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Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF

Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF
Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF
The purpose of the study was to establish the optimal dose of capecitabine (X) to be used within a multicentre, randomised study evaluating the potential roles of oxaliplatin (O) and X in chemonaive patients (pts) with advanced oesophagogastric cancer. Two by two design was used, and pts were randomised to one of four regimens and stratified for extent of disease, performance status (PS) and centre. The treatment regimens are epirubicin, cisplatin, 5-fluorouracil (ECF), EOF, ECX or EOX. Doses: E 50 mg m-2, C 60 mg m-2 and O 130 mg m-2 i.v. 3 weekly; F 200 mg m-2 day-1 i.v. and X 500 mg m-2 b.i.d.-1 (escalated to 625 mg m-2 b.i.d.-1 after results of first interim analysis) p.o., continuously. First interim analysis was performed when 80 pts had been randomised. Dose-limiting fluoropyrimidine toxicities were stomatitis, palmar plantar erythema (PPE) and diarrhoea; 5.1% of X-treated pts experienced grade 3/4 toxicity. Protocol planned dose escalation of X to 625 mg m-2 b.i.d.-1 was instituted and a second interim analysis has been performed; results are presented in this paper. A total of 204 pts were randomised at the time of the protocol planned 2nd interim analysis. Grade 3/4 fluoropyrimidine-related toxicity was seen in 13.7% pts receiving F, 8.4% pts receiving X 500 mg m-2 b.i.d.-1 and 14.7% pts receiving X 625 mg m-2 b.i.d.-1. Combined complete and partial response rates were ECF 31% (95% CI 18.7-46.3), EOF 39% (95% CI 25.9-53.1), ECX 35% (95% CI 21.4-50.3), EOX 48% (95% CI 33.3-62.8). Grade 3/4 fluoropyrimidine toxicity affected 14.7% of pts treated with X 625 mg m-2 b.i.d.-1, which is similar to that observed with F, confirming this to be the optimal dose. The replacement of C by O and F by X does not appear to impair efficacy. The trial continues to total accrual of 1000 pts.
0007-0920
1976-1983
Sumpter, K.
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Harper-Wynne, C.
ded0c299-df22-498f-b2af-af6d723b361d
Cunningham, D.
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Rao, S.
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Tebbutt, N.
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Norman, A.R.
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Ward, C.
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Iveson, T.
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Nicolson, M.
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Hickish, T.
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Hill, M.
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Oates, J.
813bc998-fd2e-4f29-bae2-8881beabba0e
Sumpter, K.
0fc3e3c9-bc28-4fe1-9900-5de36c048fec
Harper-Wynne, C.
ded0c299-df22-498f-b2af-af6d723b361d
Cunningham, D.
02b4fd3a-f452-4419-96a7-f98f609f098d
Rao, S.
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Tebbutt, N.
158f2e3e-ef39-4295-9e27-4c24b76e94da
Norman, A.R.
9d5636c7-72da-4a29-80f1-e3d79c501639
Ward, C.
49730117-7b7d-4410-b590-0314cb81d0d7
Iveson, T.
867cb6c5-ea9a-4521-a4cc-4cd4d2503b3a
Nicolson, M.
293bfbb1-f76e-408e-a6e3-615dffb59acd
Hickish, T.
d17bf903-3f13-4b46-9389-f0f458083442
Hill, M.
c50e3b2f-2e91-488a-b89a-88f98d46661e
Oates, J.
813bc998-fd2e-4f29-bae2-8881beabba0e

Sumpter, K., Harper-Wynne, C., Cunningham, D., Rao, S., Tebbutt, N., Norman, A.R., Ward, C., Iveson, T., Nicolson, M., Hickish, T., Hill, M. and Oates, J. (2005) Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF. British Journal of Cancer, 92 (11), 1976-1983. (doi:10.1038/sj.bjc.6602572).

Record type: Article

Abstract

The purpose of the study was to establish the optimal dose of capecitabine (X) to be used within a multicentre, randomised study evaluating the potential roles of oxaliplatin (O) and X in chemonaive patients (pts) with advanced oesophagogastric cancer. Two by two design was used, and pts were randomised to one of four regimens and stratified for extent of disease, performance status (PS) and centre. The treatment regimens are epirubicin, cisplatin, 5-fluorouracil (ECF), EOF, ECX or EOX. Doses: E 50 mg m-2, C 60 mg m-2 and O 130 mg m-2 i.v. 3 weekly; F 200 mg m-2 day-1 i.v. and X 500 mg m-2 b.i.d.-1 (escalated to 625 mg m-2 b.i.d.-1 after results of first interim analysis) p.o., continuously. First interim analysis was performed when 80 pts had been randomised. Dose-limiting fluoropyrimidine toxicities were stomatitis, palmar plantar erythema (PPE) and diarrhoea; 5.1% of X-treated pts experienced grade 3/4 toxicity. Protocol planned dose escalation of X to 625 mg m-2 b.i.d.-1 was instituted and a second interim analysis has been performed; results are presented in this paper. A total of 204 pts were randomised at the time of the protocol planned 2nd interim analysis. Grade 3/4 fluoropyrimidine-related toxicity was seen in 13.7% pts receiving F, 8.4% pts receiving X 500 mg m-2 b.i.d.-1 and 14.7% pts receiving X 625 mg m-2 b.i.d.-1. Combined complete and partial response rates were ECF 31% (95% CI 18.7-46.3), EOF 39% (95% CI 25.9-53.1), ECX 35% (95% CI 21.4-50.3), EOX 48% (95% CI 33.3-62.8). Grade 3/4 fluoropyrimidine toxicity affected 14.7% of pts treated with X 625 mg m-2 b.i.d.-1, which is similar to that observed with F, confirming this to be the optimal dose. The replacement of C by O and F by X does not appear to impair efficacy. The trial continues to total accrual of 1000 pts.

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Published date: 2005
Additional Information: Clinical Study

Identifiers

Local EPrints ID: 26631
URI: http://eprints.soton.ac.uk/id/eprint/26631
ISSN: 0007-0920
PURE UUID: b808b305-13f6-4802-a030-6abdf2354784
ORCID for T. Iveson: ORCID iD orcid.org/0000-0002-4681-2712

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Date deposited: 10 Apr 2006
Last modified: 16 Mar 2024 02:58

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Contributors

Author: K. Sumpter
Author: C. Harper-Wynne
Author: D. Cunningham
Author: S. Rao
Author: N. Tebbutt
Author: A.R. Norman
Author: C. Ward
Author: T. Iveson ORCID iD
Author: M. Nicolson
Author: T. Hickish
Author: M. Hill
Author: J. Oates

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