Quality of life of older adult patients receiving docetaxel-based chemotherapy triplets for esophagogastric adenocarcinoma: a randomized study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)

Abstract

Background Treatment of patients with advanced or metastatic esophagogastric adenocarcinoma should not only prolong life but also provide relief of symptoms and improve quality of life (QOL). Esophagogastric adenocarcinoma mainly occurs in elderly patients, but they are underrepresented in most clinical trials and often do not receive effective combination chemotherapy, most probably for fear of intolerance. Using validated instruments, we prospectively assessed QOL within the randomized FLOT65? phase II trial. Methods Within the FLOT65? trial, a total of 143 patients aged C65 years were randomly allocated to receive biweekly oxaliplatin plus 5-fluorouracil (5-FU) continuous infusion and folinic acid (FLO) or the same regimen in combination with docetaxel 50 mg/m 2 (FLOT).The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the gastric module STO22 were administered every 8 weeks until progression. Time to definitive deterioration of QOL parameters was analyzed and compared within the treatment arms. Results The median age of patients was 70 years. Patients receiving FLOT exhibited higher response rates and had improved disease-free and progression-free survival (PFS). The proportions of patients with evaluable baseline EORTC QLQ-C30 and STO22 questionnaires were balanced (83 % in FLOT and 89 % in FLO). Considering evaluable patients with assessable questionnaires (n = 123), neither functioning nor symptom parameters differed significantly in favor of one of the two treatment groups. Particularly, there was no significant difference regarding time to definitive deterioration of global health status/quality of life from baseline (primary endpoint). Notably, patients receiving FLO or FLOT as palliative treatment (n = 98) achieved comparable QOL results. Conclusions Although toxicity was higher in patients receiving FLOT, no negative impact of the addition of docetaxel on QOL parameters could be demonstrated. Thus, elderly patients in need of intensified chemotherapy may receive FLOT without compromising patient-reported outcome parameters.

Stellungnahme der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) zur Ramucirumab-Nutzenbewertung gemäß § 35a SGB V des G-BA

“…Vergleichbare eigene Lebensqualitätsstudien zur Erst-oder Zweitlinientherapie belegen die Qualität, aber auch den hohen Aufwand in der Beurteilung der Lebensqualität [9,10].…”

Reply to the Letter to the Editor

“…We appreciate the comments on our article ''Quality of life of older adult patients receiving docetaxel-based chemotherapy triplets for esophagogastric adenocarcinoma: a randomized study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)'' [1].…”

“…study included an add-on quality-of-life (QoL) substudy with its own predefined end points. The primary end point of this QoL substudy [1] was the time to 5 % definitive deterioration of global health status (GHS) from the baseline, on the basis of the TAX 325 trial [3,4], as assessed by time-to-event methods (Kaplan-Meier curves). In our article, we focused on the predefined end points of the substudy.…”

“…All analyses have methodological advantages and disadvantages, the explanation of which would extend beyond this letter. See the discussion section in our article [1] for a comprehensive discussion of this point.…”

Inconsistent conclusions on QoL outcomes from the same clinical trial

“…Therefore, the article by Kripp et al [3] is to be welcomed. However, we have some queries and would like to see the following issues addressed by the authors: with regard to study design and report the result for the statistically significant difference at week 8 (and also refer to this result in the discussion).…”