Combination of low-dose docetaxel and standard-dose S-1 for the treatment of advanced gastric cancer: efficacy, toxicity, and potential predictive factor

Cui, Yuehong; Li, Qian; Yu, Yiyi; Chen, Yong; Feng, Yi; Wang, Yan; Liu, Tianshu

doi:10.1007/s00280-012-1991-y

Cited by 10 publications

(8 citation statements)

References 25 publications

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“…What is more, the cutoff levels were determined by standard statistic analysis, not the simple median or mean. The plasmic expression of DPD in this study was consistent with previously reported with ELISA; however, no report for plasmic OPRT, TP, or TS was available [7]. The frequencies of CYP2A6 alleles in this population were compatible with other Asian population [31–33].…”

Section: Discussionsupporting

confidence: 90%

“…Besides, high OPRT/DPD, OPRT/TP, OPRT/TS, OPRT/DPD + TP + TS, OPRT/DPD + TS, OPRT/TP + TS, and OPRT/DPD + TP were all associated with grade 3–4 AEs, among which, high OPRT/DPD exhibited the highest accuracy. Cui et al [7] reported lower baseline plasmic DPD correlated with higher grade of toxicities in AGC patients with S-1 plus docetaxel by ELISA. Further studies were warranted to decide whether OPRT or OPRT/DPD better predicts grade 3–4 AEs.…”

Section: Discussionmentioning

confidence: 99%

“…The plasmic protein expression level of DPD, OPRT, TS, and TP was determined by an enzyme-linked immunosorbent assay (ELISA), as described by Cui et al [7]. …”

Section: Methodsmentioning

confidence: 99%

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Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway

Zhang

Wang

et al. 2016

Cancer Chemother Pharmacol

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BackgroundThe first one-arm phase II trial aimed to evaluate and predict efficacy and safety of S-1 plus oral leucovorin (S-1/LV) as first-line chemotherapy for patients with advanced gastric cancer (AGC), using S-1 pharmacogenetic pathway approach.Patients and methodsA total of 39 patients orally took S-1 at conventional dose and LV simultaneously at a dose of 25 mg twice daily for a week, within a 2-week cycle. The primary endpoint was overall response rate (ORR), while the secondary endpoints were progression-free survival (PFS), time to failure (TTF), overall survival (OS), disease control rate (DCR), and adverse events (AEs). Peripheral blood was sampled prospectively for baseline expression of dihydropyrimidine dehydrogenase (DPD), orotate phosphoribosyltransferase (OPRT), thymidine phosphorylase (TP), and thymidylate synthase (TS), CYP2A6 gene polymorphisms, and 5-FU pharmacokinetics.ResultsThe ORR and DCR were 41.0 and 76.9%. The median PFS, TTF, and OS were 4.13, 3.70, and 11.40 months. Grade 3–4 AEs occurred in only 13 patients, and grade 4 AEs occurred in only 1 of them. High OPRT/TS and peritoneal metastasis (vs. liver metastasis) independently predicted responding. High OPRT/DPD independently predicted grade 3–4 AEs. High AUC0–24h of 5-FU and metastatic/recurrent sites ≤2 (vs. >3) independently predicted prolonged PFS. Low baseline plasmic DPD independently predicted prolonged OS.ConclusionsTwo-week, oral S-1/LV regimen demonstrated promising efficacy and safety as first-line chemotherapy for AGC.ClinicalTrials.gov identifierNCT02090153Electronic supplementary materialThe online version of this article (doi:10.1007/s00280-016-3209-1) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

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Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway

Zhang

Wang

et al. 2016

Cancer Chemother Pharmacol

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“…Studies showed that docetaxel in combination with S-1 led to significantly improved outcomes with tolerable toxicities. The ORRs ranged from 42.6 to 57.8%, and median OS ranged from 13.0 to 16.2 months [20,21]. …”

Section: Discussionmentioning

confidence: 99%

Docetexal plus S-1 Versus Oxaliplatin plus S-1 for First-Line Treatment of Patients with Advanced Gastric Cancer: A Retrospective Study

Wang

et al. 2014

Oncol Res Treat

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Background: Both docetexal plus S-1 (DS) and oxaliplatin plus S-1 (SOX) are active regimens currently used in patients with advanced gastric cancer. In this retrospective study, efficacy and safety of these 2 combination regimens were evaluated. Patients and Methods: Patients received docetaxel infusion 75 mg/m² in the DS group or oxaliplatin infusion 130 mg/m² in the SOX group at day 1 of each 3-week cycle. S-1 40 mg/m² was administered orally twice daily on days 1-14 in the 3-week cycle in both groups. Progression-free survival (PFS), overall survival (OS) and safety perimeters were evaluated. Results: 84 patients were retrospectively evaluated in the study: 36 patients in the DS group and 48 patients in the SOX group. The median PFS was 6.55 months in the DS group and 5.73months in the SOX group. The median OS was 13.97 in the DS group and 13.13 months in the SOX group. The overall response rates were 41.7% and 43.8% and the disease control rates were 77.8% and 87.5% for DS and SOX, respectively. The most frequent grade 3 and 4 toxicities were thrombocytopenia for DS (19.4%) and anemia for SOX (12.5%). Conclusion: Both regimens were active and well tolerated in advanced gastric cancer patients.

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“…Interindividual variation in pharmacogenetics of the S-1 metabolic pathway can affect the extent of S-1 metabolism and impact the efficacy and toxicity of S-1-based chemotherapy. Published studies all used "candidate" pharmacogenetic factors to predict the outcomes of AGC patients with S-1 or S-1-based chemotherapy, none of which used S-1 pharmacogenetic pathway approach, which means none integrated CYP2A6 polymorphism, 5-FU metabolic enzymes, and pharmacokinetics at the same time [6][7][8]. However, those factors do not act in isolation.…”

Section: Electronic Supplementary Materialsmentioning

confidence: 99%

Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway.

Zhang

et al. 2015

JCO

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blood was sampled prospectively for baseline expression of dihydropyrimidine dehydrogenase (DPD), orotate phosphoribosyltransferase (OPRT), thymidine phosphorylase (TP), and thymidylate synthase (TS), CYP2A6 gene polymorphisms, and 5-FU pharmacokinetics. Results The ORR and DCR were 41.0 and 76.9%. The median PFS, TTF, and OS were 4.13, 3.70, and 11.40 months. Grade 3-4 AEs occurred in only 13 patients, and grade 4 AEs occurred in only 1 of them. High OPRT/ TS and peritoneal metastasis (vs. liver metastasis) independently predicted responding. High OPRT/DPD independently predicted grade 3-4 AEs. High AUC 0-24h of 5-FU and metastatic/recurrent sites ≤2 (vs. >3) independently predicted prolonged PFS. Low baseline plasmic DPD independently predicted prolonged OS. Conclusions Two-week, oral S-1/LV regimen demonstrated promising efficacy and safety as first-line chemotherapy for AGC. ClinicalTrials.gov identifier NCT02090153

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Combination of low-dose docetaxel and standard-dose S-1 for the treatment of advanced gastric cancer: efficacy, toxicity, and potential predictive factor

Cited by 10 publications

References 25 publications

Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway

Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway

Docetexal plus S-1 Versus Oxaliplatin plus S-1 for First-Line Treatment of Patients with Advanced Gastric Cancer: A Retrospective Study

Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway.

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