines

Takayasu

Arii

Kudo

et al. 2012

Journal of Hepatology

197

145

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“…Several trials of combination of transarterial therapy and sorafenib or placebo are on-going: radioembolization and sorafenib (Phase II) (78), conventional TACE and sorafenib in Phase II (START trial) (79) and in Phase III (80) and DEB-TACE and sorafenib (SPACE trial) in Phase II (81), or other agent of TSU-68 in Phase II (82,83). The tolerability of the combination therapy was revealed (78,79,84,85).…”

Section: Combination Of Tace and Molecular Targeted Agentsmentioning

confidence: 99%

Transarterial Chemoembolization for Hepatocellular Carcinoma over Three Decades: Current Progress and Perspective

Takayasu

2012

Japanese Journal of Clinical Oncology

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Transcatheter arterial chemoembolization has been performed worldwide for patients with unresectable hepatocellular carcinoma for three decades. After long controversy, survival benefit was revealed by two randomized controlled trials. In Japan, chemoembolization accounted for initial treatment of 32% of patients and 58% for recurrent foci. The indications of chemoembolization are various: they are multinodular tumors in the Barcelona Clinic Liver Cancer staging system and two or three tumors .3 cm or four or more tumors in the Japanese guidelines, and both indications fulfill the Child-Pugh Class A/B or liver damage A/B and exclusion of vascular invasion or extrahepatic spread. Recently, both guidelines were identified to have almost similar content. The 4966 patients stratified to chemoembolization recommended by the Japanese guidelines showed that 3-year survival of patients with two or three tumors .3 cm or four or more tumors was 55 and 46% in Child-Pugh A, respectively, and 30 and 22% in Class B, respectively. These results would help in comparing the outcome of chemoembolization in the different backgrounds of the East and West. The modified Response Evaluation Criteria in Solid Tumor guideline is now proposed to cover the deficiency of Response Evaluation Criteria in Solid Tumor to evaluate the response to chemoembolization. Recently, chemoembolization with drug-eluting beads and radioembolization with yttrium-90 microspheres have been introduced, and each of them showed similar tumor response and median survival compared with conventional chemoembolization. Moreover, the combination of chemoembolization and molecular targeted agent is now ongoing to evaluate the synergistic effect.

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Sorafenib (SOR) or placebo (PL) in combination with transarterial chemoembolization (TACE) for intermediate-stage hepatocellular carcinoma (SPACE).

Cited by 22 publications

References 0 publications

Phase II Trial of Sorafenib Combined With Concurrent Transarterial Chemoembolization With Drug-Eluting Beads for Hepatocellular Carcinoma

Phase II Trial of Sorafenib Combined With Concurrent Transarterial Chemoembolization With Drug-Eluting Beads for Hepatocellular Carcinoma

Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines

Transarterial Chemoembolization for Hepatocellular Carcinoma over Three Decades: Current Progress and Perspective

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