Using health-related quality of life (QL) parameters as primary endpoints in a multinational prospective NSCLC chemotherapy (chemo) trial: The Asia-Pacific QL trial

8086 Background: Survival and QL improvements are major goals in treating advanced NSCLC. Enhancing survival for all treated patients (pts) with advanced NSCLC beyond that achieved with 3rd generation chemo regimens is difficult in this highly symptomatic cancer; questions remain as to the impact of chemo on QL and symptoms (“PROs” or patient reported outcomes). This study was designed to: 1) evaluate the impact of chemo on QL and symptoms for all pts, 2) evaluate QL by response category (CR+PR = MR or major response, stable disease = SD, and progression); and 3) test whether barriers in QL evaluation are overcome by using a computer-assisted validated instrument (LCSS-QL). Methods: All pts received initial docetaxel-based chemo (83% with cisplatin or carboplatin) based on known response and survival results (Fossella JCO 2003) and were assessed every 3 weeks with the LCSS-QL. Results: 300 pts are entered and 243 evaluated; 91% have repeated QL measures through 3 cycles of chemo in this ongoing trial. Demographics: 77% Stage IV; 72% men; 67% adenocarcinoma; median age 58; KPS 90–100 = 66%, 70–80 = 34%. A 37% MR rate was achieved. QL feasibility: high patient and staff acceptability found (at 43 sites, 8 countries). For the whole group (using 5% as a minimally important difference), after 3 chemo cycles all 9 LCSS parameters were stable, except overall QL and cough (> 5% and 7% improvements). Evaluating PROs by chemo response: in all parameters after completion of only 2 chemo cycles, pts with MR had better symptom control than pts with progression (p<0.05 in 4 of the 6 major symptoms after cycle 3). Total LCSS-QL score was better for pts with MR (p=.007) or SD (p=.03) compared with progressive NSCLC. Conclusions: For docetaxel-based chemo: 1) MR is associated with better symptom control and total QL than SD or progression; 2) even with only a minority (37%) having a major response, QL and PRO parameters are stable or better for the whole group by key decision points of 2 and 3 chemo cycles; 3) with 91% compliance with the computer-assisted LCSS-QL, evaluation of QL in multiple centers is achievable during chemo trials. This study demonstrates that QL and PRO evaluation is feasible and should influence chemotherapy treatment decisions. [Table: see text]