Abbreviations: EORTC LQ-C30: Western Organization for Research and Treatment of Malignancy Quality of Life Questionnaire-Core 30; EORTC QLQ-STO22: European Organization for Research and Treatment of Malignancy Quality of Life Questionnaire-gastric cancer module; EOT: end of EOX treatment; EOX: epirubicin, oxaliplatin, and capecitabine; Interval 2: time of cycle 5 of EOX with a windows of 15?days; Interval 4: planned time of the end of EOX treatment with a windows of 15?days); interval 5: from the end of EOX treatment until the last PRO collection; MMRM: mixed model for repeated steps; PPS: per protocol set; ZOL/EOX: zolbetuximab 800/600?mg/m2 plus EOX Response shift Response shift was assessed at the single item level. included 143 (ZOL/EOX: 69; EOX: 74) patients. Baseline QLQ-C30 and STO22 scores were comparable between arms and Rabbit Polyclonal to Claudin 5 (phospho-Tyr217) denoted intermediate-to-high quality of life (QoL), intermediate-to-low global health status (GHS) and low symptom burden. Descriptive analyses showed no differences between arms until end of EOX but maintenance therapy with zolbetuximab was associated with better QoL and less symptom burden thereafter. TTD for most scores favored ZOL/EOX over EOX and reached statistical significance for GHS ((%)?Female26 (38)25 (34)?Male42 (62)49 PD 198306 (66)ECOG, (%)?023 (34)24 (32)?145 (66)50 (68)Location of PD 198306 primary tumor, (%)?Esophagus2 (3)3 (4)?GEJ10 (15)12 (16)?Belly56 (82)59 (80)Disease stage, (%)?Locally advanced1 (1.5)4 (5.4) Metastatic67 (98.5)70 (94.6)Metastatic sites, mean (SD)3.12 (1.57)3.14 (1.48)?Liver, (%)25 (36)26 (35)?Lung, (%)13 (19)13 (18)?Lymph node, (%)55 (81)57 (77)Histology at diagnosis, (%)?Diffuse28 (41.2)31 (41.9)?Intestinal25 (36.8)26 (35.1)?Mixed9 (13.0)9 (12.2)?Unknown6 (8.8)8 (10.8)Peritoneal carcinomatosis, (%)17 (25)21 (28)CLDN18.2 expression??70%, n (%)53 (78)54 (73)Previous gastrectomy, (%)21 (27.63)23 (27.38) Open in a separate window Claudin 18 splice variant 2, Eastern Cooperative Oncology Group, epirubicin, oxaliplatin, and capecitabine, gastroesophageal junction, human epidermal growth factor receptor 2, per protocol set, standard deviation, zolbetuximab 800/600?mg/m2 plus EOX A similar proportion of patients completed both devices in the two arms up to cycle 8 of EOX. The proportion of patients who completed the EORTC QLQ-C30 at cycle 8 was 82% in the ZOL/EOX group and 77% in the EOX group. For the EORTC QLQ-STO22, this proportion was 66% and PD 198306 60%, respectively. From the end of the EOX treatment onwards, the proportion of patients completing the questionnaire remained high in the ZOL/EOX arm but markedly decreased in the EOX arm (Table ?(Table2).2). This is consistent with longer progression-free survival with ZOL/EOX arm (7.5?months, 95% CI [5.6C11.3]) than with EOX alone (5.3?months, 95% CI [4.1C7.1]) and PROs being collected until disease progression only [12]. Exposure to the study drug was also longer in the ZOL/EOX arm where patients received a mean quantity of 10.8 cycles of zolbetuximab vs a mean of 5.5 EOX cycles in the EOX arm. Table 2 EORTC QLQ-C30 and EORC QLQ-STO22 completion rates in FAST (PPS) European Organization for Research and Treatment of Malignancy Quality of Life Questionnaire-Core 30, European Business for Research and Treatment of Malignancy Quality of Life Questionnaire-gastric malignancy module, epirubicin, oxaliplatin, and capecitabine, assessment time after end of EOX treatment, per protocol set, zolbetuximab 800/600?mg/m2 plus EOX Baseline mean scores for EORC QLQ-C30 and STO22 were comparable between the two treatment arms (Table ?(Table3).3). In the ZOL/EOX arm, baseline scores suggest intermediate-to-high functioning, with scores ranging between 71.4 for role functioning and 91.3 for the cognitive functioning level, and low symptom burden except for QLQ-C30 fatigue (38.4) and stress (60.7). In the EOX arm, baseline scores also suggest intermediate-to-high functioning, with scores ranging between 68.8 for role functioning and 86.0 for the cognitive PD 198306 functioning level, and low symptom burden except for QLQ-C30 fatigue (43.3) and stress (63.2). In contrast, patients experienced low GHS/QoL with a mean score of 52.1 (range: 0C83.3) with ZOL/EOX and 49.9 (range: 0C91.7) with EOX. Table 3 Baseline imply EORTC QLQ-C30 and EORTC QLQ-STO22 scores (PPS) European Business for Research and Treatment of Malignancy Quality of Life Questionnaire-Core 30, European Organization for Research and Treatment of Malignancy Quality of Life Questionnaire-gastric cancer module, epirubicin, oxaliplatin, and capecitabine, per protocol set, zolbetuximab 800/600?mg/m2 plus EOX Unadjusted change from baseline in HRQoL The unadjusted change from baseline results favored ZOL/EOX over EOX alone for GHS/QoL (Fig.?1a), and physical (Fig.?1b), role, and cognitive functioning. While no clinically meaningful changes from baseline were observed during EOX treatment in any arm, ZOL/EOX led to a marked progressive improvement after the end of EOX treatment vs an initial improvement followed by worsening with EOX. For emotional and social functioning, either no changes or a progressive improvement from baseline was observed for both arms but with improvement being greater with EOX alone. For symptoms, the general pattern was either no switch.