Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

Cutsem, Éric Van; Moiseyenko, Vladimir; Tjulandin, Sergei; Majlis, Alejandro; Constenla, Manuel; Boni, C.; Rodrigues, Adriano; Fodor, M; Chao, Yee; Возный, Э К; Risse, Marie Laure; Ajani, Jaffer A.

doi:10.1200/jco.2006.06.8429

Cited by 1,694 publications

(1,395 citation statements)

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“…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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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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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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“…In particular, taxaneor oxaliplatin-based combination chemotherapies have shown high response rates from 38 to 54% and a median overall survival time of from 8.6 to 11.4 months against advanced gastric cancer (Louvet et al, 2002;De Vita et al, 2005;Lordick et al, 2005;Van Cutsem et al, 2006). Median survival duration in the present study was 11 months, which is the highest recorded to date by gastric cancer studies.…”

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confidence: 44%

A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer

Sur

Sung

et al. 2007

Br J Cancer

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Capecitabine, a prodrug of 5-FU, has been reported to generate maximal tumour activity at tumour sites and/or to improve drug tolerability as compared with 5-FU infusion, and it has also been demonstrated to act synergistically with irinotecan against some solid cancers. A previous study concluded that dose-intensified biweekly capecitabine seems to be more effective at increasing both response rate and progression-free survival time than conventional dose and schedule of capecitabine in colon cancer. We conducted this study to ascertain the efficacy and toxicity of dose-intensified biweekly capecitabine and irinotecan combination chemotherapy in chemotherapy-naïve advanced or metastatic gastric cancer patients. Patients were treated with irinotecan 130 mg m À2 intravenously for 90 min on days 1 and 15. Capecitabine at 3500 mg m À2 day À1 , divided into two sessions per day, was administered for seven consecutive days from days 1 and 15, and followed by a 7-day drug-free period, respectively. Fifty-five eligible patients were enrolled in this study from November 2003 to April 2006. There were 22 women and 33 men: median patient age was 54 years (range: 27 -81). A total of 200 treatment cycles were administered at a median number of four per patient (range: 1 -9). Intent-to-treatment analysis showed that one patient achieved complete response (1.8%), 23 partial response (41.8%), 15 stable disease (27.3%), 10 progressive disease (18.2%) and 6 were non-evaluable (10.9%). The overall response rate was 43.6% (95% confidence interval: 30.2 -56.9). The common grade 3 -4 toxicities were neutropenia in 12 (21.8%), nausea/vomiting in 3 (5.4%) and diarrhea in 4 (7.2%) patients. Median time to progression was 5 months (range: 0.5 -11 months), median survival duration was 11 months (range: 0.5 -45 months) and median response duration was 6 months (range: 0.5 -9 months). Biweekly dose-intensified capecitabine and irinotecan combination chemotherapy was active for the treatment of advanced or metastatic gastric cancers with a tolerable safety profile.

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“…The TAX-V325 trial [8], which established the role of docetaxel combinations in AGC, demonstrated a significant increase in response rate (37 vs. 25%), in time to progression (5.6 vs. 3.7 months) and in overall survival (9.2 vs. 8.6, 23% risk reduction and 18 vs. 9% of patients alive at 2 years) for DCF over CF. The cost for such advantages was high in terms of toxicity: in DCF arm, the rate of G3-4 diarrhoea, G3-4 neutropenia and febrile neutropenia was 19, 82 and 29%, respectively, and significantly higher than with CF (8, 57 and 12%, respectively).…”

Section: Discussionmentioning

confidence: 99%

“…This was achieved for the results of the TAX-V325 phase III randomized study, that randomly assigned AGC patients to the triplet combination of docetaxel, cisplatin and 5-FU (DCF) or cisplatin plus fluorouracil [8]. The taxane improved response rate, TTP and OS, but with a substantial increase in toxicity [6,9].…”

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confidence: 99%

Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma

Loupakis¹,

Masi²,

Fornaro³

et al. 2010

Cancer Chemother Pharmacol

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, et al.. Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma. Cancer Chemotherapy and Pharmacology, Springer Verlag, 2010, 66 (3), pp.559-566. <10.1007/s00280-009-1196-1>. ORIGINAL ARTICLEPhase II study of sequential cisplatin plus 5-fluorouracil/ leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma Results Forty-six patients were enrolled, median age 60 years, sites of disease (single/multiple) = 9/37, PS 0/1 = 27/19, gastric/gastro-oesophageal junction = 39/7. Median number of cycles was 9. Main grade 3-4 toxicities were neutropenia (37%), febrile neutropenia (2%), diarrhoea (4%), stomatitis (9%). Response rate after the planned 9 cycles was 45% (15 partial and 5 complete responses among 43 evaluable patients). Median PFS and OS: 6.8 and 11.1 months, respectively. Conclusion This sequential treatment is feasible with a favourable safety profile and produced encouraging results in terms of activity and efficacy.

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Phase III Study of Docetaxel and Cisplatin Plus Fluorouracil Compared With Cisplatin and Fluorouracil As First-Line Therapy for Advanced Gastric Cancer: A Report of the V325 Study Group

Cited by 1,694 publications

References 28 publications

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

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

A phase II study of biweekly dose-intensified oral capecitabine plus irinotecan (bXELIRI) for patients with advanced or metastatic gastric cancer

Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma

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