Docetaxel and Continuous-Infusion Fluorouracil Versus Epirubicin, Cisplatin, and Fluorouracil for Advanced Gastric Adenocarcinoma: A Randomized Phase II Study

Thuss‐Patience, Peter; Kretzschmar, Albrecht; Repp, Michael; Kingreen, D.; Hennesser, D.; Micheel, S.; Pink, Daniel; Scholz, Christian W.; Dörken, Bernd; Reichardt, Peter

doi:10.1200/jco.2005.02.163

Cited by 99 publications

(76 citation statements)

References 19 publications

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“…All of these features are associated with decreased response rates to chemotherapy , Mai et al, 1999, Koizumi et al, 2000, Ajani et al, 2005). Yet despite these unfavourable baseline characteristics, the combination of docetaxel and S-1 conferred an ORR that was similar to those obtained with other combination regimens (Ajani et al, 2005;Thuss-Patience et al, 2005).…”

Section: Discussionsupporting

confidence: 53%

“…Although cross-study comparisons should be taken with caution, the survival effect observed in our study compares favourably with other chemotherapy regimens, such as docetaxel (6 -8 months Mai et al, 1999)) or S-1 (7 -8 months Koizumi et al, 2000)), or the combinations DC (11 months), DF (10 months), DCF (10 months), ECF (10 months) or FOLFOX-4 (11 months) (Ajani et al, 2005;De Vita et al, 2005;Thuss-Patience et al, 2005).…”

Section: Discussionsupporting

confidence: 51%

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

et al. 2006

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The aims of this phase I/II study of docetaxel and S-1 were to determine the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and recommended dose (RD) in the phase I part and to explore the tumour response, survival and safety in the phase II part. Patients with histologically-or cytologically confirmed unresectable or recurrent gastric cancer were eligible. Treatment consisted of intravenous docetaxel on day 1 (starting dose 50 mg m À2 ) and oral S-1 at a fixed dose of 40 mg m À2 twice daily on days 1 -14, every 4 weeks up to six cycles. Nine patients took part in the phase I portion of the study. The MTD of docetaxel was determined to be 50 mg m À2 , with the DLTs of grade 3 infection associated with grade 3 neutropenia and grade 4 neutropenia during S-1 administration. The RD of docetaxel was 40 mg m À2 in combination with S-1 40 mg m À2 b.i.d. The efficacy and safety of this regimen was therefore assessed in 46 patients with at least one measurable lesion. The overall response rate and estimated median overall survival were 46% (95% CI, 31 -61%) and 14.0 months (8.3 -17.3 months), respectively. The most common grade 3/4 toxicity was neutropenia (67% of patients), which was predictable and manageable. This regimen showed promising activity with moderate toxicities in advanced gastric cancer.

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Section: Discussionsupporting

confidence: 53%

Section: Discussionsupporting

confidence: 51%

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

et al. 2006

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“…In addition to modifying the docetaxel schedule, both regimens involved an altered fluoropyrimidine schedule (either continuous-infusion 5FU or capecitabine) compared with 3-weekly TCF, which used a 4-day infusion of high-dose 5FU. This may also have contributed to lower rates of myelosuppression, as other studies have shown more manageable rates of haematological toxicities with protracted infusion schedules of 5FU (Thuss-Patience et al, 2005).…”

Section: Discussionmentioning

confidence: 96%

Randomised, non-comparative phase II study of weekly docetaxel with cisplatin and 5-fluorouracil or with capecitabine in oesophagogastric cancer: the AGITG ATTAX trial

et al. 2010

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BACKGROUND: Docetaxel administered 3-weekly with cisplatin and 5-fluorouracil leads to better survival than does standard therapy in patients with oesophagogastric cancer, but leads to high rates of haematological toxicity. Weekly docetaxel is associated with less haematological toxicity. This randomised phase II study tested weekly docetaxel-based combination chemotherapy regimens, with the aim of maintaining their activity while reducing toxicity. METHODS: Patients with histologically confirmed metastatic oesophageal or gastric carcinoma were randomised to receive weekly docetaxel (30 mg m À2 ) on days 1 and 8, cisplatin (60 mg m À2 ) on day 1, and 5-fluorouracil (200 mg m À2 per day) continuously, every 3 weeks (weekly TCF, wTCF); or docetaxel (30 mg m À2 ) on days 1 and 8 and capecitabine (1600 mg m À2 per day) on days 1 -14, every 3 weeks (weekly TX, wTX). RESULTS: A total of 106 patients were enrolled (wTCF, n ¼ 50; wTX, n ¼ 56). Response rates, the primary end point, were 47% with wTCF and 26% with wTX. Rates of febrile neutropenia were low in each arm. Median progression-free and overall survival times were 5.9 and 11.2 months for wTCF and 4.6 and 10.1 months for wTX, respectively. CONCLUSION: Weekly TCF and TX have encouraging activity and less haematological toxicity than TCF administered 3-weekly. Weekly docetaxel-based combination regimens warrant further evaluation in this disease.

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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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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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Docetaxel and Continuous-Infusion Fluorouracil Versus Epirubicin, Cisplatin, and Fluorouracil for Advanced Gastric Adenocarcinoma: A Randomized Phase II Study

Abstract: DF can be safely given in an ambulant setting. Compared with ECF, the dual combination of DF shows promising efficacy and may be an alternative treatment option that avoids cisplatin.

Cited by 99 publications

References 19 publications

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

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

Randomised, non-comparative phase II study of weekly docetaxel with cisplatin and 5-fluorouracil or with capecitabine in oesophagogastric cancer: the AGITG ATTAX trial

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

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