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.