Session Item

Sunday
August 29
16:45 - 17:45
Room 1
Proffered papers 25: Upper GI
Karin Haustermans, Belgium;
Thomas Brunner, Austria
1770
Proffered papers
Clinical
16:55 - 17:05
Quality of life associated with survival in gastric cancer patients: Results from the CRITICS trial
Romy van Amelsfoort, The Netherlands
OC-0412

Abstract

Quality of life associated with survival in gastric cancer patients: Results from the CRITICS trial
Authors:

Romy van Amelsfoort1

1Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands

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Purpose or Objective

The evaluation of health-related quality of life (HRQOL) in clinical trials has become increasingly important, since it addresses the impact of treatment from the patient’s perspective. In the multicenter randomized CRITICS trial no significant differences in overall survival (OS) and event-free survival (EFS) were found between postoperative chemotherapy (CT) and chemoradiotherapy (CRT) after neo-adjuvant chemotherapy and D2 gastric cancer surgery (intention-to-treat). The primary aim of this study was to investigate the potential prognostic value of pretreatment HRQOL on EFS and OS in the CRITICS trial.  

Material and Methods

Patients in the CRITICS trial were asked to complete HRQOL questionnaires (EORTC QLQ-C30) at baseline, after preoperative chemotherapy, after surgery, after postoperative CT or CRT and at 12 months follow-up. The 30-item EORTC QLQ-C30 questionnaire consists of five multi-item function scales (physical, role, cognitive, emotional, and social functioning), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), six single-item symptom scales (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial impact), and a two-item global quality of life scale. Thresholds for clinical importance by Giesinger et al. were used to identify specific domains of the QLQ-C30 questionnaire with problems or symptoms of clinical importance. To determine baseline characteristics associated with EFS and OS, a multivariate Cox proportional hazards analyses was constructed using a backward selection procedure, including baseline characteristics (age, sex, WHO performance score, Lauren classification) and the different QLQ-C30 domains. 

Results

Baseline characteristics of patients who completed the baseline questionnaire (301 (77%) patients in the CT group and 298 (75%) patients in the CRT group) were well balanced between treatment arms. At baseline, the HRQOL questionnaire scores did not significantly differ between treatment arms, therefore further analyses were performed for the entire study population. At baseline, worse social functioning (HR 2.20, 95% CI 1.36-3.55, p = 0.001), nausea (HR 1.89, 95% CI 1.39-2.56, p < 0.001), worse WHO performance status (HR 1.55, 95% CI 1.13-2.13, p = 0.007) and Lauren classification (diffuse compared to intestinal HR 1.94, 95% CI 1.42-2.67, p <0.001; mixed compared to intestinal HR 2.35, 95% CI 1.35-4.12, p = 0.003) were significantly associated with worse EFS and OS.

Conclusion

In the CRITICS trial, HRQOL scales at baseline were significantly associated with worse (event-free and overall) survival in gastric cancer patients. Pretreatment HRQOL can therefore play an important role in clinical decision-making and in shaping the patient’s expectations of treatment efficacy. In addition, it can be of importance in individual risk stratification and tailored supportive care.