The addition of bevacizumab (B) to platinum doublets prolongs the survival for non-squamous (NSQ) NSCLC. The role of monotherapy with B is unclear for elderly NSQ NSCLC patients (pts). We presented the comparable efficacy data in a previous meeting. Here, we present the survival and quality of life analyses of TORG1323.
Pts were pathologically diagnosed untreated elderly (≥75 years old) NSQ NSCLC, who were stage IIIB, IV, or recurrent disease, and PS 0-1. EGFR mutation or ALKrearranged pts were allowed after receiving each tyrosine kinase inhibitor. Pts were randomized 1:1 to receiving either docetaxel (D) or pemetrexed (P) with B. The primary endpoint was progression-free survival (PFS) assessed by independent review committee. B was administered 15 mg/kg, D was 50 mg/m2, or P was 500 mg/m2 every 3 weeks until disease progression or unacceptable toxicity based on our previous studies. Selection design was adopted for this study. The planned sample size was 120 pts to yield 80% power to select an optimal regimen correctly and PB is chosen for the further evaluation if the point estimate of hazard ratio (HR) for PFS was ≤1.20.
Enrollment was terminated early at the end of March 2017 because of slow accrual. A total of 103 pts (DB/PB= 51/52 pts) were enrolled and 99 pts (49/50 pts) comprise the full analysis set. Patient characteristics were well balanced between the two arms. Median age was 78 (range: 75-88) in DB and 79 (75-94) in PB. EGFR mutation+/ALK translocation+/wild type/unknown= 13/0/34/2 in DB and 13/2/33/2 in PB. A total of 77 events occurred at data cut-off, which corresponded to 77.7% power. The median PFS of DB and PB were 6.1 months (mo) and 4.6 mo (HR 1.03, 95%C.I. 0.66-1.61: p = 0.901). The median OS of DB and PB were 18.7 mo and 26.6 mo (HR 0.69, 95% C.I. 0.36-1.30; p = 0.2465). The mean change from baseline of Functional Assessment of Cancer Therapy - Lung (FACT-L) total was -8.4 in DB and -2.7 in PB (p = 0.0096).
PB results in less deterioration of QoL. The efficacy is comparable between the two arms for elderly (≥75 years old) advanced NSQ NSCLC.
Clinical trial identification
Legal entity responsible for the study
Thoracic Oncology Research Group.
Chugai Pharmacutical Co., Ltd.
All authors have declared no conflicts of interest.