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
Menée à l'Institut Gustave-Roussy entre juin 2010 et septembre 2011 auprès de 73 patients atteints d'un mélanome métastatique traité par ipilimumab à titre compassionnel, cette étude évalue la faisabilité de la prise en charge des effets toxiques du traitement
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/mm3 at the start of the second course and an increase in the eosinophil count >100/mm3 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.