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

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 -