Highlights
- •Evidence on first-line pembrolizumab in Eastern Cooperative Oncology Group performance status (PS) 2 non–small cell lung cancer (NSCLC) (PD-L1 ≥ 50%) are poor.
- •This retrospective study documented dismal outcomes in this population of interest.
- •Patients with disease burden-determined poor PS had poor prognosis.
- •Comorbidity-induced PS 2 may still benefit form pembrolizumab.
- •The differential determinants of PS 2 in NSCLC are relevant for clinical decisions.
Abstract
Background
Pembrolizumab is the first-line standard of care for advanced non–small cell lung
cancer (NSCLC) with a PD-L1 tumour proportion score (TPS) ≥ 50%. Eastern Cooperative
Oncology Group performance status (PS) 2 patients may receive pembrolizumab, despite
the absence of sustaining evidence.
Patients and methods
GOIRC-2018-01 is a multicentre, retrospective, observational study. PS 2 NSCLC patients
with a PD-L1 TPS ≥50% receiving first-line pembrolizumab from June 2017 to December
2018 at 21 Italian institutions were included. Clinical-pathological characteristics
were correlated with disease response and survival outcomes; adverse events were recorded.
The primary objective was 6-months progression-free rate (6-months PFR).
Results
One hundred fifty-three patients (median age 70 years) were enrolled. At a median
follow-up of 18.2 months, median progression-free survival (PFS) and overall survival
(OS) were 2.4 (95% confidence interval, 95% CI, 1.6–2.5) and 3.0 months (95% CI 2.4–3.5),
respectively. 6-months PFR was 27% (95% CI 21–35%). Patients with a PS 2 determined
by comorbidities (n = 41) had significantly better outcomes compared with disease
burden-induced PS 2 (n = 112). Indeed, 6-months PFR was 49% versus 19%, median PFS
5.6 versus 1.8 months and OS 11.8 versus 2.8 months, respectively. Additional potential
prognostic factors (radiotherapy, antibiotics, steroids received before pembrolizumab)
correlated with clinical outcomes. The determinant of PS 2 resulted the only factor
independently impacting on both PFS and OS. No toxicity issues emerged.
Conclusions
Outcomes of PS 2 NSCLC patients with PD-L1 TPS ≥50% receiving first-line pembrolizumab
were globally dismal but strongly dependent on the reason conditioning the poor PS
itself.
Keywords
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Article info
Publication history
Published online: March 25, 2020
Accepted:
February 20,
2020
Received in revised form:
February 20,
2020
Received:
January 12,
2020
Identification
Copyright
© 2020 Elsevier Ltd. All rights reserved.
