Cited 4 times in
A phase II open-label randomized multicenter trial of TSU-68 in combination with S-1 and oxaliplatin versus S-1 in combination with oxaliplatin in patients with metastatic colorectal cancer
DC Field | Value | Language |
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dc.contributor.author | 신상준 | - |
dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2015-01-06T17:08:03Z | - |
dc.date.available | 2015-01-06T17:08:03Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 0167-6997 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/99402 | - |
dc.description.abstract | Background Colorectal cancer (CRC) is the fourth leading cause of cancer-related deaths worldwide. The combination of oxaliplatin-based treatments (oxaliplatin plus infusional 5-fluorouracil and leucovorin [FOLFOX] or oxaliplatin plus capecitabine [CapeOX]) and bevacizumab is a standard chemotherapy regimen for metastatic CRC (mCRC). However, several clinical studies that tested S-1 plus oxaliplatin (SOX) indicate that SOX is also a treatment option for mCRC. TSU-68 is an oral compound that inhibits vascular endothelial growth factor receptor and platelet-derived growth factor receptor. The recommended dose of TSU-68 + SOX was previously determined in a phase I study of mCRC patients. The goal of this trial was to evaluate the efficacy of TSU-68 in combination with SOX. Methods This open-label multicenter randomized phase II trial was performed in Korea. Treatment-naive mCRC patients with a performance status of 0 or 1 were randomized in a 1:1 ratio to receive either TSU-68 + SOX or SOX alone. The primary endpoint was progression-free survival (PFS). Results A total of 105 patients (TSU-68 + SOX, 52 patients; SOX alone, 53 patients) were randomized. The median PFS was 7.0 months in the TSU-68 + SOX group (hazard ratio [HR], 1.057) and 7.2 months in the SOX group (p = 0.8401). The most frequent grade 3 and 4 adverse events were thrombocytopenia (9.6 % [TSU-68 + SOX] vs. 26.4 % [SOX]), neutropenia (13.5 % [TSU-68 + SOX] vs. 15.1 % [SOX]), and anemia (3.8 % [TSU-68 + SOX] vs. 13.2 % [SOX]). We observed a difference between the 2 groups for all grades of anemia (15.4 % [TSU-68 + SOX] vs. 32.1 % [SOX]), diarrhea (30.8 % [TSU-68 + SOX] vs. 47.2 % [SOX]), vomiting (50.0 % [TSU-68 + SOX] vs. 26.4 % [SOX]), and chromaturia (23.1 % [TSU-68 + SOX] vs. 0.0 % [SOX]). Analysis using a Cox proportional hazard model showed that baseline interleukin 6 (IL-6) levels were associated with a survival benefit of TSU-68 (p = 0.012). Conclusion TSU-68 + SOX had a favorable safety profile. However, TSU-68 did not have a synergistic effect on the efficacy of SOX. The baseline serum IL-6 level could be a prognostic factor for TSU-68 efficacy. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 561~568 | - |
dc.relation.isPartOf | INVESTIGATIONAL NEW DRUGS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/pharmacology | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/therapeutic use* | - |
dc.subject.MESH | C-Reactive Protein/metabolism | - |
dc.subject.MESH | Colorectal Neoplasms/blood | - |
dc.subject.MESH | Colorectal Neoplasms/drug therapy* | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Drug Combinations | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Indoles/administration & dosage | - |
dc.subject.MESH | Indoles/adverse effects | - |
dc.subject.MESH | Interleukin-6/blood | - |
dc.subject.MESH | Interleukin-8/blood | - |
dc.subject.MESH | L-Lactate Dehydrogenase/blood | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Organoplatinum Compounds/administration & dosage | - |
dc.subject.MESH | Organoplatinum Compounds/adverse effects | - |
dc.subject.MESH | Oxonic Acid/administration & dosage | - |
dc.subject.MESH | Oxonic Acid/adverse effects | - |
dc.subject.MESH | Platelet-Derived Growth Factor/metabolism | - |
dc.subject.MESH | Propionates/administration & dosage | - |
dc.subject.MESH | Propionates/adverse effects | - |
dc.subject.MESH | Proto-Oncogene Proteins c-sis/blood | - |
dc.subject.MESH | Tegafur/administration & dosage | - |
dc.subject.MESH | Tegafur/adverse effects | - |
dc.subject.MESH | Vascular Cell Adhesion Molecule-1/blood | - |
dc.subject.MESH | Vascular Endothelial Growth Factor A/blood | - |
dc.title | A phase II open-label randomized multicenter trial of TSU-68 in combination with S-1 and oxaliplatin versus S-1 in combination with oxaliplatin in patients with metastatic colorectal cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | Jeeyun Lee | - |
dc.contributor.googleauthor | Sang Joon Shin | - |
dc.contributor.googleauthor | Ik Joo Chung | - |
dc.contributor.googleauthor | Tae Won Kim | - |
dc.contributor.googleauthor | Hoo-Geun Chun | - |
dc.contributor.googleauthor | Dong Bok Shin | - |
dc.contributor.googleauthor | Yeul Hong Kim | - |
dc.contributor.googleauthor | Hong Suk Song | - |
dc.contributor.googleauthor | Sae-Won Han | - |
dc.contributor.googleauthor | Jong Gwang Kim | - |
dc.contributor.googleauthor | Sun Young Kim | - |
dc.contributor.googleauthor | Young Jin Choi | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.identifier.doi | 10.1007/s10637-014-0075-8 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A02105 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J01184 | - |
dc.identifier.eissn | 1573-0646 | - |
dc.identifier.pmid | 24573743 | - |
dc.identifier.url | http://link.springer.com/article/10.1007%2Fs10637-014-0075-8 | - |
dc.subject.keyword | Colorectal cancer | - |
dc.subject.keyword | Chemotherapy | - |
dc.subject.keyword | TSU-68 | - |
dc.contributor.alternativeName | Shin, Sang Joon | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | Shin, Sang Joon | - |
dc.contributor.affiliatedAuthor | Chung, Hyun Cheol | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 32 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 561 | - |
dc.citation.endPage | 568 | - |
dc.identifier.bibliographicCitation | INVESTIGATIONAL NEW DRUGS, Vol.32(3) : 561-568, 2014 | - |
dc.identifier.rimsid | 57245 | - |
dc.type.rims | ART | - |
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