Anti-PD1 antibodies in patients aged ≥ 75 years with metastatic melanoma: A retrospective multicentre study: Journal of Geriatric Oncology

L. Ridolfi, F. De Rosa, E. Petracci, E.T. Tanda, E. Marra, J. Pigozzo, R. Marconcini, M. Guida, G.C.A. Cappellini, G. Gallizzi, M. Occelli, L. Pala, E. Gambale, M. Bersanelli, G. Galdo, A. Cortellini, F. Morgese, F. Zoratto, L.S. Stucci, S. StrippoliM. Guidoboni, On behalf of the Italian Melanoma Intergroup (IMI)

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Advanced age is associated with comorbidities and immune system impairment, which may influence the efficacy and tolerability of immune checkpoint inhibitors. There is evidence that anti-PD1 antibodies in advanced melanoma are equally effective in patients >65 years. However, data on patients >75 years are lacking as co-morbidities and logistics often exclude them from clinical trials. Methods: We retrospectively reviewed the clinical records of older patients with advanced melanoma undergoing any-line treatment with an anti-PD1 (nivolumab/pembrolizumab) to investigate its clinical effectiveness and toxicity in a real-life setting. Clinical response was assessed using RECIST criteria and toxicity was evaluated according to CTCAE 4.0. Progression-free survival (PFS) and overall survival (OS) were estimated with the Kaplan-Meier method and the Cox model was used to assess potential prognostic factors. Results: 174 patients were considered; 59.2% males, median age 79 years (range 75–93). The majority had a performance status of 0 and normal lactate dehydrogenase (LDH) levels (55.2% and 52.4%, respectively). 69.1% had multiple co-morbidities. 56.9% received nivolumab. 36.7% of cases showed an objective response and the disease control rate was 56.3%. Median OS was 17.2 months [95% CI: 8.87-not reached] and a better prognosis was observed for patients with normal LDH (p <.001) and lower performance status (p <.001). Treatment was well tolerated, only 11 patients experiencing severe (grade 3/4) toxicity. There were no treatment-related deaths. Adverse events were managed with corticosteroids and additional immunosuppressive agents were unnecessary. Conclusions: Anti-PD1 antibodies appear effective and well tolerated in older patients with advanced melanoma. © 2020 Elsevier Inc.
Original languageEnglish
Pages (from-to)515-522
Number of pages8
JournalJ. Geriatr. Oncol.
Volume11
Issue number3
DOIs
Publication statusPublished - 2020

Keywords

  • Aging
  • Drug effects
  • Immunosenescence
  • Immunotherapy
  • Melanoma
  • Older patients
  • B Raf kinase
  • corticosteroid
  • lactate dehydrogenase
  • nivolumab
  • pembrolizumab
  • prednisone
  • Ras protein
  • aged
  • aging
  • anxiety
  • Article
  • BRAF gene
  • brain toxicity
  • cancer prognosis
  • chronic obstructive lung disease
  • comorbidity
  • comparative study
  • controlled study
  • death
  • diabetes mellitus
  • disease classification
  • drug cost
  • drug efficacy
  • drug safety
  • drug tolerability
  • exploratory research
  • female
  • follow up
  • gastrointestinal toxicity
  • gene mutation
  • health status
  • heart failure
  • human
  • hypertension
  • hypophysitis
  • information processing
  • Italian (citizen)
  • Kaplan Meier method
  • kidney failure
  • liver failure
  • liver toxicity
  • lung toxicity
  • major clinical study
  • male
  • medical record
  • melanoma
  • metastatic melanoma
  • multicenter study
  • multivariate analysis
  • mutational analysis
  • nephrotoxicity
  • oncogene
  • oncogene ras
  • overall survival
  • prevalence
  • priority journal
  • progression free survival
  • proportional hazards model
  • retrospective study
  • skin disease
  • thyroiditis
  • treatment duration
  • treatment response
  • vascular disease
  • very elderly

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