The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)

Salah Eddin Al-Batran; Claudia Pauligk; Nils Homann; Jörg T. Hartmann; Markus Moehler; Stephan Probst; Volker Rethwisch; Jan Stoehlmacher-Williams; Nicole Prasnikar; Stephan Hollerbach; Carsten Bokemeyer; Rolf Mahlberg; Ralf D. Hofheinz; Kim Luley; Frank Kullmann; Elke Jäger

doi:10.1016/j.ejca.2012.09.025

The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)

Salah Eddin Al-Batran^*, Claudia Pauligk, Nils Homann, Jörg T. Hartmann, Markus Moehler, Stephan Probst, Volker Rethwisch, Jan Stoehlmacher-Williams, Nicole Prasnikar, Stephan Hollerbach, Carsten Bokemeyer, Rolf Mahlberg, Ralf D. Hofheinz, Kim Luley, Frank Kullmann, Elke Jäger

^*Corresponding author for this work

Clinic of Internal Medicine I

141 Citations (Scopus)

Abstract

Background: We evaluated the feasibility and tolerability of triple- versus double-drug chemotherapy in elderly patients with oesophagogastric cancer. Methods: Patients aged 65 years or older with locally advanced or metastatic oesophagogastric cancer were stratified and randomised to infusional 5-FU, leucovorin and oxaliplatin without (FLO) or with docetaxel 50 mg/m² (FLOT) every 2 weeks. The study is registered at ClinicalTrials.gov, identifier NCT00737373. Findings: One hundred and forty three (FLO, 71; FLOT, 72) patients with a median age of 70 years were enrolled. The triple combination was associated with more treatment-related National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3/4 adverse events (FLOT, 81.9%; FLO, 38.6%; P <.001) and more patients experiencing a ≥10-points deterioration of European Organization for Research and Treatment of Cancer Quality of Life (EORTC QoL) global health status scores (FLOT, 47.5%; FLO 20.5%; p =.011). The triple combination was associated with more alopecia (P <.001), neutropenia (P <.001), leukopenia (P <.001), diarrhoea (P =.006) and nausea (P =.029).). No differences were observed in treatment duration and discontinuation due to toxicity, cumulative doses or toxic deaths between arms. The triple combination improved response rates and progression-free survival in the locally advanced subgroup and in the subgroup of patients aged between 65 and 70 years but not in the metastatic group or in patients aged 70 years and older. Interpretation: The triple-drug chemotherapy was feasible in elderly patients with oesophagogastric cancer. However, toxicity was significantly increased and QoL deteriorated in a relevant proportion of patients. Funding: The study was partially funded by Sanofi-Aventis.

Original language	English
Journal	European Journal of Cancer
Volume	49
Issue number	4
Pages (from-to)	835-842
Number of pages	8
ISSN	0959-8049
DOIs	https://doi.org/10.1016/j.ejca.2012.09.025
Publication status	Published - 01.03.2013

Funding

The Institute of Clinical Research at Krankenhaus Nordwest University Cancer Center Frankfurt is the legal sponsor of the study according to European Low. The study design, protocol writing and the conduct of the trial were performed by the staff of the Institute of Clinical Research and AIO. The Institute of Clinical Research has received partial funding from Sanofi Aventis, Germany. However, the funder had no role in the conduct of the trial or collection, analysis and interpretation of the data. The funder also had no role in writing or reviewing this manuscript. 3

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10.1016/j.ejca.2012.09.025

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Al-Batran, S. E., Pauligk, C., Homann, N., Hartmann, J. T., Moehler, M., Probst, S., Rethwisch, V., Stoehlmacher-Williams, J., Prasnikar, N., Hollerbach, S., Bokemeyer, C., Mahlberg, R., Hofheinz, R. D., Luley, K., Kullmann, F., & Jäger, E. (2013). The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+). European Journal of Cancer, 49(4), 835-842. https://doi.org/10.1016/j.ejca.2012.09.025

@article{43ac10864a404848bce49b40d1d12ec4,

title = "The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)",

abstract = "Background: We evaluated the feasibility and tolerability of triple- versus double-drug chemotherapy in elderly patients with oesophagogastric cancer. Methods: Patients aged 65 years or older with locally advanced or metastatic oesophagogastric cancer were stratified and randomised to infusional 5-FU, leucovorin and oxaliplatin without (FLO) or with docetaxel 50 mg/m2 (FLOT) every 2 weeks. The study is registered at ClinicalTrials.gov, identifier NCT00737373. Findings: One hundred and forty three (FLO, 71; FLOT, 72) patients with a median age of 70 years were enrolled. The triple combination was associated with more treatment-related National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3/4 adverse events (FLOT, 81.9\%; FLO, 38.6\%; P <.001) and more patients experiencing a ≥10-points deterioration of European Organization for Research and Treatment of Cancer Quality of Life (EORTC QoL) global health status scores (FLOT, 47.5\%; FLO 20.5\%; p =.011). The triple combination was associated with more alopecia (P <.001), neutropenia (P <.001), leukopenia (P <.001), diarrhoea (P =.006) and nausea (P =.029).). No differences were observed in treatment duration and discontinuation due to toxicity, cumulative doses or toxic deaths between arms. The triple combination improved response rates and progression-free survival in the locally advanced subgroup and in the subgroup of patients aged between 65 and 70 years but not in the metastatic group or in patients aged 70 years and older. Interpretation: The triple-drug chemotherapy was feasible in elderly patients with oesophagogastric cancer. However, toxicity was significantly increased and QoL deteriorated in a relevant proportion of patients. Funding: The study was partially funded by Sanofi-Aventis.",

author = "Al-Batran, \{Salah Eddin\} and Claudia Pauligk and Nils Homann and Hartmann, \{J{\"o}rg T.\} and Markus Moehler and Stephan Probst and Volker Rethwisch and Jan Stoehlmacher-Williams and Nicole Prasnikar and Stephan Hollerbach and Carsten Bokemeyer and Rolf Mahlberg and Hofheinz, \{Ralf D.\} and Kim Luley and Frank Kullmann and Elke J{\"a}ger",

year = "2013",

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doi = "10.1016/j.ejca.2012.09.025",

language = "English",

volume = "49",

pages = "835--842",

journal = "European Journal of Cancer",

issn = "0959-8049",

publisher = "Elsevier Ltd",

number = "4",

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Al-Batran, SE, Pauligk, C, Homann, N, Hartmann, JT, Moehler, M, Probst, S, Rethwisch, V, Stoehlmacher-Williams, J, Prasnikar, N, Hollerbach, S, Bokemeyer, C, Mahlberg, R, Hofheinz, RD, Luley, K, Kullmann, F & Jäger, E 2013, 'The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)', European Journal of Cancer, vol. 49, no. 4, pp. 835-842. https://doi.org/10.1016/j.ejca.2012.09.025

The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+). / Al-Batran, Salah Eddin; Pauligk, Claudia; Homann, Nils et al.
In: European Journal of Cancer, Vol. 49, No. 4, 01.03.2013, p. 835-842.

Research output: Journal Articles › Journal articles › Research › peer-review

TY - JOUR

T1 - The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)

AU - Al-Batran, Salah Eddin

AU - Pauligk, Claudia

AU - Homann, Nils

AU - Hartmann, Jörg T.

AU - Moehler, Markus

AU - Probst, Stephan

AU - Rethwisch, Volker

AU - Stoehlmacher-Williams, Jan

AU - Prasnikar, Nicole

AU - Hollerbach, Stephan

AU - Bokemeyer, Carsten

AU - Mahlberg, Rolf

AU - Hofheinz, Ralf D.

AU - Luley, Kim

AU - Kullmann, Frank

AU - Jäger, Elke

PY - 2013/3/1

Y1 - 2013/3/1

N2 - Background: We evaluated the feasibility and tolerability of triple- versus double-drug chemotherapy in elderly patients with oesophagogastric cancer. Methods: Patients aged 65 years or older with locally advanced or metastatic oesophagogastric cancer were stratified and randomised to infusional 5-FU, leucovorin and oxaliplatin without (FLO) or with docetaxel 50 mg/m2 (FLOT) every 2 weeks. The study is registered at ClinicalTrials.gov, identifier NCT00737373. Findings: One hundred and forty three (FLO, 71; FLOT, 72) patients with a median age of 70 years were enrolled. The triple combination was associated with more treatment-related National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3/4 adverse events (FLOT, 81.9%; FLO, 38.6%; P <.001) and more patients experiencing a ≥10-points deterioration of European Organization for Research and Treatment of Cancer Quality of Life (EORTC QoL) global health status scores (FLOT, 47.5%; FLO 20.5%; p =.011). The triple combination was associated with more alopecia (P <.001), neutropenia (P <.001), leukopenia (P <.001), diarrhoea (P =.006) and nausea (P =.029).). No differences were observed in treatment duration and discontinuation due to toxicity, cumulative doses or toxic deaths between arms. The triple combination improved response rates and progression-free survival in the locally advanced subgroup and in the subgroup of patients aged between 65 and 70 years but not in the metastatic group or in patients aged 70 years and older. Interpretation: The triple-drug chemotherapy was feasible in elderly patients with oesophagogastric cancer. However, toxicity was significantly increased and QoL deteriorated in a relevant proportion of patients. Funding: The study was partially funded by Sanofi-Aventis.

AB - Background: We evaluated the feasibility and tolerability of triple- versus double-drug chemotherapy in elderly patients with oesophagogastric cancer. Methods: Patients aged 65 years or older with locally advanced or metastatic oesophagogastric cancer were stratified and randomised to infusional 5-FU, leucovorin and oxaliplatin without (FLO) or with docetaxel 50 mg/m2 (FLOT) every 2 weeks. The study is registered at ClinicalTrials.gov, identifier NCT00737373. Findings: One hundred and forty three (FLO, 71; FLOT, 72) patients with a median age of 70 years were enrolled. The triple combination was associated with more treatment-related National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3/4 adverse events (FLOT, 81.9%; FLO, 38.6%; P <.001) and more patients experiencing a ≥10-points deterioration of European Organization for Research and Treatment of Cancer Quality of Life (EORTC QoL) global health status scores (FLOT, 47.5%; FLO 20.5%; p =.011). The triple combination was associated with more alopecia (P <.001), neutropenia (P <.001), leukopenia (P <.001), diarrhoea (P =.006) and nausea (P =.029).). No differences were observed in treatment duration and discontinuation due to toxicity, cumulative doses or toxic deaths between arms. The triple combination improved response rates and progression-free survival in the locally advanced subgroup and in the subgroup of patients aged between 65 and 70 years but not in the metastatic group or in patients aged 70 years and older. Interpretation: The triple-drug chemotherapy was feasible in elderly patients with oesophagogastric cancer. However, toxicity was significantly increased and QoL deteriorated in a relevant proportion of patients. Funding: The study was partially funded by Sanofi-Aventis.

UR - https://www.scopus.com/pages/publications/84873720456

U2 - 10.1016/j.ejca.2012.09.025

DO - 10.1016/j.ejca.2012.09.025

M3 - Journal articles

C2 - 23063354

AN - SCOPUS:84873720456

SN - 0959-8049

VL - 49

SP - 835

EP - 842

JO - European Journal of Cancer

JF - European Journal of Cancer

IS - 4

ER -

The feasibility of triple-drug chemotherapy combination in older adult patients with oesophagogastric cancer: A randomised trial of the Arbeitsgemeinschaft Internistische Onkologie (FLOT65+)

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