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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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; Hartmann, Jörg T; Moehler, Markus; Probst, Stephan; Rethwisch, Volker; Stoehlmacher-Williams, Jan; Prasnikar, Nicole; Hollerbach, Stephan; Bokemeyer, Carsten; Mahlberg, Rolf; Hofheinz, Ralf D; Luley, Kim; Kullmann, Frank; Jäger, Elke.
In: EUR J CANCER, Vol. 49, No. 4, 4, 2013, p. 835-842.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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
N1 - Copyright © 2012 Elsevier Ltd. All rights reserved.
PY - 2013
Y1 - 2013
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/m(2) (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/m(2) (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.
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Prospective Studies
KW - Prognosis
KW - Survival Rate
KW - Follow-Up Studies
KW - Neoplasm Staging
KW - Feasibility Studies
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Leucovorin/administration & dosage
KW - Quality of Life
KW - Esophageal Neoplasms/drug therapy/pathology
KW - Taxoids/administration & dosage
KW - Organoplatinum Compounds/administration & dosage
KW - Adenocarcinoma/drug therapy/secondary
KW - Neoplasm Recurrence, Local/drug therapy
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Prospective Studies
KW - Prognosis
KW - Survival Rate
KW - Follow-Up Studies
KW - Neoplasm Staging
KW - Feasibility Studies
KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
KW - Leucovorin/administration & dosage
KW - Quality of Life
KW - Esophageal Neoplasms/drug therapy/pathology
KW - Taxoids/administration & dosage
KW - Organoplatinum Compounds/administration & dosage
KW - Adenocarcinoma/drug therapy/secondary
KW - Neoplasm Recurrence, Local/drug therapy
U2 - 10.1016/j.ejca.2012.09.025
DO - 10.1016/j.ejca.2012.09.025
M3 - SCORING: Journal article
C2 - 23063354
VL - 49
SP - 835
EP - 842
JO - EUR J CANCER
JF - EUR J CANCER
SN - 0959-8049
IS - 4
M1 - 4
ER -