Docetaxel (TaxotereTM) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group

Sulkes, Aarón; Smyth, J. F.; Sessa, C.; Dirix, Luc; Vermorken, J. B.; Kaye, SB; Wanders, J.; Franklin, H. R.; LeBail, N; Verweij, Jaap

doi:10.1038/bjc.1994.310

Cited by 208 publications

(89 citation statements)

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“…The most common haematological toxicities were neutropenia and leucopenia. The incidence of grade 3/4 neutropenia was similar to those previously reported with docetaxel monotherapy (Sulkes et al, 1994;Einzig et al, 1996;Taguchi et al, 1998;Mai et al, 1999). Despite the lack of corticosteroid prophylaxis, only three patients developed fluid retention (all grade 1), and no patients had a hypersensitivity reaction.…”

Section: Discussionsupporting

confidence: 87%

“…A preclinical study of docetaxel showed a synergistic antitumour activity in combination with 5-FU (Bissery et al, 1995), which led to several clinical studies in advanced GC. In this setting, docetaxel has been evaluated both as a single agent (Sulkes et al, 1994;Einzig et al, 1996;Taguchi et al, 1998;Mai et al, 1999) and in combination with fluoropyrimidines (Constenla et al, 2002;Park et al, 2004), cisplatin (Roth et al, 2000), and cisplatin plus 5-FU (Van Custem et al, 2003). In a randomised phase III study, this latter regimen (TCF) improved overall survival compared to cisplatin plus 5-FU (Moiseyenko et al, 2005).…”

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confidence: 99%

“…In a randomised phase III study, this latter regimen (TCF) improved overall survival compared to cisplatin plus 5-FU (Moiseyenko et al, 2005). The docetaxel containing combination regimens are associated with severe leucopenia and febrile neutropenia, and although these adverseevents can be managed, efforts must be made to minimise such toxicities (Sulkes et al, 1994;Einzig et al, 1996;Taguchi et al, 1998;Mai et al, 1999).…”

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confidence: 99%

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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: 87%

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confidence: 99%

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confidence: 99%

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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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“…Another relatively new drug, docetaxel, has also proven to be quite active against gastric cancer, with ORR ranging from 17 to 24% as a single agent (Sulkes et al, 1994;Einzig et al, 1996). 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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“…Response rates of 5% -21% have been reported for single-agent chemotherapy, with 5-fluorouracil (5-FU), in chemonaive patients (Wils and Bleiberg, 1989;Loehrer et al, 1994). Other agents, when used as monotherapy, have produced response rates as follows: paclitaxel 20% ), adriamycin 24% (O'Connell, 1985, docetaxel 25% (Sulkes et al, 1994), cisplatin 25% (O'Connell, 1985), UFT 28% (Takiuchi and Ajani, 1998) and mitomycin C 30% (Comis and Carter, 1974).…”

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Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multicentric trial

et al. 2003

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To assess the response rate and the tolerance of irinotecan as first-line therapy, 40 patients with metastatic gastric cancer received irinotecan 350 mg m À2 every 3 weeks administered as a 30 min infusion. Among the 35 patients evaluable for response, two complete and five partial responses were recorded (response rate: 20.0% (95% CI:8.4 -36.9%)). In total, 16 patients achieved stable disease and 12 progressive disease. In all, 66 percent of the patients benefited from tumour growth control. The median time to progression was 3.0 months (95% CI: 2.3 -4.4%). The median overall survival was 7.1 months (95% CI: 5.2 -9.0%). The probability of being alive at 6 months and 9 months was 61.0 and 32.4%, respectively. The median number of cycles per patient was 3 (range 1 -14), and the relative dose intensity was 0.98. The most common grade 3 -4 toxicities by patients were diarrhoea 20%, asthenia 10%, nausea 7.5%, vomiting 5.0%, abdominal pain 5%, neutropenia 38.5%, leucopenia 28.2%, anaemia 12.8% and thrombocytopenia 5.1%. Febrile neutropenia occurred in 12.5% of patients. These findings indicate that irinotecan is active and well tolerated in patients with metastatic gastric adenocarcinoma and warrants further evaluation in this clinical setting.

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Docetaxel (TaxotereTM) in advanced gastric cancer: results of a phase II clinical trial. EORTC Early Clinical Trials Group

Cited by 208 publications

References 13 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

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

Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multicentric trial

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