First-line pembrolizumab in advanced non–small cell lung cancer patients with poor performance status

F. Facchinetti, G. Mazzaschi, F. Barbieri, F. Passiglia, F. Mazzoni, R. Berardi, C. Proto, F.L. Cecere, S. Pilotto, V. Scotti, S. Rossi, A. Del Conte, E. Vita, C. Bennati, A. Ardizzoni, G. Cerea, M.R. Migliorino, E. Sala, A. Camerini, A. BearzE. De Carlo, F. Zanelli, G. Guaitoli, M.C. Garassino, L.P. Ciccone, G. Sartori, L. Toschi, F.G. Dall'Olio, L. Landi, E.G. Pizzutilo, G. Bartoli, C. Baldessari, S. Novello, E. Bria, D.L. Cortinovis, G. Rossi, A. Rossi, G.L. Banna, R. Camisa, M. Di Maio, M. Tiseo

Research output: Contribution to journalArticlepeer-review

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. © 2020 Elsevier Ltd
Original languageEnglish
Pages (from-to)155-167
Number of pages13
JournalEur. J. Cancer
Volume130
DOIs
Publication statusPublished - 2020

Keywords

  • ECOG PS 2
  • Immune checkpoint inhibitors
  • Immunotherapy
  • NSCLC
  • PD-1
  • aminotransferase
  • antibiotic agent
  • antineoplastic metal complex
  • pembrolizumab
  • prednisone
  • steroid
  • monoclonal antibody
  • programmed death 1 receptor
  • adult
  • advanced cancer
  • aged
  • Article
  • cancer chemotherapy
  • cancer immunotherapy
  • cancer patient
  • cancer prognosis
  • cancer radiotherapy
  • cancer survival
  • clinical outcome
  • cohort analysis
  • colitis
  • comorbidity
  • comparative study
  • correlation coefficient
  • disease burden
  • disease course
  • drug efficacy
  • drug fatality
  • drug safety
  • female
  • flu like syndrome
  • follow up
  • functional status
  • human
  • immunotoxicity
  • infusion related reaction
  • loss of appetite
  • lung toxicity
  • major clinical study
  • male
  • median survival time
  • myocarditis
  • non small cell lung cancer
  • observational study
  • overall survival
  • paraneoplastic neuropathy
  • priority journal
  • progression free survival
  • retrospective study
  • side effect
  • skin toxicity
  • steroid therapy
  • survival analysis
  • survival rate
  • thyroid disease
  • treatment response
  • lung tumor
  • Aged
  • Antibodies, Monoclonal, Humanized
  • Carcinoma, Non-Small-Cell Lung
  • Female
  • Humans
  • Lung Neoplasms
  • Male
  • Programmed Cell Death 1 Receptor
  • Retrospective Studies

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