Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer

Yamaguchi, Kensei; Shimamura, T; Hyodo, Ichinosuke; Koizumi, Wasaburo; Doi, Toshihiko; Narahara, Hiroyuki; Komatsu, Yoshito; Kato, Takeshi; Saitoh, S; Akiya, Toshikazu; Munakata, Masaki; Miyata, Yoshinori; Maeda, Yoshiharu; Takiuchi, Hiroya; Nakano, Susumu; Esaki, Taito; Kinjo, Fukunori; Sakata, Yuh

doi:10.1038/sj.bjc.6603196

Cited by 60 publications

(48 citation statements)

References 25 publications

(30 reference statements)

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“…Ajani et al (2005) reported that a combination of docetaxel, cisplatin, and fluorouracil is highly active against advanced untreated gastric or gastroesophageal adenocarcinoma. Docetaxel has also been combined with TS-1, and available evidence indicates that this combination is effective and well tolerated in patients with advanced gastric cancer (Yamaguchi et al, 2006).…”

Section: Discussionmentioning

confidence: 99%

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

et al. 2006

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Both paclitaxel and S-1 are effective against gastric cancer, but the optimal regimen for combined chemotherapy with these drugs remains unclear. This phase I/II study was designed to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicity (DLT), and objective response rate of paclitaxel in combination with S-1. S-1 was administered orally at a fixed dose of 80 mg m À2 day À1 from days 1 to 14 of a 28-day cycle. Paclitaxel was given intravenously on days 1, 8, and 15, starting with a dose of 40 mg m À2 day À1 . The dose was increased in a stepwise manner to 70 mg m À2 . Treatment was repeated every 4 weeks unless disease progression was confirmed. In the phase I portion, 17 patients were enrolled. The MTD of paclitaxel was estimated to be 70 mg m À2 because 40% of the patients given this dose level (two of five) had DLT. The RD was determined to be 60 mg m À2 . In the phase II portion, 24 patients, including five with assessable disease who received the RD in the phase I portion, were evaluated. The median number of treatment courses was six (range: 1 -17). The incidence of the worst-grade toxicity in patients given the RD was 28 and 8%, respectively. All toxic effects were manageable. The response rate was 54.1%, and the median survival time was 15.5 months. Our phase I/II trial showed that S-1 combined with paclitaxel is effective and well tolerated in patients with advanced gastric cancer.

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Section: Discussionmentioning

confidence: 99%

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

et al. 2006

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“…The recent introduction of a new oral drug, S-1 (Shirasaka et al, 1996), which was developed on the basis of biochemical modulation to inhibit dihydropyrimidine dehydrogenase and orotate phosphoribosyltransferase to therapeutic modality for gastric cancer, has enabled us to increase ORR to 46 -74% and MST to 10.9 -14.8 months by its combination with cisplatin (CDDP), docetaxel or CTP-11, with less toxicity than 5-FU (Koizumi et al, 2003;Ajani et al, 2006;Inokuchi et al, 2006;Yamaguchi et al, 2006).…”

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confidence: 99%

“…In combination with CDDP, 5-FU or CDDP plus 5-FU or S-1, docetaxel has shown a higher ORR of 37 to 56% and MST of 9.0 to 14.3 months (Roth et al, 2000;Thuss-Patience et al, 2005;Van Cutsem et al, 2006;Yamaguchi et al, 2006).…”

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confidence: 99%

Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer

et al. 2007

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The aim of this dose escalation study was to determine the maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs) and preliminary efficacy of docetaxel, S-1 and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Seventeen patients received oral S-1 (40 mg m À2 bid) on days 1 -14, intravenous cisplatin (60 mg m À2 ) and docetaxel (60, 70 or 80 mg m À2 depending on DLT) on day 8 every 3 weeks. The MTD of this combination was presumed to be docetaxel 70 mg m À2 . At this dose level, 40% of the patients (two of five) developed grade 4 neutropenia and 20% (one of five) exhibited grade 3 nausea during the first course. Therefore, the recommended dose of docetaxel was defined as 60 mg m À2 . The DLT was neutropenia. The response rate (RR) was 88.2% (15 of 17), consisting of one complete response and 14 partial responses. There were two stable diseases but no progressive disease. Of these 15 responders, four (23.5%) with high VEGF expression showed rapid tumour regression and achieved downstaging, leading to subsequent curative gastrectomy. Three of these have been disease free for about 3 years, suggesting a complete cure. In conclusion, this regimen was tolerable and showed a quite high RR, with an appreciable downstaging rate in metastatic gastric cancer.

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“…[5][6][7] Docetaxel showed synergism with S-1 in vitro, and the response rate was 46%-67% in several phase 2 trials. [9][10][11] Based on these findings, we designed a randomized phase 2 study to determine whether S-1 or cisplatin shows greater promise as a combination partner of docetaxel for a subsequent phase 3 study. We adopted a weekly docetaxel regimen to assess whether split administration improves drug tolerability and tested the predictive values of biomarkers for treatment-related outcomes.…”

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confidence: 99%

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

Jeung

Rha

et al. 2010

Cancer

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BACKGROUND:The purpose of this study was to compare 2 weekly docetaxel-based regimens as first-line treatments for advanced gastric cancer and to investigate the expression of secreted protein acidic and rich in cysteine (SPARC) and its abilities to predict treatment-related clinical outcomes. METHODS: Patients were randomly selected to receive 3 weekly cycles of docetaxel (35 mg/m 2 on days 1 and 8) plus S-1 (35 mg/m 2 each twice daily on days 1-14)

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Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer

Cited by 60 publications

References 25 publications

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

Phase I/II study of S-1 combined with paclitaxel in patients with unresectable and/or recurrent advanced gastric cancer

Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer

A randomized phase 2 study of docetaxel and S‐1 versus docetaxel and cisplatin in advanced gastric cancer with an evaluation of SPARC expression for personalized therapy

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