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Conference Paper: Phase II trial of sorafenib with capecitabine and oxaliplatin (SECOX) in patients with locally advanced or metastatic hepatocellular carcinoma

TitlePhase II trial of sorafenib with capecitabine and oxaliplatin (SECOX) in patients with locally advanced or metastatic hepatocellular carcinoma
Authors
Issue Date2009
PublisherElsevier BV. The Journal's web site is located at www.ejcancer.info/supplements
Citation
The 34th ESMO Multidisciplinary Congress (Joint ECCO 2015), Berlin, Germany, 20–24 September 2009. In European Journal of Cancer Supplements, 2009, v. 7 n. 3, p. 20-21, abstract no. 47LBA How to Cite?
AbstractBackground: This is a single arm, multi-centre, phase II study to assess the efficacy and tolerability of sorafenib combining oxaliplatin and capecitabine for the treatment of advanced hepatocellular carcinoma (HCC) patients. Methods: Advanced HCC patients with no prior systemic therapy received SECOX regime – sorafenib 400 mg bid (Day 1−14), oxaliplatin 85 mg/m2 (Day 1) and capecitabine 1700 mg/m2 (Day 1−7) every two weeks. Response assessment using RECIST criteria was performed after 4 cycles. Patients who achieved partial response or stable disease would receive another 4 cycles till a maximum of 8 cycles. Afterwards, sorafenib was continued till disease progression. The primary endpoint was time-toprogression (TTP) and the secondary endpoints were tumor response rate (RR), overall survival (OS) and tolerability. Results: A total of 51 patients were enrolled in the trial. The median age was 58 years (range, 28−81) and all patients were in ECOG Performance Status 0−1. Eighty-four percent of patients were chronic hepatitis B carriers and 98% of patients had Child A cirrhosis. Ten (20%) patients had tumor vascular invasion and 41 (80%) patients had extra-hepatic metastasis. The best RR was 14 % and another 61% of patients achieved stable disease. Overall, 75% of patients derived clinical benefits from SECOX regime for at least 8 weeks. The median TTP was 7.1 months (1.7–19.9) and OS was 10.2 months (2.1–20.5). Hand-Foot-Skin reaction (73%), diarrhea (69%) and neutropenia (63%) were the most commonly encountered toxicities, with the majority of patients having grade 1 or 2 toxicity. No treatmentrelated death was reported. Conclusion: The SECOX regime demonstrates highly significant clinical activity and good tolerability in advanced HCC patients. Our data support a randomized trial comparing SECOX versus Sorafenib alone for treatment of advanced HCC.
DescriptionPresidential sessions Late breaking and Best of ECCO 15 – ESMO 34 Abstracts and Best of 2009 Abstracts
Persistent Identifierhttp://hdl.handle.net/10722/186805
ISSN
2010 Impact Factor: 9.386
2023 SCImago Journal Rankings: 0.759
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorYau, TCCen_US
dc.contributor.authorChan, Pen_US
dc.contributor.authorCheung, FYen_US
dc.contributor.authorLee, ASen_US
dc.contributor.authorYau, TKen_US
dc.contributor.authorChoo, SPen_US
dc.contributor.authorLau, Jen_US
dc.contributor.authorWong, JSen_US
dc.contributor.authorFan, STen_US
dc.contributor.authorPoon, RTPen_US
dc.date.accessioned2013-08-20T12:21:06Z-
dc.date.available2013-08-20T12:21:06Z-
dc.date.issued2009en_US
dc.identifier.citationThe 34th ESMO Multidisciplinary Congress (Joint ECCO 2015), Berlin, Germany, 20–24 September 2009. In European Journal of Cancer Supplements, 2009, v. 7 n. 3, p. 20-21, abstract no. 47LBAen_US
dc.identifier.issn1359-6349-
dc.identifier.urihttp://hdl.handle.net/10722/186805-
dc.descriptionPresidential sessions Late breaking and Best of ECCO 15 – ESMO 34 Abstracts and Best of 2009 Abstracts-
dc.description.abstractBackground: This is a single arm, multi-centre, phase II study to assess the efficacy and tolerability of sorafenib combining oxaliplatin and capecitabine for the treatment of advanced hepatocellular carcinoma (HCC) patients. Methods: Advanced HCC patients with no prior systemic therapy received SECOX regime – sorafenib 400 mg bid (Day 1−14), oxaliplatin 85 mg/m2 (Day 1) and capecitabine 1700 mg/m2 (Day 1−7) every two weeks. Response assessment using RECIST criteria was performed after 4 cycles. Patients who achieved partial response or stable disease would receive another 4 cycles till a maximum of 8 cycles. Afterwards, sorafenib was continued till disease progression. The primary endpoint was time-toprogression (TTP) and the secondary endpoints were tumor response rate (RR), overall survival (OS) and tolerability. Results: A total of 51 patients were enrolled in the trial. The median age was 58 years (range, 28−81) and all patients were in ECOG Performance Status 0−1. Eighty-four percent of patients were chronic hepatitis B carriers and 98% of patients had Child A cirrhosis. Ten (20%) patients had tumor vascular invasion and 41 (80%) patients had extra-hepatic metastasis. The best RR was 14 % and another 61% of patients achieved stable disease. Overall, 75% of patients derived clinical benefits from SECOX regime for at least 8 weeks. The median TTP was 7.1 months (1.7–19.9) and OS was 10.2 months (2.1–20.5). Hand-Foot-Skin reaction (73%), diarrhea (69%) and neutropenia (63%) were the most commonly encountered toxicities, with the majority of patients having grade 1 or 2 toxicity. No treatmentrelated death was reported. Conclusion: The SECOX regime demonstrates highly significant clinical activity and good tolerability in advanced HCC patients. Our data support a randomized trial comparing SECOX versus Sorafenib alone for treatment of advanced HCC.-
dc.languageengen_US
dc.publisherElsevier BV. The Journal's web site is located at www.ejcancer.info/supplements-
dc.relation.ispartofEuropean Journal of Cancer Supplementsen_US
dc.rightsNOTICE: this is the author’s version of a work that was accepted for publication in European Journal of Cancer Supplements. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in European Journal of Cancer Supplements, 2009, v. 7 n. 3, p. 20-21, abstract no. 47LBA DOI# 10.1016/S1359-6349(09)72082-8-
dc.titlePhase II trial of sorafenib with capecitabine and oxaliplatin (SECOX) in patients with locally advanced or metastatic hepatocellular carcinomaen_US
dc.typeConference_Paperen_US
dc.identifier.emailYau, TCC: tyaucc@hku.hken_US
dc.identifier.emailFan, ST: stfan@hku.hken_US
dc.identifier.emailPoon, RTP: poontp@hku.hken_US
dc.identifier.authorityYau, TCC=rp01466en_US
dc.identifier.authorityFan, ST=rp00355en_US
dc.identifier.authorityPoon, RTP=rp00446en_US
dc.identifier.doi10.1016/S1359-6349(09)72082-8-
dc.identifier.hkuros217127en_US
dc.identifier.volume7-
dc.identifier.issue3-
dc.identifier.spage20, abstract no. 47LBAen_US
dc.identifier.epage21, abstract no. 47LBAen_US
dc.identifier.isiWOS:000270645000061-
dc.publisher.placeUnited Kingdom-
dc.identifier.issnl1359-6349-

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