Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study

Eric Van Cutsem; C. Boni; J. Tabernero; B. Massuti; G. Middleton; F. Dane; P. Reichardt; F. L. Pimentel; A. Cohn; P. Follana; M. Clemens; A. Zaniboni; V. Moiseyenko; M. Harrison; D. A. Richards; H. Prenen; S. Pernot; E. Ecstein-Fraisse; S. Hitier; P. Rougier

doi:10.1093/annonc/mdu496

Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study

Eric Van Cutsem, C. Boni, J. Tabernero, B. Massuti, G. Middleton, F. Dane, P. Reichardt, F. L. Pimentel, A. Cohn, P. Follana, M. Clemens, A. Zaniboni, V. Moiseyenko, M. Harrison, D. A. Richards, H. Prenen, S. Pernot, E. Ecstein-Fraisse, S. Hitier, P. Rougier

Department of Medicine

Research output: Contribution to journal › Article › Research › peer-review

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Abstract

© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Background: Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. Patients and methods: Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1: 1: 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). Results: Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97-9.40] months) versus TE (4.50 [3.68-5.32] months) and TEX (5.55 [4.30-6.37] months). Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97 (7.79-10.87) months for TE and 11.30 (8.08-14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9-57.5) for TEF versus 23.1% (14.3-34.0) for TE and 25.6% (16.6-36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. Conclusion: These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC.

Original language	English
Pages (from-to)	149-156
Journal	Annals of Oncology
Volume	26
Issue number	1
DOIs	https://doi.org/10.1093/annonc/mdu496
Publication status	Published - 1 Jan 2015

Keywords

Antineoplastic agents
Combined
Platinum compounds
Stomach neoplasms
Taxoids

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/annonc/mdu496

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Van Cutsem, E., Boni, C., Tabernero, J., Massuti, B., Middleton, G., Dane, F., Reichardt, P., Pimentel, F. L., Cohn, A., Follana, P., Clemens, M., Zaniboni, A., Moiseyenko, V., Harrison, M., Richards, D. A., Prenen, H., Pernot, S., Ecstein-Fraisse, E., Hitier, S., & Rougier, P. (2015). Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study. Annals of Oncology, 26(1), 149-156. https://doi.org/10.1093/annonc/mdu496

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title = "Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study",

abstract = "{\textcopyright} The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Background: Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. Patients and methods: Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1: 1: 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). Results: Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97-9.40] months) versus TE (4.50 [3.68-5.32] months) and TEX (5.55 [4.30-6.37] months). Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97 (7.79-10.87) months for TE and 11.30 (8.08-14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9-57.5) for TEF versus 23.1% (14.3-34.0) for TE and 25.6% (16.6-36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. Conclusion: These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC.",

keywords = "Antineoplastic agents, Combined, Platinum compounds, Stomach neoplasms, Taxoids",

author = "{Van Cutsem}, Eric and C. Boni and J. Tabernero and B. Massuti and G. Middleton and F. Dane and P. Reichardt and Pimentel, {F. L.} and A. Cohn and P. Follana and M. Clemens and A. Zaniboni and V. Moiseyenko and M. Harrison and Richards, {D. A.} and H. Prenen and S. Pernot and E. Ecstein-Fraisse and S. Hitier and P. Rougier",

year = "2015",

month = jan,

day = "1",

doi = "10.1093/annonc/mdu496",

language = "English",

volume = "26",

pages = "149--156",

number = "1",

}

Van Cutsem, E, Boni, C, Tabernero, J, Massuti, B, Middleton, G, Dane, F, Reichardt, P, Pimentel, FL, Cohn, A, Follana, P, Clemens, M, Zaniboni, A, Moiseyenko, V, Harrison, M, Richards, DA, Prenen, H, Pernot, S, Ecstein-Fraisse, E, Hitier, S & Rougier, P 2015, 'Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study', Annals of Oncology, vol. 26, no. 1, pp. 149-156. https://doi.org/10.1093/annonc/mdu496

TY - JOUR

T1 - Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study

AU - Van Cutsem, Eric

AU - Boni, C.

AU - Tabernero, J.

AU - Massuti, B.

AU - Middleton, G.

AU - Dane, F.

AU - Reichardt, P.

AU - Pimentel, F. L.

AU - Cohn, A.

AU - Follana, P.

AU - Clemens, M.

AU - Zaniboni, A.

AU - Moiseyenko, V.

AU - Harrison, M.

AU - Richards, D. A.

AU - Prenen, H.

AU - Pernot, S.

AU - Ecstein-Fraisse, E.

AU - Hitier, S.

AU - Rougier, P.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Background: Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. Patients and methods: Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1: 1: 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). Results: Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97-9.40] months) versus TE (4.50 [3.68-5.32] months) and TEX (5.55 [4.30-6.37] months). Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97 (7.79-10.87) months for TE and 11.30 (8.08-14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9-57.5) for TEF versus 23.1% (14.3-34.0) for TE and 25.6% (16.6-36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. Conclusion: These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC.

AB - © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Background: Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. Patients and methods: Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1: 1: 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). Results: Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97-9.40] months) versus TE (4.50 [3.68-5.32] months) and TEX (5.55 [4.30-6.37] months). Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97 (7.79-10.87) months for TE and 11.30 (8.08-14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9-57.5) for TEF versus 23.1% (14.3-34.0) for TE and 25.6% (16.6-36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. Conclusion: These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC.

KW - Antineoplastic agents

KW - Combined

KW - Platinum compounds

KW - Stomach neoplasms

KW - Taxoids

U2 - 10.1093/annonc/mdu496

DO - 10.1093/annonc/mdu496

M3 - Article

SN - 0923-7534

VL - 26

SP - 149

EP - 156

JO - Annals of Oncology

JF - Annals of Oncology

IS - 1

ER -

Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: A randomized phase II study

Abstract

Keywords

UN SDGs

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