Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

G. Metro, A. Passaro, G. Lo Russo, L. Bonanno, R. Giusti, V. Gregorc, E. Capelletto, O. Martelli, F.L. Cecere, D. Giannarelli, A. Luciani, A. Bearz, A. Tuzi, V. Scotti, G. Tonini, D. Galetta, A. Carta, H. Soto Parra, A. Rebonato, A. MorabitoR. Chiari

Research output: Contribution to journalArticlepeer-review

Abstract

Aim: Ceritinib was evaluated within a compassionate use program of Italian patients. Patients & methods: 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib. Results: Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07). Conclusion: The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome. © 2018 2018 Future Medicine Ltd.
Original languageEnglish
Pages (from-to)353-361
Number of pages9
JournalFuture Oncology
Volume14
Issue number4
DOIs
Publication statusPublished - 2018

Keywords

  • ALK
  • ceritinib
  • non-small-cell lung cancer
  • alanine aminotransferase
  • aspartate aminotransferase
  • creatinine
  • crizotinib
  • gamma glutamyltransferase
  • triacylglycerol lipase
  • anaplastic lymphoma kinase
  • protein kinase inhibitor
  • protein tyrosine kinase
  • pyrazole derivative
  • pyridine derivative
  • pyrimidine derivative
  • sulfone
  • abdominal pain
  • adult
  • advanced cancer
  • aged
  • alanine aminotransferase blood level
  • Article
  • aspartate aminotransferase blood level
  • cancer growth
  • cancer recurrence
  • chronic kidney failure
  • constipation
  • controlled clinical trial
  • controlled study
  • creatinine blood level
  • dehydration
  • diarrhea
  • drug dose reduction
  • drug efficacy
  • drug safety
  • drug tolerability
  • fatigue
  • female
  • gamma glutamyl transferase blood level
  • human
  • hypotension
  • major clinical study
  • male
  • nausea
  • non small cell lung cancer
  • overall survival
  • peripheral edema
  • pneumonia
  • population research
  • priority journal
  • progression free survival
  • rash
  • recommended drug dose
  • recurrent disease
  • side effect
  • treatment outcome
  • treatment response
  • triacylglycerol lipase blood level
  • vomiting
  • antagonists and inhibitors
  • clinical trial
  • compassionate use
  • disease free survival
  • dose response
  • drug effect
  • drug resistance
  • gene rearrangement
  • genetics
  • middle aged
  • mutation
  • pathology
  • very elderly
  • Adult
  • Aged
  • Aged, 80 and over
  • Carcinoma, Non-Small-Cell Lung
  • Compassionate Use Trials
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Drug Resistance, Neoplasm
  • Female
  • Gene Rearrangement
  • Humans
  • Male
  • Middle Aged
  • Mutation
  • Protein Kinase Inhibitors
  • Pyrazoles
  • Pyridines
  • Pyrimidines
  • Receptor Protein-Tyrosine Kinases
  • Sulfones

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