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.
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).
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.
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.
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J.B. Kuon: Non-Financial Interests, Institutional, Research Grant: AstraZeneca. All other authors have declared no conflicts of interest.