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 | Lee, J[Lee, Jeeyun] | - |
dc.contributor.author | Shin, SJ[Shin, Sang Joon] | - |
dc.contributor.author | Chung, IJ[Chung, Ik Joo] | - |
dc.contributor.author | Kim, TW[Kim, Tae Won] | - |
dc.contributor.author | Chun, HG[Chun, Hoo-Geun] | - |
dc.contributor.author | Shin, DB[Shin, Dong Bok] | - |
dc.contributor.author | Kim, YH[Kim, Yeul Hong] | - |
dc.contributor.author | Song, HS[Song, Hong Suk] | - |
dc.contributor.author | Han, SW[Han, Sae-Won] | - |
dc.contributor.author | Kim, JG[Kim, Jong Gwang] | - |
dc.contributor.author | Kim, SY[Kim, Sun Young] | - |
dc.contributor.author | Choi, YJ[Choi, Young Jin] | - |
dc.contributor.author | Chung, HC[Chung, Hyun Cheol] | - |
dc.date.accessioned | 2021-08-03T15:56:20Z | - |
dc.date.available | 2021-08-03T15:56:20Z | - |
dc.date.created | 2016-08-06 | - |
dc.date.issued | 2014-06 | - |
dc.identifier.issn | 0167-6997 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/52836 | - |
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.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.affiliatedAuthor | Lee, J[Lee, Jeeyun] | - |
dc.identifier.doi | 10.1007/s10637-014-0075-8 | - |
dc.identifier.scopusid | 2-s2.0-84904655668 | - |
dc.identifier.wosid | 000337084000020 | - |
dc.identifier.bibliographicCitation | INVESTIGATIONAL NEW DRUGS, v.32, no.3, pp.561 - 568 | - |
dc.relation.isPartOf | INVESTIGATIONAL NEW DRUGS | - |
dc.citation.title | INVESTIGATIONAL NEW DRUGS | - |
dc.citation.volume | 32 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 561 | - |
dc.citation.endPage | 568 | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.subject.keywordAuthor | Chemotherapy | - |
dc.subject.keywordAuthor | Colorectal cancer | - |
dc.subject.keywordAuthor | TSU-68 | - |
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