Ramdomized 3-armed phase III study of S-1 monotherapy versus S-1/CDDP (SP) versus 5-FU/CDDP (FP) in patients (pts) with advanced gastric cancer (AGC): SC-101 study

Jin, Mu; Lu, Huishan; Li, J.; Shen, Lin; Chen, Z.; Shi, Yi; Song, Shenghua; Qin, Shukui; Liu, J.; Ouyang, Xin

doi:10.1200/jco.2008.26.15_suppl.4533

Cited by 29 publications

(36 citation statements)

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“…From the abstracts and virtual meeting presentations in ASCO held between 2000 and 2009, we identified 234 abstracts that included S-1. Three additional trials [20][21][22] were included to the meta-analysis, after all the relevant abstracts were read to decide whether it was eligible. Finally, four RCTs were included in the meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

S-1-based therapy versus 5-FU-based therapy in advanced gastric cancer: a meta-analysis

Huang

Cao

et al. 2010

Med Oncol

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We set out to evaluate the efficacy and safety of S-1-based therapy versus fluorouracil (5-FU)-based therapy in advanced gastric cancer (AGC). Eligible studies were identified from Pubmed, EMBASE, and Cochrane Library. Additionally, abstracts presented at American Society of Clinical Oncology (ASCO) conferences held between January 2000 and November 2009 were searched to identify relevant clinical trials. The outcome included overall survival (OS), overall response rate (ORR), and grade 3/4 advent events. Four randomized controlled trials (one full text and three abstracts) with 2,115 participants in AGC were identified in our analysis(1,065 patients were in the S-1-based group, 1,050 patients were in the 5-FU-based group). Meta-analysis showed there was significant OS benefit in favor of S-1-based therapy (hazard ratio [HR]=0.87, 95% confidence interval [CI]: 0.79 to 0.96). Pooled estimate for ORR showed no significant difference between S-1-based group and 5-FU-based group (OR=1.25, 95%CI: 0.31 to 5.09). Lower incidence of grade 3/4 neutropenia was observed in patients with S-1-based therapy (OR=0.33, 95%CI: 0.25 to 0.44). With regard to grade 3/4 anemia (OR=1.20, 95%CI: 0.74 to 1.96), leucopenia (OR=1.09, 95%CI: 0.43 to 2.74), stomatitis (OR=2.65, 95%CI: 0.12 to 58.89), diarrhea (OR=0.53, 95% CI: 0.00 to 229.10), nausea (OR=1.36, 95%CI: 0.68 to 2.72), and treatment-related deaths (OR=1.84, 95%CI: 0.95 to 3.54), equivalent frequencies were found between groups. S-1-based therapy significantly improved OS in relation to 5-FU-based therapy. ORR and safety profile were considerable between two groups. These results needed to be confirmed by high-quality trials and further studies in the West.

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Section: Resultsmentioning

confidence: 99%

S-1-based therapy versus 5-FU-based therapy in advanced gastric cancer: a meta-analysis

Huang

Cao

et al. 2010

Med Oncol

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“…A randomized phase III study comparing S-1 alone with S-1 plus cisplatin (CDDP) as a first-line treatment showed a significant improvement in the median survival time of patients receiving a combination of S-1 and CDDP (The SPIRITS trial [2]). More recently, a study conducted in China [3] demonstrated similar results to the SPIRITS trial. These clinical trials highlight the importance of S-1 plus CDDP as a first-line chemotherapeutic regimen for gastric cancer.…”

Section: Introductionmentioning

confidence: 61%

A phase I study of sorafenib in combination with S-1 plus cisplatin in patients with advanced gastric cancer

et al. 2013

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Background Sorafenib inhibits several receptor tyrosine kinases involved in tumor progression and angiogenesis. S-1, an oral fluorouracil antitumor drug, plus cisplatin (CDDP) is the standard regimen for advanced gastric adenocarcinoma (AGC) in Japan. The purpose of this phase I study was to evaluate the safety, pharmacokinetics, and preliminary efficacy of sorafenib in combination with S-1 plus CDDP. Methods Patients with histologically confirmed previously untreated AGC were evaluated for eligibility and treated with sorafenib (400 mg bid, days 1-35), S-1 (40 mg/m 2 bid, days 1-21), and CDDP (60 mg/m 2 , day 8). Treatment was continued until disease progression or unacceptable toxicity. Pharmacokinetics for sorafenib, 5-FU, and CDDP were investigated in cycle 1.

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“…Given the large numbers of trials and the many different comparisons in the trials retrieved, the gi dsg made an a posteriori decision to focus on the individual contributions of fluoropyrimidines 20,24,25,28,[32][33][34][35][36][37][38][39][40] , platinum agents 9,23,26,30,36,[41][42][43][44][45] , anthracyclines 34,46 -50,79 , taxanes 22,51,52 , and irinotecan 9,53 . The dsg also decided to determine whether the available evidence supports the regimens that are currently in common use in Ontario 21,24,25,36,48,[55][56][57][58] and to determine the contribution of targeted therapies 59,80 .…”

Section: Resultsmentioning

confidence: 99%

“…This recommendation is based on results of a meta-analysis of eight randomized controlled trials (rcts) 9,23,25,26,30,[42][43][44] that indicated a significant survival benefit for chemotherapy including a platinum agent compared with the same chemotherapy without a platinum agent [hazard ratio (hr): 0.74; 95% confidence interval (ci): 0.65 to 0.84; p < 0.00001]. Many of those rcts were small or phase ii trials (or both).…”

Section: Recommendations and Key Evidencementioning

confidence: 99%

Systemic Therapy for Advanced Gastric Cancer: A Clinical Practice Guideline

2011

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• Within a combination chemotherapy regimen, oral capecitabine is preferred over intravenous 5-fluorouracil (5fu)-that is, epirubicin-cisplatincapecitabine is preferred over the prior standard regimen, epirubicin-cisplatin-5fu (ecf).• Epirubicin-oxaliplatin-capecitabine (eox) is a reasonable alternative to ecf. The choice between ecf and eox should be based on patient preference.• Trastuzumab in combination with cisplatin and a fluoropyrimidine (5fu or oral capecitabine) is recommended for advanced gastric cancer positive for the human epidermal growth factor receptor 2 (her2/neu). KEY WORDSAdvanced gastric cancer, systemic therapy, practice guideline QUESTIONWhat is the optimal chemotherapy regimen in advanced gastric cancer? Outcomes of interest were overall survival (os), objective response rate (complete plus partial responses), time to disease progression, adverse effects, and quality of life. INTRODUCTIONGastric cancer is a virulent disease that is the second leading cause of cancer mortality worldwide 1 . There is significant geographic variation in the incidence of gastric cancer, with incidence and mortality being particularly high in Japan, China, Korea, Chile, and Costa Rica 2 . Even though the incidence rate for gastric cancer in Ontario is one of the lowest worldwide 3 , overall prognosis is bleak, with 5-year survival rates of approximately 23% in Canada 4 and 23%-25% in the United States for all stages combined 5 .Despite the considerable body of research available on chemotherapy for advanced gastric cancer, ABSTRACT QuestionWhat is the optimal chemotherapy regimen in advanced gastric cancer? PerspectivesGastric cancer is the second leading cause of cancer mortality worldwide. Despite low incidence rates for gastric cancer in Ontario, the overall prognosis is bleak, with 5-year survival rates of approximately 23% in Canada. Even with the considerable body of research available on chemotherapy for advanced gastric cancer, uncertainty remains. There is no recognized standard treatment, and there appears to be geographic variation in practice. OutcomesOutcomes of interest were overall survival, objective response rate (complete plus partial responses), time to disease progression, adverse effects, and quality of life. MethodologyAfter a systematic review, a practice guideline containing clinical recommendations relevant to patients in Ontario was drafted. The practice guideline was reviewed and approved by the Gastrointestinal Disease Site Group (gi dsg) and the Report Approval Panel of the Program in Evidence-Based Care. External review by Ontario practitioners was obtained through a survey, the results of which were incorporated into the practice guideline. Practice GuidelineThe gi dsg makes the following recommendations:• To improve survival, a platinum agent should be included in any combination chemotherapy regimen.

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Ramdomized 3-armed phase III study of S-1 monotherapy versus S-1/CDDP (SP) versus 5-FU/CDDP (FP) in patients (pts) with advanced gastric cancer (AGC): SC-101 study

Cited by 29 publications

References 0 publications

S-1-based therapy versus 5-FU-based therapy in advanced gastric cancer: a meta-analysis

S-1-based therapy versus 5-FU-based therapy in advanced gastric cancer: a meta-analysis

A phase I study of sorafenib in combination with S-1 plus cisplatin in patients with advanced gastric cancer

Systemic Therapy for Advanced Gastric Cancer: A Clinical Practice Guideline

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