Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial

Abstract

Purpose: Effective interventions to improve prognosis in metastatic esophagogastric cancer (EGC) are urgently needed. We assessed the effect of the early integration of interdisciplinary supportive care for patients with metastatic EGC on overall survival (OS).

Patients and methods: An open-label, phase III, randomized, controlled trial was conducted at Peking University Cancer Hospital & Institute. Patients with previously untreated metastatic EGC were enrolled. Patients were randomly assigned (2:1) to either early interdisciplinary supportive care (ESC) integrated into standard oncologic care or standard care (SC). ESC was provided by a team of GI medical oncologists, oncology nurse specialists, dietitians, and psychologists; patients in the SC group received standard oncologic care alone. The primary end point was OS in the intention-to-treat population.

Results: Between April 16, 2015, and December 29, 2017, 328 patients were enrolled: 214 in the ESC group and 114 in the SC group. At the data cutoff date of January 26, 2019, 15 (5%) patients were lost to follow-up. The median number of cycles of first-line chemotherapy was five (interquartile range [IQR], 4-7) in the ESC group and four (IQR, 2-6) in the SC group. The median OS was 14.8 months (95% CI, 13.3 to 16.3) in the ESC group and 11.9 months (95% CI, 9.6 to 13.6) in the SC group (hazard ratio, 0.68; 95% CI, 0.51 to 0.9; P = .021).

Conclusion: The early integration of interdisciplinary supportive care is an effective intervention with survival benefits for patients with metastatic EGC. Further optimization and standardization are warranted.

Trial registration: ClinicalTrials.gov NCT02375997.

Figures

FIG 1.

Trial profile.

FIG 2.

Kaplan-Meier analyses of survival. (A) OS. (B) PFS. ESC, early interdisciplinary supportive care; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; SC, standard care.

FIG 3.

HRs and 95% CIs for overall survival by subgroup. The forest plot shows the HRs and the corresponding 95% CIs for ESC compared with SC. HRs were calculated using the unstratified Cox proportional hazard model. ECOG, Eastern Cooperative Oncology Group; ESC, early interdisciplinary supportive care; HR, hazard ratio; SC, standard care.

FIG 4.

Mean quality-of-life scores at baseline and week 9 in the SC group and the ESC group. QoL (EORTC QLQ-C30) was analyzed in the per protocol population. Bars represent the mean scores on the EORTC QLQ-C30 at baseline (blue) and week 9 (red) for both the SC group and the early supportive care group. The error bar represents SE. For the global health status and functioning scales, higher scores denoted improved function; for symptom scales and single items, higher scores denoted worse symptoms. The effect of ESC on QoL outcomes was assessed by multivariate regression with adjustment for baseline QoL scores. The adjusted effect of ESC was significant for emotional functioning (5.87; 95% CI, 0.05 to 11.69; P = .048) and cognitive functioning (5.77; 95% CI, 0.28 to 11.25; P = .039). EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30; ESC, early interdisciplinary supportive care; QoL, quality of life; SC, standard care.

FIG A1.

Early interdisciplinary supportive care team workflow. DT, distress thermometer; EORTC-QLQ-C30, European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30; NRS 2002, Nutritional Risk Screening 2002; PHQ-9, Patient Health Questionnaire-9; PG-SGA, Patient-Generated Subjective Global Assessment.

FIG A2.

Boxplots for NRS 2002 and PG-SGA scale scores at baseline and week 9 in the ESC group. NRS 2002 and PG-SGA scales were analyzed at baseline (blue) and week 9 (red) in the early supportive care group. Boxplots for the NRS2002 and PG-SGA scales display the total range, interquartile range (box) and median (line). Significant improvements were observed in the mean score from baseline to week 9 in NRS 2002 (1.61, 95% CI, 1.45 to 1.78, v 0.73, 95% CI, 0.54 to 0.91, P < .001) and PG-SGA (7.55, 95% CI, 6.95 to 8.15, v 3.40, 95% CI, 2.90 to 3.90, P < .001). NRS 2002, Nutritional Risk Screening 2002; PG-SGA, Patient-Generated Subjective Global Assessment.

FIG A3.

Boxplots for DT, HADS-Anxiety, HADS-Depression, and PHQ-9 scales at baseline and week 9 in the ESC group. DT, HADS-A, HADS-D and PHQ-9 scales were analyzed at baseline (blue) and week 9 (red) in the early supportive care group. Boxplots for the DT, HADS-A, HADS-D and PHQ-9 scales display the total range, interquartile range (box) and median (line). Significant improvements were observed in the mean score from baseline to week 9 in DT (3.22, 95% CI, 2.91 to 3.52, v 2.28, 95% CI, 1.98 to 2.58, P < .001), HADS-Anxiety (3.54, 95% CI, 3.01 to 4.08, v 2.26, 95% CI, 1.77 to 2.75, P < .001), HADS-Depression (3.92, 95% CI, 3.35 to 4.49, v 2.67, 95% CI, 2.13 to 3.20, P < .001), and PHQ-9 (4.05, 95% CI, 3.51 to 4.59, v 2.73, 95% CI, 2.24 to 3.22, P < .001). DT, Distress Thermometer; HADS-A, Hospital Anxiety and Depression Scale-anxiety; HADS-D, Hospital Anxiety and Depression Scale-depression; PHQ-9, Patient Health Questionnaire-9.

FIG A4.

Proportion of weight change in patients from baseline to week 6, week 9, and week 12 in the SC group and the ESC group. Bars represent the percentage of patients with decreased (blue) or increased (red) weight compared with baseline. ESC, early supportive care; SC, standard care.