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. PATIENTS AND 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. CONCLUSION: 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.
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. PATIENTS AND 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. CONCLUSION: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: Alexander Martens; Kilian Wistuba-Hamprecht; Jianda Yuan; Michael A Postow; Phillip Wong; Mariaelena Capone; Gabriele Madonna; Amir Khammari; Bastian Schilling; Antje Sucker; Dirk Schadendorf; Peter Martus; Brigitte Dreno; Paolo A Ascierto; Jedd D Wolchok; Graham Pawelec; Claus Garbe; Benjamin Weide Journal: Clin Cancer Res Date: 2016-05-11 Impact factor: 12.531
Authors: Encouse B Golden; Sandra Demaria; Peter B Schiff; Abraham Chachoua; Silvia C Formenti Journal: Cancer Immunol Res Date: 2013-12 Impact factor: 11.151
Authors: C Brüggemann; M C Kirchberger; S M Goldinger; B Weide; A Konrad; M Erdmann; D Schadendorf; R S Croner; L Krähenbühl; K C Kähler; C Hafner; W Leisgang; F Kiesewetter; R Dummer; G Schuler; M Stürzl; L Heinzerling Journal: J Cancer Res Clin Oncol Date: 2017-06-14 Impact factor: 4.553
Authors: Christopher A Barker; Michael A Postow; Shaheer A Khan; Kathryn Beal; Preeti K Parhar; Yoshiya Yamada; Nancy Y Lee; Jedd D Wolchok Journal: Cancer Immunol Res Date: 2013-07-25 Impact factor: 11.151
Authors: Rafael Carretero; Ibrahim M Sektioglu; Natalio Garbi; Oscar C Salgado; Philipp Beckhove; Günter J Hämmerling Journal: Nat Immunol Date: 2015-04-27 Impact factor: 25.606