Association of radiological tumor status (TS; progressed vs non-progressed) and QoL has not been systematically explored in randomized clinical trials (RCTs) of gastroesophageal cancers. Furthermore, TS is affected by disease measurability (DM) as defined by RECIST. We explored these factors using data from two phase 3 RCTs of previously treated gastric or GEJ cancer: RAINBOW (ramucirumab + paclitaxel vs placebo + paclitaxel) and REGARD (ramucirumab vs placebo).
Pts completed the EORTC QLQ-C30 at baseline and every 6 weeks (wks) while on therapy. DM was assessed at baseline. Multivariate logistic regression evaluated associations among DM, TS and QoL with covariates of gender, age, ethnicity, geographical regions and performance status (PS). Models explored QoL and TS as dependent variables and were varied by using data from specific timepoints or maximum change.
Of 1020 randomized pts, 97% provided baseline QoL, 53% at Wk 6, and 46% at Wk 12. DM was reported for 1019 (measurable 83%, non-measurable [NMD] 17%). More pts with measurable disease vs NMD were male (73% vs 57%), white (69% vs 55%) and from Europe, North America and Australia (66% vs 49%); no differences were seen for age, PS or ethnicity. Baseline QoL scores were not statistically different between pts with measurable versus NMD even when adjusted by covariates. At Wk 6, NMD predicted worsening in diarrhea (p = .02) and non-progression predicted better role functioning (fxn) (p = .01) and pain (p = .02) especially in NMD pts. At Wk 12, NMD predicted worsening in emotional fxn (p = .03) and dyspnea (p = .01). DM interacted with both emotional and role fxn to predict non-progression (all p
This is the largest RCT dataset exploring DM, TS and QoL in pts with previously treated gastric or GEJ cancer. Although baseline QoL did not differ based on DM, changes in QoL were associated with disease (non-) progression and these changes differed by DM.
Clinical trial identification
Legal entity responsible for the study
Eli Lilly and Company
Eli Lilly and Company
I. Chau: Advisory Board: Sanofi Oncology, Eli-Lilly, Bristol Meyers Squibb, MSD, Merck Serono, Gilead Science. Research funding: Janssen-Cilag, Sanofi Oncology, Roche, Merck-Serono, Novartis. Honoraria: Taiho, Pfizer, Amgen, Eli Lilly, Bayer. S-E. Al-Batran: Advisory role: Merck, Roche, Celgene, Lilly, Nordic Pharma. Speaker: Roche, Celgene, Lilly, Nordic Pharma. Research grants: Merck, Roche, Celgene, Vifor, Medac, Hospira, Lilly. A.M. Liepa, Z. Cui, Y. Hsu, S. Chin: Employee and stock owner. All other authors have declared no conflicts of interest.