title: Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival.
abstract: BACKGROUND
  Ipilimumab is a recently approved immunotherapy that has demonstrated an improvement in the overall survival (OS) of patients with metastatic melanoma. We report a single-institution experience in patients treated in a compassionate-use program.
  
  
  METHODS
  In this prospective study, patients were treated between June 2010 and September 2011. Inclusion criteria were a diagnosis of unresectable stage III or IV melanoma, at least one previous line of chemotherapy, and survival 12 weeks after the first perfusion. Four courses of ipilimumab were administered at a dose of 3 mg/kg every 3 weeks.
  
  
  RESULTS
  Seventy-three patients were included. Median OS was 9.1 months (95% CI 6.4-11.3) from the start of ipilimumab. Immune-related adverse events were observed in 45 patients (62%), including 19 grade 3-4 events (26%). No drug-related death occurred. A lymphocyte count >1000/mm(3) at the start of the second course and an increase in the eosinophil count >100/mm(3) between the first and second infusions were correlated with an improved OS.
  
  
  CONCLUSIONS
  Ipilimumab toxic effect is manageable in real life. Biological data such as lymphocyte and eosinophil counts at the time of the second ipilimumab infusion appear to be early markers associated with better OS.
authors: Dermatology Unit, Institut de Cancérologie Gustave Roussy, Villejuif, France. delyon.julie@gmail.com
authors: J
authors: J
authors: Delyon
authors: C
authors: C
authors: Mateus
authors: D
authors: D
authors: Lefeuvre
authors: E
authors: E
authors: Lanoy
authors: L
authors: L
authors: Zitvogel
authors: N
authors: N
authors: Chaput
authors: S
authors: S
authors: Roy
authors: A M M
authors: AM
authors: Eggermont
authors: E
authors: E
authors: Routier
authors: C
authors: C
authors: Robert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D004804:Eosinophils / Q000187:drug effects / Q000378:metabolism* / Q000473:pathology; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D018655:Lymphocyte Count; D008214:Lymphocytes / Q000187:drug effects / Q000378:metabolism* / Q000473:pathology; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000911:Antibodies, Monoclonal; D000074324:Ipilimumab
keywords: eosinophil count; ipilimumab; lymphocyte count; metastatic melanoma; overall survival; toxic effect