Randomized trial of adjuvant chemotherapy with mitomycin plus ftorafur versus mitomycin alone in resected locally advanced gastric cancer.

Grau, Juan J.; Vila, Jordi; Fuster, J.; Filella, Xavier; Visa, Josep; Terés, Josep; Soler, Gwendoline; Albiol, Santiago; García‐Valdecasas, Juan Carlos; Grande, Luís; Bombí, J.A.; Bordas, J.M.; Alcobendas, F

doi:10.1200/jco.1998.16.3.1036

Cited by 48 publications

(20 citation statements)

References 11 publications

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“…The 5-year OS rates of both groups in the present study seem to be superior to the results of western series, and even somewhat better than those of other Korean institutions [5,10,13,14,17,29,33]. Although the OS and DFS were significantly higher in the IV group for stage IIIB, the significance of this result is questionable due to the small number of patients.…”

Section: Discussioncontrasting

confidence: 52%

“…Third, in a study that compared tegafur + MMC and UFT + MMC as adjuvant treatment for gastric cancer, the UFT + MMC group had a higher survival rate [32]. Fourth, although no study has yet compared adjuvant UFT and IV CTX, reports have been presented on the superior effect of tegafur + MMC compared to surgery or MMC alone in gastric cancer [5,33]. Finally, several trials have demonstrated improvement of OS following use of adjuvant CITX, compared with CTX alone in LAGC [13,14,15,16].…”

Section: Discussionmentioning

confidence: 99%

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5-Fluorouracil, Mitomycin-C, and Polysaccharide-K versus Uracil-Ftorafur and Polysaccharide-K as Adjuvant Chemoimmunotherapy for Patients with Locally Advanced Gastric Cancer with Curative Resection

et al. 2013

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Background: Despite the small but significant survival benefit of adjuvant chemotherapy in locally advanced gastric cancer (LAGC), the optimal regimen remains to be determined. We conducted a randomized trial comparing oral (PO) chemoimmunotherapy (CITX) with intravenous (IV) CITX in LAGC patients (stages IB-IIIB) with curative resection (≥ D2 dissection). Methods: The patients were randomized to the IV (5-fluorouracil 500 mg/m² weekly for 24 weeks, mitomycin-C 8 mg/m² every 6 weeks × 4) or the PO (uracil-ftorafur (UFT) 400-600 mg/day for 12 months) group. Patients in both groups received PO polysaccharide-K (3 g/day for 4 months). The planned number of patients was 368 for proving the non-inferiority of PO CITX compared to IV CITX for overall survival. Results: The trial was closed prematurely after enrolling 82 patients (44 in the IV group, 38 in the PO group). With a median follow-up of 82 months, there were no significant differences in the 5-year disease-free survival (73% vs. 55%, p = 0.358) and overall survival (77% vs. 66%, p = 0.159) between the 2 groups. The IV group demonstrated a higher incidence of grade 2 or 3 neutropenia, thrombocytopenia, and vomiting. Conclusions: PO CITX with UFT appeared to be at least non-inferior to 5-fluorouracil and mitomycin-C CITX, with lower toxicity in the adjuvant treatment for LAGC.

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Section: Discussioncontrasting

confidence: 52%

Section: Discussionmentioning

confidence: 99%

5-Fluorouracil, Mitomycin-C, and Polysaccharide-K versus Uracil-Ftorafur and Polysaccharide-K as Adjuvant Chemoimmunotherapy for Patients with Locally Advanced Gastric Cancer with Curative Resection

et al. 2013

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“…on day 1 every 6 weeks) plus tegafur (500 mg /m 2 day 1 for 36 consecutive days) (n ¼ 65). The courses were repeated four times as reported previously (Grau et al, 1998).…”

Section: Methodsmentioning

confidence: 99%

p53 and VEGF expression are independent predictors of tumour recurrence and survival following curative resection of gastric cancer

et al. 2004

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This study was undertaken to determine the value of tumour microvessel density (MVD) and the expression of p53 and vascular endothelial growth factor (VEGF) as prognostic markers in patients with gastric cancer operated on for cure. In all, 156 patients with curatively resected gastric cancer constituted the basis of this blinded retrospective evaluation. Patients were treated with either surgery alone (n ¼ 53) or surgery plus adjuvant chemotherapy (n ¼ 103). Tumour MVD, p53 expression, and VEGF expression were assayed using immunohistochemical techniques. After a mean follow-up of 43 months, 64 (41%) patients had died and 55 (35%) patients developed tumour recurrence. Positive correlations between MVD and both p53 (P ¼ 0.005) and VEGF (P ¼ 0.005) expression were observed. Both MVD X100 (P ¼ 0.05) and positive VEGF expression (Po0.02) were associated with shorter disease-free survival, and positive VEGF expression (P ¼ 0.01) was also associated with shorter overall survival. Multivariate analysis confirmed that, in addition to the pathological tumour stage, lymph node ratio, the extent of lymphadenectomy and perineural invasion, p53 expression, and VEGF expression were independently associated with both disease-free survival (Po0.0005 and 0.02, respectively) and overall survival (Po0.02 and 0.01, respectively). Finally, patients whose tumours did not show p53 expression had a survival benefit compared to those expressing p53 when treated with adjuvant chemotherapy (P ¼ 0.01).This investigation demonstrates that p53 expression and VEGF expression are independent prognostic factors for both disease-free survival and overall survival in patients with curatively resected gastric cancer, and that p53 status may also influence response to chemotherapy.

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“…Toxicity consisted of thrombopenia (25% of the patients), leukopenia in 22% of the patients, vomiting in 12% of the patients, and asthenia (related to Tegafur) in 3% of the patients, always less than grade 3 of the WHO classification [13]. As reported before, main toxicity consisted of three cases of hemolytic-uremic syndrome in patients treated with MMC 20 mg/m 2 plus TG [1]. Two toxicityrelated deaths were observed and the third patient is under permanent dialysis.…”

Section: Resultsmentioning

confidence: 87%

“…In 1998 we published a report on the efficacy of mitomycin C (MMC) plus Tegafur (TG) over MMC alone in locally advanced gastric cancer [1]. We used mitomycin alone as a control arm based on our previous randomized studies showing a significant advantage of adjuvant chemotherapy over no further treatment after definitive surgery [2][3][4].…”

Section: Introductionmentioning

confidence: 99%

Impact of adjuvant chemotherapy in the long‐term outcome of patients with resected gastric cancer

Grau

Martín

Fuster

et al. 2003

Journal of Surgical Oncology

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Randomized trial of adjuvant chemotherapy with mitomycin plus ftorafur versus mitomycin alone in resected locally advanced gastric cancer.

Abstract: Significantly better survival results were observed for MMC-FT versus MMC alone. Subset analysis suggest a strong benefit in patients with node-negative and early-stage resected gastric cancer.

Cited by 48 publications

References 11 publications

5-Fluorouracil, Mitomycin-C, and Polysaccharide-K versus Uracil-Ftorafur and Polysaccharide-K as Adjuvant Chemoimmunotherapy for Patients with Locally Advanced Gastric Cancer with Curative Resection

5-Fluorouracil, Mitomycin-C, and Polysaccharide-K versus Uracil-Ftorafur and Polysaccharide-K as Adjuvant Chemoimmunotherapy for Patients with Locally Advanced Gastric Cancer with Curative Resection

p53 and VEGF expression are independent predictors of tumour recurrence and survival following curative resection of gastric cancer

Impact of adjuvant chemotherapy in the long‐term outcome of patients with resected gastric cancer

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