A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Lee, Jae Jin; Kim, Sang Yong; Chung, Hyun Cheol; Lee, Kyung Hee; Song, Hong Suk; Kang, Won Ki; Hong, Young Seon; Choi, In Sil; Lee, Young Yeul; Woo, In Sook; Choi, Jin Hyuk

doi:10.1007/s00280-008-0818-3

Cited by 13 publications

(11 citation statements)

References 20 publications

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“…Unfortunately, there are no data directly comparing the anti-tumor activity of 5-FU plus taxane (paclitaxel or docetaxel) with that of S-1 plus taxane. Although there are limitations in comparing the results of different studies, the efficacy of S-1 plus paclitaxel has been reported in phase II trials with a response rate of 40–55% and a median survival of 9–15 months, and this is comparable to the present data for FLTAX [31,32,33]. Accordingly, the FLTAX regimen may be a good option for GC patients who are not suitable for treatment with platinum agents.…”

Section: Discussionsupporting

confidence: 76%

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Matsubara¹,

Shimada²,

Kato³

et al. 2011

Oncology

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Objective: We evaluated the efficacy and safety of bolus 5-fluorouracil (5-FU) and leucovorin combined with weekly paclitaxel (FLTAX) in advanced gastric cancer (GC) patients. Methods: Patients with untreated stage IV GC received paclitaxel 80 mg/m² as a 1-hour infusion, followed by 5-FU 600 mg/m² as a bolus infusion and L-leucovorin 250 mg/m² as a 2-hour infusion on days 1, 8 and 15. Treatment cycles were repeated every 28 days. The primary endpoint was response rate. Results: Thirty-five patients were enrolled. The median age was 62 years (range 34–75). Twenty-one patients (60%) had diffuse-type cancer and 11 had peritoneal metastasis. The confirmed response rate was 43% (95% CI 26–61) with 15 partial responses. Stable disease was observed in 16 (46%) patients. Median progression-free survival and overall survival were 6.8 months (95% CI 5.8–7.4) and 16.2 months (95% CI 10.0–22.8), respectively. Grade 3–4 adverse events were: neutropenia (54%), febrile neutropenia (3%), diarrhea (6%) and sensory neuropathy (11%). Conclusion: FLTAX showed a desirable safety profile, and the efficacy against advanced GC was encouraging. FLTAX may be a good option for GC patients with deteriorated general condition, and a randomized clinical trial in such patients is currently underway.

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Section: Discussionsupporting

confidence: 76%

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Matsubara¹,

Shimada²,

Kato³

et al. 2011

Oncology

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“…Many phase II studies have also been performed to investigate the safety profi le and effectiveness of weekly paclitaxel-containing combination therapies for advanced and metastatic gastric cancers (Table 4) [ [45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61].…”

Section: Weekly Administration Of Paclitaxelmentioning

confidence: 99%

“…Studies of combinations with oral S-1 (tegafur, gimeracil, oteracil) have also been performed [47,49,[55][56][57][58][59]. In these trials, response rates ranged from 40% to 65% and MSTs ranged from 8.9 to 15.5 months.…”

Section: Weekly Administration Of Paclitaxelmentioning

confidence: 99%

Paclitaxel chemotherapy for the treatment of gastric cancer

2009

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cause of cancer mortality. Although the incidence of gastric cancer has been declining in most developed countries, esophago-gastric junctional tumor and tumor in the cardia has, conversely, been increasing [2] and these tumors still remain one of the biggest problems worldwide.The prognosis of patients with advanced (i.e., unresectable or metastatic) gastric cancer is very poor. The median survival time for such patients is 6 to 9 months [3]. For many years, various chemotherapeutic agents have been used in attempts to improve survival, progression free-survival, response rate, and quality of life in patients with advanced gastric cancer as well as to improve disease-free survival in patients in whom curative resection of the cancers has been performed. 5-Fluorouracil (5-FU) and cisplatin-based regimens have long been considered reference treatments. Commonly used regimens have included epirubicin, cisplatin, and continuous infusion of 5-FU; 5 days' infusion of 5-FU plus cisplatin every 4 weeks; a weekly infusion regimen of 5-FU/leucovorin (LV) over 24 h plus cisplatin every 2 weeks; and 5-FU bolus plus 22-h infusion of 5-FU on days 1 and 2, in combination with cisplatin every 2 weeks. The results with these regimens, together with other study results, suggested that combination regimens including fl uorinated pyrimidines, cisplatin, doxorubicin, epirubicin, and methotrexate, had better response rates than single agents. Although gastric cancer is a relatively chemosensitive disease, with response rates of 30% to 40%, these treatments have shown a modest but unsatisfactory increase in overall survival [4]. In this regard, chemotherapy in the advanced gastric cancer setting is limited by a low complete response rate, response durations that are shortlived, and considerable toxicities.Nevertheless, recently, the development of new chemotherapeutic and molecular targeting agents has opened the door to various clinical trials to fi nd novel therapeutic strategies to improve the outcome of Abstract A comprehensive review of phase I and phase II clinical trials of paclitaxel and paclitaxel-containing chemotherapy regimens for advanced gastric cancer was performed. Response rates, median progression-free survivals, and median overall survivals were examined, together with the treatment regimens and the numbers of patients registered in each trial. Although paclitaxel monotherapy produced considerable improvement in tumor response and prognosis, combination doublet or triplet chemotherapy with fl uoropyrimidines and/ or platinum compounds showed better results than the paclitaxel monotherapy. With regard to the schedule of paclitaxel administration, weekly injection seemed to show less toxicity and better results than administration every 3 weeks. Adjuvant therapies, chemoradiation therapies, and paclitaxel treatment for gastric ascites were also investigated and are discussed.

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“…Additionally, recent reports indicate that one of the molecular events of apoptosis is activation of the caspases by a signal transduction cascade [10] . Currently, chemotherapy using plant-derived, anti-cancer drugs such as paclitaxel [11] , vinorelbine [12] , or vincristine [13] has been proven to be effective in clinical settings. It was shown that these products enhance cell growth inhibition in different cancer cell lines and are highly effective and safe in clinical trials.…”

Section: Introductionmentioning

confidence: 99%

The combination of baicalin and baicalein enhances apoptosis via the ERK/p38 MAPK pathway in human breast cancer cells

et al. 2009

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Aim:To examine whether the cell growth inhibitory effect of the combination of baicalin and baicalein is related to apoptosis. Moreover, to determine whether the expression of some apoptosis-related proteins is regulated by the ERK/p38 MAPK pathway. Methods: Cell viability was measured using a 3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide (MTT) assay. Apoptosis was detected by acridine orange (AO) staining, DNA ladder assay and flow cytometric analysis. Apoptosis-related proteins were observed using Western blot analysis. Results: Compared with baicalin or baicalein alone, the combination treatment of baicalin (50 µmol/L) and baicalein (25 µmol/L) had an anti-proliferative effect in a time-dependent manner. Isobologram analysis demonstrated that the combination treatment had a synergistic effect. Moreover, apoptosis in MCF-7 cells was increased by 12% and 20% with the combination treatment at 24 h and 48 h, respectively. With the combination treatment in MCF-7 cells, cleaved caspase-3 and caspase-9 were observed, and the level of bcl-2 expression was decreased approximately 20% and 40% at 24 h and 48 h, respectively. The expression of bax and p53 were increased about 25% and 15% at 48 h, respectively. Moreover, the activation of caspase-3, -9 and the regulation of bcl-2, bax and p53 were related to ERK /p38 MAPK activation. Conclusion: In this study, apoptosis was enhanced by the combination treatment of baicalin and baicalein, which activated caspases-3 and caspase-9, downregulated the level of bcl-2 and upregulated the level of bax or p53 via the ERK/p38 MAPK pathway.

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A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer

Cited by 13 publications

References 20 publications

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer

Paclitaxel chemotherapy for the treatment of gastric cancer

The combination of baicalin and baicalein enhances apoptosis via the ERK/p38 MAPK pathway in human breast cancer cells

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