Quality of life (QoL) as a prognostic factor for survival in previously treated advanced gastric or gastroesophageal junction (GEJ) cancer: Analysis of pooled data from two phase 3 studies (REGARD and RAINBOW)

Material and Methods: Pts in both trials completed the EORTC QLQ-C30 (v3) at baseline. For this analysis, all 15 QoL scales were evaluated, along with 12 baseline clinical characteristics and lab parameters that had been previously identified as independent prognostic factors for OS in this pooled dataset. QoL scales were scored 0–100 and dichotomized by median values (or 0 vs >0 if median=0). To identify QoL prognostic factors, univariate Cox models were first used to select covariates with p≤0.05. For these QoL factors, a multivariate Cox model was used for stepwise selection with entry and exit p=0.01; previously selected 12 factors had forced inclusion in the model. Once QoL factors were selected, the model was refitted to include only selected factors, to avoid exclusion of pts with missing data in unselected variables who were included in the selection pool. Also, a model with entry and exit p=0.05 was explored. All models were stratified by treatment and geographic region.

Results: Of 1020 pts, 927 (91%) were included in the final Cox regression, after excluding pts with missing covariate values. In univariate analyses, 13 QoL factors had p≤0.05. In the multivariate analysis using entry and exit p=0.01, only one QoL factor (ie. appetite loss) was selected, along with all the previously identified factors.

The multivariate analysis using entry and exit p=0.05 also selected nausea/vomiting, with scores >0 as a poor prognostic factor.

Conclusions: In addition to clinical characteristics and lab parameters, baseline pt-reported appetite loss was independently prognostic for OS for previously treated advanced gastric/GEJ cancer. This symptom had more prognostic value than pt-reported functioning domains including global health status.

Conflict of interest: Ownership: Hsu: Lilly (ownership/stock) Liepa: Lilly (ownership/stock) Chandrawansa: Lilly (ownership/stock) Emig: Lilly (ownership/stock) Ferry: Lilly (ownership/stock). Advisory Board: Chau: Sanofi Oncology, Lilly, Bristol Meyers Squibb, Merck Serono, Gilead Science, Bayer Fuchs: Eli Lilly, Genentech, Sanofi, Pfizer, Bristol Myers Squibb, Merck, Amegn, Entrinsic Health, Bayer, Medimmune, Celgene, Gilead, Macrogenics, Acceleron Tomase: Roche, Amgen, Lilly Ferry: Sanofi, Roche, Lilly Wilke: Lilly Al-Batran: Lilly. Corporate-sponsored Research: Chau: Novartis, Roche, Merck-Serono (grant to institution) Muro: Lilly, BMS, Merck Tomasek: Amgen, Novartis, Lilly Van Cutsem: Lilly Shimada: Lilly Japan Ferry: Roche, Sanofi, Astra-Zeneca.