Abstract 1021P
Background
Although frail and older pts represent a major fraction of NSCLC pts in routine clinical practice, this population is still underrepresented in clinical trials. The DURATION trial is a prospective, stratified, randomized, multicenter phase II study aiming to provide evidence on first line D after two cycles CTX in this population. Here we report the results for the efficacy endpoints within the first year of follow-up.
Methods
In this trial (NCT03345810), 201 pts diagnosed with stage IV NSCLC and ≥70 years of age and/or Charlson Comorbidity Index > 1 and/or performance status (PS) ECOG ≥ 2 were stratified according to the Cancer and Age Research Group (CARG) score in “fit” (combination CTX, cCTX) for CARG ≤3 and “unfit” (mono CTX, mCTX). After stratification pts were randomized 1:1 to receive 4 cycles of cCTX (n=49) versus 2 cycles of cCTX and D (cCTX-D, n=48) or 4 cycles of mCTX (n=52) versus 2 cycles of mCTX and D (mCTX-D, n=52).
Results
The median age was 76 years (range 56-90), 131 pts (65%) were men, 59 pts (30%) had a PS ECOG ≥2. The PD-L1 expression was 0%, 1-49% and ≥50% in 42%, 51% and 7% of pts, respectively. Compared to the “unfit” group, “fit” pts showed longer progression free survival (PFS, HR 0.54, log-rank p<0.001) and overall survival (OS, HR 0.45, log-rank p<0.001). The 1-year PFS rate was 12% vs. 21% for cCTX and cCTX-D and 3% vs. 12% for mCTX and mCTX-D, while the 1-year OS was 53% vs. 41% for cCTX and cCTX-D and 22% vs. 24% for mCTX and mCTX-D, respectively. The median PFS was 6 and 5 months (mo) for cCTX and cCTX-D (log-rank p= 0.921) and 4 and 3 mo for mCTX and mCTX-D (log-rank p= 0.951), respectively. The median OS was not reached for cCTX and 10 mo for cCTX-D (log-rank p=0.142), while it was 6 and 5 mo for mCTX and mCTX-D (log-rank p=0.995), respectively.
Conclusions
cCTX or mCTX according to risk stratification (CARG score) with two cycles followed by D showed an antitumor activity comparable to those of 4 cycles of standard CT in the frontline treatment of older and/or frail stage IV NSCLC pts. The results of the safety primary endpoint for this trial are pending.
Clinical trial identification
NCT03345810.
Editorial acknowledgement
Legal entity responsible for the study
AIO StudiengGmbH.
Funding
AstraZeneca, BMS.
Disclosure
J.B. Kuon: Non-Financial Interests, Institutional, Research Grant: AstraZeneca. All other authors have declared no conflicts of interest.